All Adverse Reactions with Strattera as Primary Suspect Drug
culled from MedWatch Individual Safety Reports (ISRs) submitted to the FDA between January 2004 and December 2010

Serious Adverse Reactions, Outcomes and Reporting Violations are highlighted in red.

Reported By Codes: CN = Consumer; LW = Lawyer; MD = Medical Doctor; OT = Other Healthcare Professional; PH = Pharmacist; Blank = Not Reported
Report Type Codes: DIRect to FDA; EXPedited report from Manufacturer to FDA; PERiodic report from Manufacturer to FDA

Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
3894364 4331186 10 Years M 4/23/2002 3/16/2004 3/31/2004 15 OT EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Blood Glucose Increased, Blood Ketone Body Present, Diabetes Mellitus Inadequate Control, Diarrhoea, Large Intestinal Haemorrhage, Pyrexia, Vomiting Hospitalization - Initial or Prolonged
3894364 4781624 10 Years M 4/23/2002 9/8/2005 9/27/2005 19 OT EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Blood Bicarbonate Decreased, Blood Glucose Increased, Blood Sodium Decreased, Dehydration, Diabetes Mellitus Inadequate Control, Gastroenteritis, Hypoglycaemia, Ketoacidosis, Otitis Media, Viral Infection Hospitalization - Initial or Prolonged
3894364 4804891 10 Years M 4/23/2002 9/26/2005 10/17/2005 21 OT EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Blood Bicarbonate Decreased, Blood Sodium Decreased, Body Temperature Increased, Dehydration, Diabetes Mellitus Inadequate Control, Diarrhoea, Gastroenteritis, Gastrointestinal Haemorrhage, Ketoacidosis, Malaise, Nausea, Otitis Media, Social Problem, Viral Infection, Vomiting Hospitalization - Initial or Prolonged
3915409 4401982 22 Years M 2/14/2003 2/24/2003 7/14/2004 506 MD EXP Strattera Convulsion, Multiple Drug Overdose Intentional Hospitalization - Initial or Prolonged
3927393 4401978 8 Years M 1/16/2003 6/30/2004 7/14/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aspartate Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Body Temperature Increased, Drug Hypersensitivity, Headache, Hepatic Enzyme Increased, Pain, Pain in Extremity Hospitalization - Initial or Prolonged
3927714 4381473 15 Years M 3/1/2003 5/28/2004 6/16/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Overdose Hospitalization - Initial or Prolonged
3938132 4440506 7 Years M 3/1/2004 7/28/2004 149 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Psychomotor Hyperactivity, Somnolence
3938194 4296909 8 Years M 9/17/2003 1/26/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Disturbance in Attention, Eye Swelling, Mood Swings, Weight Decreased
3938280 4296910 6 Years F 10/20/2003 1/26/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Hypokinesia, Somnolence
3940044 4580196 12 Years F 1/1/2003 11/1/2004 1/27/2005 87 CN PER Strattera Drug Ineffective, Fatigue, Feeling Abnormal, Headache, Somnolence, Stomach Discomfort
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
3940095 4580194 4 Years F 1/17/2003 8/23/2004 1/27/2005 157 CN PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Impulsive Behaviour
3940171 4726688 9 Years M 1/10/2003 3/14/2005 7/25/2005 133 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort, Abnormal Behaviour, Anxiety, Attention Deficit Hyperactivity Disorder, Attention-Seeking Behaviour, Constipation, Disturbance in Attention, Dysphonia, Eructation
3940206 4296900 13 Years M 11/12/2003 11/13/2003 1/26/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder, Impulsive Behaviour Chest Pain, Disturbance in Attention, Drug Ineffective, Impulsive Behaviour, Nausea, Oesophageal Pain, Somnolence, Throat Irritation
3940773 4296906 15 Years M 1/1/2003 10/6/2003 1/26/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Cystitis, Dizziness, Dyspnoea Exertional, Fatigue, Hearing Impaired, Irritability, Rash
3940773 4349673 15 Years M 1/1/2003 2/11/2004 3/29/2004 47 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Cystitis, Decreased Appetite, Dizziness, Dyspnoea Exertional, Educational Problem, Expressive Language Disorder, Fatigue, Hearing Impaired, Irritability, Memory Impairment, Rash, Self Esteem Decreased, Weight Decreased
3940778 4296907 11 Years F 1/25/2003 10/6/2003 1/26/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Daydreaming, Decreased Appetite, Depressed Mood, Depression, Disturbance in Attention, Feeling Abnormal, Irritability, Memory Impairment, Vomiting
3940778 4349675 11 Years F 1/25/2003 2/11/2004 3/29/2004 47 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Daydreaming, Decreased Appetite, Depressed Mood, Depression, Disturbance in Attention, Fatigue, Feeling Abnormal, Irritability, Memory Impairment, Somnolence, Vomiting
3941222 4349672 8 Years M 1/25/2003 12/17/2003 3/29/2004 103 PER Strattera Anorexia, Asthenia, Fluid Intake Reduced, Restlessness
3941288 4401973 10 Years M 1/1/2003 7/1/2004 7/14/2004 13 PH EXP Strattera Impulsive Behaviour Abnormal Behaviour, Erythema, Feeling Hot, Jaundice Other
3941288 4493305 10 Years M 1/1/2003 10/25/2004 11/2/2004 8 PH EXP Strattera Impulsive Behaviour Abnormal Behaviour, Erythema, Hormone Level Abnormal, Puberty, Skin Warm
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
3954800 4457404 11 Years M 9/7/2004 9/22/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Disturbance in Attention, Grandiosity, Homicidal Ideation, Impulsive Behaviour, Insomnia, Irritability, Mania, Nausea, Oppositional Defiant Disorder, Physical Assault, Psychomotor Hyperactivity, Screaming Hospitalization - Initial or Prolonged
3957615 4401981 7 Years F 5/15/2003 7/14/2004 426 MD EXP Strattera Convulsion Other
3962353 4386852 19 Years M 6/4/2004 6/23/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Agitation, Alanine Aminotransferase Increased, Alcohol Use, Aspartate Aminotransferase Increased, Cardiac Murmur, Depressed Level of Consciousness, Drug Screen Positive, Electrocardiogram QT Corrected Interval Prolonged, Excoriation, Haematocrit Decreased, Hallucination (Auditory), Hallucination (Visual), Head Banging, Heart Rate Increased, Intentional Self-Injury, Laceration, Multiple Drug Overdose, Mydriasis, Neurological Examination Abnormal, Respiratory Rate Increased, Scratch, Self Injurious Behaviour, Somnolence, Suicidal Ideation, Suicide Attempt, Vomiting, White Blood Cell Count Decreased Hospitalization - Initial or Prolonged
3966975 4401984 27 Years M 6/18/2003 7/14/2004 392 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion Other
3970831 4501064 16 Years M 6/12/2003 6/16/2003 10/27/2004 11/9/2004 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Acute Respiratory Distress Syndrome, Blood Amylase Increased, Cardiac Arrest, Congestive Cardiomyopathy, Dehydration, Dyspnoea, Epistaxis, Headache, Insomnia, Lipase Increased, Listless, Nausea, Pericardial Effusion, Syncope, Vomiting Death, Hospitalization - Initial or Prolonged, Other
3973374 4296858 19 Years F 2/17/2003 10/2/2003 1/26/2004 116 PER Strattera Insomnia, Psychomotor Hyperactivity, Tic
3981137 4296872 9 Years F 4/17/2003 9/12/2003 1/26/2004 136 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Disturbance in Attention, Fatigue, Feeling Abnormal, Psychomotor Hyperactivity, Retching, Vomiting
3981137 4440510 8 Years F 4/17/2003 3/11/2004 7/28/2004 139 CN PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Constipation, Crying, Depressed Mood, Disturbance in Attention, Fatigue, Feeling Abnormal, Obsessive Thoughts, Psychomotor Hyperactivity, Retching, Vomiting
3981137 4501259 8 Years F 4/17/2003 7/22/2004 9/27/2004 67 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Constipation, Crying, Depressed Mood, Disturbance in Attention, Epistaxis, Fatigue, Feeling Abnormal, Obsessive Thoughts, Psychomotor Hyperactivity, Retching, Vomiting
3981137 4580207 10 Years F 1/1/2004 10/12/2004 1/27/2005 107 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Constipation, Crying, Decreased Appetite, Depressed Mood, Disturbance in Attention, Drug Ineffective, Epistaxis, Fatigue, Feeling Abnormal, Obsessive Thoughts, Psychomotor Hyperactivity, Retching, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
3981162 4349685 4 Years M 4/19/2003 2/18/2004 3/29/2004 40 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fear, Retching
3982017 4501257 51 Years F 3/22/2003 7/20/2004 9/27/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Drug Ineffective, Dysuria, Insomnia, Urine Output Decreased, Visual Disturbance
3984013 4401980 12 Years M 4/9/2003 7/14/2004 462 MD EXP Strattera Electrocardiogram QT Corrected Interval Prolonged Other
3984250 4296866 6 Years M 3/1/2003 10/10/2003 1/26/2004 108 PER Strattera Attention Deficit/Hyperactivity Disorder Haematochezia, Mydriasis
3992838 4401853 19 Years F 4/1/2003 4/17/2003 7/14/2004 454 MD EXP Strattera Aggression, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Circadian Rhythm Sleep Disorder, Fungal Infection, Head Banging, Lipase Increased, Pyrexia, Self Injurious Behaviour Hospitalization - Initial or Prolonged
3992838 4501090 19 Years F 4/1/2003 10/26/2004 11/9/2004 14 MD EXP Strattera Abnormal Behaviour, Aggression, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Candidiasis, Head Banging, Insomnia, Lipase Increased, Patient Restraint, Pyrexia, Self Injurious Behaviour, Stress Symptoms Hospitalization - Initial or Prolonged
3996464 4401975 13 Years M 3/1/2003 6/30/2004 7/14/2004 14 MD EXP Strattera Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Decreased Appetite, Fatigue, Mydriasis, Ocular Icterus, Somnolence Other
3997636 4296836 11 Years M 1/1/2003 11/26/2003 1/26/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Crying, Depressed Mood, Depression, Tremor
3997636 4349686 11 Years M 1/1/2003 11/26/2003 3/29/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Crying, Depressed Mood, Depression, Tremor
4011255 4296913 50 Years M 2/1/2003 10/7/2003 1/26/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Irritability, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4011257 4296915 13 Years F 10/21/2003 1/26/2004 97 MD PER Strattera Attention Deficit/Hyperactivity Disorder Trichotillomania
4016853 4412804 11 Years M 7/8/2004 7/27/2004 19 MD EXP Strattera Alanine Aminotransferase Increased, Nausea
4016853 4517492 5 Years M 3/1/2003 11/18/2004 11/30/2004 12 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Fatigue, Lethargy, Nausea, Viral Infection
4016853 4572193 5 Years M 3/1/2003 1/11/2005 2/2/2005 22 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Fatigue, Lethargy, Nausea, Viral Infection
4017787 4315347 14 Years M 8/29/2003 2/25/2004 3/9/2004 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Cholecystectomy, Pancreatitis Acute Hospitalization - Initial or Prolonged, Other
4024358 4373140 9 Years F 9/24/2003 5/19/2004 6/3/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Atrioventricular Block, Blood Pressure Decreased, Cardiac Murmur, Coma, Contusion, Head Injury, Headache, Heart Rate Decreased, Pallor, Somnolence, Syncope Vasovagal Hospitalization - Initial or Prolonged, Other
4024360 4373143 17 Years M 5/17/2004 6/3/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion, Loss of Consciousness Hospitalization - Initial or Prolonged, Other
4024364 4361155 13 Years M 3/1/2003 10/13/2003 5/11/2004 211 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drooling, Gait Disturbance, Hallucination (Auditory), Homicidal Ideation, Pain, Posture Abnormal, Psychomotor Hyperactivity, Psychotic Disorder, Screaming, Social Avoidant Behaviour, Somnolence Hospitalization - Initial or Prolonged
4024371 4444654 17 Years M 9/1/2003 8/18/2004 9/2/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Arthralgia, Aspartate Aminotransferase Increased, Gamma-Glutamyltransferase Increased, Viral Infection Other
4024371 4518002 17 Years M 9/1/2003 11/16/2004 11/30/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Arthralgia, Hepatitis Infectious Mononucleosis, Viral Infection Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4024371 4545554 17 Years M 9/1/2003 12/14/2004 1/3/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Antinuclear Antibody Positive, Arthralgia, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Gamma-Glutamyltransferase Increased, Infectious Mononucleosis Other
4024378 4315348 8 Years M 2/24/2004 3/9/2004 14 MD EXP Strattera Psychomotor Hyperactivity Abasia, Abnormal Behaviour, Aggression, Asthenia, Cerebrovascular Accident, Convulsion, Hemiparesis, Regressive Behaviour, Speech Disorder, Staring Hospitalization - Initial or Prolonged
4026981 4296884 50 Years M 10/8/2003 1/26/2004 110 MD PER Strattera Feeling Abnormal, Pain, Sedation
4028029 4531403 37 Years F 10/14/2003 11/29/2004 12/16/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Decreased, Blood Pressure Decreased, Loss of Consciousness, Sleep Apnoea Syndrome Hospitalization - Initial or Prolonged
4028155 4367694 13 Years M 3/1/2003 10/15/2003 5/26/2004 224 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Psychomotor Hyperactivity, Weight Increased Hospitalization - Initial or Prolonged
4028881 4296868 14 Years M 3/25/2003 9/3/2003 1/26/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Hypothyroidism, Irritability, Rash
4028932 4349681 9 Years F 3/1/2003 1/26/2004 3/29/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Headache, Increased Appetite, Insomnia, Weight Increased
4032520 4296876 8 Years F 4/1/2003 11/17/2003 1/26/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Blood Cortisol Decreased, Cushing's Syndrome, Cushingoid, Dizziness, Drug Interaction, Insomnia, Muscle Cramp, Nausea, Skin Discolouration
4032598 4296834 7 Years M 9/3/2003 1/26/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Eye Disorder, Fatigue, Injury, Irritability, Psychomotor Hyperactivity, Weight Decreased
4034110 4474077 9 Years M 9/17/2004 10/8/2004 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Decreased Appetite, Drug Interaction, Drug Toxicity, Dyskinesia, Fear, Hallucination (Visual), Insomnia, Speech Disorder Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4034111 4315349 5 Years M 10/1/2003 2/23/2004 3/9/2004 15 MD EXP Strattera Tic Electroencephalogram Abnormal, Grand Mal Convulsion Other
4034112 4474075 18 Years F 9/17/2004 10/8/2004 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Dyskinesia, Heart Rate Increased Hospitalization - Initial or Prolonged
4034162 4440508 40 Years M 3/9/2003 4/14/2004 7/28/2004 105 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Decreased Appetite, Dysuria, Feeling Jittery, Micturition Urgency, Testicular Pain, Tremor, Urinary Tract Disorder
4035571 4349676 5 Years M 2/24/2003 1/9/2004 3/29/2004 80 PER Strattera Attention Deficit/Hyperactivity Disorder, Autism Fatigue, Nausea, Platelet Count Decreased, Somnolence, White Blood Cell Count Decreased
4035571 4501254 5 Years M 2/24/2003 6/22/2004 9/27/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Fatigue, Nausea, Platelet Count Decreased, Psychomotor Hyperactivity, Somnolence, Stomach Discomfort, White Blood Cell Count Decreased
4037231 4349679 7 Years F 1/22/2004 3/29/2004 67 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Chest Discomfort, Crying, Decreased Appetite, Dyspepsia, Headache, Middle Insomnia, Mood Swings, Rash Pruritic, Somnolence, Weight Decreased
4038443 4637498 59 Years F 12/8/2004 3/28/2005 110 PER Strattera Blood Pressure Increased, Emotional Distress, Fatigue
4041277 4356760 12 Years M 11/4/2003 11/4/2003 4/15/2004 5/7/2004 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Uric Acid Increased, Cardiomegaly, Granulocyte Count Decreased, Lymphocyte Count Decreased, Myocarditis, Nausea, Upper Respiratory Tract Infection, Viral Infection, White Blood Cell Count Increased Death
4041277 4368795 12 Years M 11/4/2003 11/4/2003 5/11/2004 5/27/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Atelectasis, Blood Bilirubin Increased, Blood Lactate Dehydrogenase Increased, Blood Urea Increased, Blood Uric Acid Increased, Cardiomegaly, Dilatation Ventricular, Foaming at Mouth, Intracardiac Thrombus, Nausea, Pulmonary Oedema, Upper Respiratory Tract Infection, Viral Myocarditis Death
4041450 4356761 16 Years M 11/9/2003 4/19/2004 5/7/2004 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Loss of Consciousness, Opisthotonus, Respiratory Rate Decreased, Syncope Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4042209 4349683 18 Years F 1/1/2003 2/20/2004 3/29/2004 38 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Somnolence
4042866 4299775 13 Years M 11/13/2003 11/20/2003 1/26/2004 67 MD PER Strattera Convulsion Other
4042866 4401852 13 Years M 11/13/2003 1/13/2004 7/14/2004 183 MD EXP Strattera Convulsion Other
4042874 4289648     1/1/2003 11/18/2003 1/26/2004 69 PH PER Strattera Limb Malformation Congenital Anomaly
4042874 4341872     F 3/24/2004 4/15/2004 22 PH EXP Strattera Drug Exposure During Pregnancy
4042903 4299812 7 Years M 8/1/2003 11/20/2003 1/26/2004 67 PH PER Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion, Muscle Twitching Other
4042956 4296856 6 Years F 1/1/2003 9/30/2003 1/26/2004 118 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Erythema, Oral Pain, Weight Decreased, Weight Increased
4042990 4263769 7 Years M 12/18/2003 1/2/2004 15 MD EXP Strattera Drug Interaction, Electrocardiogram QT Corrected Interval Prolonged Other
4043346 4580204 9 Years M 1/1/2003 11/10/2004 1/27/2005 78 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Agitation, Disturbance in Attention, Fatigue, Mental Impairment, Nervousness, Psychomotor Hyperactivity, Weight Increased
4045824 4284317 8 Years F 11/15/2003 1/13/2004 1/30/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Apnoea, Convulsion, Loss of Consciousness, Tonic Clonic Movements Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4045824 4299849 8 Years F 11/15/2003 11/25/2003 1/26/2004 62 MD PER Strattera Attention Deficit/Hyperactivity Disorder Convulsion
4045824 4401850 8 Years F 11/15/2003 1/13/2004 7/14/2004 183 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion, Loss of Consciousness, Respiratory Arrest Other
4045830 4299846 15 Years F 11/21/2003 1/26/2004 66 MD PER Strattera Convulsion Other
4045830 4401851 15 Years F 11/21/2003 7/14/2004 236 MD EXP Strattera Convulsion Other
4045851 4299861 8 Years M 11/20/2003 1/26/2004 67 MD PER Strattera Attention Deficit/Hyperactivity Disorder Convulsion Other
4045851 4401983 8 Years M 11/20/2003 7/14/2004 237 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion Other
4045855 4289645 59 Years F 11/1/2003 11/24/2003 1/26/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Hyperhidrosis, Pneumonia Hospitalization - Initial or Prolonged
4045855 4307184 59 Years F 11/1/2003 2/5/2004 2/25/2004 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Disease Recurrence, Hyperhidrosis, Pneumonia Hospitalization - Initial or Prolonged
4049824 4319018 8 Years M 1/1/2003 2/26/2004 3/16/2004 19 EXP Strattera Convulsion, Drug Ineffective, Epilepsy, Psychotic Disorder Hospitalization - Initial or Prolonged
4054689 4325743 7 Years M 1/1/2003 3/2/2004 3/24/2004 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Blood Alkaline Phosphatase Increased, Blood Calcium Increased, Blood Creatinine Increased, Body Temperature Increased, Dyskinesia, Dystonia, Eye Injury, Eye Penetration, Iridocele, Movement Disorder, Nasopharyngitis, Neutrophil Percentage Increased, Opisthotonus, Therapeutic Response Decreased, Varicella, Vomiting Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4054692 4307185 6 Years M 12/3/2003 2/11/2004 2/25/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Gastric Disorder, Tremor Other
4054694 4268935 46 Years 11/1/2003 12/24/2003 1/8/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Cardiac Disorder, Cerebral Infarction, Cerebrovascular Accident, Weight Increased Other
4054699 4279009     M 11/1/2003 1/7/2004 1/21/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Dyspnoea, Electrocardiogram QT Corrected Interval Prolonged, Heart Rate Increased, Palpitations Life-Threatening
4054763 4263770 13 Years M 6/1/2003 12/18/2003 1/2/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Immune System Disorder, Lung Infection Hospitalization - Initial or Prolonged
4057482 4265584 44 Years F 10/29/2003 1/7/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Depressed Level of Consciousness, Feeling Abnormal, Loss of Consciousness, Road Traffic Accident Other
4058049 4299751 69 Years F 1/1/2003 12/10/2003 1/26/2004 47 MD PER Strattera Attention Deficit/Hyperactivity Disorder Atrial Fibrillation, Tachycardia, Thyroid Disorder Other
4060611 4263698 50 Years M 12/9/2003 1/2/2004 24 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Atrial Fibrillation, Dyspnoea, Pallor Other
4060613 4263700 13 Years F 12/15/2003 1/2/2004 18 EXP Strattera Chest Pain, Dyspnoea, Electrocardiogram QT Prolonged Other
4060613 4351259 13 Years F 12/9/2003 4/20/2004 4/28/2004 8 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Chest Injury, Chest Pain, Dyspnoea, Electrocardiogram QT Prolonged, Fall
4060620 4263701 8 Years F 12/16/2003 1/2/2004 17 EXP Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Loss of Consciousness Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4060625 4263703 9 Years M 12/17/2003 1/2/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Other
4060625 4284314 9 Years M 1/1/2003 1/14/2004 1/30/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Condition Aggravated, Confusional State, Grand Mal Convulsion Other
4060630 4263704 15 Years F 12/1/2003 12/18/2003 1/2/2004 15 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Clonus, Diplopia, Dystonia, Headache, Muscle Twitching, Mydriasis Hospitalization - Initial or Prolonged
4060630 4284311 15 Years F 12/1/2003 1/8/2004 1/30/2004 22 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Diplopia, Dyskinesia, Dystonia, Headache, Muscle Twitching, Mydriasis, Myoclonus Hospitalization - Initial or Prolonged
4060630 4411823 15 Years F 12/1/2003 7/12/2004 7/28/2004 16 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Diplopia, Dystonia, Hallucination, Muscle Twitching, Mydriasis, Myoclonus Hospitalization - Initial or Prolonged
4061085 4263654 14 Years F 12/1/2003 12/19/2003 1/2/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Condition Aggravated, Convulsion Hospitalization - Initial or Prolonged, Other
4061085 4313579 20 Years F 12/3/2003 2/17/2004 3/4/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Condition Aggravated, Convulsion, Postictal State, Status Epilepticus Hospitalization - Initial or Prolonged, Other
4061085 4378775 20 Years F 12/30/2003 5/20/2004 6/9/2004 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Condition Aggravated, Grand Mal Convulsion, Status Epilepticus Hospitalization - Initial or Prolonged, Other
4061085 4481995 20 Years F 12/3/2003 10/4/2004 10/20/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Confusional State, Fatigue, Lethargy, Loss of Consciousness, Status Epilepticus Hospitalization - Initial or Prolonged, Other
4061785 4263792 9 Years M 2/1/2003 12/18/2003 1/2/2004 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion, Psychomotor Hyperactivity Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4061785 4336556 9 Years M 2/1/2003 3/23/2004 4/7/2004 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion, Psychomotor Hyperactivity Other
4062830 4289660 9 Years M 5/10/2003 8/27/2003 1/26/2004 152 MD PER Strattera Attention Deficit/Hyperactivity Disorder Vomiting Hospitalization - Initial or Prolonged
4062842 4289656 56 Years F 6/24/2003 9/9/2003 1/26/2004 139 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Constipation Hospitalization - Initial or Prolonged
4063012 4268800 14 Years M 1/12/2004 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Depression Other
4064189 4263819 8 Years 2/4/2003 1/5/2004 PH DIR Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Elevated Mood, Irritability, Oppositional Defiant Disorder
4066873 4269444 52 Years M 1/12/2004 MD DIR Strattera Bipolar Disorder Histamine Level Decreased Other
4068133 4269044 9 Years M 12/12/2003 1/12/2004 OT DIR Strattera Attention Deficit/Hyperactivity Disorder Nausea, Vomiting Other
4070834 4296488 12 Years F 8/1/2003 9/9/2003 1/26/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Drug Interaction, Dyspepsia, Fatigue, Headache, Hypersomnia, Nausea, Somnolence
4076439 4278454 11 Years F 1/7/2004 1/21/2004 14 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Loss of Consciousness, Vomiting Other
4076439 4368789 11 Years F 11/17/2003 5/10/2004 5/27/2004 17 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dizziness, Feeling Abnormal, Loss of Consciousness, Vomiting Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4076509 4278453     M 12/1/2003 1/7/2004 1/21/2004 14 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Heart Rate Increased, Ventricular Hypertrophy Other
4076509 4368800 11 Years M 12/1/2003 5/10/2004 5/27/2004 17 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Heart Rate Increased, QRS Axis Abnormal, Ventricular Hypertrophy Other
4076509 4464727 11 Years M 12/1/2003 9/14/2004 9/29/2004 15 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anxiety, Chest Pain, Decreased Appetite, Emotional Disorder, Heart Rate Increased, Insomnia, Mental Impairment, Mood Altered, Nightmare, Panic Attack, Pollakiuria, Psychomotor Hyperactivity, Respiratory Rate Increased, Therapy Non-Responder, Ventricular Hypertrophy, Weight Increased Other
4078518 4279028 9 Years M 11/1/2003 12/23/2003 1/22/2004 30 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Cardiomegaly, Cardiomyopathy, Chest Discomfort, Ventricular Dysfunction Other
4078518 4356757 9 Years M 11/1/2003 4/16/2004 5/7/2004 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Cardiomegaly, Cardiomyopathy, Chest Discomfort, Ventricular Dysfunction Other
4086017 4319620 8 Years M 2/19/2004 3/8/2004 3/16/2004 8 EXP Strattera Attention Deficit/Hyperactivity Disorder, Bipolar Disorder Abdominal Pain Upper, Aggression, Blood Pressure Decreased, Cerebral Palsy, Confusional State, Dyspepsia, Dyspnoea, Feeling Abnormal, Feeling Cold, Grand Mal Convulsion, Loss of Consciousness, Psychomotor Hyperactivity, Pyrexia, Speech Disorder, Tachycardia, Tremor Hospitalization - Initial or Prolonged, Other
4086169 4284407 16 Years F 12/1/2003 1/14/2004 1/30/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Dystonia, Hallucination, Muscle Twitching, Myoclonus Hospitalization - Initial or Prolonged
4086169 4411819 16 Years F 12/1/2003 7/12/2004 7/28/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Dystonia, Hallucination, Muscle Twitching Hospitalization - Initial or Prolonged
4086179 4284409 7 Years M 12/31/2003 1/8/2004 1/30/2004 22 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Condition Aggravated, Confusional State, Convulsion, Dyskinesia, Insomnia, Muscle Twitching Other
4086179 4348025 7 Years M 12/31/2003 4/5/2004 4/22/2004 17 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Confusional State, Dyskinesia, Insomnia, Muscle Twitching Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4086274 4284495 14 Years F 10/8/2003 1/8/2004 1/30/2004 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Intentional Self-Injury, Scratch, Self-Injurious Ideation Hospitalization - Initial or Prolonged
4086274 4307124 14 Years F 10/8/2003 2/9/2004 2/25/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Depression, Hallucination (Auditory), Oppositional Defiant Disorder, Self-Injurious Ideation, Suicidal Ideation Hospitalization - Initial or Prolonged
4086275 4284497 18 Years M 1/8/2004 1/30/2004 22 MD EXP Strattera Convulsion Other
4087462 4289435 7 Years M 2/2/2004 2/6/2004 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper Other
4088451 4291515     M 2/2/2001 2/10/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Ejaculation Disorder, Erectile Dysfunction, Feeling Abnormal, Pain, Testicular Pain Other, Required Intervention to Prevent Permanent Impairment/Damage
4089284 4287618 8 Years M 10/21/2003 1/26/2004 2/5/2004 10 MD EXP Strattera Chest Pain, Depressed Level of Consciousness, Dyspnoea, Fatigue, Headache, Miosis, Sedation Hospitalization - Initial or Prolonged
4089288 4287619 31 Years F 1/19/2004 2/5/2004 17 EXP Strattera Burning Sensation, Condition Aggravated, Grand Mal Convulsion Other
4089288 4319617 31 Years F 3/3/2004 3/16/2004 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Burning Sensation, Grand Mal Convulsion, Somnolence, Tongue Biting, Visual Disturbance Other
4089290 4287632 50 Years F 1/23/2004 2/5/2004 13 OT EXP Strattera Cognitive Disorder, Multiple Sclerosis Aortic Valve Incompetence, Condition Aggravated, Pancreatitis Hospitalization - Initial or Prolonged, Other
4089290 4325606 50 Years F 3/1/2004 3/10/2004 3/24/2004 14 OT EXP Strattera Cognitive Disorder, Multiple Sclerosis Aortic Valve Incompetence, Pancreatitis, Pericardial Effusion, Post Procedural Complication, Surgical Procedure Repeated, Ventricular Dysfunction Hospitalization - Initial or Prolonged, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4089293 4287634 7 Years M 11/13/2003 1/23/2004 2/5/2004 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Depression, Electroencephalogram Abnormal, Simple Partial Seizures Hospitalization - Initial or Prolonged, Other
4089293 4307187 7 Years M 11/13/2003 2/11/2004 2/25/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Depression, Electroencephalogram Abnormal, Fatigue, Hyperhidrosis, Postictal State, Simple Partial Seizures Hospitalization - Initial or Prolonged, Other
4089713 4289650 11 Years M 1/1/2003 9/8/2003 1/26/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Weight Decreased Hospitalization - Initial or Prolonged
4092075 4294015 32 Years M 11/1/2003 1/22/2004 2/11/2004 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Dyspnoea, Electrocardiogram QT Corrected Interval Prolonged, Heart Rate Increased, Palpitations Life-Threatening
4092336 4337920 6 Years M 2/4/2004 3/29/2004 54 PER Strattera Abnormal Behaviour, Aggression, Anger, Attention Deficit Hyperactivity Disorder, Constipation, Drug Ineffective, Drug Interaction, Dyspnoea, Dysuria, Fight In School, Hunger, Hyperphagia, Insomnia, Intentional Self-Injury, Irritability, Oppositional Defiant Disorder, Weight Increased Other
4092478 4294427 5 Years M 1/25/2004 1/26/2004 2/11/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Vomiting Other
4092478 4341941 5 Years M 1/25/2004 3/30/2004 4/15/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Coma, Drooling, Electroencephalogram Abnormal, Epilepsy, Fall, Vomiting Other
4092867 4294143 14 Years M 1/27/2004 2/11/2004 15 EXP Strattera Epistaxis, Ventricular Extrasystoles Other
4092867 4307189 14 Years M 2/5/2004 2/25/2004 20 EXP Strattera Epistaxis, Ventricular Extrasystoles Other
4092870 4294144 20 Years M 1/28/2004 2/11/2004 14 PH EXP Strattera Infection, Road Traffic Accident, Spinal Cord Injury Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4093706 4297366     2/17/2004 DIR Strattera
4094000 4296844 9 Years F 9/8/2003 1/26/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Decreased Appetite, Decreased Interest, Depression, Emotional Disorder
4094003 4296846 11 Years F 1/1/2003 9/8/2003 1/26/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Disturbance in Attention, Dyspepsia, Somnolence, Tic
4094005 4296847 7 Years M 9/8/2003 9/8/2003 1/26/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Pallor, Vomiting
4094007 4296853 8 Years M 1/1/2003 9/8/2003 1/26/2004 140 PER Strattera Blister Infected, Feeling Cold, Nightmare, Pruritus, Rash, Urticaria
4094008 4296855 8 Years M 9/4/2003 9/8/2003 1/26/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Disturbance in Attention, Somnolence
4094010 4296859 38 Years M 9/8/2003 9/8/2003 1/26/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Fatigue, Hyperhidrosis, Nausea, Pallor, Somnolence
4094011 4296861 11 Years M 9/8/2003 9/8/2003 1/26/2004 140 PER Strattera Throat Irritation
4094013 4297069 58 Years M 8/21/2003 11/24/2003 1/26/2004 63 OT PER Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder, Testicular Pain, Urinary Hesitation
4094013 4349150 58 Years M 8/21/2003 11/24/2003 3/29/2004 126 OT PER Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder, Testicular Pain, Urinary Hesitation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4094014 4296862     F 9/5/2003 1/26/2004 143 MD PER Strattera Attention Deficit/Hyperactivity Disorder Flushing, Paraesthesia
4094015 4297070 10 Years M 8/1/2003 9/2/2003 1/26/2004 146 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Fatigue, Feeling Abnormal, Headache, Nausea
4094016 4296863 25 Years M 9/2/2003 9/16/2003 1/26/2004 132 OT PER Strattera Drug Screen Positive
4094018 4297071 6 Years M 8/1/2003 9/29/2003 1/26/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Choking, Retching, Vomiting
4094019 4296865 14 Years M 9/8/2003 1/26/2004 140 MD PER Strattera Dizziness, Visual Disturbance
4094021 4297072 10 Years M 7/25/2003 9/24/2003 1/26/2004 124 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Chills, Decreased Appetite, Dyspepsia, Erythema, Feeling Abnormal, Feeling Hot, Flushing, Headache, Hyperacusis, Nausea, Peripheral Coldness, Somnolence, Temperature Intolerance, Temperature Regulation Disorder
4094022 4297073 10 Years M 8/1/2003 9/2/2003 1/26/2004 146 PER Strattera Attention Deficit/Hyperactivity Disorder Rash
4094023 4297074 7 Years F 8/1/2003 9/2/2003 1/26/2004 146 PER Strattera Blood Pressure Increased, Oropharyngeal Swelling, Pharyngolaryngeal Pain
4094025 4297075 7 Years M 8/1/2003 9/2/2003 1/26/2004 146 PER Strattera Attention Deficit/Hyperactivity Disorder Cough, Multiple Allergies, Nasopharyngitis, Sinusitis
4094027 4297076 9 Years M 9/2/2003 1/26/2004 146 PER Strattera Retching
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4094028 4296806 9 Years F 9/5/2003 1/26/2004 143 PER Strattera Abnormal Behaviour, Aggression, Anorexia, Impulse-Control Disorder
4094030 4296809 6 Years M 8/1/2003 9/5/2003 1/26/2004 143 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Pharyngitis Streptococcal, Weight Decreased
4094034 4296810 15 Years M 9/3/2003 9/5/2003 1/26/2004 143 PER Strattera Dyspepsia, Gastrooesophageal Reflux Disease
4094037 4297077 11 Years M 9/2/2003 1/26/2004 146 MD PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Lethargy, Pallor
4094040 4296814 8 Years M 9/1/2003 9/5/2003 1/26/2004 143 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Emotional Distress
4094041 4297078 11 Years M 8/29/2003 9/11/2003 1/26/2004 137 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Somnolence
4094042 4296817 8 Years M 9/5/2003 1/26/2004 143 PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Migraine
4094044 4297120 33 Years F 9/17/2003 1/26/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Disturbance in Attention, Drug Ineffective, Dry Mouth, Fatigue, Headache, Nervousness, Weight Decreased
4094045 4297122 12 Years 9/3/2003 1/26/2004 145 MD PER Strattera
4094046 4297124 9 Years M 8/1/2003 9/3/2003 1/26/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Body Temperature Decreased, Chills, Feeling Hot and Cold, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4094048 4297131 12 Years M 9/3/2003 1/26/2004 145 MD PER Strattera Abnormal Behaviour, Psychomotor Hyperactivity
4094056 4296655 16 Years M 8/1/2003 9/8/2003 1/26/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Acne
4094057 4296662 5 Years F 9/4/2003 9/8/2003 1/26/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination, Somnolence
4094058 4296690 8 Years M 9/9/2003 1/26/2004 139 MD PER Strattera Mania
4094059 4296820 39 Years M 9/1/2003 9/5/2003 1/26/2004 143 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Anger, Bipolar Disorder, Psychomotor Hyperactivity, Suicidal Ideation
4094060 4296697 5 Years M 9/9/2003 1/26/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
4094063 4296702 13 Years M 9/9/2003 1/26/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
4094065 4296708 43 Years F 9/1/2003 9/9/2003 1/26/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fatigue, Hyperhidrosis, Peripheral Coldness, Vision Blurred, Vomiting
4094067 4296711 9 Years M 9/5/2003 9/9/2003 1/26/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Dreams, Aggression, Anxiety, Feeling Abnormal, Insomnia, Restlessness
4094069 4296713 18 Years M 9/9/2003 1/26/2004 139 MD PER Strattera Anger, Feeling Jittery, Headache
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4094070 4296823 14 Years M 9/4/2003 9/5/2003 1/26/2004 143 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Hyperhidrosis, Somnolence
4094071 4296715 12 Years M 9/9/2003 1/26/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Delayed Puberty
4094072 4296825 8 Years M 9/5/2003 1/26/2004 143 MD PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Hesitation
4094073 4296717 9 Years M 9/9/2003 1/26/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
4094077 4296753 54 Years F 9/9/2003 1/26/2004 139 PER Strattera Fatigue, Hypervigilance, Palpitations, Somnolence
4094078 4296826 8 Years M 8/1/2003 9/5/2003 1/26/2004 143 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Psychomotor Hyperactivity
4094081 4296829 10 Years M 9/3/2003 9/23/2003 1/26/2004 125 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
4094082 4296754 13 Years M 9/25/2003 1/26/2004 123 MD PER Strattera Attention Deficit/Hyperactivity Disorder Cyanosis, Pulse Abnormal
4094084 4296757 8 Years M 8/1/2003 9/9/2003 1/26/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Psychomotor Hyperactivity
4094086 4296759 7 Years M 9/9/2003 9/10/2003 1/26/2004 138 PER Strattera Eye Disorder, Insomnia, Tooth Discolouration, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4094088 4296761 6 Years M 9/10/2003 1/26/2004 138 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Logorrhoea
4094090 4296763 9 Years M 9/8/2003 9/10/2003 1/26/2004 138 PER Strattera Anxiety, Crying, Nervousness, Vomiting
4094092 4296765 32 Years F 9/10/2003 1/26/2004 138 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Interest, Depressed Mood
4094093 4296767 12 Years M 9/10/2003 1/26/2004 138 MD PER Strattera
4094096 4296771 28 Years M 8/1/2003 9/10/2003 1/26/2004 138 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Somnolence
4094097 4296775 5 Years M 8/24/2003 11/18/2003 1/26/2004 69 PER Strattera Oppositional Defiant Disorder Abdominal Pain Upper, Drug Ineffective, Weight Increased
4094097 4349153 5 Years M 8/24/2003 1/30/2004 3/29/2004 59 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Drug Ineffective, Weight Increased
4094121 4296867 15 Years F 9/16/2003 1/26/2004 132 OT PER Strattera Attention Deficit/Hyperactivity Disorder Nasal Discomfort
4094123 4296869 7 Years M 8/1/2003 9/8/2003 1/26/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Gastrooesophageal Reflux Disease
4094126 4296873 13 Years F 9/6/2003 9/8/2003 1/26/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Nausea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4094131 4296880 6 Years F 9/1/2003 9/8/2003 1/26/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Psychomotor Hyperactivity, Somnolence
4094132 4296883 8 Years M 9/8/2003 1/26/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder
4094134 4296885 9 Years F 1/1/2003 9/8/2003 1/26/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Feeling Abnormal, Memory Impairment, Thinking Abnormal
4094136 4296887 11 Years F 1/1/2003 10/14/2003 1/26/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Impulse-Control Disorder, Somnolence
4094137 4296889 7 Years M 1/1/2003 10/14/2003 1/26/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Fatigue, Psychomotor Hyperactivity, Somnolence
4094138 4296894 10 Years M 9/9/2003 9/9/2003 1/26/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Drug Ineffective, Dyskinesia, Fatigue
4094278 4298571 6 Years F 9/23/2003 1/26/2004 125 CN PER Strattera Daydreaming, Disturbance in Attention Hyperkinesia, Logorrhoea, Psychomotor Hyperactivity
4094288 4298554 14 Years F 1/1/2003 9/22/2003 1/26/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Nausea
4094293 4298167 5 Years M 9/22/2003 1/26/2004 126 MD PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Sleep Disorder
4094296 4297858 5 Years M 9/1/2003 9/22/2003 1/26/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Flatulence, Headache
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4094313 4297768 36 Years F 9/19/2003 1/26/2004 129 OT PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Drug Interaction, Hyperhidrosis, Vision Blurred
4094448 4297089 10 Years F 9/3/2003 1/26/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Vomiting
4094450 4297090 15 Years F 8/8/2003 9/3/2003 1/26/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Depressed Mood, Dizziness, Psychomotor Hyperactivity, Tremor
4094452 4297091     F 9/3/2003 9/3/2003 1/26/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Nervousness
4094456 4297092 15 Years F 9/3/2003 9/3/2003 1/26/2004 145 PER Strattera Chills, Dizziness, Drug Interaction, Dyspnoea, Fatigue, Nausea, Palpitations
4094459 4297094     M 8/1/2003 9/3/2003 1/26/2004 145 PER Strattera Abdominal Pain Upper, Fatigue, Insomnia
4094461 4297096 16 Years M 1/1/2003 9/3/2003 1/26/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Crying, Depression, Depression Suicidal, Emotional Distress, Piloerection
4094462 4297097     M 9/3/2003 1/26/2004 145 OT PER Strattera Aggression, Psychomotor Hyperactivity
4094468 4297099 9 Years M 1/1/2003 9/3/2003 1/26/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Memory Impairment
4094472 4297102 17 Years M 7/1/2003 9/3/2003 1/26/2004 145 OT PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Lethargy
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4094474 4297108 7 Years F 9/3/2003 1/26/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Decreased Appetite, Disturbance in Attention, Mood Swings, Somnolence
4094696 4296864 13 Years M 7/11/2003 8/27/2003 1/26/2004 152 PH PER Strattera Somnolence, Weight Fluctuation
4094697 4296870 15 Years M 8/1/2003 8/27/2003 1/26/2004 152 PER Strattera Attention Deficit/Hyperactivity Disorder Discomfort, Priapism
4094697 4473909 15 Years M 8/1/2003 9/22/2004 10/8/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Genital Disorder Male, Priapism
4094699 4296874     F 8/1/2003 8/27/2003 1/26/2004 152 MD PER Strattera Agitation
4094701 4296878 10 Years M 8/27/2003 1/26/2004 152 PER Strattera Attention Deficit/Hyperactivity Disorder Blepharospasm, Mydriasis, Nausea, Somnolence, Weight Increased
4094704 4296881 12 Years M 8/27/2003 1/26/2004 152 MD PER Strattera Anxiety, Psychomotor Hyperactivity
4094707 4296886 7 Years M 8/25/2003 8/27/2003 1/26/2004 152 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Fatigue, Mood Swings, Nervousness, Yawning
4094709 4296888     M 8/27/2003 1/26/2004 152 PER Strattera Micturition Disorder
4094710 4297140 12 Years M 9/3/2003 9/9/2003 1/26/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Hyperhidrosis, Insomnia, Mood Swings, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4094712 4296891 6 Years M 8/27/2003 1/26/2004 152 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Stomach Discomfort, Vomiting
4094713 4297141 7 Years M 9/3/2003 9/11/2003 1/26/2004 137 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Fatigue, Headache, Pallor, Vomiting
4094713 4349151 7 Years M 8/29/2003 2/17/2004 3/29/2004 41 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Fatigue, Headache, Pallor, Vomiting
4094714 4296895 10 Years M 8/27/2003 1/26/2004 152 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
4094715 4297142 22 Years F 9/3/2003 9/10/2003 1/26/2004 138 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Feeling Hot and Cold, Headache, Vomiting
4094716 4296936 41 Years F 8/21/2003 8/27/2003 1/26/2004 152 PER Strattera Asthenia, Feeling Abnormal, Hyperhidrosis, Nausea, Vomiting
4094717 4297143 9 Years M 8/1/2003 9/3/2003 1/26/2004 145 PH PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Laziness, Lethargy, Psychomotor Hyperactivity
4094718 4297144     M 8/1/2003 9/3/2003 1/26/2004 145 PER Strattera
4094719 4296938 18 Years M 8/6/2003 8/27/2003 1/24/2004 150 PER Strattera Decreased Appetite, Feeling Abnormal, Lethargy, Mood Swings
4094721 4297145 9 Years F 9/3/2003 1/26/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anxiety, Crying, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4094722 4296939 16 Years F 8/1/2003 8/27/2003 1/26/2004 152 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Insomnia, Psychomotor Hyperactivity
4094723 4296940 11 Years M 8/27/2003 8/27/2003 1/26/2004 152 PER Strattera Attention Deficit/Hyperactivity Disorder Accident, Decreased Appetite, Diplopia, Dizziness, Dysgeusia, Dyspepsia, Fatigue
4094725 4296941 10 Years M 8/27/2003 8/27/2003 1/26/2004 152 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fatigue, Hyperacusis, Thirst
4094726 4296942 42 Years M 8/1/2003 8/27/2003 1/26/2004 152 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Disturbance in Attention, Dysuria, Erectile Dysfunction, Insomnia, Loss of Libido, Negative Thoughts, Premature Ejaculation, Psychomotor Hyperactivity, Urinary Hesitation
4094727 4296944 8 Years F 1/1/2003 8/27/2003 1/26/2004 152 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Nervousness, Somnolence, Weight Gain Poor
4094729 4296945     M 8/27/2003 1/24/2004 150 PER Strattera Choking
4094730 4296947 10 Years M 8/27/2003 1/26/2004 152 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Psychomotor Hyperactivity
4094732 4296948 35 Years M 8/24/2003 10/15/2003 1/26/2004 103 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anorexia, Chest Pain, Nausea
4094911 4296949 12 Years 8/28/2003 1/26/2004 151 MD PER Strattera Hyperhidrosis
4094913 4296951 10 Years F 8/28/2003 1/26/2004 151 PER Strattera Drug Ineffective, Fatigue, Feeling Abnormal, Middle Insomnia, Mydriasis, Psychomotor Hyperactivity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4094914 4296952 7 Years M 8/28/2003 8/28/2003 1/26/2004 151 OT PER Strattera Abnormal Behaviour
4094916 4296954 9 Years M 8/1/2003 8/28/2003 1/26/2004 151 PER Strattera Attention Deficit/Hyperactivity Disorder Eye Irritation, Eye Pruritus, Mydriasis, Vision Blurred
4094917 4296956 34 Years M 8/28/2003 8/28/2003 1/26/2004 151 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Nausea
4094918 4296959 17 Years F 8/27/2003 11/5/2003 1/26/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Back Pain, Decreased Appetite, Drug Interaction, Insomnia, Nausea, Somnolence
4094920 4296961 29 Years F 8/22/2003 8/28/2003 1/26/2004 151 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal
4094922 4296964 10 Years F 1/1/2003 8/28/2003 1/26/2004 151 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Excitability, Flushing, Memory Impairment
4094925 4300482 9 Years M 1/29/2004 1/29/2004 2/18/2004 20 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Increased, Epilepsy, Lung Infection, Petit Mal Epilepsy, Tic Other
4094926 4296972     F 8/21/2003 8/28/2003 1/26/2004 151 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective
4094928 4296973     M 7/21/2003 1/26/2004 189 MD PER Strattera Testicular Pain
4094931 4296978 5 Years 8/25/2003 1/26/2004 154 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4094932 4296991 8 Years M 8/1/2003 8/28/2003 1/26/2004 151 PER Strattera Dyspepsia, Feeling Abnormal
4094933 4296992 5 Years 8/25/2003 1/26/2004 154 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger
4094934 4296994 12 Years M 8/27/2003 8/28/2003 1/26/2004 151 OT PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Pain
4094935 4300485 12 Years M 1/26/2004 1/29/2004 2/18/2004 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion, Headache, Loss of Consciousness Other
4094938 4296995 26 Years M 8/28/2003 1/26/2004 151 OT PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Pain
4094953 4300489 7 Years M 1/27/2004 1/29/2004 2/18/2004 20 OT EXP Strattera Complex Partial Seizures Other
4094953 4378776 7 Years M 1/27/2004 5/21/2004 6/9/2004 19 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Clonus, Complex Partial Seizures Other
4094991 4300165 15 Years F 2/2/2004 2/2/2004 2/18/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Nausea, Overdose, Suicide Attempt, Vomiting Other
4094994 4300167 34 Years F 1/1/2003 1/30/2004 2/18/2004 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Hallucination, Mania, Toxicologic Test Abnormal, Weight Increased Hospitalization - Initial or Prolonged
4094998 4300168 1 Day M 12/18/2003 1/29/2004 2/18/2004 20 EXP Strattera Forceps Delivery, Intraventricular Haemorrhage, Maternal Drugs Affecting Foetus, Neonatal Disorder, Pain Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4094998 4356767 1 Day M 12/18/2003 4/15/2004 5/7/2004 22 MD EXP Strattera Intraventricular Haemorrhage Neonatal, Maternal Drugs Affecting Foetus, Pain Other
4095005 4300170 11 Years M 2/9/2004 2/18/2004 9 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Urinary Retention
4095239 4300513 8 Years M 2/3/2004 2/18/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Arrhythmia, Psychomotor Hyperactivity Other
4095239 4341942 8 Years M 3/31/2004 4/15/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Arrhythmia, Electrocardiogram Abnormal, Psychomotor Hyperactivity Other
4095239 4378778 8 Years M 1/1/2003 5/21/2004 6/9/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Decreased, Electrocardiogram PR Prolongation, Electrocardiogram QRS Complex Prolonged, Electrocardiogram QT Corrected Interval Prolonged, Electrocardiogram QT Prolonged, Heart Rate Increased, Ventricular Extrasystoles Other
4095247 4300518 7 Years M 2/2/2004 2/3/2004 2/18/2004 15 OT EXP Strattera Abnormal Behaviour, Impulsive Behaviour, Psychomotor Hyperactivity Coma, Grand Mal Convulsion Hospitalization - Initial or Prolonged, Other
4095664 4297060 9 Years M 9/15/2003 1/26/2004 133 PER Strattera Disturbance in Attention Decreased Appetite, Dizziness, Drug Ineffective, Feeling Abnormal, Mydriasis
4095676 4297061 11 Years M 9/15/2003 1/26/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Feeling Abnormal, Feeling Hot, Insomnia
4095683 4297049 8 Years M 1/1/2003 9/15/2003 1/26/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Nervousness, Psychomotor Hyperactivity
4095687 4297062 33 Years M 8/1/2003 9/16/2003 1/26/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dry Mouth, Genital Burning Sensation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4095690 4297050     F 9/13/2003 9/15/2003 1/26/2004 133 PER Strattera Abdominal Pain Upper, Anxiety, Crying, Depression
4095695 4297051 11 Years M 9/15/2003 1/26/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder
4095699 4297063     M 9/1/2003 9/15/2003 1/26/2004 133 PER Strattera Ejaculation Disorder, Testicular Pain
4095703 4297052 16 Years M 1/1/2003 9/15/2003 1/26/2004 133 MD PER Strattera Depression, Suicidal Ideation
4095710 4297053 10 Years M 9/15/2003 9/15/2003 1/26/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Crying, Depression, Headache
4095713 4297064 9 Years M 9/15/2003 1/26/2004 133 MD PER Strattera Hallucination (Auditory)
4095715 4297054 46 Years M 9/15/2003 9/15/2003 1/26/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Abnormal, Nausea
4095721 4297055 17 Years M 9/15/2003 1/26/2004 133 MD PER Strattera Paraesthesia
4095725 4297056 12 Years M 9/15/2003 1/26/2004 133 PER Strattera Psychomotor Hyperactivity
4095729 4297065 41 Years M 9/1/2003 9/15/2003 1/26/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Scrotal Pain, Urinary Hesitation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4095738 4297066 10 Years M 9/12/2003 9/16/2003 1/26/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Insomnia, Staring
4095750 4297067 34 Years F 9/11/2003 9/16/2003 1/26/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Asthenia, Depressed Mood, Fatigue, Feeling Abnormal, Somnolence
4095756 4297068 6 Years M 9/15/2003 9/16/2003 1/26/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Fatigue, Pallor, Somnolence, Vomiting
4095768 4297057 8 Years M 9/1/2003 9/15/2003 1/26/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Disturbance in Attention, Somnolence
4095779 4297058 7 Years M 9/1/2003 9/15/2003 1/26/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Dyspepsia, Fatigue
4096062 4296549 10 Years M 8/23/2003 8/25/2003 1/26/2004 154 CN PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Migraine, Rash, Tremor
4096256 4296551 7 Years M 8/25/2003 1/26/2004 154 CN PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Decreased Appetite, Disturbance in Attention, Drug Ineffective, Fatigue, Nervousness, Speech Disorder
4096260 4296996 11 Years M 1/1/2003 8/28/2003 1/26/2004 151 PER Strattera Anger, Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anger, Irritability, Mood Swings, Rash, Restlessness, Suicidal Ideation
4096263 4297000 44 Years F 8/26/2003 8/28/2003 1/26/2004 151 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Insomnia, Somnolence, Thinking Abnormal
4096264 4297005 12 Years 8/28/2003 1/26/2004 151 MD PER Strattera Palpitations
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4096268 4296553 7 Years M 8/24/2003 8/25/2003 1/26/2004 154 CN PER Strattera Impulsive Behaviour Decreased Appetite, Hypersomnia, Nausea
4096270 4297006 8 Years M 8/1/2003 8/28/2003 1/26/2004 151 PER Strattera Asperger's Disorder Abnormal Behaviour, Drug Ineffective, Psychomotor Hyperactivity, Retching, Screaming, Somnolence
4096271 4297034 7 Years F 8/27/2003 8/28/2003 1/26/2004 151 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Hot, Flushing, Headache
4096378 4301728 11 Years M 9/1/2003 10/6/2003 1/26/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Decreased Appetite, Depression, Dyspepsia, Irritability, Mydriasis, Pain
4096404 4301763 18 Years M 10/1/2003 10/30/2003 1/26/2004 88 PER Strattera Attention Deficit/Hyperactivity Disorder Disorientation, Disturbance in Attention, Lethargy, Somnolence
4096407 4301764     M 10/4/2003 10/6/2003 1/26/2004 112 PER Strattera Psychomotor Hyperactivity
4096414 4301765 6 Years F 9/1/2003 10/6/2003 1/26/2004 112 PER Strattera Dyskinesia
4096418 4301766 13 Years M 1/1/2003 10/6/2003 1/26/2004 112 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Tic
4096421 4301767 11 Years M 10/5/2003 10/6/2003 1/26/2004 112 PER Strattera Oppositional Defiant Disorder Chest Pain
4096421 4349284 11 Years M 10/5/2003 1/14/2004 3/29/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4096427 4301768 13 Years F 10/6/2003 1/26/2004 112 PER Strattera Oppositional Defiant Disorder Drug Ineffective
4096428 4301769 12 Years M 10/5/2003 10/6/2003 1/26/2004 112 PER Strattera Psychomotor Hyperactivity
4096442 4301770 9 Years M 10/6/2003 10/6/2003 1/26/2004 112 PER Strattera Oppositional Defiant Disorder Diarrhoea, Dyspepsia, Retching, Vomiting
4096448 4302793     M 2/1/2004 2/23/2004 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Anger, Insomnia, Mood Altered, Sleep Talking Other
4096510 4299715 12 Years M 11/11/2003 1/26/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Agitation, Drug Ineffective, Dyspnoea, Nasopharyngitis, Somnolence
4096511 4299716 11 Years M 11/1/2003 11/11/2003 1/26/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Bronchitis, Diarrhoea, Nausea
4096514 4299719 6 Years M 11/11/2003 1/26/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Dysphemia, Insomnia, Mania, Psychomotor Hyperactivity
4096515 4299720 10 Years M 11/11/2003 1/26/2004 76 MD PER Strattera Pupils Unequal
4096515 4342224 10 Years M 1/19/2004 3/29/2004 70 MD PER Strattera Pupils Unequal
4096518 4299721 13 Years M 1/1/2003 11/11/2003 1/26/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4096521 4299722 15 Years M 5/1/2003 11/20/2003 1/26/2004 67 PER Strattera Vision Blurred Chest Pain, Dyspepsia, Hypersomnia, Insomnia, Palpitations
4096521 4342225 15 Years M 5/1/2003 11/20/2003 3/29/2004 130 CN PER Strattera Chest Pain, Dyspepsia, Hypersomnia, Insomnia, Palpitations
4096522 4299723     M 11/11/2003 1/26/2004 76 PER Strattera Pruritus
4096524 4299725 58 Years F 11/11/2003 1/26/2004 76 MD PER Strattera Aphasia
4096526 4299727     M 11/11/2003 1/26/2004 76 CN PER Strattera Bipolar I Disorder Depression
4096529 4299728 7 Years M 10/20/2003 12/29/2003 1/26/2004 28 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4096529 4342226 7 Years M 10/20/2003 1/28/2004 3/29/2004 61 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic, Tourette's Disorder
4096529 4440747 7 Years M 10/20/2003 3/31/2004 7/28/2004 119 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic, Tourette's Disorder
4096534 4299678 7 Years M 8/24/2003 9/24/2003 1/26/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Nightmare
4096538 4299692 7 Years M 11/10/2003 1/26/2004 77 CN PER Strattera Anger
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4096540 4299693 12 Years M 11/10/2003 1/26/2004 77 CN PER Strattera Anger
4096541 4299694 6 Years F 11/9/2003 11/10/2003 1/26/2004 77 CN PER Strattera Attention Deficit/Hyperactivity Disorder Buccoglossal Syndrome, Face Oedema
4096546 4299695 12 Years M 11/9/2003 11/10/2003 1/26/2004 77 CN PER Strattera Asthenia, Chills, Dizziness, Flushing, Headache, Mood Swings, Pruritus
4096548 4299696 4 Years M 1/1/2003 11/10/2003 1/26/2004 77 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
4096552 4299697     M 11/10/2003 1/26/2004 77 OT PER Strattera Attention Deficit/Hyperactivity Disorder Migraine
4096552 4342223 8 Years M 12/22/2003 3/29/2004 98 MD PER Strattera Attention Deficit/Hyperactivity Disorder Migraine
4096558 4299774 52 Years F 11/12/2003 12/18/2003 1/26/2004 39 PER Strattera Attention Deficit/Hyperactivity Disorder Hot Flush, Sluggishness, Tic
4096558 4342228 52 Years F 11/12/2003 12/18/2003 3/29/2004 102 CN PER Strattera Attention Deficit/Hyperactivity Disorder Hot Flush, Sluggishness, Tic
4096559 4299698 5 Years M 9/1/2003 11/10/2003 1/26/2004 77 CN PER Strattera Attention Deficit/Hyperactivity Disorder
4096561 4299734 51 Years F 11/8/2003 11/12/2003 1/26/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Elevated Mood
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4096561 4501308 51 Years F 11/8/2003 6/15/2004 9/27/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Elevated Mood, Hyperhidrosis
4096562 4299776 14 Years M 10/1/2003 11/13/2003 1/26/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Blepharospasm, Disturbance in Attention, Staring, Weight Increased
4096565 4299778     F 11/10/2003 1/26/2004 77 OT PER Strattera Attention Deficit/Hyperactivity Disorder Migraine
4096565 4342229 38 Years F 12/22/2003 3/29/2004 98 MD PER Strattera Attention Deficit/Hyperactivity Disorder Migraine
4096566 4299699 9 Years F 11/2/2003 11/10/2003 1/26/2004 77 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Heart Rate Increased
4096569 4299780 36 Years M 11/13/2003 1/26/2004 74 PER Strattera Disturbance in Attention Confusional State
4096570 4299700 8 Years M 11/10/2003 1/26/2004 77 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Somnolence
4096572 4299701 6 Years F 11/10/2003 1/26/2004 77 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Confusional State, Crying, Faecal Incontinence, Hallucination (Auditory), Urinary Incontinence
4096576 4299724 14 Years M 11/23/2003 11/14/2003 1/26/2004 73 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anxiety, Nervousness, Pruritus
4096580 4299726 12 Years M 11/1/2003 12/9/2003 1/26/2004 48 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4096580 4342231 12 Years M 11/1/2003 2/12/2004 3/29/2004 46 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Injury, Weight Decreased
4096580 4440750 12 Years M 11/1/2003 3/2/2004 7/28/2004 148 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Suicidal Ideation, Weight Decreased
4096582 4299738 12 Years M 10/1/2003 11/12/2003 1/26/2004 75 CN PER Strattera Abnormal Behaviour, Disturbance in Attention, Drug Ineffective
4096583 4299763 69 Years M 11/13/2003 1/26/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Depression
4096584 4299739 10 Years M 11/11/2003 11/12/2003 1/26/2004 75 MD PER Strattera Headache, Palpitations, Rash
4096584 4342227 11 Years M 11/11/2003 1/22/2004 3/29/2004 67 MD PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Palpitations, Rash
4096586 4299764 11 Years M 11/13/2003 1/26/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Enuresis, Somnolence
4096588 4299765 37 Years F 11/13/2003 1/26/2004 74 PER Strattera Dizziness, Nasopharyngitis, Sensation of Block in Ear, Vertigo
4096589 4299766 9 Years M 1/1/2003 11/13/2003 1/26/2004 74 PER Strattera Abnormal Behaviour, Drug Ineffective, Vomiting, Weight Increased
4096590 4299767 8 Years M 11/8/2003 11/13/2003 1/26/2004 74 OT PER Strattera Attention Deficit/Hyperactivity Disorder Cough, Dyspepsia, Dyspnoea, Pharyngitis Streptococcal, Pyrexia, Somnolence, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4096593 4299740 48 Years F 10/1/2003 11/12/2003 1/26/2004 75 PER Strattera Bipolar Disorder Feeling Abnormal, Nausea
4096596 4299742 9 Years M 11/9/2003 11/12/2003 1/26/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Irritability, Lethargy
4096597 4299729 48 Years F 11/1/2003 11/14/2003 1/26/2004 73 CN PER Strattera Disturbance in Attention, Nervousness Anuria, Confusional State, Urinary Hesitation
4096599 4299705 36 Years M 11/10/2003 1/26/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention
4096601 4299706 17 Years F 11/11/2003 1/26/2004 76 MD PER Strattera Drug Interaction, Swollen Tongue, Tremor
4096602 4299768 36 Years F 11/13/2003 11/14/2003 1/26/2004 73 PER Strattera Feeling Abnormal, Headache, Insomnia
4096603 4299730 11 Years F 11/14/2003 1/26/2004 73 CN PER Strattera Headache, Nausea, Vomiting
4096605 4299707 8 Years F 11/14/2003 1/26/2004 73 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Constipation, Dysphagia, Headache, Heart Rate Increased
4096606 4299731 8 Years M 1/1/2003 11/14/2003 1/26/2004 73 CN PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Decreased Appetite, Disturbance in Attention, Mood Swings, Vomiting, Weight Decreased
4096608 4299679 11 Years M 6/1/2003 10/9/2003 1/26/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Memory Impairment
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4096609 4299708 5 Years M 11/7/2003 11/11/2003 1/26/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Decreased Appetite, Somnolence, Vomiting
4096610 4299732 16 Years F 11/1/2003 11/14/2003 1/26/2004 73 CN PER Strattera Abnormal Behaviour, Insomnia, Mood Swings, Paranoia
4096610 4806566 16 Years F 11/1/2003 9/29/2005 10/19/2005 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Hypersomnia, Insomnia, Irritability, Mood Swings, Paranoia, Psychotic Disorder Hospitalization - Initial or Prolonged
4096612 4299680 8 Years M 9/24/2003 1/26/2004 124 PH PER Strattera Enuresis
4096614 4299733 17 Years F 11/14/2003 1/26/2004 73 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Decreased
4096615 4299709 36 Years F 10/1/2003 11/11/2003 1/26/2004 76 PER Strattera Depression Headache, Infection, Psychomotor Hyperactivity, Vision Blurred
4096616 4299682 12 Years M 9/24/2003 1/26/2004 124 OT PER Strattera Attention Deficit/Hyperactivity Disorder Epistaxis, Increased Tendency to Bruise, Nausea
4096617 4299710 44 Years F 11/11/2003 1/26/2004 76 PER Strattera Blood Pressure Increased, Urine Odour Abnormal
4096618 4299711 12 Years M 11/11/2003 1/26/2004 76 MD PER Strattera Attention Deficit/Hyperactivity Disorder Mydriasis, Vision Blurred
4096619 4299683 8 Years M 9/24/2003 1/26/2004 124 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Drug Ineffective, Nightmare, Retching
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4096622 4299712 14 Years M 11/11/2003 11/11/2003 1/26/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Fatigue, Nausea
4096623 4299753     M 11/12/2003 1/26/2004 75 MD PER Strattera Drug Screen Positive
4096625 4299737 10 Years M 11/17/2003 1/26/2004 70 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety
4096626 4299713 8 Years M 11/11/2003 1/26/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Faecaloma
4096627 4299754     F 11/12/2003 1/26/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Drug Ineffective, Hypotension
4096627 4637505 42 Years F 11/30/2004 3/28/2005 118 PER Strattera Dizziness, Drug Ineffective, Fatigue, Hypotension, Somnolence
4096628 4299714     M 11/11/2003 1/26/2004 76 PH PER Strattera Gastrointestinal Disorder
4096629 4299755 10 Years M 1/1/2003 11/12/2003 1/26/2004 75 MD PER Strattera Tic Tic
4096631 4301619 48 Years M 9/9/2003 10/1/2003 1/26/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Testicular Pain, Testicular Swelling
4096632 4299756 16 Years F 11/12/2003 11/12/2003 1/26/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Dizziness, Fatigue, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4096634 4299757 11 Years M 10/1/2003 11/12/2003 1/26/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Drug Ineffective, Mood Swings
4096635 4301660 10 Years F 10/1/2003 1/26/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Somnolence
4096636 4299758 11 Years M 11/12/2003 1/26/2004 75 MD PER Strattera Attention Deficit/Hyperactivity Disorder Mania
4096637 4299741 6 Years M 1/1/2003 11/17/2003 1/26/2004 70 CN PER Strattera Attention Deficit/Hyperactivity Disorder Middle Insomnia, Night Cramps
4096639 4299759 10 Years M 10/1/2003 11/12/2003 1/26/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Increased
4096640 4301663 10 Years M 9/1/2003 10/1/2003 1/26/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Fatigue, Insomnia, Sluggishness
4096641 4301544 12 Years 9/17/2003 1/26/2004 131 PER Strattera Suicidal Ideation
4096644 4299760 12 Years M 11/11/2003 11/12/2003 1/26/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Psychomotor Hyperactivity
4096645 4301546 9 Years M 1/1/2003 10/1/2003 1/26/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Somnolence, Tic
4096647 4299761 68 Years M 10/1/2003 11/13/2003 1/26/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Hyperhidrosis, Impulsive Behaviour, Mood Swings, Muscle Rigidity, Myalgia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4096648 4299762     M 11/13/2003 11/13/2003 1/26/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
4096649 4299684 14 Years M 9/24/2003 9/24/2003 1/26/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Hypersensitivity, Pruritus, Swelling, Urticaria Other
4096651 4299685 16 Years M 9/24/2003 1/26/2004 124 PER Strattera
4096653 4301670 11 Years M 9/10/2003 10/1/2003 1/26/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Dyspepsia, Fatigue, Hot Flush, Hyperhidrosis, Somnolence
4096656 4301705 7 Years M 10/2/2003 10/2/2003 1/26/2004 116 CN PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Retching
4096657 4299769 8 Years M 11/14/2003 1/26/2004 73 MD PER Strattera Dysuria, Pollakiuria
4096658 4301706 12 Years 10/1/2003 10/1/2003 1/26/2004 117 CN PER Strattera Cough, Nasopharyngitis, Psychomotor Hyperactivity
4096659 4299770 6 Years M 10/28/2003 11/14/2003 1/26/2004 73 PER Strattera Attention Deficit/Hyperactivity Disorder Emotional Distress, Retching
4096660 4299686 9 Years M 9/24/2003 9/24/2003 1/26/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dyspepsia, Fatigue, Headache, Heart Rate Increased, Hyperhidrosis, Nausea, Somnolence, Vomiting
4096660 4349170 9 Years M 9/24/2003 1/6/2004 3/29/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dyspepsia, Fatigue, Headache, Heart Rate Increased, Hyperhidrosis, Nausea, Somnolence, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4096661 4299771 18 Years M 11/14/2003 1/26/2004 73 MD PER Strattera Pubic Pain
4096662 4301709 11 Years F 8/1/2003 10/2/2003 1/26/2004 116 OT PER Strattera Attention Deficit/Hyperactivity Disorder Mydriasis
4096663 4299772 52 Years F 11/12/2003 11/14/2003 1/26/2004 73 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Disturbance in Attention, Fatigue, Trance
4096664 4301548 12 Years 9/17/2003 1/26/2004 131 PER Strattera Suicidal Ideation
4096665 4299690 34 Years F 9/22/2003 9/24/2003 1/26/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Agitation, Decreased Appetite, Dissociation, Dry Mouth, Fatigue, Nervousness, Thinking Abnormal
4096666 4301710 9 Years F 1/1/2003 10/2/2003 1/26/2004 116 CN PER Strattera Abdominal Pain Upper, Angina Pectoris, Crying, Feeling Abnormal, Mydriasis
4096667 4301712 6 Years M 9/30/2003 10/2/2003 1/26/2004 116 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Eye Rolling, Logorrhoea, Muscle Twitching, Restlessness, Tic
4096668 4299691     M 9/24/2003 1/26/2004 124 MD PER Strattera Tic
4096669 4301550 12 Years 9/17/2003 1/26/2004 131 PER Strattera Suicidal Ideation
4096670 4301714     M 10/2/2003 1/26/2004 116 MD PER Strattera Eye Rolling, Feeling Abnormal, Mydriasis
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4096671 4301553 12 Years 9/17/2003 1/26/2004 131 PER Strattera Suicidal Ideation
4096672 4301556 12 Years 9/17/2003 1/26/2004 131 PER Strattera Suicidal Ideation
4096673 4299647 8 Years M 9/5/2003 9/24/2003 1/26/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Cough, Dyspepsia, Fatigue, Malaise, Pyrexia, Rhinorrhoea
4096674 4301570 12 Years 9/17/2003 1/26/2004 131 PER Strattera Suicidal Ideation
4096675 4301575 10 Years F 9/1/2003 10/1/2003 1/26/2004 117 PER Strattera Phobia
4096676 4299657 8 Years 9/18/2003 1/26/2004 130 MD PER Strattera Psychomotor Hyperactivity
4096677 4301576 7 Years F 10/1/2003 1/26/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Psychomotor Hyperactivity, Weight Increased
4096679 4301580 7 Years M 9/1/2003 10/1/2003 1/26/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Psychomotor Hyperactivity
4096680 4299660 12 Years M 9/23/2003 1/26/2004 125 MD PER Strattera Attention Deficit/Hyperactivity Disorder Gastrointestinal Disorder
4096683 4299661 19 Years M 9/24/2003 1/26/2004 124 OT PER Strattera Penile Discharge
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4096685 4299664 10 Years M 9/24/2003 1/26/2004 124 MD PER Strattera Abnormal Behaviour, Aggression
4096686 4299666 14 Years F 9/24/2003 1/26/2004 124 MD PER Strattera Attention Deficit/Hyperactivity Disorder Flushing, Heart Rate Increased
4096686 4349169 14 Years F 9/23/2003 1/6/2004 3/29/2004 83 MD PER Strattera Attention Deficit/Hyperactivity Disorder Flushing, Heart Rate Increased
4096687 4299667 55 Years F 9/24/2003 1/26/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Dysgeusia
4096688 4299669 6 Years M 9/24/2003 1/26/2004 124 PER Strattera Decreased Appetite, Feeling Abnormal, Vomiting, Weight Decreased
4096690 4299671 9 Years F 9/21/2003 9/24/2003 1/26/2004 124 PER Strattera Abdominal Pain Upper, Drug Withdrawal Headache, Headache
4096692 4299673 47 Years F 9/24/2003 9/24/2003 1/26/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Fatigue
4096694 4299853 11 Years M 11/19/2003 1/26/2004 68 MD PER Strattera Abnormal Behaviour
4096696 4299854 7 Years M 11/18/2003 11/19/2003 1/26/2004 68 CN PER Strattera Drug Ineffective, Psychomotor Hyperactivity
4096697 4299855 20 Years M 11/1/2003 11/19/2003 1/26/2004 68 MD PER Strattera Depression Hypomania
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4096697 4313368 20 Years M 11/1/2003 2/17/2004 3/4/2004 16 MD EXP Strattera Depression Bipolar I Disorder, Hypomania Hospitalization - Initial or Prolonged, Other
4096698 4299856     M 11/1/2003 11/19/2003 1/26/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Incontinence, Insomnia
4096706 4299857 35 Years M 10/1/2003 11/20/2003 1/26/2004 67 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4096708 4299858 14 Years M 11/20/2003 11/25/2003 1/26/2004 62 OT PER Strattera Abdominal Pain Upper, Decreased Appetite, Fatigue, Headache, Hypersomnia, Pallor
4096710 4299859 28 Years M 10/1/2003 11/17/2003 1/26/2004 70 MD PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Somnolence
4096711 4299860 12 Years M 11/14/2003 12/16/2003 1/26/2004 41 OT PER Strattera Attention Deficit/Hyperactivity Disorder Viral Infection
4096711 4335942 12 Years M 11/14/2003 12/16/2003 3/29/2004 104 OT PER Strattera Attention Deficit/Hyperactivity Disorder Viral Infection
4096713 4299862 12 Years 11/19/2003 1/26/2004 68 PER Strattera Fatigue, Malaise
4096738 4301804 12 Years 9/26/2003 1/26/2004 122 OT PER Strattera Psychomotor Hyperactivity
4096739 4301807 12 Years 9/26/2003 1/26/2004 122 OT PER Strattera Psychomotor Hyperactivity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4096740 4301808 42 Years F 9/1/2003 10/2/2003 1/26/2004 116 PER Strattera Bradyphrenia, Insomnia
4096741 4301809 9 Years F 10/2/2003 1/26/2004 116 PER Strattera Alopecia
4096742 4301811 7 Years F 9/1/2003 10/6/2003 1/26/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Dyspepsia, Eructation, Weight Decreased
4096743 4301815 10 Years M 10/2/2003 1/26/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Somnolence
4096745 4301817 6 Years M 9/19/2003 10/2/2003 1/26/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Mood Swings
4096746 4301819 44 Years F 8/20/2003 10/16/2003 1/26/2004 102 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dysphagia, Oesophageal Spasm
4096750 4301822 48 Years F 10/3/2003 1/26/2004 115 OT PER Strattera Anxiety, Feeling Jittery, Hyperhidrosis, Restless Legs Syndrome
4096804 4296877 19 Years F 9/8/2003 1/26/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness
4096837 4301085 12 Years 2/2/2004 2/18/2004 16 MD EXP Strattera Loss of Consciousness, Tic Other
4096839 4301086 18 Years M 8/1/2003 2/4/2004 2/18/2004 14 EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Agitation, Eye Movement Disorder, Insomnia, Suicidal Ideation Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4096839 4336522 18 Years M 8/7/2003 3/22/2004 4/7/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Emotional Disorder, Eye Movement Disorder, Impulse-Control Disorder, Insomnia, Legal Problem, Suicidal Ideation Hospitalization - Initial or Prolonged
4096839 4662377 18 Years M 8/4/2003 4/25/2005 5/12/2005 17 EXP Strattera Abnormal Behaviour, Affect Lability, Aggression, Anger, Corneal Reflex Decreased, Drug Interaction, Eye Movement Disorder, Impaired Work Ability, Irritability, Mood Altered, Suicidal Ideation Hospitalization - Initial or Prolonged
4096844 4299736     F 10/1/2003 11/12/2003 1/26/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Nausea
4097650 4299840 60 Years F 1/1/2003 12/15/2003 1/26/2004 42 MD PER Strattera Attention Deficit/Hyperactivity Disorder Flushing, Hyperhidrosis, Hyperthermia, Middle Insomnia
4097650 4335572 60 Years F 1/1/2003 12/15/2003 3/29/2004 105 MD PER Strattera Attention Deficit/Hyperactivity Disorder Flushing, Hyperhidrosis, Hyperthermia, Middle Insomnia
4097706 4302143 12 Years M 10/7/2003 10/7/2003 1/26/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Lethargy, Rhinorrhoea
4097707 4302157 6 Years F 10/7/2003 1/26/2004 111 PH PER Strattera Stomatitis
4097708 4302158 14 Years M 10/4/2003 10/7/2003 1/26/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Belligerence, Fatigue, Nausea, Psychomotor Hyperactivity
4097711 4302160 11 Years M 10/7/2003 10/7/2003 1/26/2004 111 PER Strattera Infection, Rash
4097715 4302164 4 Years M 10/7/2003 10/7/2003 1/26/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Mood Swings
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4097718 4302168 13 Years M 10/1/2003 10/8/2003 1/26/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Overdose
4097721 4302172 9 Years M 9/1/2003 10/8/2003 1/26/2004 110 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Headache, Personality Change
4097723 4302176 13 Years M 10/8/2003 10/8/2003 1/26/2004 110 PER Strattera Aggression, Dizziness, Fatigue, Mood Swings, Thirst
4097724 4302178 9 Years F 1/1/2003 10/8/2003 1/26/2004 110 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Disturbance in Attention, Drug Ineffective, Headache
4097725 4302183 7 Years F 10/8/2003 1/26/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Retching
4097727 4302185 10 Years M 10/1/2003 10/8/2003 1/26/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Drug Ineffective, Dry Mouth, Fatigue, Headache, Insomnia, Mood Swings, Nausea, Restlessness
4097731 4302188     M 9/16/2003 10/8/2003 1/26/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Epistaxis, Fatigue
4097732 4302191 9 Years M 10/6/2003 10/8/2003 1/26/2004 110 PER Strattera Nervousness Abnormal Behaviour, Insomnia
4097734 4302193     M 10/7/2003 10/7/2003 1/26/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Irritability, Mood Swings, Movement Disorder, Social Avoidant Behaviour, Somnolence
4097736 4302196 12 Years 10/8/2003 1/26/2004 110 PER Strattera Stomatitis
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4097738 4302199 8 Years M 10/1/2003 10/8/2003 1/26/2004 110 OT PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Personality Change
4097740 4302203 7 Years M 6/1/2003 10/8/2003 1/26/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Drug Interaction, Dyspepsia, Fear, Hyperhidrosis, Panic Attack, Psychiatric Symptom, Respiratory Rate Increased
4097742 4302206 7 Years M 9/1/2003 10/8/2003 1/26/2004 110 PER Strattera Pallor
4097743 4299813 11 Years M 1/1/2003 11/18/2003 1/26/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anorexia, Dizziness, Mood Swings, Weight Decreased
4097745 4302210 10 Years M 1/1/2003 10/8/2003 1/26/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Heart Rate Increased, Weight Decreased, Weight Increased
4097747 4302214 8 Years M 10/1/2003 10/8/2003 1/26/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Mastication Disorder, Tic, Traumatic Ulcer
4097751 4302252 7 Years M 10/1/2003 10/22/2003 1/26/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Dizziness, Drug Ineffective, Ear Infection, Fatigue, Headache, Heart Rate Increased, Pallor, Somnolence, Vomiting
4097751 4501296 7 Years M 10/1/2003 6/24/2004 9/27/2004 95 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anger, Decreased Appetite, Dizziness, Drug Ineffective, Dyskinesia, Ear Infection, Fatigue, Headache, Heart Rate Increased, Mood Swings, Pallor, Psychotic Disorder, Somnolence, Vomiting, Weight Decreased
4097752 4299834 6 Years F 11/18/2003 1/26/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder
4097753 4302254 7 Years F 10/8/2003 10/8/2003 1/26/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder, Disturbance in Attention Drug Ineffective, Psychomotor Hyperactivity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4097754 4302255 6 Years F 10/1/2003 10/9/2003 1/26/2004 109 PER Strattera Contusion
4097756 4302257     F 10/8/2003 1/26/2004 110 PH PER Strattera Drug Screen Positive
4097757 4302258 6 Years F 1/1/2003 10/9/2003 1/26/2004 109 PER Strattera Decreased Appetite, Insomnia, Irritability
4097758 4302260 46 Years F 10/1/2003 10/9/2003 1/26/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Confusional State, Depression, Somnolence
4097759 4302261 10 Years M 10/9/2003 1/26/2004 109 MD PER Strattera Chest Pain, Tachycardia
4097760 4302262 11 Years M 1/1/2003 10/9/2003 1/26/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Fatigue, Headache, Mood Swings, Psychomotor Hyperactivity
4097762 4302263 9 Years F 10/8/2003 10/9/2003 1/26/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Decreased Appetite, Dysuria
4097763 4302264 17 Years F 1/1/2003 10/9/2003 1/26/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Headache, Nausea, Vomiting
4097764 4302265 9 Years F 1/1/2003 10/9/2003 1/26/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Early Morning Awakening, Fatigue, Insomnia
4097765 4302267 9 Years M 9/21/2003 10/9/2003 1/26/2004 109 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4097766 4302268 45 Years F 1/1/2003 10/9/2003 1/26/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Angina Pectoris, Apathy, Constipation, Depression, Eating Disorder, Eye Pain, Fatigue, Feeling Abnormal, Headache, Irritability, Lethargy, Memory Impairment, Sleep Disorder, Suicidal Ideation
4097767 4302270 11 Years M 1/1/2003 10/9/2003 1/26/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Irritability
4097768 4302272 7 Years M 1/1/2003 10/9/2003 1/26/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation
4097769 4302274 8 Years M 10/8/2003 10/9/2003 1/26/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Dysphagia, Retching
4097771 4302276 8 Years F 10/2/2003 10/9/2003 1/26/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Dysphagia, Retching
4097774 4302281     M 1/1/2003 10/10/2003 1/26/2004 108 PER Strattera Disturbance in Attention Body Temperature Decreased, Burning Sensation, Constipation, Defaecation Urgency, Drug Ineffective, Feeling Abnormal, Nausea, Vomiting
4097775 4302288 8 Years F 10/8/2003 10/10/2003 1/26/2004 108 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Skin Chapped
4097776 4299792 14 Years M 11/18/2003 1/26/2004 69 MD PER Strattera Fatigue, Hallucination (Visual)
4097777 4302320 5 Years M 9/1/2003 10/3/2003 1/26/2004 115 MD PER Strattera Attention Deficit/Hyperactivity Disorder Pollakiuria
4097780 4302324 12 Years M 10/3/2003 1/26/2004 115 MD PER Strattera Tachycardia Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4097786 4302325 15 Years M 10/3/2003 1/26/2004 115 OT PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4097791 4302326 6 Years F 10/1/2003 10/3/2003 1/26/2004 115 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4097794 4302327 55 Years F 10/21/2003 1/26/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Anorgasmia, Increased Appetite, Somnolence
4097795 4302328 5 Years M 8/1/2003 10/2/2003 1/26/2004 116 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Elevated Mood, Insomnia, Psychomotor Hyperactivity
4097796 4302329 8 Years F 10/3/2003 1/26/2004 115 OT PER Strattera Attention Deficit/Hyperactivity Disorder Mood Swings, Tic
4097798 4302330 35 Years F 10/3/2003 1/26/2004 115 MD PER Strattera Attention Deficit/Hyperactivity Disorder Arthralgia, Constipation, Dry Mouth, Dysstasia, Insomnia, Joint Stiffness, Joint Swelling, Musculoskeletal Stiffness, Nausea, Oedema Peripheral, Pain, Pain in Extremity, Palpitations, Weight Decreased
4097799 4302331 11 Years F 10/3/2003 1/26/2004 115 PER Strattera Choking
4097800 4302332 20 Years M 9/1/2003 10/3/2003 1/26/2004 115 MD PER Strattera Mania
4097802 4302335 12 Years F 10/10/2003 10/10/2003 1/26/2004 108 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Dizziness, Feeling Abnormal, Vomiting
4097803 4302336 6 Years F 10/8/2003 10/10/2003 1/26/2004 108 PER Strattera Attention Deficit/Hyperactivity Disorder Eye Swelling, Fatigue, Impulse-Control Disorder, Rash, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4097804 4302338 10 Years F 1/1/2003 10/10/2003 1/26/2004 108 PER Strattera Abnormal Behaviour, Agitation, Anger, Educational Problem, Headache
4097805 4302339 38 Years M 10/10/2003 1/26/2004 108 MD PER Strattera Attention Deficit/Hyperactivity Disorder Muscle Cramp
4097806 4302343 13 Years F 10/1/2003 10/10/2003 1/26/2004 108 PER Strattera Abdominal Pain Upper, Dizziness, Hot Flush, Somnolence
4097810 4302356 8 Years M 1/1/2003 10/10/2003 1/26/2004 108 PER Strattera Attention Deficit/Hyperactivity Disorder Weight Increased
4097812 4302360     F 10/10/2003 1/26/2004 108 OT PER Strattera Abnormal Behaviour, Dizziness, Feeling Abnormal, Nausea, Somnolence
4097813 4302362 8 Years F 10/9/2003 10/10/2003 1/26/2004 108 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Crying, Eating Disorder, Somnolence, Vomiting
4097817 4302364 12 Years M 10/10/2003 1/26/2004 108 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Drug Ineffective, Feeling Abnormal
4097822 4302370 13 Years M 11/24/2003 12/10/2003 1/26/2004 47 PER Strattera Asthma, Dizziness, Dyspepsia, Insomnia, Nausea, Psychomotor Hyperactivity, Somnolence
4097822 4349287 13 Years M 11/24/2003 12/10/2003 3/29/2004 110 PER Strattera Asthma, Dizziness, Dyspepsia, Insomnia, Nausea, Psychomotor Hyperactivity, Somnolence
4097822 4580214 13 Years M 1/1/2003 8/30/2004 1/27/2005 150 CN PER Strattera Asthma, Dizziness, Drug Ineffective, Dyspepsia, Insomnia, Mood Swings, Nausea, Psychomotor Hyperactivity, Somnolence, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4097824 4302372 11 Years F 1/1/2003 12/8/2003 1/26/2004 49 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Headache, Visual Disturbance
4097824 4349601 11 Years F 1/1/2003 12/8/2003 3/29/2004 112 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Headache, Visual Disturbance
4097827 4302374 13 Years F 10/13/2003 1/26/2004 105 MD PER Strattera Sleep Disorder
4097828 4302376 38 Years M 10/13/2003 1/26/2004 105 MD PER Strattera Attention Deficit/Hyperactivity Disorder Penile Pain, Testicular Pain
4097829 4302378 8 Years F 10/13/2003 10/13/2003 1/26/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
4097831 4302379     M 10/9/2003 10/13/2003 1/26/2004 105 PER Strattera Anhidrosis, Cold Sweat, Decreased Appetite, Erectile Dysfunction, Feeling Abnormal
4097832 4302381 8 Years F 1/1/2003 10/14/2003 1/26/2004 104 PER Strattera Disturbance in Attention, Drug Ineffective, Emotional Distress
4097833 4302383 12 Years M 3/4/2003 11/7/2003 1/26/2004 80 MD PER Strattera Dizziness, Hyperhidrosis
4097834 4302384 10 Years M 1/1/2003 10/14/2003 1/26/2004 104 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dermatitis Exfoliative
4097836 4302385 30 Years F 10/13/2003 10/14/2003 1/26/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Nausea, Tremor
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4097837 4302386 10 Years M 10/13/2003 1/26/2004 105 MD PER Strattera Attention Deficit/Hyperactivity Disorder Paranoia
4097838 4302387 13 Years M 10/10/2003 1/26/2004 108 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger
4097839 4302388 14 Years M 10/3/2003 1/26/2004 115 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4097841 4302389 12 Years 12/9/2003 1/26/2004 48 MD PER Strattera Psychotic Disorder
4097841 4349286 12 Years 12/9/2003 3/29/2004 111 MD PER Strattera Psychotic Disorder
4097842 4302390 9 Years F 10/1/2003 10/13/2003 1/26/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Drug Ineffective, Nervousness
4097844 4302391 9 Years M 10/10/2003 10/13/2003 1/26/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Body Temperature Decreased, Chills, Dizziness, Emotional Distress, Feeling Abnormal, Memory Impairment
4097845 4302392 14 Years F 10/13/2003 1/26/2004 105 MD PER Strattera Weight Increased
4097847 4302393 5 Years F 10/13/2003 1/26/2004 105 PER Strattera Anorexia, Hyperhidrosis, Rash, Somnolence, Vomiting
4097849 4302394 46 Years F 10/10/2003 10/13/2003 1/26/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Fatigue, Hypogeusia, Insomnia, Nasopharyngitis, Nausea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4097851 4302395 8 Years M 10/1/2003 10/13/2003 1/26/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Lethargy, Masked Facies, Sleep Talking, Tremor
4097864 4302078 12 Years M 9/4/2003 1/26/2004 144 OT PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Swelling Face, Vomiting
4097865 4302068     F 9/2/2003 1/26/2004 146 MD PER Strattera Jaundice
4097867 4302066 9 Years M 8/28/2003 1/26/2004 151 PER Strattera Aggression, Drug Ineffective
4097868 4302064     M 8/28/2003 1/26/2004 151 MD PER Strattera Penile Discharge, Testicular Pain
4097869 4302063 7 Years F 8/27/2003 1/26/2004 152 PER Strattera Attention Deficit/Hyperactivity Disorder Dysphemia
4097871 4302061 12 Years M 8/22/2003 1/26/2004 157 PER Strattera Dry Skin, Rash Pruritic
4097872 4302060 19 Years M 8/25/2003 1/26/2004 154 PER Strattera Disturbance in Attention Disturbance in Attention, Nausea, Somnolence
4097873 4302022 18 Years M 9/12/2003 1/26/2004 136 PER Strattera Decreased Appetite, Decreased Interest, Feeling Abnormal, Hypersomnia, Lethargy, Personality Change, Weight Decreased
4097874 4302013 48 Years F 8/7/2003 1/26/2004 172 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Sleep-Related Event, Anger, Arthralgia, Crying, Decreased Appetite, Depression, Dizziness, Dyspnoea, Eye Disorder, Fatigue, Feeling Abnormal, Feeling Hot and Cold, Headache, Incoherent, Irritability, Lethargy, Mood Swings, Nausea, Pain, Palpitations, Paraesthesia, Psychotic Disorder, Somnolence, Swelling, Tremor, Urinary Incontinence, Urinary Retention, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4097875 4302012 8 Years M 3/1/2003 8/29/2003 1/26/2004 150 PER Strattera Headache, Intestinal Functional Disorder, Mood Swings, Vomiting, Weight Decreased
4097876 4302099 16 Years 10/2/2003 1/26/2004 116 MD PER Strattera Attention Deficit/Hyperactivity Disorder Flat Affect
4097877 4302097     F 10/2/2003 1/26/2004 116 MD PER Strattera Tooth Discolouration
4097878 4302093     M 10/1/2003 1/26/2004 117 MD PER Strattera Aggression, Intentional Self-Injury
4097879 4302091 12 Years 9/30/2003 1/26/2004 118 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Nausea, Throat Irritation
4097881 4302089     M 9/15/2003 1/26/2004 133 MD PER Strattera Micturition Disorder
4097882 4302087 10 Years M 9/9/2003 1/26/2004 139 PER Strattera Anger, Depression, Mood Altered
4097884 4302084 17 Years M 9/15/2003 1/26/2004 133 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Heart Rate Increased, Hyperhidrosis
4097886 4302083 55 Years F 9/4/2003 1/26/2004 144 MD PER Strattera Nervousness, Tachycardia
4097888 4302081 10 Years M 9/10/2003 1/26/2004 138 PER Strattera Rash Pruritic, Swelling Face
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4097889 4302079 10 Years M 9/2/2003 1/26/2004 146 PER Strattera Decreased Appetite, Somnolence
4097890 4302138 12 Years 10/17/2003 1/26/2004 101 MD PER Strattera Disturbance in Attention
4097891 4302136     F 10/20/2003 1/26/2004 98 OT PER Strattera Abnormal Behaviour, Disturbance in Attention
4097892 4302134 7 Years F 10/15/2003 1/26/2004 103 PER Strattera Abnormal Behaviour, Crying, Emotional Disorder, Fear, Screaming
4097893 4302131 16 Years 10/15/2003 1/26/2004 103 MD PER Strattera Anger, Mood Swings
4097894 4302115     M 10/15/2003 1/26/2004 103 MD PER Strattera Depression
4097895 4302112 11 Years M 10/14/2003 1/26/2004 104 OT PER Strattera Anger, Crying, Irritability
4097896 4302110 13 Years M 12/8/2003 1/26/2004 49 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4097896 4337881 13 Years M 12/8/2003 3/29/2004 112 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4097899 4302104     F 10/3/2003 1/26/2004 115 MD PER Strattera Premenstrual Syndrome Premenstrual Syndrome
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4097900 4302103     F 10/2/2003 1/26/2004 116 MD PER Strattera Hyperhidrosis
4097901 4302101     F 10/3/2003 1/26/2004 115 MD PER Strattera Premenstrual Syndrome Premenstrual Syndrome
4097902 4302182     F 11/11/2003 1/26/2004 76 MD PER Strattera Panic Attack
4097903 4302179 12 Years 11/5/2003 1/26/2004 82 MD PER Strattera Agitation
4097904 4302177 11 Years F 11/10/2003 1/26/2004 77 PER Strattera Anxiety, Dyspepsia
4097905 4301512 8 Years F 9/1/2003 9/30/2003 1/26/2004 118 MD PER Strattera Corneal Disorder
4097906 4302174 8 Years M 11/7/2003 1/26/2004 80 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Depression
4097907 4302173 10 Years M 11/6/2003 1/26/2004 81 OT PER Strattera Tic
4097909 4302169 12 Years F 10/29/2003 1/26/2004 89 MD PER Strattera Sexual Activity Increased
4097910 4302167 12 Years 10/29/2003 1/26/2004 89 MD PER Strattera Depression
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4097911 4302165 12 Years 10/24/2003 1/26/2004 94 MD PER Strattera Anger, Nervousness
4097913 4302150 12 Years 10/16/2003 1/26/2004 102 MD PER Strattera Disturbance in Attention, Lethargy
4097915 4301812 9 Years M 8/1/2003 10/7/2003 1/26/2004 111 PER Strattera Abnormal Behaviour, Disturbance in Attention, Drug Ineffective, Dyspepsia, Nervousness
4097916 4301814 13 Years F 1/1/2003 10/7/2003 1/26/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder, Depression Dyspnoea, Lethargy, Mononucleosis Syndrome
4097917 4301825 7 Years M 1/1/2003 10/7/2003 1/26/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Dysphagia, Somnolence, Stomach Discomfort, Vomiting
4097918 4299744 9 Years M 11/1/2003 11/12/2003 1/26/2004 75 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4097919 4301827 46 Years M 9/8/2003 10/7/2003 1/26/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Dysuria, Hot Flush, Hyperhidrosis, Urinary Retention
4097920 4301828 11 Years F 9/1/2003 10/7/2003 1/26/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Emotional Disorder, Fatigue, Somnolence
4097921 4301830 8 Years M 10/7/2003 1/26/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Vomiting
4097922 4301836 4 Years 10/7/2003 1/26/2004 111 MD PER Strattera Pyrexia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4097923 4299746 7 Years M 12/23/2003 1/26/2004 34 MD PER Strattera Drug Interaction, Electrocardiogram QT Corrected Interval Prolonged Other
4097924 4301845 16 Years F 10/7/2003 10/7/2003 1/26/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Pyrexia
4097925 4301854 9 Years 10/7/2003 1/26/2004 111 MD PER Strattera Pyrexia
4097926 4299747     F 11/1/2003 11/12/2003 1/26/2004 75 PER Strattera Disturbance in Attention, Drug Ineffective, Impulsive Behaviour
4097927 4301879 16 Years F 10/7/2003 1/26/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Dyspepsia, Mood Swings
4097928 4301783 45 Years F 8/1/2003 10/6/2003 1/26/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Dysgeusia, Postmenopausal Haemorrhage
4097929 4299752 7 Years M 10/1/2003 11/12/2003 1/26/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort, Phobia
4097930 4301788 10 Years M 9/1/2003 10/6/2003 1/26/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Dyskinesia, Muscle Twitching
4097931 4301790 59 Years M 10/6/2003 1/26/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Micturition Disorder, Middle Insomnia
4097933 4301791 14 Years M 10/6/2003 1/26/2004 112 PH PER Strattera
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4097934 4301792 12 Years F 1/1/2003 10/6/2003 1/26/2004 112 MD PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence, Tic
4097936 4301795     F 10/6/2003 10/6/2003 1/26/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Jittery
4097937 4301796 13 Years F 7/1/2003 10/6/2003 1/26/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Binge Eating, Derealisation, Hyperphagia, Impulsive Behaviour, Insomnia, Mental Impairment
4097938 4301799 50 Years F 10/1/2003 10/6/2003 1/26/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal
4097940 4301802 7 Years M 10/7/2003 1/26/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective
4098024 4302677 14 Years M 1/1/2003 10/14/2003 1/26/2004 104 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anorexia, Diarrhoea, Dyspepsia, Migraine, Weight Decreased
4098025 4302678 12 Years M 10/21/2003 1/26/2004 97 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Fight In School
4098028 4302679     M 11/4/2003 1/26/2004 83 MD PER Strattera Drug Ineffective, Intentional Overdose
4098030 4301757 11 Years M 9/30/2003 10/2/2003 1/26/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4098032 4301760 7 Years M 9/29/2003 12/2/2003 1/26/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Lip Dry, Nausea, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4098032 4349197 7 Years M 9/29/2003 12/2/2003 3/29/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Lip Dry, Nausea, Vomiting
4098033 4302680 9 Years M 10/14/2003 1/26/2004 104 MD PER Strattera Urinary Retention
4098035 4301762 44 Years M 9/25/2003 10/20/2003 1/26/2004 98 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea
4098036 4302681 9 Years M 10/12/2003 1/26/2004 106 CN PER Strattera Hallucination
4098041 4301782 8 Years M 10/2/2003 1/26/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Fight In School, Irritability, Mood Swings, Mydriasis
4098044 4301785 14 Years M 10/2/2003 10/2/2003 1/26/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Eye Swelling, Somnolence
4098049 4301786     M 1/1/2003 10/2/2003 1/26/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal
4098055 4301787 9 Years M 10/2/2003 1/26/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention
4098060 4302683 47 Years M 10/17/2002 1/26/2004 466 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anaemia, Gastrointestinal Haemorrhage, Oesophageal Disorder
4098061 4301789 46 Years F 8/13/2003 11/21/2003 1/26/2004 66 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Tachycardia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4098061 4349283 46 Years F 8/13/2003 11/21/2003 3/29/2004 129 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Tachycardia
4098065 4302685 8 Years M 1/1/2003 10/14/2003 1/26/2004 104 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Crying, Irritability, Mood Swings
4098067 4302686 11 Years M 7/26/2003 10/14/2003 1/26/2004 104 CN PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Disturbance in Attention, Fatigue, Headache, Mydriasis, Somnolence
4098072 4302689 12 Years M 10/14/2003 1/26/2004 104 MD PER Strattera Attention Deficit/Hyperactivity Disorder Bone Pain, Pain in Extremity
4098073 4302691 8 Years F 10/1/2003 10/14/2003 1/26/2004 104 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Educational Problem
4098082 4302635 11 Years M 10/2/2003 10/10/2003 1/26/2004 108 PER Strattera Psychomotor Hyperactivity Abdominal Pain Upper, Confusional State, Disturbance in Attention, Drug Ineffective, Emotional Disorder, Memory Impairment, Psychomotor Hyperactivity, Somnolence
4098083 4302636 12 Years 11/11/2003 1/26/2004 76 MD PER Strattera Hypothermia, Viral Infection
4098085 4302637 12 Years 11/11/2003 1/26/2004 76 MD PER Strattera Hypothermia, Viral Infection
4098088 4302639 9 Years M 9/27/2003 10/10/2003 1/26/2004 108 PER Strattera Attention Deficit/Hyperactivity Disorder Cough, Increased Appetite, Mood Swings, Nasopharyngitis, Vomiting
4098089 4302651 15 Years M 10/1/2003 10/13/2003 1/26/2004 105 PER Strattera Anorexia, Decreased Interest, Epistaxis, Gingival Bleeding, Insomnia, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4098092 4302654 12 Years F 10/10/2003 10/13/2003 1/26/2004 105 PER Strattera Dizziness, Vomiting
4098094 4302657     M 7/1/2003 10/13/2003 1/26/2004 105 PER Strattera Disturbance in Attention, Psychomotor Hyperactivity, Somnolence
4098095 4302670     M 10/13/2003 1/26/2004 105 PER Strattera
4098097 4302671 10 Years M 10/6/2003 10/15/2003 1/26/2004 103 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Eye Disorder, Somnolence
4098100 4302672     F 10/11/2003 10/13/2003 1/26/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Agitation, Anxiety, Chills, Crying, Decreased Appetite, Disturbance in Attention, Feeling Abnormal, Feeling Jittery, Insomnia, Psychomotor Agitation
4098103 4302736 33 Years M 10/14/2003 1/26/2004 104 MD PER Strattera Ejaculation Disorder
4098104 4302738 6 Years M 10/14/2003 1/26/2004 104 CN PER Strattera Drug Interaction, Tachycardia, Tic
4098106 4302745 7 Years M 10/15/2003 1/26/2004 103 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Eating Disorder
4098108 4302774 6 Years M 10/15/2003 10/15/2003 1/26/2004 103 CN PER Strattera Attention Deficit/Hyperactivity Disorder Fall, Retching
4098109 4302781 7 Years M 1/1/2003 10/14/2003 1/26/2004 104 CN PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Gastroenteritis Viral, Headache, Irritability
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4098111 4302783     M 10/15/2003 1/26/2004 103 CN PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Emotional Distress, Fatigue, Middle Insomnia
4098112 4302790 7 Years F 10/14/2003 1/26/2004 104 PER Strattera
4098115 4302792 12 Years M 9/1/2003 10/15/2003 1/26/2004 103 OT PER Strattera
4098118 4302795 8 Years 10/14/2003 1/26/2004 104 CN PER Strattera
4098119 4302796 12 Years F 10/13/2003 10/15/2003 1/26/2004 103 OT PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Hypersomnia, Retching
4098122 4302695 14 Years M 1/1/2003 10/14/2003 1/26/2004 104 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Psychomotor Hyperactivity
4098125 4302698 12 Years F 10/14/2003 1/26/2004 104 MD PER Strattera Sexual Dysfunction
4098126 4302700     M 10/1/2003 10/14/2003 1/26/2004 104 CN PER Strattera Aggression, Attention Deficit Hyperactivity Disorder, Mood Swings, Retching
4098128 4302702 16 Years M 10/14/2003 1/26/2004 104 MD PER Strattera Attention Deficit/Hyperactivity Disorder Bipolar Disorder
4098130 4302704     M 1/1/2003 10/14/2003 1/26/2004 104 CN PER Strattera Drug Ineffective, Headache, Mood Swings, Pallor, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4098130 4349603 11 Years M 1/1/2003 2/12/2004 3/29/2004 46 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Depressed Mood, Drug Ineffective, Headache, Mood Swings, Pallor, Personality Change, Vomiting
4098131 4302711 11 Years M 10/13/2003 10/14/2003 1/26/2004 104 CN PER Strattera Abnormal Behaviour, Diarrhoea, Dizziness, Dyspepsia, Lethargy, Somnolence
4098134 4302717 9 Years M 1/1/2003 10/14/2003 1/26/2004 104 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Weight Decreased
4098136 4302719 11 Years M 10/11/2003 10/14/2003 1/26/2004 104 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Nausea, Somnolence
4098138 4302720 11 Years F 1/1/2003 10/14/2003 1/26/2004 104 CN PER Strattera Fatigue, Feeling Abnormal
4098138 4440741 11 Years F 1/1/2003 5/25/2004 7/28/2004 64 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Vomiting, Weight Decreased
4098138 4501300 11 Years F 5/25/2004 9/27/2004 125 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Vomiting, Weight Decreased
4098141 4302733 35 Years F 10/14/2003 1/26/2004 104 MD PER Strattera Insomnia, Restlessness
4098219 4296602 10 Years M 8/26/2003 1/26/2004 153 PER Strattera Psychomotor Hyperactivity Abdominal Pain Upper, Chest Pain, Decreased Appetite
4098220 4296605 53 Years M 6/1/2003 8/26/2003 1/26/2004 153 PER Strattera Attention Deficit/Hyperactivity Disorder Erectile Dysfunction, Orgasmic Sensation Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4098220 4440498 53 Years M 1/1/2003 3/31/2004 7/28/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Erectile Dysfunction, Impaired Work Ability, Orgasm Abnormal, Orgasmic Sensation Decreased, Sexual Dysfunction
4098221 4296607     F 8/26/2003 1/26/2004 153 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Weight Increased
4098222 4296610 8 Years M 8/24/2003 8/26/2003 1/26/2004 153 PER Strattera Attention Deficit/Hyperactivity Disorder Affect Lability, Crying, Depressed Mood, Drug Interaction, Lethargy
4098223 4296611 12 Years M 8/26/2003 1/26/2004 153 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Hypersomnia, Insomnia
4098224 4296613 17 Years F 8/26/2003 1/26/2004 153 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Disturbance in Attention, Muscle Twitching, Myalgia
4098225 4296616 13 Years M 8/26/2003 1/26/2004 153 PER Strattera Abdominal Pain Upper, Pallor, Pruritus
4098226 4296617 8 Years M 8/20/2003 8/26/2003 1/26/2004 153 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Disturbance in Attention, Fatigue, Feeling Abnormal, Feeling Hot, Psychomotor Hyperactivity
4098227 4296619 16 Years M 8/26/2003 1/26/2004 153 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Hepatic Enzyme Increased
4098227 4518229 16 Years M 8/26/2003 11/16/2004 11/30/2004 14 EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Hepatic Enzyme Increased
4098228 4296622     M 8/1/2003 8/26/2003 1/26/2004 153 PER Strattera Attention Deficit/Hyperactivity Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4098229 4296668 9 Years M 5/1/2003 9/24/2003 1/26/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dry Mouth, Headache, Vision Blurred, Weight Decreased
4098303 4301771 60 Years M 10/7/2003 1/26/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Libido Decreased, Nocturia, Urinary Hesitation
4098305 4301772 7 Years M 10/1/2003 10/7/2003 1/26/2004 111 PER Strattera Crying, Psychomotor Hyperactivity
4098307 4301773 13 Years F 1/1/2003 10/7/2003 1/26/2004 111 PER Strattera Oppositional Defiant Disorder Urinary Incontinence
4098308 4301774 12 Years 11/11/2003 1/26/2004 76 MD PER Strattera Hypothermia, Viral Infection
4098309 4301775 12 Years F 10/7/2003 1/26/2004 111 MD PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Nervousness, Somnolence
4098310 4301776     M 10/7/2003 10/7/2003 1/26/2004 111 PER Strattera Psychomotor Hyperactivity, Rash Papular
4098312 4301777 8 Years M 1/1/2003 10/7/2003 1/26/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Hallucination, Somnolence
4098312 4349285 8 Years M 1/1/2003 1/6/2004 3/29/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Hallucination, Somnolence
4098314 4301778 14 Years M 10/1/2003 10/7/2003 1/26/2004 111 PER Strattera Dyspepsia, Mood Swings, Screaming
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4098317 4296719 6 Years M 9/4/2003 9/4/2003 1/26/2004 144 CN PER Strattera Abnormal Behaviour, Vomiting
4098320 4301780 6 Years M 10/7/2003 1/26/2004 111 OT PER Strattera Dyspepsia, Somnolence, Staring
4098321 4301781 8 Years M 10/7/2003 10/7/2003 1/26/2004 111 PER Strattera Psychomotor Hyperactivity
4098326 4296724 19 Years M 9/4/2003 1/26/2004 144 CN PER Strattera Attention Deficit/Hyperactivity Disorder
4098330 4296730 7 Years F 8/26/2003 9/4/2003 1/26/2004 144 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Decreased Appetite, Gastroenteritis Viral, Nausea, Somnolence, Vomiting, Weight Decreased
4098331 4296733 42 Years F 9/4/2003 1/26/2004 144 CN PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Constipation, Drug Ineffective, Early Morning Awakening, Fatigue, Pollakiuria, Speech Disorder
4098334 4296735 10 Years M 9/4/2003 9/4/2003 1/26/2004 144 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Excitability, Fatigue, Logorrhoea, Nervousness
4098343 4296738 8 Years M 8/5/2003 9/4/2003 1/26/2004 144 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Nervousness
4098345 4296740 17 Years F 9/4/2003 9/4/2003 1/26/2004 144 CN PER Strattera Feeling Abnormal
4098346 4296741     M 9/1/2003 9/5/2003 1/26/2004 143 CN PER Strattera Depression Dysuria, Micturition Urgency, Urinary Hesitation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4098350 4296744 7 Years M 9/5/2003 9/5/2003 1/26/2004 143 CN PER Strattera Abnormal Behaviour, Disturbance in Attention, Fatigue, Pallor
4098352 4296745 11 Years M 9/5/2003 1/26/2004 143 PH PER Strattera Anxiety Disturbance in Attention, Drug Ineffective, Emotional Distress
4098375 4302939     F 11/15/2003 2/23/2004 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anger, Anxiety, Hostility, Irritability, Suicidal Ideation Other
4099143 4302798     M 10/14/2003 1/26/2004 104 MD PER Strattera Urinary Hesitation
4099152 4302800 35 Years M 10/15/2003 1/26/2004 103 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort, Anxiety
4099159 4302801 10 Years M 10/1/2003 10/15/2003 1/26/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dyspepsia
4099165 4302803 14 Years M 1/1/2003 10/15/2003 1/26/2004 103 PER Strattera Oesophageal Pain
4099165 4580218 15 Years M 1/1/2003 8/24/2004 1/27/2005 156 CN PER Strattera Oesophageal Pain, Somnolence
4099168 4302805 10 Years M 10/1/2003 10/15/2003 1/26/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Dysphagia, Nervousness, Vomiting Projectile
4099172 4302807 12 Years M 10/15/2003 1/26/2004 103 MD PER Strattera Attention Deficit/Hyperactivity Disorder Trichotillomania
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4099180 4302809 14 Years M 10/15/2003 1/26/2004 103 OT PER Strattera Disturbance in Attention Crying, Insomnia, School Refusal, Stress Symptoms
4099185 4302811 7 Years M 1/1/2003 10/15/2003 1/26/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anger, Mood Swings, Restlessness
4099189 4302812 46 Years F 10/15/2003 1/26/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia, Drug Ineffective
4099200 4302814 9 Years F 10/15/2003 10/15/2003 1/26/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Dyspepsia, Feeling Abnormal
4099803 4296561 19 Years M 6/1/2003 8/25/2003 1/26/2004 154 OT PER Strattera Abdominal Pain, Penile Pain, Testicular Pain, Urinary Hesitation
4099804 4296563 16 Years F 8/24/2003 8/25/2003 1/26/2004 154 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Diarrhoea, Feeling Abnormal, Pallor
4099806 4296565 5 Years 8/25/2003 1/26/2004 154 CN PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger
4099807 4296580 58 Years F 9/17/2003 1/26/2004 131 CN PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Infection, Tension
4099808 4296587 10 Years M 7/7/2003 8/25/2003 1/26/2004 154 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4099813 4296589 12 Years M 8/1/2003 8/26/2003 1/26/2004 153 CN PER Strattera Attention Deficit/Hyperactivity Disorder Memory Impairment
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4099816 4296591 5 Years M 7/1/2003 8/26/2003 1/26/2004 153 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4100298 4299839 55 Years F 1/1/2003 12/15/2003 1/26/2004 42 MD PER Strattera Attention Deficit/Hyperactivity Disorder Flushing, Hyperhidrosis, Hyperthermia
4100298 4342696 55 Years F 1/1/2003 12/15/2003 3/29/2004 105 MD PER Strattera Attention Deficit/Hyperactivity Disorder Flushing, Hyperhidrosis, Hyperthermia
4100306 4299841 12 Years M 11/18/2003 11/18/2003 1/26/2004 69 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Fatigue, Headache, Hypersomnia, Pain, Vomiting
4100321 4299842 11 Years 11/6/2003 11/18/2003 1/26/2004 69 CN PER Strattera Attention Deficit/Hyperactivity Disorder Back Pain, Chest Pain, Chest Wall Pain
4100321 4440755 11 Years M 11/9/2003 3/30/2004 7/28/2004 120 MD PER Strattera Attention Deficit/Hyperactivity Disorder Back Pain, Chest Pain, Chest Wall Pain, Dizziness, Dyspnoea, Pharyngolaryngeal Pain, Pyrexia
4100323 4299843 7 Years M 11/1/2003 11/19/2003 1/26/2004 68 CN PER Strattera Attention Deficit/Hyperactivity Disorder Educational Problem, Fatigue, Nasopharyngitis, Nausea
4100330 4299844 12 Years F 11/19/2003 1/26/2004 68 MD PER Strattera Urinary Retention
4100334 4299847 6 Years M 11/19/2003 11/19/2003 1/26/2004 68 CN PER Strattera Attention Deficit/Hyperactivity Disorder Choking, Retching
4100337 4299848 8 Years M 10/1/2003 11/19/2003 1/26/2004 68 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Drug Ineffective, Flushing, Hyperhidrosis, Insomnia, Nervousness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4100591 4303092 66 Years F 9/1/2003 11/10/2003 1/26/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Blood Pressure Increased, Constipation, Cystitis, Haemorrhoidal Haemorrhage, Headache, Psychomotor Hyperactivity, Weight Decreased
4100593 4303076 6 Years F 9/29/2003 1/26/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Initial Insomnia, Vomiting, Weight Decreased
4100594 4303079 16 Years F 9/1/2003 9/29/2003 1/26/2004 119 PER Strattera Abnormal Behaviour, Aggression, Decreased Appetite, Nausea
4100595 4303093     M 9/29/2003 9/29/2003 1/26/2004 119 PER Strattera
4100597 4303080 10 Years F 9/1/2003 9/29/2003 1/26/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Crying, Dizziness, Drug Ineffective, Dyspnoea, Ear Infection, Fatigue, Mood Swings, Pharyngitis Streptococcal, Psychomotor Hyperactivity, Somnolence
4100597 4440502 10 Years F 9/1/2003 3/24/2004 7/28/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Crying, Dizziness, Drug Ineffective, Dyspnoea, Ear Infection, Educational Problem, Fatigue, Mood Swings, Pharyngitis Streptococcal, Psychomotor Hyperactivity, Somnolence
4100598 4303081 6 Years F 9/29/2003 1/26/2004 119 PH PER Strattera Drug Interaction, Psychomotor Hyperactivity
4100600 4303083 10 Years F 8/1/2003 9/29/2003 1/26/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Dizziness, Fatigue, Headache, Retching, Vomiting
4100602 4303085 9 Years M 9/29/2003 1/26/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Dental Caries, Gingival Infection
4100605 4303087 40 Years F 9/29/2003 1/26/2004 119 MD PER Strattera Dyspnoea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4100607 4303088     F 9/1/2003 9/29/2003 1/26/2004 119 PER Strattera Disturbance in Attention
4100609 4303090 7 Years M 9/12/2003 9/29/2003 1/26/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Disturbance in Attention, Psychomotor Hyperactivity
4100610 4303091 17 Years F 9/11/2003 9/29/2003 1/26/2004 119 MD PER Strattera Eye Rolling, Sinusitis
4100653 4303155 35 Years F 9/24/2003 9/25/2003 1/26/2004 123 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Cold Sweat, Feeling Hot, Insomnia, Vision Blurred
4100657 4303153 12 Years 9/25/2003 1/26/2004 123 MD PER Strattera Personality Change
4100662 4303152 35 Years M 9/1/2003 9/24/2003 1/26/2004 124 MD PER Strattera Feeling Abnormal
4100663 4303151 18 Years M 9/24/2003 1/26/2004 124 MD PER Strattera Feeling Abnormal
4100665 4303147 7 Years M 9/1/2003 9/25/2003 1/26/2004 123 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Tongue Ulceration, Vomiting
4100667 4303077 9 Years M 9/24/2003 10/8/2003 1/26/2004 110 OT PER Strattera Attention Deficit/Hyperactivity Disorder Psychotic Disorder, Suicide Attempt, Vision Blurred
4100668 4303063 22 Years M 10/13/2003 1/26/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Drug Ineffective, Emotional Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4100675 4303017 8 Years F 10/22/2003 1/26/2004 96 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Tachycardia Other
4100676 4303014 47 Years F 9/1/2003 9/25/2003 1/26/2004 123 PER Strattera Attention Deficit/Hyperactivity Disorder Hangover, Nausea
4100685 4303012 15 Years M 9/24/2003 1/26/2004 124 MD PER Strattera Dysuria, Urinary Hesitation, Urinary Incontinence
4100691 4303190 12 Years F 8/1/2003 9/26/2003 1/26/2004 122 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Lethargy
4100700 4303185 10 Years M 9/26/2003 9/26/2003 1/26/2004 122 PER Strattera Psychomotor Hyperactivity
4100701 4303182 7 Years M 1/1/2003 9/26/2003 1/26/2004 122 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Head Banging, Weight Decreased
4100702 4303179 14 Years F 9/26/2003 1/26/2004 122 PER Strattera Attention Deficit/Hyperactivity Disorder Communication Disorder, Depression
4100708 4303178 8 Years F 9/20/2003 12/10/2003 1/26/2004 47 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Headache
4100708 4350570 8 Years F 9/20/2003 12/10/2003 3/29/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Headache
4100780 4307057 11 Years F 10/8/2003 2/26/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Crying, Dizziness, Fear, Oppositional Defiant Disorder, Panic Reaction, Paranoia, Sensory Disturbance Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4100824 4303166 7 Years M 9/1/2003 9/25/2003 1/26/2004 123 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Crying, Decreased Appetite, Drug Ineffective, Emotional Distress, Eye Disorder, Fatigue, Feeling Abnormal, Screaming, Thirst Decreased
4100826 4303164 8 Years M 9/1/2003 9/25/2003 1/26/2004 123 PER Strattera Abdominal Pain, Abnormal Behaviour, Vomiting
4100945 4297853 5 Years M 9/1/2003 9/22/2003 1/26/2004 126 PER Strattera Abnormal Behaviour, Aggression, Mood Swings
4100969 4297855     F 1/1/2003 9/22/2003 1/26/2004 126 MD PER Strattera Piloerection
4100973 4296566 7 Years M 1/1/2003 9/2/2003 1/26/2004 146 PER Strattera Aggression, Anger, Mood Swings
4100976 4297856 9 Years M 1/1/2003 9/22/2003 1/26/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Drug Ineffective, Irritability, Mood Swings
4100979 4296601 13 Years F 8/1/2003 9/2/2003 1/26/2004 146 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fatigue, Pallor, Somnolence, Thirst
4100982 4297859 20 Years M 1/1/2003 9/22/2003 1/26/2004 126 LW PER Strattera Mood Swings
4100985 4297861 15 Years F 9/22/2003 1/26/2004 126 PER Strattera Disturbance in Attention, Initial Insomnia, Irritability, Mood Swings, Somnolence
4100991 4296603     M 6/1/2003 9/2/2003 1/26/2004 146 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Psychomotor Hyperactivity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4100995 4298124 20 Years F 9/17/2003 9/22/2003 1/26/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Jittery, Initial Insomnia
4100997 4296606 8 Years M 9/2/2003 1/26/2004 146 PER Strattera Attention Deficit/Hyperactivity Disorder Fear, Nervousness, Tremor
4100999 4296608 8 Years M 8/1/2003 9/2/2003 1/26/2004 146 CN PER Strattera Glossodynia, Retching
4101006 4296609 57 Years M 8/1/2003 9/2/2003 1/26/2004 146 CN PER Strattera Abnormal Behaviour Dysuria, Testicular Pain
4101010 4298214 9 Years M 9/22/2003 1/26/2004 126 MD PER Strattera Chest Pain
4101011 4296612 10 Years M 8/1/2003 9/2/2003 1/26/2004 146 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4101014 4296615     M 9/2/2003 1/26/2004 146 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger
4101019 4296618 40 Years M 8/1/2003 9/2/2003 1/26/2004 146 PER Strattera Anxiety, Disturbance in Attention Fatigue, Feeling Abnormal, Insomnia
4101021 4296621 29 Years F 8/31/2003 9/2/2003 1/26/2004 146 PER Strattera Attention Deficit/Hyperactivity Disorder Back Pain, Uterine Pain
4101022 4298314 6 Years M 9/22/2003 1/26/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Emotional Disorder, Fear
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101029 4297830     M 9/22/2003 1/26/2004 126 PER Strattera Drug Screen Positive
4101032 4297831     M 9/22/2003 1/26/2004 126 PER Strattera Asthma
4101039 4303207 10 Years F 9/26/2003 1/26/2004 122 MD PER Strattera Attention Deficit/Hyperactivity Disorder Confusional State, Emotional Disorder, Hallucination
4101040 4297835 11 Years F 8/1/2003 9/22/2003 1/26/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Nausea, Somnolence
4101041 4303659 9 Years F 9/1/2003 9/30/2003 1/26/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Eating Disorder, Fatigue, Headache
4101043 4303204 13 Years M 9/1/2003 9/26/2003 1/26/2004 122 PER Strattera Anorexia, Drug Ineffective, Dyspepsia, Hyperhidrosis, Pallor, Vomiting
4101045 4303667 9 Years M 3/1/2003 9/30/2003 1/26/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder
4101046 4303202 42 Years M 9/1/2003 10/10/2003 1/26/2004 108 PER Strattera Erectile Dysfunction, Nausea, Pollakiuria, Sexual Dysfunction
4101048 4303680 12 Years 7/19/2003 9/24/2003 1/26/2004 124 MD PER Strattera
4101050 4297837 52 Years F 8/1/2003 9/22/2003 1/26/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Mental Impairment
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101051 4303201 12 Years 9/26/2003 1/26/2004 122 OT PER Strattera Psychomotor Hyperactivity
4101052 4303681     M 9/30/2003 1/26/2004 118 PER Strattera Abnormal Behaviour
4101055 4297839 8 Years M 9/19/2003 1/26/2004 129 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
4101057 4303682 12 Years M 6/1/2003 9/30/2003 1/26/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Depression, Negativism
4101058 4303199 5 Years M 9/1/2003 10/17/2003 1/26/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Disturbance in Attention, Drug Interaction, Dysphagia, Fatigue, Hypertension, Irritability, Psychomotor Hyperactivity, Vomiting
4101062 4303198 7 Years M 9/26/2003 1/26/2004 122 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective
4101063 4297841 16 Years M 9/19/2003 9/22/2003 1/26/2004 126 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Crying
4101064 4303683 41 Years M 1/1/2003 10/22/2003 1/26/2004 96 MD PER Strattera Attention Deficit/Hyperactivity Disorder Intraocular Pressure Increased
4101066 4303197 9 Years M 9/18/2003 9/26/2003 1/26/2004 122 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Eye Disorder, Sedation
4101068 4303685 16 Years M 7/1/2003 9/30/2003 1/26/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Pallor, Somnolence, Weight Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101069 4297844 10 Years M 1/1/2003 9/22/2003 1/26/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Pollakiuria
4101071 4303195 50 Years F 8/1/2003 10/13/2003 1/26/2004 105 PER Strattera Disturbance in Attention Visual Disturbance
4101074 4297846 39 Years F 9/18/2003 9/22/2003 1/26/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Dizziness, Nausea, Tremor
4101076 4303194 8 Years F 9/26/2003 9/26/2003 1/4/2004 100 PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Retching, Somnolence
4101079 4303094 8 Years F 1/1/2003 9/29/2003 1/26/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Amnesia, Cognitive Disorder, Disturbance in Attention, Drug Ineffective, Increased Appetite, Weight Increased
4101081 4303193 9 Years M 9/1/2003 9/26/2003 1/26/2004 122 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Psychomotor Hyperactivity
4101082 4297849 13 Years M 1/1/2003 9/22/2003 1/26/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Somnolence
4101083 4303686 25 Years F 9/30/2003 1/26/2004 118 PER Strattera Depression, Fatigue Crying, Dizziness, Dyspnoea, Tremor
4101085 4303688     M 9/30/2003 1/26/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity, Sleep Disorder
4101086 4297851 9 Years M 9/22/2003 1/26/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Psychomotor Hyperactivity, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101089 4303689 4 Years M 9/1/2003 10/14/2003 1/26/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Constipation, Fatigue, Headache, Mydriasis, Social Avoidant Behaviour
4101095 4303096 49 Years F 9/29/2003 1/26/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Cognitive Disorder, Disturbance in Attention, Emotional Distress, Feeling of Despair, Insomnia, Negativism
4101107 4303097 19 Years M 9/26/2003 9/29/2003 1/26/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Belligerence, Fatigue, Somnolence
4101113 4303098 8 Years 4/1/2003 9/29/2003 1/26/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Disturbance in Attention, Restlessness
4101118 4303099 13 Years M 9/29/2003 1/26/2004 119 PER Strattera Anger, Psychomotor Hyperactivity
4101120 4303103 9 Years F 9/29/2003 1/26/2004 119 MD PER Strattera Myalgia
4101129 4303108 47 Years M 9/1/2003 9/29/2003 1/26/2004 119 PER Strattera Asthenia, Chills, Feeling Abnormal, Hyperhidrosis, Micturition Disorder
4101137 4298750 12 Years 10/22/2003 1/26/2004 96 MD PER Strattera Abnormal Behaviour
4101138 4298752 7 Years M 10/22/2003 1/26/2004 96 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction
4101138 4349614 7 Years M 10/10/2003 12/24/2003 3/29/2004 96 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Drug Level Above Therapeutic
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101140 4298753 12 Years M 10/22/2003 1/26/2004 96 MD PER Strattera Attention Deficit/Hyperactivity Disorder Delirium, Hypertension, Mydriasis, Speech Disorder, Tachycardia
4101140 4349615 12 Years M 10/19/2003 12/24/2003 3/29/2004 96 MD PER Strattera Attention Deficit/Hyperactivity Disorder Delirium, Hypertension, Mydriasis, Speech Disorder, Tachycardia
4101141 4298756     F 10/22/2003 1/26/2004 96 OT PER Strattera Aggression
4101143 4298758 8 Years M 10/1/2003 11/18/2003 1/26/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective
4101143 4349616 8 Years M 10/1/2003 11/18/2003 3/29/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective
4101143 4501305 10 Years M 10/1/2003 7/21/2004 9/27/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective
4101144 4298768 7 Years M 10/22/2003 1/26/2004 96 PER Strattera Dyspnoea, Heart Rate Increased, Retching, Somnolence, Thirst
4101146 4298769     M 10/22/2003 1/26/2004 96 OT PER Strattera Aggression
4101148 4298778 13 Years F 10/15/2003 10/22/2003 1/26/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Drug Interaction, Sinusitis
4101151 4298780 11 Years M 1/1/2003 10/23/2003 1/26/2004 95 PER Strattera Anger, Anorexia, Drug Ineffective, Dyspnoea, Epistaxis, Feeling Abnormal, Mood Swings, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101151 4342211 11 Years M 1/1/2003 1/8/2004 3/29/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anger, Anorexia, Apathy, Bradyphrenia, Drug Ineffective, Dyspnoea, Epistaxis, Fatigue, Feeling Abnormal, Mood Swings, Somnolence, Weight Decreased
4101152 4298702 9 Years F 10/1/2003 11/17/2003 1/26/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia, Hair Texture Abnormal, Hypotrichosis, Skin Odour Abnormal
4101156 4298781 38 Years M 10/22/2003 1/26/2004 96 OT PER Strattera Erectile Dysfunction, Penile Pain
4101159 4298705     M 10/22/2003 1/26/2004 96 MD PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Irritability, Negativism
4101161 4298708     M 10/27/2003 1/26/2004 91 MD PER Strattera Attention Deficit/Hyperactivity Disorder Cough, Tardive Dyskinesia, Tic
4101166 4298709 15 Years F 10/27/2003 1/26/2004 91 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Depression, Insomnia, Mood Swings
4101169 4297753     F 10/29/2003 1/26/2004 89 PER Strattera Constipation, Hyperhidrosis, Panic Disorder
4101176 4298711 24 Years M 1/1/2003 10/28/2003 1/26/2004 90 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
4101177 4297766 7 Years M 10/1/2003 11/21/2003 1/26/2004 66 PER Strattera Abdominal Pain Upper, Aggression, Disturbance in Attention, Dysphemia, Fatigue, Nasopharyngitis, Psychomotor Hyperactivity, Vomiting
4101177 4342213 7 Years M 10/1/2003 11/21/2003 3/29/2004 129 PER Strattera Abdominal Pain Upper, Aggression, Disturbance in Attention, Dysphemia, Fatigue, Nasopharyngitis, Psychomotor Hyperactivity, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101181 4297775 13 Years F 10/1/2003 10/29/2003 1/26/2004 89 MD PER Strattera Abnormal Dreams
4101182 4298713     M 10/28/2003 1/26/2004 90 MD PER Strattera Confusional State
4101183 4298716 10 Years 10/28/2003 1/26/2004 90 MD PER Strattera Suicidal Ideation
4101188 4298718     M 10/27/2003 1/26/2004 91 MD PER Strattera Tic
4101192 4298720 13 Years 10/28/2003 1/26/2004 90 MD PER Strattera Suicidal Ideation
4101197 4298723 59 Years M 10/21/2003 11/11/2003 1/26/2004 76 MD PER Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder, Sexual Dysfunction
4101200 4298725 19 Years M 10/14/2003 10/28/2003 1/26/2004 90 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Hunger, Renal Pain
4101204 4298728     F 10/1/2003 10/28/2003 1/26/2004 90 MD PER Strattera Tic
4101214 4298729 32 Years M 10/30/2003 1/26/2004 88 PER Strattera Blood Pressure Increased, Chest Discomfort, Muscle Tightness
4101216 4298731 6 Years F 1/1/2003 10/28/2003 1/26/2004 90 MD PER Strattera Antisocial Behaviour, Nervousness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101217 4298733 7 Years M 10/25/2003 10/29/2003 1/26/2004 89 PER Strattera Disturbance in Attention Aggression, Agitation
4101219 4298740 13 Years M 10/29/2003 1/26/2004 89 MD PER Strattera Abnormal Behaviour
4101220 4297820 6 Years M 10/29/2003 10/29/2003 1/26/2004 89 CN PER Strattera Psychomotor Hyperactivity Eye Disorder, Muscle Twitching
4101222 4298743 7 Years F 1/1/2003 10/29/2003 1/26/2004 89 PER Strattera Disturbance in Attention Crying, Decreased Appetite, Depression, Dermatitis Contact, Drug Interaction, Lacrimation Increased, Negative Thoughts, Personality Change, Pruritus, Somnolence, Weight Decreased
4101223 4307632 12 Years M 2/3/2004 2/27/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Dyskinesia, Eye Disorder, Tic Other
4101224 4297826 8 Years M 11/4/2003 1/26/2004 83 MD PER Strattera Disturbance in Attention, Psychomotor Hyperactivity, Tic
4101225 4298745 12 Years 10/29/2003 1/26/2004 89 PER Strattera Feeling Hot and Cold
4101226 4298134 10 Years M 10/22/2003 1/26/2004 96 MD PER Strattera Dysuria
4101228 4297829 10 Years M 10/29/2003 1/26/2004 89 CN PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity, Tic
4101229 4298747 12 Years M 10/30/2003 1/26/2004 88 PER Strattera Anorexia, Feeling Abnormal, Headache, Hyperphagia, Somnolence, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101230 4298749 8 Years M 10/1/2003 10/29/2003 1/26/2004 89 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Feeling Jittery
4101231 4298189 17 Years M 10/20/2003 10/23/2003 1/26/2004 95 PER Strattera Bradyphrenia, Dyspepsia
4101300 4298766 59 Years F 8/11/2003 9/11/2003 1/26/2004 137 PER Strattera Abnormal Dreams, Drug Withdrawal Headache, Dry Mouth, Middle Insomnia, Skin Discolouration, Vertigo
4101303 4298765 41 Years M 7/1/2003 9/11/2003 1/26/2004 137 PER Strattera Disturbance in Attention, Drug Ineffective
4101304 4298763 4 Years M 9/1/2003 9/11/2003 1/26/2004 137 PER Strattera Bruxism
4101308 4298762     F 3/1/2003 9/11/2003 1/26/2004 137 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Orthostatic Hypotension, Somnolence
4101309 4298761 7 Years M 7/1/2003 10/2/2003 1/26/2004 116 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Psychomotor Hyperactivity
4101311 4298760 36 Years F 9/11/2003 9/11/2003 1/26/2004 137 OT PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Nausea, Retching
4101312 4298759     M 9/11/2003 1/26/2004 137 PH PER Strattera Abnormal Behaviour, Aggression, Drug Interaction
4101313 4298757 9 Years M 1/1/2003 9/11/2003 1/26/2004 137 PER Strattera
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101314 4298755 11 Years M 1/1/2003 9/11/2003 1/26/2004 137 PH PER Strattera Crying, Emotional Distress
4101316 4298754 8 Years M 9/11/2003 9/11/2003 1/26/2004 137 PER Strattera Retching, Vomiting
4101395 4303095 37 Years M 8/29/2003 9/29/2003 1/26/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Dizziness, Headache, Irritability, Nausea
4101395 4349185 37 Years M 8/29/2003 12/29/2003 3/29/2004 91 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Dizziness, Feeling Abnormal, Headache, Irritability, Mood Swings, Nausea
4101423 4303174     M 9/26/2003 1/26/2004 122 PER Strattera Drug Screen Positive
4101425 4303176 8 Years M 8/1/2003 9/26/2003 1/26/2004 122 PER Strattera Attention Deficit/Hyperactivity Disorder Mydriasis, Psychomotor Hyperactivity
4101712 4298903 5 Years M 10/1/2003 10/20/2003 1/26/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Psychomotor Hyperactivity
4101712 4782214 5 Years M 10/1/2003 6/1/2005 9/27/2005 118 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Fatigue, Hyperkinesia, Psychomotor Hyperactivity
4101713 4306021 36 Years M 2/6/2004 2/25/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Supraventricular Tachycardia Other
4101713 4348029 36 Years M 1/29/2004 4/7/2004 4/22/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Supraventricular Tachycardia Hospitalization - Initial or Prolonged, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101715 4298904 8 Years M 10/20/2003 1/26/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Decreased Appetite, Feeling Abnormal
4101717 4298905 13 Years M 10/20/2003 1/26/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Headache
4101719 4298906 40 Years M 10/20/2003 1/26/2004 98 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression
4101722 4306022 35 Years F 1/1/2004 1/1/2004 2/6/2004 2/25/2004 19 MD EXP Strattera Completed Suicide Death
4101722 4373135 35 Years F 6/29/2003 6/29/2003 5/19/2004 6/3/2004 15 MD EXP Strattera Completed Suicide, Contusion, Drug Toxicity, Multiple Drug Overdose Death
4101726 4298908     F 9/23/2003 1/26/2004 125 OT PER Strattera
4101727 4298909     M 9/1/2003 9/23/2003 1/26/2004 125 PH PER Strattera Drug Interaction, Somnolence
4101728 4306769 17 Years F 1/1/2003 2/5/2004 2/25/2004 20 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Complex Partial Seizures Other
4101728 4315587 16 Years F 1/1/2003 2/24/2004 3/9/2004 14 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Complex Partial Seizures, Confusional State, Depressed Level of Consciousness, Difficulty in Walking, Fatigue, Incoherent, Pallor, Speech Disorder Other
4101728 4433959 16 Years F 1/1/2003 8/9/2004 8/25/2004 16 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Complex Partial Seizures, Confusional State, Depressed Level of Consciousness, Fatigue, Pallor, Speech Disorder Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101729 4298910 11 Years M 9/1/2003 9/23/2003 1/26/2004 125 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Chills, Disturbance in Attention, Drug Ineffective, Dry Mouth, Nausea, Thirst
4101730 4298911 7 Years M 9/23/2003 1/26/2004 125 PER Strattera Attention Deficit/Hyperactivity Disorder Aphthous Stomatitis, Drug Ineffective
4101732 4298279 7 Years F 10/23/2003 1/26/2004 95 PER Strattera Abdominal Pain, Constipation, Drug Ineffective, Eye Irritation, Middle Insomnia, Mydriasis
4101733 4298912 12 Years M 9/23/2003 1/26/2004 125 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Drug Ineffective, Feeling Abnormal, Somnolence
4101734 4298913 10 Years M 9/23/2003 1/26/2004 125 PER Strattera Attention Deficit/Hyperactivity Disorder Mood Altered
4101735 4298914 13 Years M 9/11/2003 9/23/2003 1/26/2004 125 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Depression, Drug Ineffective, Mood Swings
4101736 4298915 12 Years M 9/23/2003 1/26/2004 125 PER Strattera Attention Deficit/Hyperactivity Disorder Throat Irritation
4101738 4298916 6 Years M 9/24/2003 1/26/2004 124 OT PER Strattera Sleep Walking
4101740 4298372 25 Years M 1/1/2003 11/26/2003 1/26/2004 61 MD PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Peripheral Coldness, Semen Abnormal
4101740 4342212 25 Years M 1/1/2003 11/26/2003 3/29/2004 124 MD PER Strattera Abnormal Behaviour Decreased Appetite, Peripheral Coldness, Semen Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101741 4298917 9 Years F 9/1/2003 11/5/2003 1/26/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder, Dyslexia Anorexia, Chapped Lips, Disturbance in Attention, Drug Ineffective, Dysgeusia, Fatigue, Rash Pruritic, Somnolence, Weight Decreased
4101742 4306024 11 Years M 10/1/2003 2/6/2004 2/25/2004 19 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Affect Lability, Appendicectomy, Drug Ineffective, Fatigue, Impulsive Behaviour Hospitalization - Initial or Prolonged
4101743 4298463 9 Years M 9/1/2003 10/23/2003 1/26/2004 95 PER Strattera Hypoglycaemia
4101745 4306083 14 Years M 2/9/2004 2/25/2004 16 MD EXP Strattera Syncope Other
4101745 4315333 14 Years M 2/23/2004 3/9/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Syncope Other
4101748 4298505 9 Years M 5/1/2003 10/23/2003 1/26/2004 95 PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Mydriasis
4101759 4298516 8 Years M 1/1/2003 10/22/2003 1/26/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Somnolence, Weight Increased
4101763 4306147 6 Years M 2/9/2004 2/11/2004 2/25/2004 14 CN EXP Strattera Abnormal Behaviour, Depressed Mood, Fear, Insomnia, Lower Limb Fracture, Mental Disorder, Open Fracture, Road Traffic Accident, Self Injurious Behaviour Hospitalization - Initial or Prolonged
4101763 4487884 6 Years M 1/1/2004 10/13/2004 10/26/2004 13 EXP Strattera Attention Deficit/Hyperactivity Disorder Depressed Mood, Headache, Mental Disorder, Open Fracture, Road Traffic Accident Hospitalization - Initial or Prolonged
4101776 4298524 25 Years M 9/1/2003 10/23/2003 1/26/2004 95 PER Strattera Attention Deficit/Hyperactivity Disorder Dehydration, Dyspnoea, Dysuria, Fatigue
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101777 4298532 6 Years M 10/23/2003 1/26/2004 95 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
4101779 4298540 12 Years F 10/23/2003 1/26/2004 95 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Educational Problem, Somnolence
4101787 4297779 12 Years M 8/1/2003 10/29/2003 1/26/2004 89 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Increased Appetite, Insomnia, Memory Impairment, Psychomotor Hyperactivity
4101790 4297784 49 Years M 10/1/2003 11/12/2003 1/26/2004 75 OT PER Strattera Attention Deficit/Hyperactivity Disorder, Depression Asthenia, Blood HIV RNA Increased, Decreased Appetite, Dehydration, Dizziness, Drug Ineffective, Drug Interaction, Dry Throat, Exercise Capacity Decreased, Feeling Abnormal, Feeling Hot, Heart Rate Decreased, Insomnia, Orthostatic Hypotension, Paraesthesia, Psychomotor Hyperactivity, Somnolence, Staring, Vocal Cord Paralysis
4101794 4297788 10 Years M 2/1/2003 10/29/2003 1/26/2004 89 PER Strattera Abdominal Pain Upper, Anorexia, Drug Ineffective, Growth Retardation, Weight Decreased
4101796 4297791 60 Years M 10/29/2003 1/26/2004 89 OT PER Strattera Memory Impairment Dry Mouth, Mobility Decreased
4101798 4297806 9 Years M 10/29/2003 1/26/2004 89 OT PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Pallor
4101800 4297810 11 Years M 10/29/2003 1/26/2004 89 PER Strattera Somnolence, Yawning
4101801 4297813 8 Years F 1/1/2003 10/29/2003 1/26/2004 89 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Impulsive Behaviour, Irritability, Paraesthesia, Pharyngitis Streptococcal, Pruritus
4101814 4297789 8 Years M 9/22/2003 1/26/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101816 4297794 7 Years M 9/16/2003 9/19/2003 1/26/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder, Oppositional Defiant Disorder Oppositional Defiant Disorder
4101818 4297798 18 Years F 9/19/2003 1/26/2004 129 OT PER Strattera Mononucleosis Syndrome, Platelet Count Increased
4101820 4297801 10 Years M 9/1/2003 9/19/2003 1/26/2004 129 PH PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity
4101823 4297811 8 Years M 7/1/2003 9/19/2003 1/26/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder Eye Haemorrhage, Mydriasis
4101824 4297815 11 Years M 1/1/2003 9/19/2003 1/26/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Disturbance in Attention, Drug Ineffective, Memory Impairment
4101827 4297388 15 Years M 1/1/2003 9/15/2003 1/26/2004 133 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
4101828 4297818 12 Years M 9/16/2003 1/26/2004 132 MD PER Strattera Mania
4101829 4297392 7 Years F 1/1/2003 9/15/2003 1/26/2004 133 CN PER Strattera Abnormal Behaviour, Crying, Daydreaming, Drug Ineffective, Somnolence
4101830 4297395 47 Years M 9/13/2003 9/15/2003 1/26/2004 133 CN PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dry Mouth, Pollakiuria, Sexual Dysfunction
4101831 4297401 13 Years M 9/1/2003 9/15/2003 1/26/2004 133 CN PER Strattera Attention Deficit/Hyperactivity Disorder Mood Swings, Personality Change
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101833 4297413 11 Years M 9/13/2003 9/22/2003 1/26/2004 126 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Apathy, Burning Sensation, Disturbance in Attention, Drug Ineffective, Educational Problem, Nasal Discomfort
4101834 4297415 8 Years M 9/1/2003 9/15/2003 1/26/2004 133 CN PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Feeling Abnormal, Somnolence
4101835 4297416 14 Years M 7/1/2003 9/15/2003 1/26/2004 133 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Fatigue, Impulsive Behaviour, Insomnia, Psychomotor Hyperactivity, Tremor
4101836 4297530 16 Years F 7/1/2003 8/29/2003 1/26/2004 150 MD PER Strattera Attention Deficit/Hyperactivity Disorder Menstruation Irregular
4101837 4297532 13 Years M 9/17/2003 1/26/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Irritability
4101838 4297468 9 Years M 9/15/2003 1/26/2004 133 CN PER Strattera Attention Deficit/Hyperactivity Disorder Diarrhoea, Feeling Abnormal, Hypersomnia
4101839 4297469 10 Years M 9/15/2003 1/26/2004 133 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Crying, Depression, Hypersomnia, Nausea
4101841 4297527 5 Years M 9/15/2003 1/26/2004 133 OT PER Strattera Hallucination (Visual)
4101844 4297533 36 Years M 8/25/2003 8/29/2003 1/26/2004 150 PER Strattera Penis Disorder
4101846 4297535 11 Years F 8/19/2003 8/29/2003 1/26/2004 150 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Crying, Drug Ineffective, Educational Problem, Memory Impairment
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101856 4297536 12 Years M 8/29/2003 1/26/2004 150 PER Strattera
4101857 4297537 10 Years M 8/1/2003 8/29/2003 1/26/2004 150 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea Exertional, Erythema, Fatigue
4101858 4297767 12 Years M 11/6/2003 11/6/2003 1/26/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Somnolence, Thirst
4101863 4297770     M 11/6/2003 11/6/2003 1/26/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Incoherent, Somnolence
4101866 4297773 8 Years M 11/6/2003 1/26/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anorexia, Drug Ineffective, Insomnia, Weight Decreased
4101868 4297538 16 Years M 8/1/2003 8/29/2003 1/26/2004 150 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Disturbance in Attention, Drug Ineffective, Heart Rate Increased, Weight Decreased
4101870 4297691 44 Years F 9/18/2003 1/26/2004 130 MD PER Strattera Hoarseness
4101871 4297786     M 11/6/2003 1/26/2004 81 PH PER Strattera Disturbance in Attention
4101873 4297793     F 1/1/2003 11/6/2003 1/26/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Flat Affect
4101875 4297797 12 Years 11/6/2003 1/26/2004 81 PH PER Strattera Abnormal Behaviour
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101876 4297539 8 Years M 8/22/2003 8/29/2003 1/26/2004 150 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Anger, Impulsive Behaviour, Nervousness
4101878 4297693 27 Years M 9/18/2003 9/24/2003 1/26/2004 124 MD PER Strattera Dysuria, Penile Discharge, Prostatitis
4101878 4349157 27 Years M 9/18/2003 9/24/2003 3/29/2004 187 MD PER Strattera Dysuria, Penile Discharge, Prostatitis
4101881 4297541 7 Years M 8/1/2003 10/15/2003 1/26/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Psychomotor Hyperactivity
4101884 4297542 10 Years M 8/29/2003 1/26/2004 150 PER Strattera Attention Deficit/Hyperactivity Disorder Choking
4101885 4297698 12 Years M 9/18/2003 1/26/2004 130 MD PER Strattera Contusion, Excoriation, Nausea, Road Traffic Accident
4101886 4297799 50 Years M 11/6/2003 1/26/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fatigue, Food Craving
4101888 4297583     M 11/4/2003 1/26/2004 83 MD PER Strattera Tic
4101889 4297724 24 Years F 1/1/2003 9/18/2003 1/26/2004 130 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disorientation, Feeling Abnormal, Nausea
4101890 4297726 8 Years 9/18/2003 1/26/2004 130 MD PER Strattera Psychomotor Hyperactivity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101892 4297700 68 Years F 9/1/2003 9/18/2003 1/26/2004 130 PER Strattera Depression Fatigue, Headache, Insomnia, Piloerection
4101894 4297854 8 Years M 10/1/2003 10/30/2003 1/26/2004 88 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Drug Ineffective, Irritability, Negativism
4101895 4297756 13 Years F 9/17/2003 9/18/2003 1/26/2004 130 CN PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal
4101897 4297857 6 Years M 10/26/2003 10/30/2003 1/26/2004 88 PER Strattera Disturbance in Attention Excitability
4101902 4297862     M 10/1/2003 10/30/2003 1/26/2004 88 PER Strattera Buccoglossal Syndrome
4101904 4297759 13 Years M 1/1/2003 9/19/2003 1/26/2004 129 CN PER Strattera Crying, Depression, Disturbance in Attention, Feeling Abnormal
4101905 4297863 50 Years F 10/30/2003 1/26/2004 88 OT PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
4101906 4297702 36 Years F 9/18/2003 1/26/2004 130 MD PER Strattera Attention Deficit/Hyperactivity Disorder Intentional Overdose
4101909 4297865 9 Years F 1/1/2003 10/30/2003 1/26/2004 88 PH PER Strattera Disturbance in Attention, Drug Ineffective, Logorrhoea, Psychomotor Hyperactivity, Vomiting
4101910 4297866 11 Years F 10/29/2003 10/30/2003 1/26/2004 88 PER Strattera Attention Deficit/Hyperactivity Disorder Lacrimation Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101912 4297832 40 Years M 10/23/2003 10/29/2003 1/26/2004 89 CN PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Dry Mouth, Erectile Dysfunction, Sexual Dysfunction
4101913 4297873     F 10/30/2003 1/26/2004 88 PER Strattera Drug Ineffective, Drug Interaction
4101914 4297836 10 Years M 10/29/2003 1/26/2004 89 MD PER Strattera Tic
4101915 4297840 32 Years M 10/27/2003 10/29/2003 1/26/2004 89 CN PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Sexual Dysfunction, Urinary Hesitation
4101916 4297875 8 Years F 10/1/2003 10/30/2003 1/26/2004 88 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Confusional State, Crying, Disorientation
4101918 4297845 10 Years M 10/29/2003 1/26/2004 89 PH PER Strattera Retching
4101919 4297958 15 Years M 10/25/2003 10/30/2003 1/26/2004 88 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Increased Appetite, Somnolence
4101921 4297848 6 Years 9/1/2003 10/29/2003 1/26/2004 89 MD PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
4101923 4297983     M 10/30/2003 1/26/2004 88 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Impaired Driving Ability
4101925 4298559 12 Years F 10/1/2003 10/23/2003 1/26/2004 95 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Decreased Appetite, Nausea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101929 4298563 63 Years F 10/24/2003 1/26/2004 94 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Nervousness
4101931 4298570     M 10/24/2003 1/26/2004 94 MD PER Strattera Attention Deficit/Hyperactivity Disorder Sexual Dysfunction
4101934 4298573 12 Years 10/24/2003 1/26/2004 94 MD PER Strattera Hypomania
4101936 4298574 8 Years F 10/1/2003 10/24/2003 1/26/2004 94 PER Strattera Attention Deficit/Hyperactivity Disorder Gingival Bleeding
4101938 4298575 46 Years M 10/24/2003 1/26/2004 94 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Somnolence, Thinking Abnormal
4101939 4298579 9 Years M 10/1/2003 10/27/2003 1/26/2004 91 PER Strattera Anorexia, Mood Swings, Weight Decreased
4101941 4297852 12 Years M 10/29/2003 10/29/2003 1/26/2004 89 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
4101942 4298634 12 Years 10/25/2003 1/26/2004 93 PH PER Strattera Hair Plucking
4101943 4297762 15 Years M 9/18/2003 9/19/2003 1/26/2004 129 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Insomnia, Tremor
4101945 4298637     M 10/22/2003 1/26/2004 96 MD PER Strattera Attention Deficit/Hyperactivity Disorder Irritability, Negativism
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101946 4298650     M 10/22/2003 1/26/2004 96 MD PER Strattera Attention Deficit/Hyperactivity Disorder Irritability, Negativism, Somnolence
4101952 4297803 50 Years F 11/6/2003 1/26/2004 81 MD PER Strattera Chest Pain, Extrasystoles, Insomnia
4101954 4297807 30 Years M 11/6/2003 1/26/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Pain
4101955 4297757 7 Years M 8/29/2003 11/3/2003 1/26/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Decreased Appetite, Dyspnoea
4101957 4297765 36 Years M 9/19/2003 1/26/2004 129 CN PER Strattera Attention Deficit/Hyperactivity Disorder Scrotal Pain
4101959 4297761 46 Years F 10/29/2003 11/3/2003 1/26/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Hypoaesthesia, Tinnitus
4101961 4297774 41 Years M 9/13/2003 9/19/2003 1/26/2004 129 CN PER Strattera Attention Deficit/Hyperactivity Disorder, Depression Erectile Dysfunction, Euphoric Mood, Feeling Abnormal, Insomnia
4101962 4297763 51 Years M 10/1/2003 11/3/2003 1/26/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Hypoaesthesia, Mood Swings, Urinary Hesitation
4101963 4303016 42 Years F 8/1/2003 9/26/2003 1/26/2004 122 CN PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Blood Pressure Decreased, Communication Disorder, Heart Rate Increased, Insomnia
4101964 4297780 9 Years M 9/1/2003 9/19/2003 1/26/2004 129 CN PER Strattera Throat Irritation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101965 4303041 9 Years M 9/26/2003 9/26/2003 1/26/2004 122 CN PER Strattera Decreased Appetite, Dyspepsia, Malaise
4101968 4297783 10 Years M 9/19/2003 9/19/2003 1/26/2004 129 LW PER Strattera Attention Deficit/Hyperactivity Disorder Chest Discomfort
4101972 4297771 12 Years F 10/1/2003 11/4/2003 1/26/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Eye Swelling, Rash, Swelling Face
4101975 4297809 12 Years M 11/6/2003 11/6/2003 1/26/2004 81 PER Strattera Chest Pain, Nausea
4101975 4342219 12 Years M 11/6/2003 1/7/2004 3/29/2004 82 CN PER Strattera Chest Pain, Decreased Appetite, Nausea
4101976 4297678 9 Years M 11/3/2003 1/26/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder
4101978 4303050 11 Years F 1/1/2003 9/26/2003 1/26/2004 122 OT PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Depression, Insomnia, Mania, Suicidal Ideation
4101980 4297781 7 Years F 10/1/2003 11/4/2003 1/26/2004 83 PER Strattera Disturbance in Attention, Irritability, Lethargy, Mood Swings
4101981 4297680 16 Years F 11/3/2003 1/26/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Increased Appetite, Weight Increased
4101983 4297790 10 Years M 11/4/2003 1/26/2004 83 OT PER Strattera Erythema
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101986 4303052     M 9/26/2003 9/26/2003 1/26/2004 122 CN PER Strattera
4101987 4297795 12 Years 11/4/2003 1/26/2004 83 MD PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective
4101988 4297640 14 Years M 10/1/2003 11/5/2003 1/26/2004 82 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
4101989 4303053 9 Years M 9/26/2003 1/26/2004 122 CN PER Strattera Dyspepsia, Tic
4101990 4297684 50 Years F 10/9/2003 12/3/2003 1/26/2004 54 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Drug Ineffective, Mood Swings, Nervousness
4101990 4342214 50 Years F 10/9/2003 12/3/2003 3/29/2004 117 CN PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Drug Ineffective, Mood Swings, Nervousness
4101993 4297643 12 Years M 9/1/2003 12/3/2003 1/26/2004 54 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Heart Rate Increased, Overdose, Somnolence
4101993 4342217 12 Years M 9/1/2003 12/3/2003 3/29/2004 117 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Heart Rate Increased, Overdose, Somnolence
4101994 4303055 10 Years F 9/26/2003 1/26/2004 122 OT PER Strattera Abdominal Discomfort, Loose Stools
4101995 4297647 12 Years M 11/5/2003 1/26/2004 82 MD PER Strattera Depression, Drug Ineffective, Educational Problem, Self-Injurious Ideation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4101996 4297800 6 Years M 11/4/2003 11/4/2003 1/26/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Heart Rate Increased, Hyperhidrosis, Mood Swings
4101997 4303057 7 Years M 9/22/2003 9/26/2003 1/26/2004 122 CN PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Disturbance in Attention, Social Avoidant Behaviour
4101998 4297652     F 11/5/2003 1/26/2004 82 MD PER Strattera Feeling Abnormal
4101999 4303059 10 Years F 9/1/2003 9/29/2003 1/26/2004 119 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Fatigue
4102000 4297804 10 Years M 11/4/2003 1/26/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Decreased Appetite, Drug Interaction, Fatigue, Insomnia, Irritability, Mood Swings
4102002 4303062 14 Years F 9/29/2003 1/26/2004 119 MD PER Strattera Attention Deficit/Hyperactivity Disorder Piloerection, Rash, Somnolence
4102003 4297656 16 Years F 8/28/2003 12/3/2003 1/26/2004 54 MD PER Strattera Attention Deficit/Hyperactivity Disorder Amenorrhoea
4102003 4342218 16 Years F 8/28/2003 12/3/2003 3/29/2004 117 MD PER Strattera Attention Deficit/Hyperactivity Disorder Amenorrhoea
4102005 4303065 14 Years F 8/1/2003 9/29/2003 1/26/2004 119 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4102007 4297664 42 Years F 11/4/2003 1/26/2004 83 MD PER Strattera Chest Discomfort, Dyspnoea, Pollakiuria
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102008 4297514 28 Years M 11/6/2003 1/26/2004 81 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Insomnia, Mania
4102010 4297667     M 1/1/2003 11/7/2003 1/26/2004 80 MD PER Strattera Ejaculation Disorder
4102012 4297670     F 1/1/2003 11/5/2003 1/26/2004 82 CN PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Fatigue, Headache, Hyperhidrosis, Insomnia, Irritability, Mood Swings
4102013 4297517 13 Years M 11/7/2003 1/26/2004 80 PER Strattera Attention Deficit/Hyperactivity Disorder Thinking Abnormal
4102015 4297673 4 Years M 11/5/2003 1/26/2004 82 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Crying, Drug Ineffective, Middle Insomnia, Mood Swings, Restlessness, Screaming, Sleep Walking
4102016 4297518     M 11/1/2003 11/6/2003 1/26/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Excitability, Insomnia
4102019 4297682 20 Years F 11/5/2003 1/26/2004 82 CN PER Strattera Disturbance in Attention, Thinking Abnormal
4102024 4297519 26 Years F 10/24/2003 11/6/2003 1/26/2004 81 OT PER Strattera Attention Deficit/Hyperactivity Disorder Delusion, Hallucinations (Mixed), Psychotic Disorder
4102028 4297687 7 Years M 2/3/2003 11/22/2003 1/26/2004 65 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tachycardia
4102030 4297572 6 Years M 11/7/2003 1/26/2004 80 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort, Abdominal Pain Upper, Insomnia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102032 4297689 8 Years M 10/1/2003 11/3/2003 1/26/2004 84 PER Strattera Anger, Anorexia, Cognitive Disorder, Depressed Mood, Feeling Abnormal
4102036 4297690 5 Years M 10/27/2003 11/3/2003 1/26/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Psychomotor Hyperactivity
4102038 4297692 6 Years F 11/2/2003 11/3/2003 1/26/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Emotional Distress, Mydriasis
4102039 4298874     F 10/1/2003 11/7/2003 1/26/2004 80 CN PER Strattera Abdominal Pain Upper, Abnormal Behaviour, Anxiety, Crying
4102040 4298873 12 Years M 11/1/2003 11/10/2003 1/26/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Fatigue, Nasal Congestion
4102041 4297695     F 10/1/2003 11/3/2003 1/26/2004 84 PER Strattera Ageusia
4102042 4298872 60 Years F 11/7/2003 1/26/2004 80 MD PER Strattera Fatigue, Panic Disorder
4102043 4298871 30 Years F 11/7/2003 11/7/2003 1/26/2004 80 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Insomnia
4102044 4298867 12 Years 11/7/2003 1/26/2004 80 PER Strattera Appetite Disorder
4102045 4298865     F 1/1/2003 11/7/2003 1/26/2004 80 CN PER Strattera Asthenia, Blepharospasm, Chills, Dizziness, Paraesthesia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102046 4298863 9 Years M 1/1/2003 11/7/2003 1/26/2004 80 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Nightmare
4102047 4297730 8 Years M 10/1/2003 11/3/2003 1/26/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder, Pervasive Developmental Disorder Attention Deficit Hyperactivity Disorder, Fatigue, Flatulence, Mydriasis, Pervasive Developmental Disorder
4102048 4297732 7 Years M 10/1/2003 11/3/2003 1/26/2004 84 PER Strattera Fear
4102049 4298862 45 Years F 11/1/2003 11/10/2003 1/26/2004 77 PER Strattera Depression Depression
4102050 4297739 9 Years M 1/1/2003 11/3/2003 1/26/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Fatigue, Mood Swings, Tic
4102051 4297741 11 Years F 11/3/2003 11/3/2003 1/26/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Fatigue, Headache, Pallor, Tremor
4102052 4298860 4 Years M 1/1/2003 11/7/2003 1/26/2004 80 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Agitation, Dysphagia, Excitability, Feeling Jittery
4102053 4297709 26 Years M 10/1/2003 11/3/2003 1/26/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Dizziness, Feeling Abnormal
4102054 4298858     M 11/7/2003 11/7/2003 1/26/2004 80 PER Strattera Dizziness, Fatigue, Photopsia, Visual Field Defect
4102055 4297742 12 Years M 4/1/2003 12/10/2003 1/26/2004 47 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Malaise, Nausea, Retching, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102055 4342215 12 Years M 4/1/2003 12/10/2003 3/29/2004 110 CN PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Malaise, Nausea, Retching, Weight Decreased
4102056 4298854 51 Years M 1/1/2003 11/7/2003 1/26/2004 80 MD PER Strattera Bladder Pain, Dyspareunia, Painful Erection
4102057 4298853     M 11/7/2003 1/26/2004 80 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Psychomotor Hyperactivity
4102058 4297744 8 Years M 10/1/2003 11/3/2003 1/26/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Initial Insomnia, Psychomotor Hyperactivity
4102059 4298850 13 Years M 10/1/2003 11/7/2003 1/26/2004 80 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Depression, Feeling Abnormal
4102060 4297747 10 Years M 11/3/2003 1/26/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder
4102061 4298849 10 Years M 10/1/2003 10/20/2003 1/26/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Crying, Fatigue, Mood Swings, Nausea
4102062 4298847 13 Years F 10/16/2003 10/20/2003 1/26/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Dyspepsia, Feeling Abnormal, Insomnia, Nausea, Vomiting
4102063 4297544 55 Years M 8/28/2003 1/26/2004 151 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Excitability
4102064 4298846 5 Years F 1/1/2003 10/20/2003 1/26/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Decreased Appetite, Fatigue, Headache, Hypersomnia, Restlessness, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102065 4297749 15 Years F 11/3/2003 1/26/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Anxiety, Depression, Educational Problem, Irritability
4102066 4298845 10 Years M 9/1/2003 10/20/2003 1/26/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Fatigue, Insomnia, Psychomotor Hyperactivity
4102067 4297751 14 Years M 11/1/2003 11/3/2003 1/26/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain
4102068 4298838 7 Years M 10/1/2003 10/20/2003 1/26/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anorexia, Eye Disorder, Weight Decreased
4102069 4298837 10 Years M 9/1/2003 10/20/2003 1/26/2004 98 OT PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Somnolence
4102070 4298836 52 Years F 10/20/2003 10/20/2003 1/26/2004 98 PER Strattera Contusion, Insomnia, Pain
4102072 4297754 11 Years 11/3/2003 1/26/2004 84 OT PER Strattera Attention Deficit/Hyperactivity Disorder Dysphemia
4102074 4298694     M 10/21/2003 1/26/2004 97 MD PER Strattera Prostatitis
4102075 4298695 12 Years 10/21/2003 1/26/2004 97 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Crying, Irritability, Mood Swings
4102077 4298697 9 Years M 10/21/2003 1/26/2004 97 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102079 4298698 14 Years F 10/21/2003 1/26/2004 97 MD PER Strattera Confusional State, Drug Interaction
4102080 4297547 9 Years M 8/29/2003 8/29/2003 1/26/2004 150 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Fatigue, Feeling Abnormal, Headache, Vomiting
4102081 4297548 56 Years F 8/1/2003 8/29/2003 1/26/2004 150 PER Strattera Brain Damage Dyspnoea
4102083 4297550 34 Years M 8/29/2003 1/26/2004 150 PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Depression, Drug Ineffective, Fatigue
4102084 4297553     M 1/1/2003 8/29/2003 1/26/2004 150 PER Strattera
4102085 4297522 19 Years M 10/1/2003 10/31/2003 1/26/2004 87 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue
4102086 4297557 13 Years M 8/29/2003 8/29/2003 1/26/2004 150 PER Strattera Bipolar Disorder Epistaxis
4102087 4297524 30 Years M 10/31/2003 1/26/2004 87 MD PER Strattera Pelvic Pain
4102088 4297559 10 Years M 7/1/2003 8/29/2003 1/26/2004 150 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Drug Ineffective, Irritability
4102089 4297561 10 Years M 8/1/2003 9/2/2003 1/26/2004 146 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Depressed Mood, Depression, Sluggishness, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102090 4297566 57 Years M 8/1/2003 9/2/2003 1/26/2004 146 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Dysgeusia, Loss of Libido
4102093 4297526 8 Years M 10/31/2003 1/26/2004 87 MD PER Strattera Logorrhoea
4102095 4297528 12 Years M 10/1/2003 10/31/2003 1/26/2004 87 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Cold Sweat, Dyspnoea, Hyperhidrosis
4102096 4297569 9 Years M 8/1/2003 9/2/2003 1/26/2004 146 PER Strattera Attention Deficit/Hyperactivity Disorder Emotional Distress, Fatigue, Feeling Abnormal, Insomnia, Somnolence
4102097 4297723 25 Years M 9/17/2003 1/26/2004 131 MD PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Pain
4102098 4297529 8 Years M 10/1/2003 10/31/2003 1/26/2004 87 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Insomnia, Irritability, Nausea, Pollakiuria, Somnolence
4102099 4298715 24 Years M 10/20/2003 1/26/2004 98 OT PER Strattera Testicular Pain, Urinary Incontinence
4102100 4297531 14 Years M 10/31/2003 10/31/2003 1/26/2004 87 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Somnolence
4102101 4298717 6 Years F 10/1/2003 10/21/2003 1/26/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Initial Insomnia, Insomnia, Middle Insomnia, Nightmare
4102102 4297722 45 Years M 9/17/2003 1/26/2004 131 MD PER Strattera Attention Deficit/Hyperactivity Disorder Genital Discharge, Infection, Testicular Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102104 4297540 11 Years M 10/31/2003 1/26/2004 87 PER Strattera
4102105 4298719 11 Years M 10/21/2003 1/26/2004 97 OT PER Strattera Attention Deficit/Hyperactivity Disorder Amnesia, Daydreaming, Feeling Abnormal
4102106 4297545 9 Years M 10/31/2003 1/26/2004 87 MD PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Retention
4102107 4298721 9 Years F 1/1/2003 10/21/2003 1/26/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Gastrooesophageal Reflux Disease
4102108 4297719 8 Years M 9/17/2003 9/17/2003 1/26/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Feeling Abnormal
4102109 4298722 6 Years M 10/29/2003 1/26/2004 89 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Pharyngolaryngeal Pain, Pyrexia, Tachycardia Other
4102110 4297552     M 10/31/2003 1/26/2004 87 MD PER Strattera Bladder Disorder, Testicular Pain
4102111 4298726 1 Year 10/21/2003 10/22/2003 1/26/2004 96 PH PER Strattera
4102112 4297556 47 Years M 10/31/2003 1/26/2004 87 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Dysuria, Feeling Jittery, Insomnia, Nausea
4102113 4298730 6 Years M 10/21/2003 1/21/2004 92 PER Strattera Attention Deficit/Hyperactivity Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102113 4349606 6 Years M 1/15/2004 3/29/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Personality Change
4102114 4297716 15 Years M 9/16/2003 11/24/2003 1/26/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Chest Discomfort, Diarrhoea, Headache, Nasopharyngitis, Somnolence, Staring
4102114 4350549 15 Years M 9/16/2003 11/24/2003 3/29/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Chest Discomfort, Diarrhoea, Headache, Nasopharyngitis, Somnolence, Staring
4102114 4637502 15 Years M 9/16/2003 2/2/2005 3/28/2005 54 PER Strattera Abdominal Pain Upper, Abnormal Behaviour, Chest Discomfort, Diarrhoea, Headache, Nasopharyngitis, Somnolence, Staring
4102115 4298732 9 Years M 10/21/2003 1/26/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder
4102116 4298735 11 Years M 10/21/2003 1/26/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Hallucination, Panic Attack
4102117 4297705 36 Years F 11/5/2003 1/26/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Pruritus
4102118 4298736 8 Years F 10/20/2003 11/3/2003 1/26/2004 84 PER Strattera Abnormal Behaviour Abnormal Behaviour, Dyskinesia, Dyspepsia, Fatigue, Headache, Muscle Twitching, Pain in Extremity, Somnolence
4102119 4297717 12 Years 11/5/2003 1/26/2004 82 MD PER Strattera Chest Pain
4102119 4440745 12 Years F 3/9/2004 7/28/2004 141 MD PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102120 4297713     M 9/18/2003 1/26/2004 130 MD PER Strattera Urine Analysis Abnormal
4102121 4298738 37 Years F 11/12/2003 1/26/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Increased, Middle Insomnia, Nervousness
4102122 4297720 14 Years M 11/5/2003 1/26/2004 82 OT PER Strattera Fatigue, Staring
4102123 4298741 9 Years F 11/12/2003 1/26/2004 75 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4102124 4297727 10 Years M 11/5/2003 1/26/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Anxiety, Mood Swings, Tension
4102125 4297728 18 Years F 11/5/2003 11/5/2003 1/26/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Dysuria, Nausea
4102127 4297710 7 Years F 9/17/2003 1/26/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder
4102128 4297733 59 Years F 11/5/2003 1/26/2004 82 PER Strattera Pervasive Developmental Disorder Abnormal Dreams, Agitation, Anorexia, Irritability, Nightmare, Weight Decreased
4102129 4298764     F 11/10/2003 1/26/2004 77 PER Strattera Fatigue, Fibromyalgia Disorientation, Fatigue, Hot Flush, Insomnia
4102130 4297734 13 Years M 1/1/2003 11/5/2003 1/26/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Crying, Decreased Appetite, Mood Swings
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102131 4297745 7 Years F 11/6/2003 1/26/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Fatigue, Pruritus, Psychomotor Hyperactivity
4102132 4297708 8 Years M 9/1/2003 9/16/2003 1/26/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Bruxism, Hallucination (Visual), Somnolence
4102133 4298767     M 11/11/2003 1/26/2004 76 MD PER Strattera Overdose
4102134 4297746 15 Years M 11/5/2003 1/26/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
4102135 4298770     M 11/17/2003 1/26/2004 70 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety
4102136 4297760 9 Years F 11/6/2003 1/26/2004 81 PER Strattera Crying
4102137 4298771 12 Years 11/18/2003 1/26/2004 69 MD PER Strattera Hypocoagulable State
4102137 4337883 11 Years M 7/29/2003 1/14/2004 3/29/2004 75 MD PER Strattera Attention Deficit/Hyperactivity Disorder Activated Partial Thromboplastin Time Prolonged, Hypocoagulable State
4102139 4297703 29 Years M 9/17/2003 9/17/2003 1/26/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Disorientation, Memory Impairment, Paraesthesia, Vision Blurred
4102140 4297699 5 Years F 8/1/2003 9/17/2003 1/26/2004 131 PER Strattera
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102141 4298772 10 Years M 10/21/2003 1/26/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Adjustment Disorder, Crying, Personality Change, Tension
4102144 4297694 9 Years M 9/17/2003 1/26/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder
4102146 4298774     M 10/20/2003 1/26/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Genital Disorder Male, Pollakiuria
4102147 4298776 12 Years M 10/1/2003 10/21/2003 1/26/2004 97 MD PER Strattera Attention Deficit/Hyperactivity Disorder Glaucoma
4102148 4298777     M 10/21/2003 1/26/2004 97 MD PER Strattera Hepatic Enzyme Increased
4102150 4297587 11 Years M 10/22/2003 11/4/2003 1/26/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Somnolence, Swelling Face, Thinking Abnormal
4102151 4297588 8 Years M 10/31/2003 11/4/2003 1/26/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Dissociation, Fatigue, Feeling Abnormal, Vomiting
4102152 4298814 12 Years F 10/30/2003 1/26/2004 88 CN PER Strattera Drug Ineffective, Fatigue, Insomnia, Markedly Reduced Dietary Intake, Somnolence
4102153 4297590 6 Years M 11/4/2003 1/26/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Bilirubin Increased, Jaundice
4102153 4342216 6 Years M 2/6/2004 3/29/2004 52 OT PER Strattera Attention Deficit/Hyperactivity Disorder Blood Bilirubin Increased, Jaundice
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102154 4297593 5 Years M 1/1/2003 11/4/2003 1/26/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder, Autism Eye Irritation, Mydriasis, Visual Disturbance
4102155 4298818     F 10/1/2003 10/30/2003 1/26/2004 88 CN PER Strattera Dizziness, Dysmenorrhoea, Hot Flush, Menstrual Disorder, Multiple Allergies, Nausea, Tension Headache
4102156 4298821     M 10/30/2003 1/26/2004 88 MD PER Strattera Migraine, Vomiting
4102158 4297595 10 Years M 11/4/2003 1/26/2004 83 PER Strattera Abnormal Behaviour, Disturbance in Attention, Drug Ineffective
4102159 4298823 17 Years M 10/1/2003 10/30/2003 1/26/2004 88 CN PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Diarrhoea, Feeling Abnormal
4102162 4298699 59 Years F 10/21/2003 1/26/2004 97 PER Strattera Memory Impairment, Somnolence
4102162 4349608 59 Years F 1/26/2004 3/29/2004 63 PER Strattera Disturbance in Attention Drug Ineffective, Memory Impairment, Somnolence
4102163 4298700 6 Years 10/21/2003 1/26/2004 97 PER Strattera Retching, Vomiting
4102163 4349610 6 Years M 2/11/2004 3/29/2004 47 PER Strattera Retching, Somnolence, Vomiting
4102165 4298704     M 10/20/2003 1/26/2004 98 MD PER Strattera Drug Ineffective, Urinary Hesitation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102166 4298824 22 Years F 10/22/2003 10/30/2003 1/26/2004 88 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Headache, Hot Flush, Nausea, Vomiting
4102167 4298827 17 Years F 10/30/2003 1/26/2004 88 MD PER Strattera Alopecia
4102168 4298839 13 Years M 10/1/2003 10/30/2003 1/26/2004 88 CN PER Strattera Abdominal Pain Upper, Fatigue, Feeling Hot, Hyperhidrosis, Nausea, Retching, Somnolence, Tremor, Vomiting
4102169 4298840 10 Years M 10/31/2003 1/26/2004 87 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Epistaxis, Headache
4102170 4298707 9 Years M 7/1/2003 10/21/2003 1/26/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Communication Disorder
4102171 4298710 16 Years F 10/21/2003 1/26/2004 97 OT PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
4102172 4297599 12 Years M 11/4/2003 1/26/2004 83 PER Strattera Retching
4102173 4298714 16 Years M 10/21/2003 1/26/2004 97 MD PER Strattera Arrhythmia, Atrial Flutter
4102173 4349612 16 Years M 12/1/2003 1/13/2004 3/29/2004 76 MD PER Strattera Arrhythmia Supraventricular, Atrial Flutter
4102174 4298841 37 Years F 10/29/2003 10/30/2003 1/26/2004 88 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Feeling of Body Temperature Change, Headache, Hot Flush, Hyperhidrosis, Insomnia, Nausea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102175 4297602 12 Years 11/4/2003 1/26/2004 83 MD PER Strattera Agitation, Anger, Irritability, Screaming
4102176 4298843 12 Years 10/30/2003 1/26/2004 88 OT PER Strattera Ear Pain, Pain in Jaw
4102177 4297604 11 Years M 11/4/2003 1/26/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Educational Problem
4102178 4298556 17 Years M 9/22/2003 1/26/2004 126 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blood Corticotrophin Increased
4102179 4298558 17 Years F 9/20/2003 9/23/2003 1/26/2004 125 CN PER Strattera Feeling Abnormal
4102180 4298542 17 Years M 10/21/2003 1/26/2004 97 OT PER Strattera Paraesthesia
4102181 4297606     F 11/4/2003 1/26/2004 83 MD PER Strattera Muscle Twitching
4102182 4298561 7 Years F 2/1/2003 9/23/2003 1/26/2004 125 CN PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Drug Ineffective, Dysphonia, Fatigue, Mood Swings
4102183 4298562 13 Years M 9/18/2003 9/23/2003 1/26/2004 125 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective
4102185 4298564 14 Years F 9/1/2003 9/23/2003 1/26/2004 125 CN PER Strattera Chills, Fatigue, Feeling Hot and Cold
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102186 4298566 18 Years M 9/23/2003 1/26/2004 125 MD PER Strattera Drug Screen Positive
4102187 4298567 6 Years M 9/23/2003 1/26/2004 125 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Enuresis, Initial Insomnia
4102189 4298569 8 Years M 9/1/2003 9/23/2003 1/26/2004 125 CN PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Drug Ineffective, Psychomotor Hyperactivity, Somnolence
4102190 4298555 27 Years M 10/22/2003 10/22/2003 1/26/2004 96 OT PER Strattera Drug Screen Positive
4102192 4298576     M 10/22/2003 1/26/2004 96 PER Strattera Feeling Abnormal, Nausea
4102193 4298577 7 Years F 10/22/2003 1/26/2004 96 PER Strattera Abnormal Behaviour, Aggression, Decreased Appetite, Disturbance in Attention, Fatigue, Insomnia, Mood Swings, Mydriasis, Psychomotor Hyperactivity
4102195 4298572 11 Years F 9/1/2003 9/23/2003 1/26/2004 125 CN PER Strattera Abdominal Pain Upper, Dyspepsia, Hot Flush, Nightmare, Sleep Talking, Somnolence
4102205 4298475 11 Years M 9/19/2003 9/22/2003 1/26/2004 126 CN PER Strattera Abdominal Pain Upper, Dizziness, Nausea, Paraesthesia, Somnolence
4102208 4298499 10 Years M 9/22/2003 1/26/2004 126 CN PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Nail Disorder
4102211 4298504 15 Years M 9/1/2003 9/22/2003 1/26/2004 126 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Educational Problem
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102213 4297777 11 Years M 11/4/2003 1/26/2004 83 PER Strattera Autism Aggression, Drug Interaction, Feeling Abnormal
4102216 4298508 61 Years F 1/1/2003 10/9/2003 1/26/2004 109 CN PER Strattera Attention Deficit/Hyperactivity Disorder Blood Potassium Decreased, Crying, Dyspnoea, Fatigue, Fluid Retention, Heart Rate Increased, Hypertension, Impulse-Control Disorder, Insomnia, Muscle Cramp
4102225 4298529 19 Years M 9/22/2003 1/26/2004 126 CN PER Strattera Disturbance in Attention
4102227 4298535 17 Years M 9/22/2003 9/22/2003 1/26/2004 126 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Fatigue, Feeling Abnormal, Restlessness, Somnolence
4102229 4298545     F 9/5/2003 1/26/2004 143 PH PER Strattera Muscle Twitching
4102231 4298549 12 Years F 9/1/2003 9/22/2003 1/26/2004 126 CN PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Decreased Appetite, Fatigue, Flatulence, Food Craving, Somnolence
4102232 4298552 14 Years M 5/1/2003 10/13/2003 1/26/2004 105 MD PER Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
4102232 4448973 14 Years M 5/1/2003 8/23/2004 9/9/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
4102232 4501278 14 Years M 5/1/2003 8/23/2004 9/27/2004 35 MD PER Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
4102237 4297822 49 Years M 9/1/2003 9/19/2003 1/26/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Hyperhidrosis, Irritability, Peripheral Coldness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102238 4297823 19 Years M 9/1/2003 9/19/2003 1/26/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Tremor
4102239 4297825 12 Years M 9/1/2003 9/15/2003 1/26/2004 133 PH PER Strattera Contusion, Tonsillectomy
4102247 4297575 53 Years F 10/30/2003 11/5/2003 1/26/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea
4102248 4297579 17 Years M 10/1/2003 10/31/2003 1/26/2004 87 MD PER Strattera Attention Deficit/Hyperactivity Disorder Nightmare
4102249 4297581 8 Years M 10/31/2003 1/26/2004 87 MD PER Strattera Feeling Abnormal
4102251 4297629 14 Years F 10/1/2003 11/26/2003 1/26/2004 61 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Tic, Tremor, Weight Decreased
4102252 4297632 5 Years M 10/31/2003 1/26/2004 87 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Vomiting
4102253 4297651 10 Years M 10/1/2003 10/31/2003 1/26/2004 87 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Feeling Abnormal
4102255 4297653 63 Years F 10/1/2003 11/3/2003 1/26/2004 84 PER Strattera Depression Diarrhoea, Dry Mouth, Dysgeusia, Nausea
4102257 4297655 8 Years M 10/22/2003 10/31/2003 1/26/2004 87 PER Strattera Attention Deficit/Hyperactivity Disorder Nervousness, Psychomotor Hyperactivity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102259 4297661 43 Years M 10/20/2003 10/31/2003 1/26/2004 87 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Sensation in Eye, Drug Ineffective, Feeling Abnormal, Nervousness
4102261 4297675 17 Years F 11/3/2003 11/3/2003 1/26/2004 84 PER Strattera Anxiety, Attention Deficit/Hyperactivity Disorder Dizziness, Mydriasis, Nausea, Pallor, Paraesthesia, Somnolence
4102444 4298712 10 Years M 9/11/2003 1/26/2004 137 MD PER Strattera Abnormal Behaviour, Urinary Incontinence
4102447 4298706 56 Years M 1/1/2003 9/11/2003 1/26/2004 137 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Blood Pressure Increased, Chest Discomfort
4102449 4298703 9 Years M 1/1/2003 9/10/2003 1/26/2004 138 CN PER Strattera Attention Deficit/Hyperactivity Disorder Crying, School Refusal
4102451 4298701 6 Years M 1/1/2003 9/10/2003 1/26/2004 138 MD PER Strattera Attention Deficit/Hyperactivity Disorder Parkinsonian Rest Tremor
4102453 4298696 31 Years M 9/3/2003 9/10/2003 1/26/2004 138 CN PER Strattera Attention Deficit/Hyperactivity Disorder Ear Pain, Pain, Pruritus, Pyrexia, Rash
4102456 4298693     M 9/10/2003 1/26/2004 138 OT PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Erectile Dysfunction, Mood Altered, Nausea, Premature Ejaculation, Visual Disturbance, Vomiting
4102457 4298692 17 Years M 9/10/2003 1/26/2004 138 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Mood Swings, Overdose
4102458 4298691 9 Years M 9/10/2003 1/26/2004 138 CN PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Depression, Mental Status Changes
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102459 4298612 14 Years M 9/6/2003 9/10/2003 1/26/2004 138 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Muscle Twitching, Somnolence
4102461 4298582 10 Years 9/10/2003 1/26/2004 138 MD PER Strattera Lower Limb Fracture
4102469 4298900 10 Years M 8/1/2003 11/10/2003 1/26/2004 77 OT PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Ear Infection, Heart Rate Increased, Hypertension, Pharyngitis
4102474 4298898     F 11/10/2003 1/26/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder, Memory Impairment Dysuria
4102477 4298888 6 Years F 11/10/2003 1/26/2004 77 PER Strattera Decreased Appetite, Dysuria, Heart Rate Increased, Palpitations, Weight Decreased
4102477 4342222 6 Years F 11/2/2003 1/14/2004 3/29/2004 75 MD PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dysuria, Heart Rate Increased, Palpitations, Weight Decreased
4102478 4298886 55 Years M 11/10/2003 1/26/2004 77 MD PER Strattera Anorexia, Ejaculation Disorder, Urinary Tract Disorder
4102478 4342221 55 Years M 10/1/2003 1/12/2004 3/29/2004 77 MD PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Ejaculation Disorder, Urinary Tract Disorder
4102480 4298885 6 Years M 11/10/2003 1/26/2004 77 PER Strattera Decreased Appetite, Drug Ineffective, Weight Decreased
4102486 4298883 10 Years F 11/10/2003 1/26/2004 77 PER Strattera Anxiety, Obsessive Thoughts, Psychomotor Hyperactivity, Restless Legs Syndrome
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102488 4298881 11 Years M 11/1/2003 11/10/2003 1/26/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue
4102490 4298877 20 Years M 12/8/2003 1/26/2004 49 MD PER Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder
4102490 4342220 20 Years M 12/8/2003 3/29/2004 112 MD PER Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder
4102491 4298876 23 Years M 11/6/2003 11/7/2003 1/26/2004 80 PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Sexual Dysfunction, Tremor
4102495 4298875     M 11/7/2003 1/26/2004 80 MD PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Incontinence
4102583 4299735     F 11/14/2003 1/26/2004 73 PH PER Strattera Drug Screen Positive
4102603 4297850 12 Years M 11/6/2003 1/26/2004 81 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Emotional Distress, Excitability, Fatigue, Growth Retardation, Headache, Irritability, Mood Swings, Personality Disorder, Psychomotor Hyperactivity, Weight Decreased
4102603 4580252 12 Years M 8/1/2004 11/5/2004 1/27/2005 83 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Constipation, Decreased Appetite, Emotional Distress, Excitability, Fatigue, Feeling Hot, Growth Retardation, Headache, Heart Rate Increased, Irritability, Mood Swings, Personality Disorder, Psychomotor Hyperactivity, Weight Decreased
4102669 4297609 88 Years M 11/4/2003 1/26/2004 83 PER Strattera Depression Abdominal Discomfort, Nausea
4102671 4297611 6 Years M 10/21/2003 11/4/2003 1/26/2004 83 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102675 4297613 16 Years M 10/1/2003 11/4/2003 1/26/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Anger, Anorexia, Crying, Obsessive-Compulsive Disorder
4102679 4297617 9 Years M 10/1/2003 11/4/2003 1/26/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Decreased Appetite, Dyspepsia, Fatigue, Pharyngolaryngeal Pain
4102684 4297618 8 Years M 11/4/2003 1/26/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Lower, Dysuria
4102686 4297620     M 11/4/2003 1/26/2004 83 OT PER Strattera Somnolence, Syncope
4102687 4297621 35 Years M 11/4/2003 1/26/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Prostatic Disorder
4102697 4297624     F 11/1/2003 11/5/2003 1/26/2004 82 PER Strattera Chest Discomfort, Dyspepsia
4102701 4297627 9 Years M 10/1/2003 11/5/2003 1/26/2004 82 PER Strattera Vomiting
4102707 4297635     F 11/5/2003 1/26/2004 82 MD PER Strattera Hair Plucking
4102720 4296812 30 Years M 8/1/2003 8/26/2003 1/26/2004 153 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
4102723 4296813 13 Years M 8/1/2003 8/26/2003 1/26/2004 153 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Disturbance in Attention
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102724 4296819 8 Years M 8/26/2003 1/26/2004 153 PER Strattera Abnormal Behaviour, Disturbance in Attention, Drug Ineffective
4102725 4296822 9 Years M 8/27/2003 10/6/2003 1/26/2004 112 PER Strattera Chest Pain, Dizziness, Nausea
4102726 4296824 10 Years F 1/1/2003 8/26/2003 1/26/2004 153 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective
4102727 4296827 15 Years M 8/1/2003 1/5/2004 1/26/2004 21 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Anxiety, Confusional State, Derealisation, Feeling Jittery, Hallucinations (Mixed), Headache, Insomnia, Nervousness, Vomiting, Weight Decreased
4102727 4348278 15 Years M 8/1/2003 1/5/2004 3/29/2004 84 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Anxiety, Confusional State, Derealisation, Feeling Jittery, Hallucinations (Mixed), Headache, Insomnia, Nervousness, Vomiting, Weight Decreased
4102728 4296828 27 Years M 8/1/2003 10/29/2003 1/26/2004 89 PER Strattera Attention Deficit/Hyperactivity Disorder Erectile Dysfunction, Semen Volume Decreased, Sperm Count Decreased, Spermatozoa Progressive Motility Decreased
4102729 4296830 12 Years M 8/26/2003 1/26/2004 153 MD PER Strattera Aggression, Anger, Mood Swings
4102730 4296831 41 Years F 8/23/2003 8/26/2003 1/26/2004 153 PER Strattera Rash Pruritic
4102731 4296833 8 Years M 8/1/2003 8/26/2003 1/26/2004 153 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Decreased Appetite, Initial Insomnia, Insomnia, Sleep Talking, Somnolence
4102732 4296832 8 Years M 8/1/2003 11/26/2003 1/26/2004 61 OT PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Fatigue, Heart Rate Increased, Lethargy, Mydriasis, Nausea, Palpitations, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102733 4296835     M 4/1/2003 12/4/2003 1/26/2004 53 OT PER Strattera Attention Deficit/Hyperactivity Disorder Lethargy, Mydriasis, Nausea, Palpitations
4102735 4296837 15 Years M 8/6/2003 9/8/2003 1/26/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Loss of Consciousness
4102738 4296849 11 Years M 8/27/2003 1/26/2004 152 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Mood Swings
4102742 4296850 29 Years F 8/26/2003 8/27/2003 1/26/2004 152 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Inappropriate Affect
4102747 4296851     F 8/27/2003 1/26/2004 152 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Headache, Nausea, Obsessive Thoughts, Pharyngolaryngeal Pain, Pyrexia, Rash, Toothache
4102749 4296852 60 Years F 7/1/2003 10/1/2003 1/26/2004 117 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Paraesthesia, Piloerection
4102755 4296854     F 8/26/2003 8/27/2003 1/26/2004 152 OT PER Strattera Drug Screen Positive
4102758 4296857 9 Years M 9/27/2003 10/6/2003 1/26/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Markedly Reduced Dietary Intake, Nausea, Weight Decreased
4102766 4296860     F 8/27/2003 1/26/2004 152 MD PER Strattera Psychomotor Hyperactivity
4102821 4311745 10 Years F 3/4/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Trichotillomania Required Intervention to Prevent Permanent Impairment/Damage
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4102998 4311738 18 Years M 3/4/2004 OT DIR Strattera Attention Deficit/Hyperactivity Disorder Cognitive Disorder, Delirium, Disorientation, Feeling Abnormal, Hallucination (Auditory), Insomnia, Paranoia
4103042 4311753     M 10/9/2003 3/4/2004 OT DIR Strattera Attention Deficit/Hyperactivity Disorder Aphasia, Convulsion Other
4103066 4299781 57 Years F 1/1/2003 11/13/2003 1/26/2004 74 OT PER Strattera Attention Deficit/Hyperactivity Disorder Aphasia, Hyperreflexia
4103069 4299782 3 Years M 11/10/2003 11/13/2003 1/26/2004 74 PER Strattera Excitability, Feeling Hot, Feeling Hot and Cold, Nervousness, Somnolence
4103071 4299783 12 Years M 11/13/2003 1/26/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Tic, Vomiting
4103073 4299784 4 Years M 1/1/2003 11/13/2003 1/26/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anger
4103074 4299785 8 Years F 11/13/2003 1/26/2004 74 OT PER Strattera Attention Deficit/Hyperactivity Disorder Trichotillomania
4103075 4299786 42 Years F 11/13/2003 1/26/2004 74 OT PER Strattera Attention Deficit/Hyperactivity Disorder Swelling
4103075 4342230 42 Years F 1/19/2004 3/29/2004 70 OT PER Strattera Attention Deficit/Hyperactivity Disorder Swelling
4103077 4296641 10 Years M 9/9/2003 9/9/2003 1/26/2004 139 PER Strattera Throat Irritation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103080 4296644     M 9/9/2003 1/26/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia
4103087 4296649 36 Years M 9/8/2003 9/24/2003 1/26/2004 124 PER Strattera Abdominal Pain, Constipation, Crying, Decreased Appetite, Dizziness, Dry Mouth, Dry Skin, Dyspepsia, Dysuria, Flatulence, Headache, Insomnia, Irritability, Mood Swings, Muscle Rigidity, Myalgia, Paraesthesia, Psychomotor Hyperactivity, Pyrexia, Sinus Headache, Somnolence, Thinking Abnormal, Tremor, Vomiting, Weight Increased
4103092 4296653 12 Years F 9/1/2003 9/9/2003 1/26/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Dyspnoea, Fear, Insomnia
4103096 4296658 9 Years M 1/1/2003 9/9/2003 1/26/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Cold
4103109 4296664 21 Years M 1/1/2003 9/9/2003 1/26/2004 139 MD PER Strattera Cardiac Murmur, Palpitations
4103120 4296742 14 Years M 8/26/2003 9/9/2003 1/26/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Weight Decreased, Weight Gain Poor
4103125 4296746 49 Years M 7/1/2003 9/9/2003 1/26/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Skin, Rash, Tinea Cruris
4103131 4296747 40 Years F 9/9/2003 9/9/2003 1/26/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Lacrimation Increased, Middle Insomnia, Nausea, Vomiting, Yawning
4103134 4296750 9 Years M 8/17/2003 10/15/2003 1/26/2004 103 MD PER Strattera Attention Deficit/Hyperactivity Disorder, Oppositional Defiant Disorder Irritable Bowel Syndrome
4103224 4298580 10 Years F 1/1/2003 9/18/2003 1/26/2004 130 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Drug Ineffective, Impulsive Behaviour
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103235 4298578 9 Years F 9/18/2003 1/26/2004 130 PH PER Strattera Body Temperature Increased, Vomiting
4103253 4298568 16 Years M 10/24/2003 10/30/2003 1/26/2004 88 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Fatigue, Feeling Abnormal, Somnolence
4103315 4296458 55 Years 7/1/2003 8/22/2003 1/26/2004 157 PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Hesitation, Urine Flow Decreased
4103316 4296460     F 8/22/2003 1/26/2004 157 MD PER Strattera Excitability
4103320 4296462 36 Years F 8/1/2003 8/22/2003 1/26/2004 157 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Depression
4103322 4296465     F 8/1/2003 8/22/2003 1/26/2004 157 MD PER Strattera Epistaxis
4103324 4296476 39 Years F 8/1/2003 8/22/2003 1/26/2004 157 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Dyspnoea, Fatigue, Feeling Hot, Piloerection
4103328 4296480 47 Years M 8/21/2003 8/22/2003 1/26/2004 157 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Hypoaesthesia
4103330 4296484 11 Years M 8/1/2003 8/22/2003 1/26/2004 157 PER Strattera Attention Deficit/Hyperactivity Disorder Hypersomnia, Piloerection
4103331 4296485 14 Years M 8/22/2003 8/22/2003 1/26/2004 157 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Nausea, Retching
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103336 4296490 12 Years M 8/22/2003 1/26/2004 157 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tuberculosis
4103360 4296623 12 Years M 8/27/2003 1/26/2004 152 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination
4103367 4296627     M 1/1/2003 8/28/2003 1/26/2004 151 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Emotional Distress, Feeling Abnormal, Hallucination, Headache, Insomnia, Mood Swings, Psychomotor Hyperactivity, Tremor
4103370 4296629 7 Years M 8/26/2003 8/28/2003 1/26/2004 151 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Blood Hyposmosis, Decreased Appetite, Fatigue, Insomnia, Lethargy
4103379 4296631 9 Years M 8/28/2003 8/28/2003 1/26/2004 151 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Feeling Abnormal, Somnolence, Vomiting
4103382 4296633 55 Years M 8/28/2003 1/26/2004 151 MD PER Strattera Aggression, Excitability
4103387 4296634 10 Years M 8/24/2003 9/12/2003 1/26/2004 136 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Decreased Appetite, Disturbance in Attention, Drug Ineffective, Irritability, Lethargy, Mood Swings, Nausea
4103391 4296635 44 Years M 8/1/2003 8/29/2003 1/26/2004 150 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Decreased, Glycosylated Haemoglobin Decreased, Hyperhidrosis, Paraesthesia
4103394 4296636 10 Years M 7/1/2003 8/29/2003 1/26/2004 150 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Disturbance in Attention, Emotional Distress, Personality Change
4103396 4296514 5 Years M 8/1/2003 8/25/2003 1/26/2004 154 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anxiety, Bruxism, Disturbance in Attention, Insomnia, Irritability, Psychomotor Hyperactivity, Rhinorrhoea, Sneezing
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103398 4296637 11 Years F 8/29/2003 1/26/2004 150 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Weight Increased
4103399 4296521 15 Years M 8/23/2003 8/25/2003 1/26/2004 154 PER Strattera Insomnia, Lethargy
4103401 4296522 11 Years M 8/1/2003 8/25/2003 1/26/2004 154 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Fatigue
4103403 4296526 14 Years M 8/23/2003 8/25/2003 1/26/2004 154 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fatigue, Feeling Abnormal, Vision Blurred
4103404 4296534 12 Years M 8/1/2003 8/25/2003 1/26/2004 154 PER Strattera Dizziness
4103407 4296537 11 Years M 8/24/2003 8/25/2003 1/26/2004 154 PER Strattera Attention Deficit/Hyperactivity Disorder Eye Redness, Eyelid Oedema, Somnolence
4103410 4296539 36 Years M 8/1/2003 8/25/2003 1/26/2004 154 PER Strattera Attention Deficit/Hyperactivity Disorder Migraine
4103415 4296543 12 Years M 8/25/2003 8/25/2003 1/26/2004 154 OT PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Fatigue
4103421 4296545 8 Years F 8/20/2003 8/25/2003 1/26/2004 154 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Epistaxis
4103422 4296547 16 Years F 8/25/2003 1/26/2004 154 PER Strattera Depression, Suicidal Ideation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103456 4302917 6 Years M 10/16/2003 1/26/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity
4103457 4302874 8 Years F 10/16/2003 1/26/2004 102 PER Strattera Psychomotor Hyperactivity
4103458 4302919 10 Years F 4/1/2003 10/16/2003 1/26/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Cystitis, Dysuria
4103459 4296756 48 Years M 9/5/2003 9/25/2003 1/26/2004 123 PER Strattera Somnolence Balance Disorder, Blood Pressure Increased, Heart Rate Increased, Middle Insomnia, Muscle Cramp, Nausea, Psychomotor Hyperactivity
4103460 4302921 46 Years F 10/16/2003 1/26/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder
4103462 4302924 12 Years M 10/16/2003 10/16/2003 1/26/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
4103463 4296758 12 Years M 9/5/2003 1/26/2004 143 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4103464 4302877 8 Years M 10/16/2003 1/26/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder
4103466 4302930 16 Years 10/13/2003 1/26/2004 105 MD PER Strattera Aggression, Mania, Mood Swings, Suicidal Ideation
4103468 4296760 8 Years M 9/1/2003 9/8/2003 1/26/2004 140 PER Strattera Oppositional Defiant Disorder Abdominal Pain Upper, Anxiety, Crying, Emotional Disorder, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103470 4302931 12 Years M 10/14/2003 1/26/2004 104 MD PER Strattera Myoclonus
4103471 4302879 17 Years M 10/1/2003 10/16/2003 1/26/2004 102 MD PER Strattera Chills, Dyskinesia, Night Sweats
4103473 4302933 5 Years M 10/1/2003 10/16/2003 1/26/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Pollakiuria
4103474 4302936 7 Years M 10/15/2003 10/16/2003 1/26/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Decreased Appetite, Headache, Pallor, Vomiting
4103476 4302882 11 Years F 10/15/2003 10/16/2003 1/26/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Feeling Abnormal, Lethargy, Somnolence
4103478 4302938 12 Years 10/15/2003 1/26/2004 103 MD PER Strattera Attention Deficit/Hyperactivity Disorder Panic Disorder
4103479 4302941 16 Years 10/16/2003 1/26/2004 102 MD PER Strattera Attention Deficit/Hyperactivity Disorder Rosacea
4103480 4302886 5 Years M 1/1/2003 10/16/2003 1/26/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Disturbance in Attention, Drug Ineffective, Dysphonia, Logorrhoea, Vomiting
4103485 4302888     M 1/1/2003 10/16/2003 1/26/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Dehydration, Dysuria, Nausea, Thirst
4103487 4302892     F 10/16/2003 1/26/2004 102 MD PER Strattera Dysmenorrhoea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103488 4302895     M 10/16/2003 1/26/2004 102 MD PER Strattera Insomnia, Mood Swings
4103492 4302899 9 Years M 10/1/2003 10/16/2003 1/26/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Vomiting
4103515 4296638 8 Years M 8/1/2003 8/29/2003 1/26/2004 150 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Increased Appetite, Psychomotor Hyperactivity
4103525 4302963 12 Years M 10/15/2003 1/26/2004 103 MD PER Strattera Attention Deficit/Hyperactivity Disorder Obsessive-Compulsive Disorder
4103526 4298786 22 Years M 10/22/2003 1/26/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Somnolence
4103526 4637503 23 Years M 2/2/2005 3/28/2005 54 PER Strattera Blepharospasm, Fatigue, Feeling Abnormal, Heart Rate Increased, Hypersomnia
4103529 4298787 6 Years M 10/22/2003 10/22/2003 1/26/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder, Autism Aggression, Attention Deficit Hyperactivity Disorder, Autistic Disorder, Decreased Appetite, Diarrhoea, Hyperacusis
4103532 4298842 10 Years F 10/22/2003 1/26/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Crying, Disturbance in Attention, Fatigue, Headache
4103532 4637504 10 Years F 12/17/2004 3/28/2005 101 PER Strattera Aggression, Crying, Disturbance in Attention, Fatigue, Headache, Pruritus
4103534 4302969     M 10/16/2003 1/26/2004 102 MD PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103537 4298844 9 Years M 7/21/2003 10/22/2003 1/26/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Masked Facies, Skin Discolouration, Sluggishness, Somnolence
4103538 4302991 11 Years M 10/16/2003 1/26/2004 102 PER Strattera Psychomotor Hyperactivity
4103540 4303009 5 Years F 10/7/2003 10/17/2003 1/26/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dyspepsia, Feeling Abnormal, Lethargy, Somnolence, Vomiting, Weight Decreased
4103541 4298848 6 Years M 10/22/2003 1/26/2004 96 OT PER Strattera Attention Deficit/Hyperactivity Disorder Muscle Cramp, Muscle Rigidity, Posture Abnormal
4103542 4298851     F 10/22/2003 10/22/2003 1/26/2004 96 PER Strattera Feeling Jittery, Heart Rate Increased
4103543 4298852 12 Years 10/22/2003 1/26/2004 96 OT PER Strattera Tic
4103544 4303022 43 Years F 10/14/2003 10/17/2003 1/26/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Insomnia, Nervousness
4103545 4303049 4 Years F 10/17/2003 1/26/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Impulse-Control Disorder
4103546 4298855 12 Years M 10/22/2003 1/26/2004 96 MD PER Strattera Psychomotor Hyperactivity
4103547 4303051 8 Years M 10/15/2003 1/26/2004 103 MD PER Strattera Hallucination
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103548 4303054 35 Years F 1/1/2003 12/15/2003 1/26/2004 42 MD PER Strattera Glaucoma
4103548 4349605 35 Years F 1/1/2003 2/20/2004 3/29/2004 38 MD PER Strattera Blood Pressure Increased, Glaucoma
4103549 4303056 12 Years F 11/3/2003 1/26/2004 84 MD PER Strattera Attention Deficit/Hyperactivity Disorder Gingival Hyperplasia
4103550 4303058 13 Years F 10/18/2003 10/17/2003 1/26/2004 101 PER Strattera Dizziness, Heart Rate Increased, Hyperventilation
4103551 4298856     M 10/1/2003 10/22/2003 1/26/2004 96 MD PER Strattera Mania
4103553 4298857 12 Years M 10/22/2003 1/26/2004 96 MD PER Strattera Abnormal Behaviour, Crying, Insomnia
4103555 4311484 34 Years M 6/1/2003 3/3/2004 CN DIR Strattera Depression, Obsessive-Compulsive Disorder Personality Change, Suicidal Ideation Life-Threatening
4103691 4303144 13 Years F 9/1/2003 9/30/2003 1/26/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Depression, Drug Ineffective, Insomnia, Somnolence, Tic, Weight Decreased
4103695 4303149     M 9/30/2003 1/26/2004 118 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Irritability, Mood Swings
4103696 4303148 24 Years M 9/30/2003 9/30/2003 1/26/2004 118 PER Strattera Dysuria, Urine Analysis Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103698 4303146 15 Years M 9/30/2003 1/26/2004 118 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hyperhidrosis, Myalgia, Serotonin Syndrome
4103699 4303145 26 Years M 8/1/2003 9/30/2003 1/26/2004 118 MD PER Strattera Attention Deficit/Hyperactivity Disorder
4103700 4303143 14 Years M 1/1/2003 9/29/2003 1/26/2004 119 OT PER Strattera Attention Deficit/Hyperactivity Disorder Epistaxis
4103701 4303142 19 Years M 9/29/2003 9/29/2003 1/26/2004 119 PER Strattera Headache, Pain in Extremity
4103702 4303139 10 Years M 9/29/2003 9/29/2003 1/26/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination (Auditory)
4103703 4303120 6 Years M 10/15/2003 1/26/2004 103 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Educational Problem
4103704 4303115 15 Years M 1/1/2003 9/29/2003 1/26/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Hypersensitivity Other
4103705 4302960     M 9/25/2003 1/26/2004 123 PER Strattera Attention Deficit/Hyperactivity Disorder Irritability
4103706 4302957     M 1/1/2003 9/25/2003 1/26/2004 123 MD PER Strattera Myoclonus
4103707 4302956 50 Years F 1/1/2003 9/25/2003 1/26/2004 123 PER Strattera Dyspnoea, Palpitations
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103708 4302953 10 Years M 9/25/2003 1/26/2004 123 PER Strattera Disturbance in Attention, Educational Problem, Psychomotor Hyperactivity
4103709 4302952 13 Years M 9/25/2003 1/26/2004 123 MD PER Strattera Rash, Swelling
4103710 4302949 13 Years M 9/1/2003 9/25/2003 1/26/2004 123 PER Strattera Anger, Disturbance in Attention, Eating Disorder, Emotional Distress, Mood Swings, Nervousness, Psychomotor Hyperactivity
4103712 4302944 4 Years M 9/1/2003 9/25/2003 1/26/2004 123 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Yawning
4103713 4302942 59 Years F 9/1/2003 9/25/2003 1/26/2004 123 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Headache, Psychomotor Hyperactivity, Thirst
4103714 4302940 15 Years M 9/1/2003 9/25/2003 1/26/2004 123 PER Strattera Aggression, Belligerence, Headache, Mood Swings
4103715 4302915 8 Years M 9/25/2003 1/26/2004 123 MD PER Strattera
4103723 4302913 8 Years F 6/1/2003 11/5/2003 1/26/2004 82 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Crying, Depression, Somnolence
4103725 4302911 29 Years M 9/25/2003 1/26/2004 123 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Fatigue
4103726 4302909 16 Years M 9/25/2003 1/26/2004 123 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Scrotal Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103727 4302906 10 Years M 8/30/2003 10/22/2003 1/26/2004 96 MD PER Strattera Attention Deficit/Hyperactivity Disorder Iridocyclitis
4103728 4302903 6 Years F 9/25/2003 1/26/2004 123 PER Strattera Attention Deficit/Hyperactivity Disorder
4103732 4302901 37 Years M 9/1/2003 9/25/2003 1/26/2004 123 PER Strattera Disturbance in Attention Feeling Abnormal, Insomnia, Somnolence
4103733 4302894 12 Years M 9/25/2003 1/26/2004 123 MD PER Strattera Dysarthria, Facial Palsy, Hypoaesthesia, Vision Blurred
4103734 4302890 12 Years M 9/1/2003 9/25/2003 1/26/2004 123 PER Strattera Hallucination (Auditory)
4103735 4301755 35 Years F 9/1/2003 10/2/2003 1/26/2004 116 PER Strattera Feeling Abnormal, Insomnia, Sleep Disorder, Sluggishness
4103736 4301753 11 Years M 10/2/2003 1/26/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Affect Lability, Anxiety, Asthenia, Chest Pain, Crying, Morbid Thoughts
4103737 4301748 12 Years 9/25/2003 1/26/2004 123 PER Strattera Personality Change
4103739 4301744 12 Years 9/25/2003 1/26/2004 123 PER Strattera Personality Change
4103740 4301740 12 Years 9/25/2003 1/26/2004 123 PER Strattera Personality Change
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103741 4301737 12 Years 9/25/2003 1/26/2004 123 MD PER Strattera Personality Change
4103742 4301735 12 Years 9/25/2003 1/26/2004 123 MD PER Strattera Personality Change
4103743 4301732 35 Years M 10/2/2003 1/26/2004 116 MD PER Strattera Dysuria, Skin Discolouration
4103744 4301730 4 Years M 1/1/2003 10/2/2003 1/26/2004 116 PER Strattera Psychomotor Hyperactivity Drug Ineffective, Insomnia, Irritability, Psychomotor Hyperactivity
4103745 4301719 10 Years M 10/2/2003 1/26/2004 116 OT PER Strattera Psychomotor Hyperactivity
4103746 4301540 8 Years M 1/1/2003 10/1/2003 1/26/2004 117 PER Strattera Anxiety, Eating Disorder, Sleep Disorder
4103748 4301537 10 Years F 9/1/2003 10/1/2003 1/26/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Nervousness
4103749 4301536 5 Years F 8/1/2003 10/1/2003 1/26/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder
4103750 4301530 25 Years M 10/6/2003 1/26/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Hyperhidrosis, Psychomotor Hyperactivity, Rash, Skin Odour Abnormal
4103751 4301529 20 Years F 9/30/2003 1/26/2004 118 OT PER Strattera Attention Deficit/Hyperactivity Disorder Irritability, Personality Change
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103752 4301527 10 Years M 1/1/2003 9/30/2003 1/26/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Infrequent Bowel Movements
4103753 4301524 9 Years M 1/1/2003 9/30/2003 1/26/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Asthma, Convulsion, Dyspnoea
4103759 4301522 5 Years M 1/1/2003 9/30/2003 1/26/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Fatigue, Nausea, Somnolence, Weight Decreased
4103763 4301516 11 Years F 7/1/2003 9/30/2003 1/26/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
4103764 4299838     F 11/17/2003 1/26/2004 70 MD PER Strattera Piloerection
4103765 4299837 60 Years F 1/1/2003 11/18/2003 1/26/2004 69 MD PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Panic Reaction
4103766 4299836     F 11/1/2003 11/18/2003 1/26/2004 69 MD PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
4103767 4299835     M 11/1/2003 11/18/2003 1/26/2004 69 PER Strattera Disorientation, Erectile Dysfunction
4103768 4299815 60 Years F 1/1/2003 11/18/2003 1/26/2004 69 OT PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Dizziness, Feeling Abnormal, Hot Flush, Tachycardia
4103768 4342689 60 Years F 1/1/2003 2/17/2004 3/29/2004 41 OT PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Dizziness, Feeling Abnormal, Hot Flush, Tachycardia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103769 4299814     M 11/17/2003 1/26/2004 70 MD PER Strattera Hallucination
4103769 4342686 24 Years F 7/24/2003 1/14/2004 3/29/2004 75 MD PER Strattera Anxiety Disorder, Attention Deficit/Hyperactivity Disorder Disorientation, Dizziness, Hallucination, Vision Blurred
4103770 4299811 14 Years F 7/1/2003 11/18/2003 1/26/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Weight Decreased
4103771 4299810 10 Years M 11/1/2003 11/18/2003 1/26/2004 69 MD PER Strattera Attention Deficit/Hyperactivity Disorder Activities of Daily Living Impaired, Crying, Emotional Disorder, Mood Swings
4103772 4299809 8 Years M 11/1/2003 11/18/2003 1/26/2004 69 PER Strattera Autism Anger, Mood Swings
4103773 4299805 10 Years F 11/1/2003 11/18/2003 1/26/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Dysphagia
4103774 4299799 13 Years F 11/18/2003 1/26/2004 69 MD PER Strattera Menstruation Irregular
4103775 4299796     M 11/9/2003 11/18/2003 1/26/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Nausea, Vomiting
4103776 4299794 14 Years F 11/1/2003 12/11/2003 1/26/2004 46 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Hypertension, Tachycardia
4103776 4342683 14 Years F 11/1/2003 12/11/2003 3/29/2004 109 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Hypertension, Tachycardia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103777 4299789 10 Years F 1/1/2003 11/18/2003 1/26/2004 69 MD PER Strattera Attention Deficit/Hyperactivity Disorder Cogwheel Rigidity, Muscle Rigidity
4103778 4299788 14 Years M 11/17/2003 11/18/2003 1/26/2004 69 PER Strattera Abdominal Pain Upper, Dizziness, Fatigue, Insomnia, Intentional Overdose, Somnolence
4103779 4299787 28 Years M 1/1/2003 11/18/2003 1/26/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Erectile Dysfunction, Somnolence, Testicular Pain
4103781 4299779 7 Years M 11/13/2003 11/17/2003 1/26/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Insomnia, Psychomotor Hyperactivity, Somnolence
4103782 4299773     M 9/1/2003 11/18/2003 1/26/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Groin Pain, Micturition Disorder
4103783 4299750 13 Years M 12/9/2003 1/26/2004 48 OT PER Strattera Chest Pain, Depression, Heart Rate Increased, Hypoaesthesia, Insomnia
4103783 4342232 13 Years M 1/23/2004 3/29/2004 66 PER Strattera Chest Pain, Electrocardiogram Abnormal, Heart Rate Increased, Hypoaesthesia
4103784 4299749 6 Years M 11/13/2003 1/26/2004 74 MD PER Strattera Anxiety
4103785 4299748 31 Years M 11/1/2003 11/17/2003 1/26/2004 70 MD PER Strattera Dermatitis Exfoliative
4103786 4299745 10 Years M 10/1/2003 11/17/2003 1/26/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Asthma
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103787 4299743 9 Years M 11/10/2003 11/17/2003 1/26/2004 70 PER Strattera Arthralgia, Rash
4103788 4298902 19 Years M 10/10/2003 10/20/2003 1/26/2004 98 MD PER Strattera Attention Deficit/Hyperactivity Disorder Epididymitis
4103789 4298901 13 Years F 10/20/2003 1/26/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Somnolence
4103790 4298899 37 Years F 10/20/2003 1/26/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Disturbance in Attention, Fatigue
4103791 4298897 11 Years M 10/6/2003 11/11/2003 1/26/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Dizziness, Fatigue, Heart Rate Decreased, Pallor, Somnolence, Speech Disorder
4103793 4298896 14 Years M 9/1/2003 10/20/2003 1/26/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Cough, Fatigue, Herpes Simplex, Weight Increased
4103794 4298895 12 Years 10/20/2003 1/26/2004 98 OT PER Strattera Tic
4103795 4298894 7 Years M 10/18/2003 10/20/2003 1/26/2004 98 PER Strattera Abnormal Behaviour, Drug Ineffective, Irritability
4103796 4298893 49 Years F 10/1/2003 10/20/2003 1/26/2004 98 PER Strattera Dizziness, Head Discomfort, Heart Rate Increased, Nausea, Paraesthesia, Vertigo
4103798 4298892 42 Years F 9/1/2003 10/20/2003 1/26/2004 98 PER Strattera
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103799 4298891 5 Years F 10/1/2003 10/20/2003 1/26/2004 98 PER Strattera Agitation, Anger, Crying, Disturbance in Attention, Drug Interaction, Insomnia, Mood Swings, Psychomotor Hyperactivity
4103800 4298890 35 Years F 10/14/2003 10/20/2003 1/26/2004 98 PER Strattera Dyspepsia, Headache, Middle Insomnia, Nausea
4103801 4298889     F 10/17/2003 10/20/2003 1/26/2004 98 PER Strattera Daydreaming, Feeling Abnormal, Feeling Hot, Heart Rate Increased, Nausea, Somnolence
4103802 4298887 10 Years M 10/15/2003 1/26/2004 103 OT PER Strattera Aggression, Anxiety, Disturbance in Attention, Nervousness
4103803 4298884 9 Years F 10/17/2003 1/26/2004 101 OT PER Strattera Crying, Depression
4103804 4298882 10 Years F 1/1/2003 10/15/2003 1/26/2004 103 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Crying, Nervousness, Paranoia, Tremor
4103805 4298880     F 10/30/2003 1/26/2004 88 OT PER Strattera Anxiety
4103806 4298879 7 Years M 10/1/2003 10/31/2003 1/26/2004 87 PER Strattera Dyspepsia, Insomnia, Pain, Vomiting
4103807 4298878 8 Years M 10/1/2003 10/31/2003 1/26/2004 87 PER Strattera Attention Deficit/Hyperactivity Disorder Weight Decreased
4103808 4298870 13 Years M 10/31/2003 10/31/2003 1/26/2004 87 PH PER Strattera Oesophageal Discomfort
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103809 4298869 12 Years M 10/30/2003 1/26/2004 88 MD PER Strattera Gastrooesophageal Reflux Disease
4103810 4298868 12 Years M 10/30/2003 1/26/2004 88 MD PER Strattera Gastrooesophageal Reflux Disease
4103811 4298866     M 10/30/2003 1/26/2004 88 PH PER Strattera Gynaecomastia
4103812 4298864 10 Years F 10/21/2003 1/26/2004 97 MD PER Strattera Abnormal Behaviour
4103813 4298861 8 Years F 10/27/2003 10/30/2003 1/26/2004 88 PER Strattera Abdominal Pain Upper, Crying, Emotional Disorder, Lethargy, Somnolence
4103814 4298859 11 Years M 1/1/2003 10/30/2003 1/26/2004 88 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Incoherent, Psychomotor Hyperactivity
4103815 4298834     M 9/12/2003 1/26/2004 136 MD PER Strattera Dizziness, Headache, Vision Blurred
4103816 4298833 34 Years F 9/11/2003 9/12/2003 1/26/2004 136 OT PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Insomnia, Yawning
4103817 4298832 18 Years F 8/28/2003 9/12/2003 1/26/2004 136 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Drug Ineffective, Fatigue, Increased Appetite, Irritability
4103818 4298831 7 Years M 1/1/2003 9/12/2003 1/26/2004 136 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103819 4298830 12 Years F 9/10/2003 1/26/2004 138 MD PER Strattera Gallbladder Disorder
4103821 4298829 10 Years M 9/5/2003 9/12/2003 1/26/2004 136 PER Strattera Attention Deficit/Hyperactivity Disorder Initial Insomnia
4103822 4298828 15 Years M 9/12/2003 1/26/2004 136 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Irritability, Memory Impairment, Mood Swings, Nausea
4103824 4298826 8 Years M 9/4/2003 9/12/2003 1/26/2004 136 PER Strattera Abnormal Behaviour
4103825 4298825 8 Years M 1/1/2003 9/12/2003 1/26/2004 136 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Irritability, Psychomotor Hyperactivity
4103825 5423700 8 Years M 1/1/2003 2/23/2007 7/25/2007 152 CN PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination (Auditory), Insomnia, Irritability, Overdose Other
4103826 4298822 12 Years F 9/12/2003 1/26/2004 136 PER Strattera Attention Deficit/Hyperactivity Disorder Acute Sinusitis
4103827 4298820 7 Years F 9/1/2003 9/12/2003 1/26/2004 136 PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia, Disturbance in Attention, Pressure of Speech
4103827 4349154 7 Years F 9/1/2003 2/6/2004 3/29/2004 52 MD PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia, Disturbance in Attention, Pressure of Speech, Restlessness
4103828 4298819 13 Years M 10/29/2003 1/26/2004 89 MD PER Strattera Attention Deficit/Hyperactivity Disorder Ventricular Extrasystoles
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103829 4298817 7 Years F 9/7/2003 9/12/2003 1/26/2004 136 PER Strattera Abnormal Behaviour, Anxiety, Psychomotor Hyperactivity Anxiety, Drug Ineffective, Feeling Abnormal, Insomnia, Irritability, Memory Impairment, Mood Swings, Mydriasis, Psychomotor Hyperactivity, Retching
4103830 4298816 8 Years M 9/12/2003 1/26/2004 136 MD PER Strattera Anxiety, Heart Rate Increased, Nervousness
4103831 4298815 7 Years M 9/12/2003 1/26/2004 136 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4103832 4298813 7 Years M 1/1/2003 9/12/2003 1/26/2004 136 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Crying
4103833 4298812 9 Years M 9/12/2003 1/26/2004 136 PER Strattera Attention Deficit/Hyperactivity Disorder
4103834 4298811 10 Years M 9/1/2003 9/12/2003 1/26/2004 136 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Hot, Flushing, Nausea, Pharyngolaryngeal Pain
4103835 4298810 44 Years M 9/7/2003 9/12/2003 1/26/2004 136 PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Pain, Urinary Tract Infection
4103836 4298807 7 Years M 9/12/2003 1/26/2004 136 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Psychomotor Hyperactivity
4103837 4298804 10 Years M 8/1/2003 9/11/2003 1/26/2004 137 PER Strattera Abnormal Behaviour, Anorexia, Disturbance in Attention, Feeling Abnormal, Hypersomnia
4103838 4298803     9/18/2003 1/26/2004 130 MD PER Strattera Mood Swings
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103839 4298785 12 Years 1/1/2003 8/25/2003 1/26/2004 154 MD PER Strattera Decreased Appetite, Dizziness, Hyperhidrosis, Insomnia, Mood Swings
4103840 4298784 12 Years 7/15/2003 1/26/2004 195 OT PER Strattera
4103841 4298783 12 Years 7/15/2003 1/26/2004 195 OT PER Strattera
4103842 4298782     M 8/1/2003 9/11/2003 1/26/2004 137 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Agitation, Crying, Drug Ineffective, Feeling Abnormal, Psychomotor Hyperactivity
4103843 4298779 12 Years 7/15/2003 1/26/2004 195 OT PER Strattera
4103844 4298775 9 Years M 1/1/2003 9/11/2003 1/26/2004 137 PER Strattera Attention Deficit/Hyperactivity Disorder, Sleep Disorder Dysuria, Pollakiuria, Sinusitis
4103845 4298773 11 Years F 9/6/2003 9/11/2003 1/26/2004 137 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Headache, Hearing Impaired, Nausea
4103852 4297378     M 9/1/2003 9/29/2003 1/26/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Somnolence
4103853 4297377 9 Years M 4/1/2003 9/15/2003 1/26/2004 133 PH PER Strattera Anxiety, Cold Sweat, Feeling Abnormal, Heart Rate Increased, Hyperhidrosis, Nausea
4103854 4297373 12 Years 9/15/2003 1/26/2004 133 MD PER Strattera Anorexia, Drug Ineffective, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103855 4297361 9 Years F 1/1/2003 9/15/2003 1/26/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dyspepsia, Feeling Abnormal, Growth Retardation, Headache, Middle Insomnia, Vomiting
4103856 4297358     9/15/2003 1/26/2004 133 MD PER Strattera Disturbance in Attention Disturbance in Attention
4103857 4297356     M 1/1/2003 9/15/2003 1/26/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Pharyngolaryngeal Pain, Prostatic Pain, Urinary Hesitation
4103858 4297354     F 9/15/2003 1/26/2004 133 MD PER Strattera Disturbance in Attention Obsessive-Compulsive Disorder
4103859 4297352 9 Years M 9/13/2003 9/15/2003 1/26/2004 133 PER Strattera Anxiety Anxiety
4103860 4297351 9 Years M 9/12/2003 1/26/2004 136 OT PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4103861 4297350 16 Years M 9/12/2003 1/26/2004 136 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4103863 4297155     F 9/4/2003 1/26/2004 144 MD PER Strattera Attention Deficit/Hyperactivity Disorder
4103864 4297154 8 Years M 8/1/2003 9/4/2003 1/26/2004 144 PER Strattera Attention Deficit/Hyperactivity Disorder Educational Problem, Stomach Discomfort
4103865 4297153     M 9/4/2003 1/26/2004 144 MD PER Strattera Mood Swings
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4103866 4297152     M 9/4/2003 1/26/2004 144 PER Strattera Disturbance in Attention, Drug Ineffective
4103867 4297151 8 Years M 11/26/2003 1/26/2004 61 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
4103867 4349152 8 Years M 11/26/2003 3/29/2004 124 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
4103868 4297150 12 Years M 9/1/2003 9/4/2003 1/26/2004 144 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Hyperhidrosis, Memory Impairment, Middle Insomnia, Somnolence
4103869 4297149 18 Years M 9/4/2003 1/26/2004 144 OT PER Strattera Attention Deficit/Hyperactivity Disorder
4103870 4297148 13 Years M 9/2/2003 9/4/2003 1/26/2004 144 PER Strattera Gastrointestinal Disorder, Vomiting
4103871 4297147 12 Years M 1/1/2003 9/4/2003 1/26/2004 144 PER Strattera Psychomotor Hyperactivity Abdominal Pain Upper, Asthenia, Fatigue, Headache, Nausea, Sinusitis, Vomiting, Weight Decreased
4103873 4297146 11 Years M 9/3/2003 9/4/2003 1/26/2004 144 PER Strattera Epistaxis
4103997 4297808 9 Years M 9/17/2003 1/26/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Nervousness
4103999 4297802 40 Years F 9/17/2003 1/26/2004 131 MD PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Headache, Nausea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4104001 4297796 5 Years M 9/17/2003 9/17/2003 1/26/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Withdrawal Headache
4104006 4297787 20 Years F 9/17/2003 9/17/2003 1/26/2004 131 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Diarrhoea, Haematochezia, Mydriasis
4104009 4297782 28 Years M 8/1/2003 9/17/2003 1/26/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Semen Abnormal
4104012 4297776     M 9/1/2003 9/17/2003 1/26/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Somnolence
4104017 4297769 39 Years F 9/17/2003 1/26/2004 131 PER Strattera Tooth Discolouration
4104066 4303064     F 10/17/2003 1/26/2004 101 MD PER Strattera Pollakiuria
4104067 4303066 7 Years M 8/1/2003 10/17/2003 1/26/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4104070 4303068 17 Years M 10/17/2003 1/26/2004 101 MD PER Strattera
4104072 4303069 10 Years M 10/1/2003 10/17/2003 1/26/2004 101 MD PER Strattera Attention Deficit/Hyperactivity Disorder Suicidal Ideation
4104074 4303070 9 Years M 9/1/2003 10/17/2003 1/26/2004 101 OT PER Strattera Abnormal Behaviour, Crying, Diarrhoea, Disturbance in Attention
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4104076 4303071     M 10/17/2003 1/26/2004 101 PH PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Vomiting
4104078 4303072 11 Years M 10/17/2003 1/26/2004 101 MD PER Strattera Back Pain
4104079 4303073     F 10/1/2003 10/17/2003 1/26/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Confusional State, Dizziness, Dry Mouth, Dysgeusia, Dysuria, Fatigue, Feeling Abnormal, Nausea, Oedema, Tension Headache, Weight Increased
4104083 4303075 12 Years F 10/17/2003 1/26/2004 101 OT PER Strattera Crying, Depression
4104087 4297764 9 Years M 9/17/2003 1/26/2004 131 MD PER Strattera Tic
4104088 4297758 12 Years M 9/1/2003 9/17/2003 1/26/2004 131 MD PER Strattera Aggression, Anger
4104089 4297725 16 Years M 9/17/2003 1/26/2004 131 MD PER Strattera Ejaculation Disorder
4104091 4298419 12 Years F 9/18/2003 1/26/2004 130 MD PER Strattera Muscle Twitching
4104093 4298230 12 Years M 9/18/2003 1/26/2004 130 MD PER Strattera Diplopia
4104095 4297842 14 Years M 9/18/2003 1/26/2004 130 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4104096 4297833 8 Years M 9/18/2003 1/26/2004 130 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Dysgraphia
4104101 4297827 30 Years F 6/1/2003 9/17/2003 1/26/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Amenorrhoea, Breast Discharge, Fatigue, Hot Flush, Hypertension, Libido Decreased, Mood Swings, Residual Urine Volume, Urinary Hesitation, Urinary Incontinence, Weight Increased
4104103 4297821 6 Years M 9/15/2003 9/18/2003 1/26/2004 130 PER Strattera Increased Appetite, Somnolence
4104105 4297819 27 Years M 9/17/2003 9/18/2003 1/26/2004 130 PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Asthenia
4104107 4297816 13 Years M 9/15/2003 9/24/2003 1/26/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Fatigue, Insomnia, Mydriasis, Somnolence
4104110 4297814 6 Years M 9/11/2003 9/17/2003 1/26/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Tic
4104111 4297812     M 9/17/2003 1/26/2004 131 OT PER Strattera Depression, Suicidal Ideation
4104114 4297660 8 Years M 9/17/2003 1/26/2004 131 PER Strattera Anxiety, Hyperhidrosis, Nervousness
4104115 4297659 12 Years M 9/16/2003 1/26/2004 132 PER Strattera Bruxism
4104117 4297638 17 Years F 9/1/2003 9/16/2003 1/26/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Insomnia, Premenstrual Syndrome
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4104118 4297628 16 Years F 9/1/2003 9/16/2003 1/26/2004 132 PER Strattera Acne
4104120 4297626     M 9/17/2003 1/26/2004 131 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
4104122 4297623     M 9/16/2003 1/26/2004 132 MD PER Strattera Tremor
4104123 4297619     M 9/16/2003 1/26/2004 132 CN PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Insomnia, Tic
4104124 4297615 46 Years M 8/1/2003 9/16/2003 1/26/2004 132 MD PER Strattera Attention Deficit/Hyperactivity Disorder Vision Blurred
4104125 4297610 5 Years M 1/1/2003 9/16/2003 1/26/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Drug Ineffective
4104126 4297608 6 Years M 9/16/2003 1/26/2004 132 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination (Auditory), Paranoia, Schizophrenia
4104127 4297605 4 Years M 9/16/2003 9/16/2003 1/26/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Hyperhidrosis
4104129 4297603 11 Years M 9/1/2003 9/16/2003 1/26/2004 132 PER Strattera Abnormal Behaviour
4104130 4297598 11 Years F 9/16/2003 1/26/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Educational Problem, Increased Appetite, Mood Swings
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4104131 4297596 7 Years 9/13/2003 9/16/2003 1/26/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Epistaxis, Headache, Somnolence
4104131 4637501 7 Years M 9/13/2003 2/23/2005 3/28/2005 33 PER Strattera Abdominal Pain Upper, Decreased Appetite, Drug Ineffective, Dyspepsia, Epistaxis, Headache, Nausea, Somnolence, Stomach Discomfort, Therapeutic Response Unexpected
4104131 4726691 7 Years M 9/13/2003 3/23/2005 7/25/2005 124 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Decreased Appetite, Drug Ineffective, Dyspepsia, Epistaxis, Headache, Nausea, Nervousness, Somnolence, Stomach Discomfort, Therapeutic Response Unexpected
4104133 4297592 9 Years M 9/1/2003 9/16/2003 1/26/2004 132 PER Strattera Abnormal Behaviour, Drug Ineffective, Insomnia, Psychomotor Hyperactivity
4104135 4297585     M 9/16/2003 1/26/2004 132 MD PER Strattera Abdominal Discomfort
4104138 4297582 11 Years M 1/1/2003 9/16/2003 1/26/2004 132 PER Strattera Mood Swings, Rebound Effect
4104139 4297578 12 Years F 9/16/2003 1/26/2004 132 MD PER Strattera Mania
4104141 4297576 12 Years M 9/16/2003 1/26/2004 132 MD PER Strattera Mania
4104142 4297573 9 Years M 9/16/2003 1/26/2004 132 MD PER Strattera Palpitations
4104146 4298751 55 Years F 9/11/2003 1/26/2004 137 PER Strattera Traumatic Brain Injury Drug Ineffective, Fatigue, Thinking Abnormal, Yawning
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4104149 4298748 12 Years M 1/1/2003 9/11/2003 1/26/2004 137 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4104150 4298746 39 Years F 9/11/2003 1/26/2004 137 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Feeling Abnormal, Hot Flush, Hypersomnia
4104152 4298744 16 Years M 9/11/2003 1/26/2004 137 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Somnolence
4104153 4298742     F 9/10/2003 9/11/2003 1/26/2004 137 PER Strattera Abnormal Behaviour
4104156 4298739 6 Years M 9/11/2003 1/26/2004 137 PH PER Strattera Retching
4104158 4298737 7 Years M 8/1/2003 9/11/2003 1/26/2004 137 PER Strattera Aggression, Psychomotor Hyperactivity
4104161 4298734 10 Years M 9/1/2003 9/11/2003 1/26/2004 137 PER Strattera Attention Deficit/Hyperactivity Disorder Educational Problem, Psychomotor Hyperactivity
4104164 4298727 34 Years M 9/11/2003 9/11/2003 1/26/2004 137 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Hot, Nausea, Nervousness
4104166 4298724 15 Years M 1/1/2003 9/11/2003 1/26/2004 137 PER Strattera Attention Deficit/Hyperactivity Disorder Hunger, Weight Increased
4104267 4296494 13 Years F 1/1/2003 10/22/2003 1/26/2004 96 MD PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Menstrual Disorder, Somnolence, Von Willebrand's Disease
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4104269 4296497 15 Years M 1/1/2003 8/22/2003 1/26/2004 157 MD PER Strattera Abnormal Dreams
4104271 4296499 7 Years M 8/22/2003 1/26/2004 157 MD PER Strattera Attention Deficit/Hyperactivity Disorder Contusion
4104275 4296501 35 Years M 8/1/2003 8/22/2003 1/26/2004 157 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Initial Insomnia
4104276 4296503 8 Years F 1/1/2003 8/22/2003 1/26/2004 157 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Aggression, Decreased Appetite, Drug Ineffective, Insomnia, Weight Decreased
4104279 4296504 13 Years F 8/25/2003 1/26/2004 154 PER Strattera Abdominal Pain Upper, Cold Sweat
4104283 4296506 12 Years M 8/25/2003 1/26/2004 154 PER Strattera Fatigue, Feeling Abnormal
4104287 4296508 8 Years M 8/25/2003 1/26/2004 154 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Mydriasis, Sedation
4104289 4296510 8 Years M 8/1/2003 8/25/2003 1/26/2004 154 MD PER Strattera Vision Blurred
4104289 4440497 8 Years M 8/1/2003 5/19/2004 7/28/2004 70 MD PER Strattera Attention Deficit/Hyperactivity Disorder Vision Blurred
4104297 4296511 29 Years M 8/25/2003 1/26/2004 154 PER Strattera Attention Deficit/Hyperactivity Disorder, Narcolepsy Eye Irritation, Visual Acuity Reduced
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4104367 4302819     M 10/15/2003 1/26/2004 103 MD PER Strattera Emotional Disorder, Fight In School
4104374 4302824 45 Years M 10/15/2003 1/26/2004 103 OT PER Strattera Prostatic Disorder, Testicular Pain
4104381 4302829 15 Years M 10/15/2003 1/26/2004 103 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Decreased Appetite, Drug Ineffective, Feeling Abnormal, Insomnia
4104386 4302832 10 Years M 1/1/2003 10/20/2003 1/26/2004 98 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Crying, Mood Swings, Self Mutilation
4104393 4302833 49 Years F 10/1/2003 10/15/2003 1/26/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Burning Sensation, Headache, Hypoaesthesia, Rash
4104396 4302834 12 Years 10/16/2003 1/26/2004 102 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4104400 4302835 50 Years M 1/1/2003 10/16/2003 1/26/2004 102 MD PER Strattera Attention Deficit/Hyperactivity Disorder Depression Suicidal
4104400 4580241 50 Years M 1/1/2003 9/14/2004 1/27/2005 135 MD PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Suicidal Ideation, Thinking Abnormal
4104404 4302838 15 Years M 7/1/2003 10/16/2003 1/26/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Somnolence
4104407 4302840 56 Years F 9/1/2003 10/23/2003 1/26/2004 95 PER Strattera Antidepressant Therapy, Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Feeling Abnormal, Memory Impairment, Nausea, Pyrexia, Somnolence, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4104411 4302842 15 Years M 10/1/2003 10/16/2003 1/26/2004 102 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Apathy, Depression, Lethargy
4104426 4296778 7 Years M 9/10/2003 1/26/2004 138 CN PER Strattera Vision Blurred Disturbance in Attention, Drug Ineffective
4104427 4296780     M 9/9/2003 9/10/2003 1/26/2004 138 MD PER Strattera Drug Screen Positive
4104429 4296782 40 Years M 9/4/2003 9/10/2003 1/26/2004 138 PER Strattera Oppositional Defiant Disorder Anger, Anxiety, Decreased Appetite, Drug Ineffective, Restlessness, Tremor
4104432 4296783 9 Years F 9/9/2003 9/10/2003 1/26/2004 138 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Irritability, Psychomotor Hyperactivity
4104435 4296789 21 Years M 9/10/2003 1/26/2004 138 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Nausea
4104436 4296792 10 Years M 1/1/2003 9/10/2003 1/26/2004 138 PER Strattera Attention Deficit/Hyperactivity Disorder Migraine
4104437 4296798 10 Years M 9/10/2003 1/26/2004 138 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Decreased Appetite, Drug Ineffective, Feeling Abnormal, Headache, Nausea, Somnolence, Stomach Discomfort
4104442 4296804 5 Years F 9/10/2003 9/10/2003 1/26/2004 138 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Somnolence
4104443 4296807     F 8/1/2003 9/10/2003 1/26/2004 138 MD PER Strattera
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4104445 4296808     F 9/10/2003 1/26/2004 138 PER Strattera Apathy, Thinking Abnormal
4104535 4297706 48 Years F 11/26/2003 1/26/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Insomnia, Nausea, Tremor
4104535 4349158 48 Years F 11/26/2003 3/29/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Insomnia, Nausea, Tremor
4104538 4297711 7 Years F 1/1/2003 9/18/2003 1/26/2004 130 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Dyspepsia
4104539 4297714 32 Years F 9/1/2003 9/18/2003 1/26/2004 130 MD PER Strattera Attention Deficit/Hyperactivity Disorder Bronchitis, Pyrexia, Sinus Tachycardia
4104542 4297721 38 Years M 1/1/2003 1/26/2004 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Asthenia, Dizziness, Feeling Abnormal, Paraesthesia, Sluggishness, Urinary Hesitation
4104741 4302898 6 Years F 9/25/2003 1/26/2004 123 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Drug Ineffective, Fatigue
4104890 4296512     M 8/21/2003 8/21/2003 1/26/2004 158 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Yawning
4104892 4296509 12 Years M 8/21/2003 1/26/2004 158 MD PER Strattera Abnormal Behaviour, Anger, Drug Ineffective, Mood Swings, Negativism
4104894 4296507 5 Years M 8/21/2003 1/26/2004 158 MD PER Strattera Hallucination (Visual)
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4104896 4296502 13 Years F 10/31/2003 1/26/2004 87 PER Strattera Excitability, Logorrhoea, Psychomotor Hyperactivity, Rebound Effect
4104899 4298835 12 Years M 9/11/2003 9/24/2003 1/26/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Depression, Feeling Cold, Lethargy, Nausea, Somnolence, Vomiting
4104899 4501276 12 Years M 9/11/2003 8/13/2004 9/27/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Decreased Appetite, Depression, Feeling Cold, Lethargy, Nausea, Somnolence, Vomiting, Weight Decreased
4104901 4296500 45 Years F 8/21/2003 1/26/2004 158 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hyperhidrosis
4104903 4296498 8 Years M 8/21/2003 8/21/2003 1/26/2004 158 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Disorientation, Fatigue, Feeling Abnormal, Headache
4104906 4296495 13 Years M 8/1/2003 8/21/2003 1/26/2004 158 OT PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Feeling Abnormal
4104908 4296492 8 Years F 1/1/2003 8/21/2003 1/26/2004 158 PER Strattera Abdominal Pain Upper, Abnormal Behaviour, Aggression, Asocial Behaviour, Decreased Appetite, Insomnia, Masked Facies, Memory Impairment, Mood Swings, Psychomotor Hyperactivity
4104909 4296489 25 Years F 1/1/2003 8/21/2003 1/26/2004 158 MD PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia
4104912 4296486 12 Years 8/21/2003 1/26/2004 158 MD PER Strattera Agitation
4104915 4296528 9 Years M 8/1/2003 8/21/2003 1/26/2004 158 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Abnormal Behaviour
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4104918 4296527 4 Years M 8/18/2003 8/21/2003 1/26/2004 158 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dysgeusia
4104921 4296525 17 Years F 8/1/2003 8/21/2003 1/26/2004 158 PER Strattera Attention Deficit/Hyperactivity Disorder Dysarthria, Fatigue, Nasopharyngitis, Nausea
4104923 4296524 15 Years F 8/1/2003 8/21/2003 1/26/2004 158 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Decreased Appetite, Dizziness, Dysgeusia, Fatigue, Feeling Abnormal, Hyperhidrosis, Nausea
4104925 4296523 5 Years M 8/21/2003 1/26/2004 158 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Psychomotor Hyperactivity
4104926 4296520 7 Years M 8/20/2003 8/21/2003 1/26/2004 158 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Somnolence, Vomiting
4104928 4296519 7 Years F 8/21/2003 1/26/2004 158 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Crying, Headache, Retching, Vomiting
4104929 4296517 9 Years F 4/1/2003 8/29/2003 1/26/2004 150 PER Strattera Attention Deficit/Hyperactivity Disorder Epistaxis
4104932 4296515 11 Years M 10/17/2003 10/31/2003 1/26/2004 87 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Educational Problem, Emotional Disorder, Memory Impairment, Nausea
4104935 4296513 8 Years M 8/27/2003 1/26/2004 152 PER Strattera Attention Deficit/Hyperactivity Disorder Choking, Drug Ineffective, Irritability, Mania, Retching
4104936 4296544     F 9/23/2003 1/26/2004 125 PER Strattera Alopecia, Chills, Fatigue, Feeling Abnormal, Pyrexia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4104941 4296541 9 Years M 3/1/2003 9/9/2003 1/26/2004 139 MD PER Strattera Attention Deficit/Hyperactivity Disorder Palpitations
4104942 4296538 14 Years M 8/6/2003 9/8/2003 1/26/2004 140 PH PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Drug Interaction, Neuropathy, Panic Attack
4104944 4296536 5 Years F 8/19/2003 8/27/2003 1/26/2004 152 PER Strattera Abdominal Pain Upper, Psychomotor Hyperactivity
4104945 4296535 11 Years M 8/1/2003 11/14/2003 1/26/2004 73 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Dysgraphia, Feeling Abnormal, Mood Swings
4104947 4296533 6 Years M 8/1/2003 8/18/2003 1/26/2004 161 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
4104949 4296532 15 Years M 8/15/2003 1/26/2004 164 MD PER Strattera Attention Deficit/Hyperactivity Disorder Cardiac Murmur
4104950 4296531 42 Years F 8/1/2003 10/7/2003 1/26/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Drug Ineffective, Erythema, Hot Flush, Hyperhidrosis, Insomnia, Nausea, Palpitations
4104951 4296530 38 Years F 1/1/2003 10/30/2003 1/26/2004 88 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Feeling Jittery, Heart Rate Increased, Meniscus Lesion
4104957 4296529 47 Years M 1/1/2003 10/29/2003 1/26/2004 89 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Back Pain, Bladder Pain, Male Sexual Dysfunction, Testicular Pain, Testicular Swelling
4104961 4296705 12 Years F 8/13/2003 10/7/2003 1/26/2004 111 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Menorrhagia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4104964 4296699 10 Years M 9/5/2003 1/26/2004 143 PER Strattera Asperger's Disorder Decreased Appetite, Growth Retardation, Weight Decreased
4104967 4296694 7 Years M 8/1/2003 10/1/2003 1/26/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dyspepsia, Increased Appetite, Vomiting
4104968 4296688 7 Years F 8/12/2003 10/6/2003 1/26/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Heart Rate Increased, Somnolence
4104969 4296684 9 Years M 1/1/2003 10/2/2003 1/26/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Memory Impairment, Thinking Abnormal
4104969 4348264 9 Years M 1/1/2003 1/14/2004 3/29/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Drug Ineffective, Memory Impairment, Thinking Abnormal
4104969 4440530 9 Years M 1/1/2003 3/2/2004 7/28/2004 148 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Drug Ineffective, Memory Impairment, Somnolence, Thinking Abnormal
4104969 4637499 9 Years M 1/1/2003 1/26/2005 3/28/2005 61 PER Strattera Abnormal Behaviour, Agitation, Disturbance in Attention, Drug Ineffective, Memory Impairment, Somnolence, Therapeutic Response Decreased, Thinking Abnormal
4104973 4296678 12 Years M 9/2/2003 11/4/2003 1/26/2004 83 PER Strattera Disturbance in Attention Abnormal Behaviour, Asthenia, Disturbance in Attention, Drug Ineffective, Fatigue, Fight In School, Hyperhidrosis, Mood Swings, Nausea, Nervousness, Pharyngolaryngeal Pain, Psychomotor Hyperactivity, Pyrexia, Somnolence, Tremor
4104977 4296676 20 Years M 8/7/2003 10/30/2003 1/26/2004 88 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Drug Ineffective, Fatigue, Psychomotor Hyperactivity
4104979 4296673 9 Years M 8/1/2003 10/2/2003 1/26/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Dysuria, Heart Rate Increased, Urine Bilirubin Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4104980 4296667 13 Years M 7/1/2003 10/22/2003 1/26/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Feeling Abnormal, Mood Swings, Psychomotor Hyperactivity, Somnolence, Weight Increased
4104987 4296739 11 Years M 7/22/2003 7/22/2003 1/26/2004 188 PER Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Increased, Pulse Pressure Increased
4104991 4296737 11 Years M 10/22/2003 1/26/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Decreased Appetite, Hypervigilance, Insomnia, Malaise, Mydriasis, Weight Decreased
4104995 4296736     M 7/17/2003 1/26/2004 193 MD PER Strattera Fatigue
4104997 4296732     M 7/22/2003 1/26/2004 188 MD PER Strattera Dehydration, Pyrexia
4104998 4296728 13 Years F 7/1/2003 7/22/2003 1/26/2004 188 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Dyspnoea, Somnolence
4105000 4296723 10 Years M 7/22/2003 1/26/2004 188 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Impulsive Behaviour
4105003 4296720 13 Years M 8/25/2003 1/26/2004 154 MD PER Strattera Attention Deficit/Hyperactivity Disorder Erection Increased
4105004 4296718 15 Years M 7/21/2003 10/1/2003 1/26/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Concussion, Disturbance in Attention, Drug Ineffective, Injury, Somnolence
4105005 4296714 35 Years F 7/7/2003 11/3/2003 1/26/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Jaundice
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4105005 4517980 38 Years F 7/7/2003 11/16/2004 11/30/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Jaundice
4105005 4577812 38 Years F 7/7/2003 1/24/2005 2/9/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Jaundice
4105008 4296712 13 Years F 7/1/2003 7/17/2003 1/26/2004 193 OT PER Strattera Attention Deficit/Hyperactivity Disorder Thyroid Function Test Abnormal
4105010 4296769 3 Years M 8/1/2003 1/26/2004 178 MD PER Strattera Ear Infection, Polyuria
4105011 4296766 19 Years F 7/26/2003 10/17/2003 1/26/2004 101 CN PER Strattera Attention Deficit/Hyperactivity Disorder, Bipolar Disorder Asthenia, Fatigue, Headache, Hypersomnia, Hypokinesia, Insomnia, Mania
4105013 4296764     7/1/2003 9/2/2003 1/26/2004 146 PER Strattera Somnolence
4105014 4296762 7 Years F 7/1/2003 9/17/2003 1/26/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Muscle Twitching, Somnolence
4105017 4296755 43 Years F 7/1/2003 9/4/2003 1/26/2004 144 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Extrasystoles, Fatigue, Feeling Drunk, Headache, Multiple Sclerosis
4105019 4296752     M 7/26/2003 9/11/2003 1/26/2004 137 MD PER Strattera Palpitations
4105020 4296751 7 Years F 7/1/2003 10/1/2003 1/26/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Insomnia, Psychomotor Hyperactivity, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4105020 4348259 7 Years F 7/1/2003 1/7/2004 3/29/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Drug Ineffective, Fatigue, Insomnia, Psychomotor Hyperactivity, Somnolence
4105021 4296749 13 Years M 7/27/2003 9/19/2003 1/26/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder, Bipolar Disorder Abnormal Behaviour, Hypersomnia, Somnolence
4105025 4296748 10 Years F 7/23/2003 9/22/2003 1/26/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Crying, Disturbance in Attention, Drug Ineffective, Fatigue, Memory Impairment, Mood Swings, Reading Disorder
4105027 4296743 13 Years M 1/1/2003 9/18/2003 1/26/2004 130 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Aggression, Disturbance in Attention, Drug Ineffective, Dyspepsia, Fatigue, Nausea, Vomiting
4105029 4296821 9 Years M 1/1/2003 10/8/2003 1/26/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Weight Increased
4105031 4296818 15 Years M 11/10/2003 1/26/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder, Tic Educational Problem, Fatigue, Feeling Abnormal, Hypersomnia, Lethargy, Pallor, Somnolence
4105032 4296811 40 Years F 7/14/2003 10/7/2003 1/26/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Dry Mouth, Hallucination, Hot Flush, Insomnia, Nausea, Somnolence, Vision Blurred, Vomiting
4105033 4296805 4 Years M 7/11/2003 11/5/2003 1/26/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Decreased Appetite, Drug Ineffective, Hunger, Parent-Child Problem, Psychomotor Hyperactivity
4105034 4296802 6 Years M 5/24/2003 9/5/2003 1/26/2004 143 MD PER Strattera Attention Deficit/Hyperactivity Disorder Muscle Rigidity, Musculoskeletal Stiffness, Somnolence, Tremor
4105035 4296790 10 Years M 9/15/2003 1/26/2004 133 MD PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Jittery, Irritability, Paranoia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4105036 4296787 9 Years M 6/1/2003 7/14/2003 1/26/2004 196 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Heart Rate Increased
4105038 4296776 8 Years M 9/19/2003 1/26/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Chest Pain, Decreased Appetite, Headache, Malaise, Weight Decreased
4105039 4296773 6 Years M 8/27/2003 1/26/2004 152 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Compulsions, Disturbance in Attention, Psychomotor Hyperactivity
4105041 4296772 41 Years F 9/24/2003 1/26/2004 124 MD PER Strattera Aortic Valve Incompetence, Heart Rate Irregular
4105042 4296848 6 Years M 1/1/2003 7/8/2003 1/26/2004 202 PER Strattera Drug Ineffective, Dyspepsia, Mood Swings
4105044 4296845 37 Years F 6/26/2003 10/15/2003 1/26/2004 103 PER Strattera Confusional State, Euphoric Mood, Somnolence
4105050 4296843 55 Years F 9/19/2003 1/26/2004 129 PER Strattera Abdominal Distension, Chromaturia, Decreased Appetite, Fatigue, Flatulence, Libido Increased, Throat Irritation
4105051 4296842     F 4/1/2003 8/26/2003 1/26/2004 153 PER Strattera Attention Deficit/Hyperactivity Disorder, Bipolar Disorder, Depression
4105053 4296841 9 Years M 6/19/2003 10/14/2003 1/26/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Asthma, Chest Discomfort, Chest Pain, Feeling Hot, Heart Rate Increased, Middle Insomnia, Somnolence, Weight Decreased
4105055 4296840 5 Years M 5/1/2003 9/17/2003 1/26/2004 131 MD PER Strattera Attention Deficit/Hyperactivity Disorder Contusion, Platelet Aggregation Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4105056 4296839 13 Years M 6/1/2003 12/15/2003 1/26/2004 42 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Dyspepsia, Fatigue, Psychomotor Hyperactivity
4105056 4348255 13 Years M 6/1/2003 12/15/2003 3/29/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Dyspepsia, Fatigue, Psychomotor Hyperactivity
4105059 4296838 8 Years F 5/16/2003 9/19/2003 1/26/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Fatigue, Feeling Abnormal, Insomnia, Malaise, Weight Decreased
4105068 4296882 12 Years M 9/2/2003 1/26/2004 146 PER Strattera Dysgraphia Disturbance in Attention, Drug Ineffective
4105069 4296879 8 Years M 4/21/2003 8/27/2003 1/26/2004 152 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anxiety, Crying, Mood Swings, Somnolence
4105073 4296871 11 Years M 4/6/2003 9/19/2003 1/26/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Decreased Appetite, Dyspepsia, Educational Problem, Emotional Distress, Mood Swings, Social Avoidant Behaviour
4105078 4297039 12 Years M 8/31/2003 9/22/2003 1/26/2004 126 PH PER Strattera Attention Deficit/Hyperactivity Disorder Swelling Face, Urticaria
4105080 4297040 13 Years M 9/15/2003 9/15/2003 1/26/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Headache, Thirst
4105084 4296935     F 8/18/2003 8/22/2003 1/26/2004 157 PER Strattera Fatigue, Tremor
4105089 4297041 20 Years F 8/1/2003 9/15/2003 1/26/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Thirst
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4105092 4297042     M 9/15/2003 1/26/2004 133 MD PER Strattera Feeling Hot
4105093 4296933 12 Years M 8/1/2003 8/22/2003 1/26/2004 157 MD PER Strattera Asthma, Tic
4105095 4297043 15 Years F 9/1/2003 9/15/2003 1/26/2004 133 CN PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Depression, Drug Ineffective, Feeling Abnormal
4105096 4296932 17 Years F 8/22/2003 8/22/2003 1/26/2004 157 MD PER Strattera Anxiety, Dyspnoea, Heart Rate Increased
4105099 4296931 17 Years F 8/1/2003 8/21/2003 1/26/2004 158 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence, Urinary Hesitation
4105101 4296928 5 Years M 7/1/2003 8/21/2003 1/26/2004 158 PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Tic
4105106 4296927     M 8/21/2003 1/26/2004 158 MD PER Strattera Trismus
4105107 4296924     F 8/21/2003 1/26/2004 158 MD PER Strattera Trismus
4105112 4296922 35 Years M 8/21/2003 1/26/2004 158 PER Strattera Abdominal Distension, Decreased Appetite, Weight Decreased
4105114 4296921 11 Years M 8/21/2003 8/21/2003 1/26/2004 158 OT PER Strattera Palpitations
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4105116 4297044 16 Years F 9/15/2003 1/26/2004 133 CN PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Morbid Thoughts
4105117 4296918 16 Years M 8/21/2003 8/21/2003 1/26/2004 158 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Screaming
4105121 4296916 8 Years M 8/21/2003 1/26/2004 158 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety
4105123 4297045 34 Years M 9/1/2003 9/15/2003 1/26/2004 133 CN PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Nausea
4105128 4297046 6 Years F 9/15/2003 1/26/2004 133 CN PER Strattera Anxiety
4105134 4297047 9 Years F 9/26/2003 1/26/2004 122 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anxiety, Crying, Fear, Headache, Somnolence
4105136 4297048 7 Years M 9/12/2003 9/15/2003 1/26/2004 133 OT PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Drug Ineffective
4105197 4298581 9 Years F 10/22/2003 10/22/2003 1/26/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Decreased Appetite, Eye Redness, Fatigue, Lacrimation Increased, Nausea, Somnolence
4105200 4298583 27 Years F 10/22/2003 1/26/2004 96 PER Strattera Disturbance in Attention, Drug Ineffective
4105204 4298613 43 Years M 11/7/2003 1/26/2004 80 MD PER Strattera Anxiety, Depression Arthralgia, Myalgia, Oedema Peripheral
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4105206 4298688     M 10/22/2003 1/26/2004 96 MD PER Strattera Apathy, Asthenia, Dependent Personality Disorder
4105207 4298689 51 Years F 8/1/2003 10/22/2003 1/26/2004 96 MD PER Strattera Attention Deficit/Hyperactivity Disorder Colitis
4105210 4298690 12 Years M 10/12/2003 10/22/2003 1/26/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Rash, Staphylococcal Infection
4105547 4298565 8 Years M 1/1/2003 9/18/2003 1/26/2004 130 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Feeling Jittery, Logorrhoea, Sedation, Somnolence, Weight Increased
4105549 4298560 12 Years M 9/10/2003 1/26/2004 138 OT PER Strattera Agitation
4105551 4298557 7 Years M 9/18/2003 1/26/2004 130 CN PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Drug Ineffective, Dyspepsia, Irritability, Mood Swings, Vomiting
4105553 4298553 21 Years F 9/18/2003 1/26/2004 130 OT PER Strattera Mood Swings
4105555 4298543 5 Years M 9/18/2003 1/26/2004 130 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dysgeusia, Glossodynia
4105556 4298526 35 Years M 9/18/2003 1/26/2004 130 OT PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Pain
4105557 4298511 6 Years M 9/1/2003 9/18/2003 1/26/2004 130 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4105912 4301761 53 Years M 9/1/2003 10/6/2003 1/26/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Dysuria, Feeling Abnormal, Insomnia, Nausea
4106339 4313386 13 Years M 2/18/2004 3/4/2004 15 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Syncope Other
4106339 4319616 14 Years M 3/3/2004 3/16/2004 13 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Syncope Other
4106339 4351252 14 Years M 2/6/2004 4/14/2004 4/28/2004 14 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Rash, Syncope Other
4106345 4313389 14 Years M 2/1/2004 2/18/2004 3/4/2004 15 MD EXP Strattera Headache, Intentional Self-Injury, Overdose Hospitalization - Initial or Prolonged
4106348 4313390     M 2/18/2004 3/4/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Anger, Dizziness, Hyperhidrosis, Irritability, Nausea, Pallor, Syncope Other
4106353 4313393 40 Years M 2/16/2004 3/4/2004 17 MD EXP Strattera Atrial Fibrillation, Syncope Other
4106353 4381483 36 Years M 6/1/2004 6/16/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Atrial Fibrillation, Syncope Other
4106357 4313394 30 Years M 2/13/2004 3/4/2004 20 MD EXP Strattera Convulsion Other
4106357 4368261 30 Years M 2/10/2004 5/7/2004 5/25/2004 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4106365 4313387 39 Years M 11/1/2003 2/18/2004 3/4/2004 15 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Electroencephalogram Abnormal, Loss of Consciousness, Syncope Other
4106383 4313391 56 Years M 1/1/2003 2/17/2004 3/4/2004 16 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Gastrointestinal Carcinoma Other
4106383 4351250 56 Years M 5/26/2003 4/12/2004 4/28/2004 16 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Aortic Disorder, Asthenia, Fatigue, Gastrointestinal Carcinoma, Neoplasm, Recurrent Cancer Hospitalization - Initial or Prolonged
4106383 4364883 56 Years M 5/26/2003 5/4/2004 5/21/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Adenocarcinoma, Asthenia, Fatigue, Gastrointestinal Carcinoma, Recurrent Cancer, Tracheal Neoplasm Disability, Hospitalization - Initial or Prolonged
4106391 4313395 8 Years F 11/4/2003 2/12/2004 3/4/2004 21 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Anger, Disturbance in Attention, Eating Disorder, Excitability, Fatigue, Feeling Abnormal, Grand Mal Convulsion, Hot Flush, Hyperhidrosis, Insomnia, Irritability, Tremor, Weight Decreased Other
4106420 4296777 12 Years F 9/5/2003 1/26/2004 143 PER Strattera Oppositional Defiant Disorder Abnormal Behaviour, Drug Ineffective, Psychomotor Hyperactivity
4106421 4296779 49 Years M 9/5/2003 1/26/2004 143 PER Strattera Attention Deficit/Hyperactivity Disorder Dermatitis Contact
4106426 4296781 14 Years M 8/1/2003 9/5/2003 1/26/2004 143 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Educational Problem, Somnolence
4106426 4440499 14 Years M 8/1/2003 5/3/2004 7/28/2004 86 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Educational Problem, Somnolence
4106429 4296785 6 Years M 9/5/2003 1/26/2004 143 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4106434 4296791     M 9/5/2003 1/26/2004 143 PER Strattera Abnormal Behaviour
4106439 4296794 13 Years M 1/1/2003 9/5/2003 1/26/2004 143 OT PER Strattera Attention Deficit/Hyperactivity Disorder Oesophageal Pain
4106451 4296800 62 Years F 9/1/2003 9/5/2003 1/26/2004 143 PER Strattera Dizziness, Fatigue, Gastrooesophageal Reflux Disease, Irritable Bowel Syndrome, Somnolence
4106474 4299777 11 Years F 11/16/2003 11/18/2003 1/26/2004 69 PER Strattera Fatigue, Headache, Pallor, Pigmentation Lip, Somnolence
4108417 4315434 13 Years M 2/3/2004 2/19/2004 3/9/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Decreased, Dizziness, Hypotension, Loss of Consciousness, Tremor Other
4108417 4476732 12 Years M 2/3/2004 9/27/2004 10/13/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Hypotension, Loss of Consciousness, Tremor Other
4108420 4315436 14 Years M 1/20/2004 2/19/2004 3/9/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Syncope Other
4108426 4315437 9 Years M 2/13/2004 2/19/2004 3/9/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Coma, Convulsion, Drooling, Lethargy, Respiratory Arrest Hospitalization - Initial or Prolonged
4108444 4315594 25 Years M 2/23/2004 3/9/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion Other
4108444 4364875 25 Years M 4/29/2004 5/21/2004 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4108445 4315597 12 Years M 2/23/2004 3/9/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Arrhythmia, Chest Pain, Ventricular Extrasystoles Other
4108447 4315600     F 2/26/2004 3/9/2004 12 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Back Pain, Chest Pain, Dyskinesia, Flushing, Nightmare, Serotonin Syndrome, Tachycardia Hospitalization - Initial or Prolonged
4108447 4330793 39 Years F 2/11/2004 3/16/2004 3/31/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Back Pain, Blood Magnesium Increased, Chest Pain, Coronary Artery Disease, Drug Ineffective, Electrocardiogram QT Prolonged, Electrocardiogram ST-T Segment Abnormal, Flushing, Myocardial Ischaemia, Nightmare, Serotonin Syndrome, Tachycardia Other
4108447 4456278 39 Years F 2/11/2004 8/31/2004 9/17/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Back Pain, Blood Glucose Increased, Blood Magnesium Increased, Blood Urea Nitrogen/Creatinine Ratio Decreased, Chest Pain, Drug Ineffective, Dyskinesia, Electrocardiogram Abnormal, Electrocardiogram QT Prolonged, Electrocardiogram ST Segment Abnormal, Electrocardiogram T Wave Abnormal, Flushing, Myocardial Infarction, Myocardial Ischaemia, Nightmare, Platelet Count Increased, Serotonin Syndrome, Tachycardia Other
4108447 4512539 39 Years F 2/11/2004 11/8/2004 11/24/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Back Pain, Blood Creatine Increased, Blood Glucose Increased, Blood Magnesium Increased, Chest Pain, Dyskinesia, Electrocardiogram QT Prolonged, Electrocardiogram ST Segment Abnormal, Electrocardiogram T Wave Abnormal, Flushing, Myocardial Infarction, Nightmare, Platelet Count Increased, Serotonin Syndrome, Tachycardia Other
4108448 4315602 14 Years 2/23/2004 3/9/2004 15 MD EXP Strattera Hepatitis Other
4108448 4356770 14 Years M 2/1/2004 4/21/2004 5/7/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Blood Albumin Increased, Blood Immunoglobulin G Increased, Cytomegalovirus Antibody Positive, Feeling Abnormal, Haematocrit Decreased, Hepatitis, Lethargy, Monocyte Count Increased, White Blood Cell Count Decreased Other
4108448 4378773 14 Years M 2/1/2004 5/25/2004 6/9/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Educational Problem, Feeling Abnormal, Lethargy Other
4108448 4381476 14 Years M 2/1/2004 6/1/2004 6/16/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Cytomegalovirus Antibody Positive, Educational Problem, Haematocrit Decreased, Haemoglobin Increased, Hepatitis, Lymphocyte Count Decreased, Monocyte Count Increased, White Blood Cell Count Decreased Other
4108448 4401581 14 Years M 2/1/2004 7/2/2004 7/14/2004 12 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Blood Albumin Increased, Cytomegalovirus Antibody Positive, Fatigue, Feeling Abnormal, Hepatitis, Lethargy, Monocyte Count Increased, Virus Serology Test Positive, White Blood Cell Count Decreased Hospitalization - Initial or Prolonged, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4108448 4421762 14 Years M 2/1/2004 7/16/2004 8/6/2004 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Blood Immunoglobulin G Increased, Cytomegalovirus Antibody Positive, Fatigue, Feeling Abnormal, Haematocrit Decreased, Hepatitis, Lethargy, Monocyte Percentage Increased, White Blood Cell Count Decreased Hospitalization - Initial or Prolonged, Other
4108448 4445242 14 Years M 2/1/2004 7/19/2004 9/2/2004 45 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Antibody Test Positive, Biopsy Liver Abnormal, Blood Albumin Increased, Bone Marrow Depression, Cholestasis, Cytomegalovirus Antibody Positive, Decreased Appetite, Educational Problem, Fatigue, Hepatic Fibrosis, Hepatitis, Hepatitis Viral, Hepatocellular Damage, Monocyte Count Increased Hospitalization - Initial or Prolonged, Other
4108448 4474249 14 Years M 2/1/2004 9/21/2004 10/8/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Autoimmune Disorder, Bone Marrow Depression, Cholestasis, Hepatic Trauma, Hepatitis Viral Hospitalization - Initial or Prolonged, Other
4108448 4488207 14 Years M 2/1/2004 9/21/2004 10/26/2004 35 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Antibody Test Positive, Biopsy Liver Abnormal, Bone Marrow Depression, Cytomegalovirus Antibody Positive, Decreased Appetite, Fatigue, Hepatic Fibrosis, Hepatitis, Neutropenia, Platelet Count Decreased Hospitalization - Initial or Prolonged, Other
4108448 4517997 14 Years M 2/1/2004 11/15/2004 11/30/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Bone Marrow Depression, Cholestasis, Haemangioma of Liver, Hepatic Fibrosis, Hepatic Trauma, Hepatitis Viral Hospitalization - Initial or Prolonged, Other
4108448 4642044 14 Years M 2/1/2004 4/5/2005 4/21/2005 16 MD EXP Strattera Blood Immunoglobulin G Increased, Bone Marrow Depression, Cholestasis, Cytomegalovirus Antibody Positive, Educational Problem, Haemangioma of Liver, Hepatic Fibrosis, Hepatitis Viral, Neutropenia, Platelet Count Decreased Hospitalization - Initial or Prolonged, Other
4108448 4658123 14 Years M 2/1/2004 4/20/2005 5/9/2005 19 MD EXP Strattera Cholestasis, Educational Problem, Hepatic Fibrosis, Hepatitis Viral, Neutropenia, Platelet Count Decreased Hospitalization - Initial or Prolonged, Other
4108449 4315606 8 Years M 11/27/2003 2/24/2004 3/9/2004 14 EXP Strattera Attention Deficit/Hyperactivity Disorder Cerebrovascular Accident, Convulsion, Depressed Level of Consciousness, Hemiparesis, Pallor Other
4108449 4359402 8 Years M 11/27/2003 4/26/2004 5/12/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Skin Discolouration Other
4108452 4315609 4 Years M 1/1/2003 2/19/2004 3/9/2004 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Cortisol Increased, Drug Interaction, Renin Decreased, Renin Increased Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4108452 4364881 4 Years M 1/1/2003 4/29/2004 5/21/2004 22 EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Cortisol Increased, Renin Increased Other
4108454 4315613     F 2/1/2004 2/19/2004 3/9/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Wegener's Granulomatosis Hospitalization - Initial or Prolonged, Other
4108454 4351256 11 Years F 11/1/2003 4/14/2004 4/28/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Respiratory Distress, Wegener's Granulomatosis Hospitalization - Initial or Prolonged, Other
4108456 4315645 6 Years F 2/19/2004 3/9/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Decreased, Blood Potassium Decreased, Blood Pressure Decreased, Depressed Level of Consciousness, Loss of Consciousness, Syncope Other
4108456 4476733 16 Years F 9/27/2004 10/13/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Basilar Migraine, Blood Glucose Decreased, Blood Potassium Decreased, Coma, Mydriasis, Syncope Other
4108499 4315332 9 Years M 2/8/2004 2/25/2004 3/9/2004 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Acute Abdomen, Blood Pressure Diastolic Decreased, Flatulence, Gastroenteritis, Haematemesis, Intestinal Obstruction, Neutropenia, Platelet Count Decreased, Poor Peripheral Circulation, Systemic Inflammatory Response Syndrome, Tachycardia, White Blood Cell Count Decreased Hospitalization - Initial or Prolonged, Other
4108542 4315341 4 Years M 1/1/2004 2/23/2004 3/9/2004 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Choking, Disturbance in Attention, Disturbance In Social Behaviour, Drug Ineffective, Dyspepsia, Feeling Abnormal, Hair Plucking, Insomnia, Irritability, Restlessness, Speech Disorder, Urinary Incontinence, Vomiting, Weight Decreased Hospitalization - Initial or Prolonged
4108550 4315342 43 Years M 2/1/2004 2/21/2004 3/9/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Ejaculation Disorder, Erectile Dysfunction, Genital Pain Male, Orgasm Abnormal, Testicular Pain, Urge Incontinence Other
4108550 4330771 43 Years M 2/1/2004 3/12/2004 3/31/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Ejaculation Delayed, Erectile Dysfunction, Orgasm Abnormal, Pain, Testicular Pain Other
4108602 4311696 7 Years M 2/24/2004 3/3/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Aggression, Weight Decreased Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4109564 4303074 19 Years M 10/20/2003 1/26/2004 98 MD PER Strattera Chills, Disturbance in Attention, Hyperhidrosis
4109565 4302884 6 Years F 8/1/2003 10/16/2003 1/26/2004 102 CN PER Strattera Attention Deficit/Hyperactivity Disorder
4110620 4318607     M 3/5/2004 3/16/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Mydriasis Other
4110653 4318525     M 11/4/2003 3/16/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Weight Decreased Other
4111690 4318474 25 Years M 3/16/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder, Stress Symptoms Atrial Fibrillation, Chest Pain, Dizziness, Feeling Abnormal, Heart Rate Increased, Ventricular Extrasystoles, Ventricular Tachycardia Required Intervention to Prevent Permanent Impairment/Damage
4112478 4319609 5 Years M 2/1/2004 2/1/2004 3/5/2004 3/16/2004 11 EXP Strattera Attention Deficit/Hyperactivity Disorder Drowning Death
4112478 4341947 5 Years M 2/7/2004 2/7/2004 3/30/2004 4/15/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Drowning, Victim of Homicide Death
4112533 4319511 18 Years M 3/2/2004 3/16/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Viral Myocarditis Other
4112533 4401863 18 Years M 2/21/2004 6/30/2004 7/14/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Viral Infection, Viral Myocarditis Hospitalization - Initial or Prolonged, Other
4112535 4319512 9 Years M 2/1/2004 2/26/2004 3/16/2004 19 MD EXP Strattera Disease Recurrence, Grand Mal Convulsion Hospitalization - Initial or Prolonged, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4112537 4319514     M 3/1/2004 3/16/2004 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Irritability, Mood Swings, Psychotic Disorder Hospitalization - Initial or Prolonged
4113043 4319624 9 Years M 2/1/2004 2/26/2004 3/16/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Wolff-Parkinson-White Syndrome Other
4113043 4421761 9 Years M 2/1/2004 7/21/2004 8/6/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Electrocardiogram Abnormal, Palpitations, Wolff-Parkinson-White Syndrome Other
4113043 4517982 9 Years M 2/1/2004 11/16/2004 11/30/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Irregular, Mitral Valve Incompetence, Wolff-Parkinson-White Syndrome Other
4113043 4595441 9 Years M 2/1/2004 2/4/2005 2/24/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Mitral Valve Incompetence, Skin Discolouration, Wolff-Parkinson-White Syndrome Other
4113046 4319622 10 Years F 1/27/2004 3/3/2004 3/16/2004 13 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Hallucination (Auditory), Suicidal Ideation Hospitalization - Initial or Prolonged
4113046 4346727 9 Years F 1/28/2004 3/29/2004 61 OT PER Strattera Attention Deficit/Hyperactivity Disorder Depression Suicidal
4114979 4322302 14 Years M 10/18/2003 3/23/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder, Depression, Mania, Oppositional Defiant Disorder Hallucination (Auditory), Irritability, Mania, Paranoia Other
4117137 4325690 10 Years M 1/1/2003 3/5/2004 3/24/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion Other
4117137 4386851 10 Years M 9/1/2003 6/8/2004 6/23/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4117137 4391972 10 Years M 9/1/2003 6/16/2004 7/1/2004 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion Other
4117138 4325695     M 3/5/2004 3/5/2004 3/24/2004 19 MD EXP Strattera Grand Mal Convulsion Other
4117138 4391974 7 Years M 3/5/2004 6/16/2004 7/1/2004 15 MD EXP Strattera Agitation, Confusional State, Convulsive Threshold Lowered, Grand Mal Convulsion, Loss of Consciousness Other
4117140 4325697 10 Years M 3/3/2004 3/5/2004 3/24/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion Other
4117142 4325700 14 Years M 3/8/2004 3/24/2004 16 MD EXP Strattera Electrocardiogram QT Corrected Interval Prolonged Other
4117142 4359406 14 Years M 12/1/2003 4/26/2004 5/12/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Electrocardiogram QT Corrected Interval Prolonged Other
4117260 4325721 21 Years M 10/1/2003 3/4/2004 3/24/2004 20 EXP Strattera Hallucination, Overdose Hospitalization - Initial or Prolonged
4117262 4325729 5 Years M 3/5/2004 3/24/2004 19 EXP Strattera Petit Mal Epilepsy, Somnolence Other
4117266 4325735 8 Years F 3/3/2004 3/8/2004 3/24/2004 16 EXP Strattera Autism, Psychomotor Hyperactivity Drug Ineffective, Drug Withdrawal Convulsions, Simple Partial Seizures Other
4117266 4351258 8 Years F 3/3/2004 4/14/2004 4/28/2004 14 EXP Strattera Autism, Psychomotor Hyperactivity Drug Ineffective, Simple Partial Seizures Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4117268 4325737 9 Years M 3/9/2004 3/24/2004 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Back Pain, Chills, Convulsion, Crying, Dyspepsia, Fatigue, Markedly Reduced Dietary Intake, Nausea, Somnolence, Tremor, Vomiting, Weight Decreased Other
4117270 4325741 13 Years F 3/1/2004 3/9/2004 3/24/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion Other
4117270 4330889 13 Years F 3/1/2004 3/22/2004 3/31/2004 9 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion Other
4117270 4351234 13 Years F 3/1/2004 4/8/2004 4/28/2004 20 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Condition Aggravated, Grand Mal Convulsion Other
4117272 4325744 6 Years M 2/23/2004 3/10/2004 3/10/2004 0 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder, Bipolar Disorder, Condition Aggravated Hospitalization - Initial or Prolonged
4117274 4325746 14 Years M 3/9/2004 3/10/2004 3/24/2004 14 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Agitation, Burns First Degree, Burns Second Degree, Depressed Mood, Impaired Self-Care, Self Injurious Behaviour, Self-Injurious Ideation Other
4117285 4325499 13 Years F 3/8/2004 3/24/2004 16 MD EXP Strattera Electrocardiogram QT Corrected Interval Prolonged Other
4117285 4359407 13 Years F 4/26/2004 5/12/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Electrocardiogram QT Corrected Interval Prolonged, Tachycardia Other
4117285 4378774 13 Years F 5/26/2004 6/9/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Electrocardiogram QT Corrected Interval Prolonged, Tachycardia Other
4117288 4325504 40 Years F 3/9/2004 3/10/2004 3/24/2004 14 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Gastrooesophageal Reflux Disease, Hyperhidrosis Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4117288 4330794 40 Years F 3/9/2004 3/10/2004 3/31/2004 21 EXP Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Gastrooesophageal Reflux Disease, Hyperhidrosis Hospitalization - Initial or Prolonged
4117289 4325507 6 Years M 3/4/2004 3/24/2004 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Hallucination, Psychotic Disorder Hospitalization - Initial or Prolonged
4117291 4325513 16 Years F 3/4/2004 3/24/2004 20 MD EXP Strattera Depressed Level of Consciousness, General Physical Health Deterioration, Panic Reaction Other
4117294 4325518 5 Years 3/4/2004 3/24/2004 20 MD EXP Strattera Convulsion Hospitalization - Initial or Prolonged, Other
4117294 4341950 5 Years 3/31/2004 4/15/2004 15 MD EXP Strattera Complex Partial Seizures, Depressed Level of Consciousness, Grand Mal Convulsion Hospitalization - Initial or Prolonged, Other
4117294 4474526 5 Years 9/17/2004 10/8/2004 21 MD EXP Strattera Attention Deficit Hyperactivity Disorder, Complex Partial Seizures Hospitalization - Initial or Prolonged, Other
4121163 4330836 9 Years M 1/28/2004 3/17/2004 3/31/2004 14 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Confusional State, Grand Mal Convulsion, Vision Blurred Other
4121163 4373132 9 Years M 1/28/2004 5/18/2004 6/3/2004 16 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion, Vision Blurred Other
4121171 4330837     F 3/15/2004 3/16/2004 3/31/2004 15 EXP Strattera Divorced, Suicide Attempt Other
4121176 4330838 12 Years M 3/6/2004 3/11/2004 3/31/2004 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Affective Disorder, Anger, Depression, Intentional Self-Injury, Malaise, Tremor, Vomiting Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4121178 4330839 25 Years M 9/1/2003 3/16/2004 3/31/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Atrial Fibrillation, Chest Pain, Dizziness, Feeling Abnormal, Ventricular Extrasystoles, Ventricular Hypertrophy, Ventricular Tachycardia Other
4122480 4332165 22 Years M 2/1/2003 2/11/2004 3/29/2004 47 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety
4122481 4332168 24 Years F 3/1/2003 2/11/2004 3/29/2004 47 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety
4122483 4332170 34 Years F 2/11/2004 3/29/2004 47 MD PER Strattera Anxiety
4122485 4332172 16 Years F 2/17/2004 2/17/2004 3/29/2004 41 PER Strattera Vomiting
4122489 4332184 16 Years 2/17/2004 3/29/2004 41 MD PER Strattera Movement Disorder, Tic
4122491 4332187 7 Years M 2/17/2004 3/29/2004 41 PER Strattera Insomnia, Nausea
4123365 4333218 16 Years F 4/1/2004 4/5/2004 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anger, Drug Withdrawal Syndrome, Fatigue, Headache, Impulsive Behaviour, Intentional Self-Injury, Irritability, Mood Swings, Nausea, Tension, Thinking Abnormal, Weight Increased Hospitalization - Initial or Prolonged, Life-Threatening, Required Intervention to Prevent Permanent Impairment/Damage
4123904 4333748 32 Years M 4/5/2004 4/6/2004 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder, Testicular Disorder, Testicular Pain
4124122 4336604     M 4/8/2004 4/9/2004 PH DIR Strattera Attention Deficit/Hyperactivity Disorder Angioneurotic Oedema Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124153 4335580 6 Years M 11/28/2003 3/29/2004 122 OT PER Strattera Attention Deficit/Hyperactivity Disorder Tourette's Disorder
4124156 4335583 7 Years M 11/1/2003 11/19/2003 3/29/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Disturbance in Attention, Drug Ineffective, Psychomotor Hyperactivity
4124157 4335586 14 Years M 11/1/2003 12/11/2003 3/29/2004 109 MD PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Heart Rate Increased, Palpitations
4124159 4335591 12 Years M 11/1/2003 11/19/2003 3/29/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Decreased Appetite, Dizziness, Fatigue, Somnolence
4124161 4335601 9 Years M 11/18/2003 11/19/2003 3/29/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Decreased Appetite, Lethargy, Mydriasis, Retching
4124166 4335648 13 Years M 11/1/2003 11/19/2003 3/29/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Asthma, Dizziness, Nasal Congestion, Nausea, Pharyngitis Streptococcal, Pharyngolaryngeal Pain, Urticaria
4124166 4726692 13 Years M 11/1/2003 3/30/2005 7/25/2005 117 PER Strattera Attention Deficit/Hyperactivity Disorder Asthma, Dizziness, Drug Ineffective, Nasal Congestion, Nausea, Pharyngitis Streptococcal, Pharyngolaryngeal Pain, Urticaria, Weight Increased
4124171 4335649 12 Years M 1/1/2003 11/19/2003 3/29/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity, Somnolence
4124173 4335652 10 Years M 1/1/2003 11/20/2003 3/29/2004 130 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
4124175 4335654 12 Years M 11/16/2003 11/20/2003 3/29/2004 130 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fatigue, Pyrexia, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124176 4335532 40 Years F 9/1/2003 2/4/2004 3/29/2004 54 PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia
4124177 4335534 53 Years F 2/4/2004 3/29/2004 54 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Feeling Abnormal, Tinnitus
4124180 4335535 18 Years M 2/4/2004 3/29/2004 54 MD PER Strattera Arrhythmia
4124181 4335537 5 Years M 2/4/2004 3/29/2004 54 PH PER Strattera Retching
4124182 4335538 51 Years M 2/4/2004 2/5/2004 3/29/2004 53 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Insomnia
4124186 4335540     F 2/5/2004 3/29/2004 53 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4124187 4335541 8 Years M 2/5/2004 3/29/2004 53 OT PER Strattera Insomnia, Vision Blurred
4124189 4335549 12 Years M 2/5/2004 3/29/2004 53 MD PER Strattera Attention Deficit/Hyperactivity Disorder
4124191 4335550 44 Years M 12/1/2003 2/5/2004 3/29/2004 53 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Dry Mouth, Irritability, Mood Swings
4124192 4335552 5 Years M 2/16/2004 3/29/2004 42 MD PER Strattera Encopresis
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124193 4336151 5 Years M 12/1/2003 1/6/2004 3/29/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Lethargy, Mood Swings, Nasopharyngitis, Nausea
4124195 4336153 8 Years M 12/1/2003 3/2/2004 3/29/2004 27 PER Strattera Attention Deficit/Hyperactivity Disorder Milk Allergy, Pharyngitis Streptococcal, Scarlet Fever, Urticaria
4124195 4440885 8 Years M 12/1/2003 2/3/2004 7/28/2004 176 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Milk Allergy, Pharyngitis Streptococcal, Scarlet Fever, Urticaria
4124196 4336156 13 Years F 1/5/2004 1/6/2004 3/29/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Angina Pectoris, Dyspepsia
4124196 4440886 13 Years F 1/5/2004 3/19/2004 7/28/2004 131 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Angina Pectoris, Stomach Discomfort
4124197 4336157 53 Years F 1/7/2004 3/29/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Erythema, Feeling Hot, Paraesthesia, Skin Lesion, Urticaria, Weight Decreased
4124200 4336159 62 Years F 1/7/2004 3/29/2004 82 PER Strattera Dyspnoea, Feeling Hot and Cold, Headache, Hyperhidrosis, Irritability, Self Esteem Decreased
4124201 4335715 9 Years M 11/1/2003 1/19/2004 3/29/2004 70 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Eye Pain, Headache, Precocious Puberty, Vomiting
4124203 4336161     F 1/7/2004 3/29/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Epistaxis
4124205 4336163 12 Years M 1/5/2004 1/7/2004 3/29/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Eye Disorder, Fatigue, Hypersomnia, Mydriasis, Visual Disturbance
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124206 4336165 6 Years F 1/7/2004 3/29/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Somnolence
4124208 4336166     F 1/7/2004 3/29/2004 82 PER Strattera Restlessness
4124209 4336167 11 Years M 1/7/2004 3/29/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Feeling Abnormal, Nausea, Somnolence, Vomiting
4124211 4336101 12 Years 12/23/2003 3/29/2004 97 MD PER Strattera Urinary Incontinence
4124214 4336103 39 Years M 12/1/2003 1/6/2004 3/29/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Antisocial Behaviour, Erectile Dysfunction, Fatigue, Insomnia, Lethargy
4124215 4336106     M 1/6/2004 3/29/2004 83 MD PER Strattera Pervasive Developmental Disorder Crying, Flushing, Headache
4124220 4336137 8 Weeks M 1/6/2004 3/29/2004 83 PH PER Strattera Diarrhoea, Lethargy, Vomiting
4124222 4336140 12 Years F 1/6/2004 3/29/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Decreased Appetite, Somnolence, Yawning
4124223 4336142 9 Years M 6/1/2003 1/6/2004 3/29/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Mood Swings
4124224 4335718 36 Years F 11/20/2003 3/29/2004 130 MD PER Strattera Attention Deficit/Hyperactivity Disorder Platelet Count Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124224 4440758 36 Years F 11/20/2003 7/28/2004 251 MD PER Strattera Attention Deficit/Hyperactivity Disorder Platelet Count Increased
4124227 4336144     F 11/1/2003 1/6/2004 3/29/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dry Mouth, Paraesthesia, Sexual Dysfunction, Weight Decreased
4124231 4336146     F 1/5/2004 1/6/2004 3/29/2004 83 PER Strattera Erythema, Feeling Hot
4124234 4336149     M 1/6/2004 1/6/2004 3/29/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Drunk, Flushing, Heart Rate Increased
4124235 4336081 8 Years M 12/30/2003 1/5/2004 3/29/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Hot, Hyperhidrosis
4124239 4336082 27 Years F 1/1/2004 1/5/2004 3/29/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Jittery, Nausea, Palpitations
4124242 4335720 12 Years M 10/1/2003 11/20/2003 3/29/2004 130 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective
4124246 4336084 12 Years M 1/5/2004 3/29/2004 84 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4124248 4336090 10 Years M 1/5/2004 3/29/2004 84 MD PER Strattera Tic
4124250 4336091 8 Years F 1/5/2004 3/29/2004 84 MD PER Strattera Tic
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124251 4335722 37 Years M 11/1/2003 11/20/2003 3/29/2004 130 MD PER Strattera Urine Abnormality
4124252 4336093 11 Years F 4/1/2003 1/5/2004 3/29/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Hot, Influenza Like Illness, Somnolence, Weight Decreased
4124253 4336095 48 Years M 1/5/2004 3/29/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Feeling Abnormal
4124254 4336096 21 Years M 1/5/2004 3/29/2004 84 MD PER Strattera Mydriasis
4124255 4335724 45 Years M 11/20/2003 3/29/2004 130 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Drug Withdrawal Syndrome
4124255 4440759 45 Years M 11/20/2003 7/28/2004 251 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Drug Withdrawal Syndrome
4124257 4336097 50 Years M 12/1/2003 1/5/2004 3/29/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Decreased Appetite, Dysuria, Erectile Dysfunction, Insomnia, Weight Decreased
4124258 4336098 9 Years M 12/26/2003 1/5/2004 3/29/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Somnolence
4124262 4335727 52 Years F 11/7/2003 11/20/2003 3/29/2004 130 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Heart Rate Increased, Palpitations
4124262 4440863 52 Years F 11/7/2003 11/20/2003 7/28/2004 251 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Heart Rate Increased, Palpitations
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124264 4335728 6 Years M 12/3/2003 3/29/2004 117 OT PER Strattera Agitation, Mood Swings
4124266 4336039 12 Years M 8/1/2003 1/5/2004 3/29/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Impulsive Behaviour
4124268 4335729     F 1/1/2003 11/20/2003 3/29/2004 130 CN PER Strattera Anxiety, Attention Deficit/Hyperactivity Disorder, Depression Dry Mouth, Sinus Congestion, Sinusitis
4124269 4336065 8 Years M 1/3/2004 2/2/2004 3/29/2004 56 OT PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Decreased Appetite, Depression Suicidal, Drug Ineffective, Dyspnoea, Fatigue, Hallucination, Headache, Insomnia, Mood Swings, Nervousness, Pallor, Panic Attack, Psychomotor Hyperactivity, Weight Decreased
4124269 4440621 8 Years M 1/3/2004 3/23/2004 7/28/2004 127 OT PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Decreased Appetite, Depression Suicidal, Drug Ineffective, Dyspnoea, Fatigue, Feeling Abnormal, Hallucination, Headache, Insomnia, Laziness, Mood Swings, Nervousness, Pallor, Panic Attack, Psychomotor Hyperactivity, Weight Decreased
4124271 4336067 13 Years M 1/4/2004 1/5/2004 3/29/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Diarrhoea, Dysuria, Pollakiuria, Polydipsia, Residual Urine Volume
4124273 4336068 11 Years F 1/4/2004 1/30/2004 3/29/2004 59 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Headache, Pharyngolaryngeal Pain
4124273 4440883 11 Years F 1/4/2004 2/26/2004 7/28/2004 153 MD PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Headache, Pharyngolaryngeal Pain
4124276 4335730 48 Years F 11/1/2003 11/20/2003 3/29/2004 130 CN PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dry Mouth, Feeling Jittery, Hypersensitivity, Insomnia, Nausea, Oedema Peripheral, Pruritus, Rash Erythematous, Red Man Syndrome
4124278 4336072 9 Years F 1/5/2004 3/29/2004 84 OT PER Strattera Dystonia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124279 4335734 12 Years 11/19/2003 3/29/2004 131 MD PER Strattera Depression
4124280 4336073 7 Years M 12/1/2003 1/5/2004 3/29/2004 84 PER Strattera Feeling Abnormal, Retching, Vomiting
4124282 4336074 8 Years F 11/1/2003 1/5/2004 3/29/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Sensation in Eye, Eye Pruritus, Madarosis
4124285 4336075     F 1/1/2003 1/6/2004 3/29/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Anaemia, Drug Ineffective, Insomnia, Skin Discolouration
4124285 4440884 43 Years F 1/1/2003 3/24/2004 7/28/2004 126 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anaemia, Drug Ineffective, Hypoaesthesia, Insomnia, Skin Discolouration
4124286 4336077 34 Years M 1/5/2004 3/29/2004 84 MD PER Strattera Attention Deficit/Hyperactivity Disorder Penile Size Reduced, Piloerection, Skin Disorder
4124287 4335991     M 12/18/2003 3/29/2004 102 OT PER Strattera Attention Deficit/Hyperactivity Disorder Enuresis, Incontinence
4124289 4335992 7 Years M 12/1/2003 12/30/2003 3/29/2004 90 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Eating Disorder, Initial Insomnia, Nausea, Sleep Disorder
4124290 4335993 13 Years F 12/1/2003 12/31/2003 3/29/2004 89 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Headache, Menstrual Disorder, Mood Swings, Mydriasis, Negativism, Weight Decreased
4124291 4335996 51 Years F 12/30/2003 12/31/2003 3/29/2004 89 PER Strattera Depression Arthralgia, Chills, Pyrexia, Skin Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124293 4335998 47 Years M 12/22/2003 2/4/2004 3/29/2004 54 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Decreased Appetite, Dry Mouth, Dysuria, Ejaculation Failure, Erectile Dysfunction, Euphoric Mood, Fear, Hot Flush, Libido Increased, Micturition Urgency, Nephrolithiasis, Nervousness, Orgasmic Sensation Decreased, Weight Decreased
4124294 4336001 60 Years F 12/1/2003 12/31/2003 3/29/2004 89 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Decreased Appetite, Eye Redness, Feeling Drunk, Muscle Rigidity, Pain in Extremity
4124297 4336003 10 Years M 1/9/2004 3/29/2004 80 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
4124300 4336034 10 Years M 12/31/2003 3/29/2004 89 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased
4124300 4440599 10 Years M 12/11/2003 3/25/2004 7/28/2004 125 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased
4124300 4501324 10 Years M 12/13/2003 6/30/2004 9/27/2004 89 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased
4124300 4509515 10 Years M 12/11/2003 10/28/2004 11/19/2004 22 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Tic, Viral Infection
4124302 4336036 14 Years M 12/1/2003 1/28/2004 3/29/2004 61 OT PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Orthostatic Hypotension, Weight Decreased
4124303 4335947 4 Years M 12/1/2003 12/22/2003 3/29/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Rectal Haemorrhage
4124303 4440574 4 Years M 12/1/2003 3/4/2004 7/28/2004 146 PER Strattera Attention Deficit/Hyperactivity Disorder Rectal Haemorrhage
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124306 4335948     M 12/23/2003 3/29/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Impulsive Behaviour, Psychomotor Hyperactivity
4124308 4335972 54 Years M 1/1/2003 12/22/2003 3/29/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Pollakiuria
4124311 4335974 14 Years M 7/1/2003 12/23/2003 3/29/2004 97 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Anxiety, Nocturnal Emission, Obsessive-Compulsive Disorder
4124312 4335975 12 Years F 12/18/2003 12/23/2003 3/29/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Communication Disorder, Crying, Disorientation, Somnolence, Thinking Abnormal
4124313 4335978 8 Years M 12/8/2003 12/23/2003 3/29/2004 97 PER Strattera Fatigue, Increased Appetite, Nervousness
4124316 4335979     M 1/1/2003 12/16/2003 3/29/2004 104 PH PER Strattera Drug Screen Positive
4124317 4335981 18 Years M 12/23/2003 12/23/2003 3/29/2004 97 PER Strattera Depression Chest Pain, Dyspnoea, Throat Tightness
4124320 4335983 12 Years M 10/1/2003 12/23/2003 3/29/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Crying, Depression, Mood Swings, Nasopharyngitis
4124322 4335986     M 12/22/2003 12/23/2003 3/29/2004 97 MD PER Strattera Urinary Incontinence
4124324 4335878 15 Years M 1/1/2003 11/20/2003 3/29/2004 130 MD PER Strattera Attention Deficit/Hyperactivity Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124325 4335892 10 Years M 11/20/2003 3/29/2004 130 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective
4124329 4335914 13 Years M 11/20/2003 3/29/2004 130 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Irritability
4124331 4335917 11 Years M 11/1/2003 11/20/2003 3/29/2004 130 PER Strattera Attention Deficit/Hyperactivity Disorder Asthma, Paraesthesia
4124333 4335923 10 Years M 11/20/2003 3/29/2004 130 MD PER Strattera Attention Deficit/Hyperactivity Disorder Affective Disorder, Anorexia, Psychotic Disorder
4124336 4335938 16 Years M 11/20/2003 11/20/2003 3/29/2004 130 OT PER Strattera Abdominal Pain Upper, Decreased Appetite, Fatigue, Headache, Hypersomnia, Pallor
4124337 4335944 44 Years M 11/19/2003 11/21/2003 3/29/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Erectile Dysfunction, Feeling Abnormal, Hyperhidrosis
4124337 4440866 44 Years M 11/19/2003 11/21/2003 7/28/2004 250 CN PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Erectile Dysfunction, Feeling Abnormal, Hyperhidrosis
4124338 4335945 9 Years M 11/21/2003 3/29/2004 129 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tooth Discolouration
4124339 4336168     M 1/29/2004 1/30/2004 3/29/2004 59 OT PER Strattera Chest Pain, Feeling Abnormal, Heart Rate Increased, Somnolence
4124341 4336169 12 Years M 1/30/2004 3/29/2004 59 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Decreased Appetite, Diarrhoea, Headache, Vomiting, Weight Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124343 4336170     M 1/30/2004 3/29/2004 59 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Dizziness, Fatigue, Pallor
4124344 4336171 12 Years M 1/27/2004 2/17/2004 3/29/2004 41 PER Strattera Dizziness, Dyspepsia, Fatigue, Headache, Heart Rate Irregular, Hypoaesthesia, Loss of Consciousness, Nausea
4124344 4336530 12 Years M 1/27/2004 3/22/2004 4/7/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Dizziness, Dyspepsia, Fatigue, Headache, Heart Rate Irregular, Hypoaesthesia, Loss of Consciousness, Malaise, Nausea Other
4124346 4336172 38 Years F 1/22/2004 2/9/2004 3/29/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Chest Pain, Dyspnoea, Feeling Abnormal, Headache, Heart Rate Increased, Heart Rate Irregular, Hypertension
4124347 4336173 8 Years M 1/30/2004 3/29/2004 59 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Flushing, Headache, Mydriasis, Weight Decreased
4124350 4336174 6 Years M 1/1/2004 1/30/2004 3/29/2004 59 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Psychomotor Hyperactivity
4124353 4336176 22 Years M 1/30/2004 2/2/2004 3/29/2004 56 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Hypokinesia
4124354 4336177     M 2/2/2004 3/29/2004 56 MD PER Strattera Insomnia, Restless Legs Syndrome
4124702 4337345 8 Years F 12/28/2003 1/14/2004 3/29/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Fatigue, Feeling Abnormal
4124704 4337347 7 Years M 10/28/2003 1/14/2004 3/29/2004 75 PH PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124705 4337162 14 Years M 11/1/2003 2/17/2004 3/29/2004 41 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Depression
4124707 4337017 11 Years M 1/16/2004 3/29/2004 73 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Drug Ineffective, Irritability
4124708 4337350 5 Years M 12/1/2003 1/14/2004 3/29/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4124714 4337353 12 Years 1/14/2004 3/29/2004 75 MD PER Strattera Psychotic Disorder
4124714 4440875 12 Years F 3/17/2004 7/28/2004 133 MD PER Strattera Attention Deficit/Hyperactivity Disorder Psychotic Disorder
4124715 4337018 8 Years M 1/16/2004 3/29/2004 73 MD PER Strattera Attention Deficit/Hyperactivity Disorder Mania
4124716 4337164 36 Years M 2/17/2004 3/29/2004 41 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Gastrooesophageal Reflux Disease, Pyrexia, Restlessness
4124717 4337360 20 Years F 1/14/2004 3/29/2004 75 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Mydriasis
4124718 4337019 5 Years M 1/16/2004 3/29/2004 73 OT PER Strattera Attention Deficit/Hyperactivity Disorder
4124719 4337165 12 Years 2/11/2004 3/29/2004 47 MD PER Strattera Gastrointestinal Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124721 4337362 14 Years M 1/1/2003 1/14/2004 3/29/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Anger, Drug Ineffective, Insomnia, Irritability
4124723 4337020 8 Years M 12/1/2003 1/16/2004 3/29/2004 73 PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity
4124724 4337364 9 Years M 1/14/2004 3/29/2004 75 MD PER Strattera Developmental Delay, Dry Mouth, Testicular Pain
4124725 4337378 8 Years M 1/14/2004 3/29/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4124727 4337021 7 Years F 1/16/2004 1/16/2004 3/29/2004 73 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Fatigue, Feeling Abnormal, Pallor, Speech Disorder
4124728 4337385 7 Years M 1/1/2004 1/14/2004 3/29/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Mood Swings
4124729 4337022 5 Years M 12/1/2003 1/16/2004 3/29/2004 73 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Decreased Appetite, Drug Ineffective, Headache, Mood Swings, Pyrexia, Weight Decreased
4124730 4337388 49 Years M 1/14/2004 3/29/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Pollakiuria, Restlessness
4124733 4337023 7 Years M 12/1/2003 1/16/2004 3/29/2004 73 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Impulsive Behaviour
4124734 4337170 10 Years 2/16/2004 2/17/2004 3/29/2004 41 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Abnormal Behaviour, Body Temperature Increased, Constipation, Diarrhoea, Fatigue, Hot Flush, Muscular Weakness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124735 4337024 6 Years M 1/16/2004 3/29/2004 73 PER Strattera Psychomotor Hyperactivity
4124736 4337171     M 2/17/2004 3/29/2004 41 MD PER Strattera Testicular Pain
4124737 4337059 7 Years M 11/1/2003 2/19/2004 3/29/2004 39 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Gastroenteritis Viral
4124738 4337025 7 Years M 1/1/2004 1/16/2004 3/29/2004 73 PER Strattera Distractibility, Disturbance in Attention
4124739 4337026 13 Years F 1/16/2004 1/16/2004 3/29/2004 73 PER Strattera Disturbance in Attention Dizziness, Dysstasia, Fatigue, Vision Blurred
4124740 4337172 11 Years F 1/20/2004 2/17/2004 3/29/2004 41 PER Strattera Hypertonia
4124742 4337173     M 2/17/2004 3/29/2004 41 MD PER Strattera Testicular Pain
4124744 4337060 11 Years M 10/1/2003 11/26/2003 3/29/2004 124 MD PER Strattera Depression, Drug Ineffective, Mood Swings
4124746 4337061 13 Years M 11/26/2003 3/29/2004 124 MD PER Strattera Drug Ineffective
4124749 4337062 37 Years M 1/1/2003 11/26/2003 3/29/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Decreased Appetite, Mood Swings, Sleep Disorder, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124750 4337177 48 Years F 12/1/2003 2/17/2004 3/29/2004 41 PER Strattera Attention Deficit/Hyperactivity Disorder Dysgeusia, Nausea, Parosmia
4124751 4337063 31 Years F 11/1/2003 11/26/2003 3/29/2004 124 PER Strattera Feeling Abnormal, Nausea
4124753 4337064 8 Years M 11/26/2003 3/29/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams
4124754 4337065 49 Years M 11/1/2003 11/26/2003 3/29/2004 124 MD PER Strattera Dysuria, Muscle Cramp, Nausea, Testicular Swelling, Urinary Hesitation
4124756 4337066 6 Years M 11/26/2003 3/29/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams
4124758 4337067     M 12/1/2003 3/29/2004 119 CN PER Strattera Drug Ineffective
4124770 4337068     M 12/1/2003 3/29/2004 119 PER Strattera Disturbance in Attention
4124805 4337058     F 2/3/2004 3/29/2004 55 PER Strattera
4124806 4337057 10 Years M 12/1/2003 2/3/2004 3/29/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Drug Ineffective, Paranoia
4124807 4337069 9 Years M 1/20/2004 1/22/2004 3/29/2004 67 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Fatigue, Retching, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124809 4337055 53 Years M 1/1/2004 2/4/2004 3/29/2004 54 PER Strattera Dysuria
4124811 4337070 10 Years M 1/1/2004 1/22/2004 3/29/2004 67 PER Strattera Emotional Distress, Feeling Abnormal
4124812 4337056 6 Years F 2/3/2004 3/29/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4124813 4337071 12 Years 12/22/2003 3/29/2004 98 MD PER Strattera Depression Hospitalization - Initial or Prolonged
4124814 4337054 12 Years M 2/3/2004 3/29/2004 55 PH PER Strattera Attention Deficit/Hyperactivity Disorder Fall, Jaw Fracture
4124816 4337072 6 Years M 1/22/2004 1/22/2004 3/29/2004 67 PER Strattera
4124817 4337007     F 1/16/2004 3/29/2004 73 PER Strattera Dysmenorrhoea, Oligomenorrhoea
4124818 4337073 7 Years F 1/22/2004 3/29/2004 67 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Skin
4124819 4337027 11 Years F 12/1/2003 1/15/2004 3/29/2004 74 PH PER Strattera Anger, Anxiety, Depression, Psychomotor Hyperactivity Blepharospasm, Eye Discharge
4124820 4337008 6 Years M 1/1/2004 1/16/2004 3/29/2004 73 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124821 4337074 46 Years F 12/19/2003 1/22/2004 3/29/2004 67 PER Strattera Attention Deficit/Hyperactivity Disorder Middle Insomnia, Paraesthesia, Postnasal Drip
4124822 4337028 64 Years F 9/19/2003 1/15/2004 3/29/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Tremor
4124823 4337053 8 Years M 1/8/2004 2/3/2004 3/29/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Agitation, Ear Infection
4124825 4337075 66 Years M 12/1/2003 1/22/2004 3/29/2004 67 PER Strattera Anxiety, Drug Ineffective
4124826 4337009 10 Years M 12/1/2003 1/16/2004 3/29/2004 73 PER Strattera Attention Deficit/Hyperactivity Disorder Faecal Incontinence, Fatigue, Somnolence
4124827 4337029 6 Years F 1/14/2004 1/15/2004 3/29/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Early Morning Awakening, Increased Appetite, Mood Swings, Pharyngeal Erythema, Pharyngolaryngeal Pain
4124828 4337076     M 1/22/2004 3/29/2004 67 PER Strattera Agitation, Dyspepsia
4124829 4337052 7 Years M 2/3/2004 3/29/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4124830 4337030 11 Years M 1/15/2004 3/29/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder, Obsessive-Compulsive Disorder Abdominal Pain, Crying, Dysuria
4124831 4337077 7 Years M 1/1/2004 1/22/2004 3/29/2004 67 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Drug Ineffective, Emotional Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124832 4337010 15 Years M 1/16/2004 3/29/2004 73 MD PER Strattera Arrhythmia
4124834 4337051 8 Years M 2/3/2004 3/29/2004 55 PER Strattera Dizziness, Fatigue, Feeling Abnormal, Somnolence, Syncope
4124834 4440704 8 Years M 5/4/2004 7/28/2004 85 PER Strattera Attention Deficit/Hyperactivity Disorder Asthma, Chest Pain, Constipation, Decreased Appetite, Dizziness, Fatigue, Feeling Abnormal, Immune System Disorder, Insomnia, Mood Swings, Nasopharyngitis, Somnolence, Syncope, Weight Decreased
4124835 4337078 5 Years M 1/1/2004 1/22/2004 3/29/2004 67 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Crying, Emotional Distress
4124837 4337050 12 Years M 2/3/2004 3/29/2004 55 MD PER Strattera Delusion
4124838 4337011 7 Years M 1/19/2004 3/29/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Emotional Disorder, Feeling Abnormal, Gastroenteritis, Mood Swings, Vomiting, Weight Decreased
4124840 4336070 10 Years M 1/5/2004 3/29/2004 84 OT PER Strattera Tachycardia
4124841 4336007 54 Years M 1/1/2003 12/31/2003 3/29/2004 89 PER Strattera Glaucoma, Visual Acuity Reduced
4124842 4335912 42 Years M 11/20/2003 3/29/2004 130 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Anxiety, Apathy, Confusional State, Depression, Dry Mouth, Dyspnoea, Migraine, Mood Swings, Sexual Dysfunction, Suicidal Ideation, Vision Blurred, Weight Decreased
4124842 4440865 42 Years M 11/20/2003 7/28/2004 251 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Anxiety, Apathy, Confusional State, Depression, Dry Mouth, Dyspnoea, Migraine, Mood Swings, Sexual Dysfunction, Suicidal Ideation, Vision Blurred, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124844 4337049 51 Years F 2/1/2004 2/18/2004 3/29/2004 40 PER Strattera Attention Deficit/Hyperactivity Disorder, Depression Drug Ineffective, Dyspepsia, Fatigue, Feeling Abnormal, Feeling Jittery, Hot Flush, Nervousness, Rash Pruritic
4124845 4337012 6 Years F 2/11/2004 3/29/2004 47 PER Strattera Attention Deficit/Hyperactivity Disorder Pneumonia
4124845 4440876 6 Years F 2/25/2004 7/28/2004 154 MD PER Strattera Attention Deficit/Hyperactivity Disorder Pneumonia
4124846 4337031 47 Years F 1/1/2003 1/16/2004 3/29/2004 73 OT PER Strattera Brain Damage, Intracranial Aneurysm Abdominal Discomfort, Decreased Appetite, Dermal Cyst, Fatigue, Loose Stools, Mental Impairment, Metrorrhagia, Nausea
4124847 4337038 9 Years F 1/22/2004 3/29/2004 67 CN PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Irritability
4124848 4337013 13 Years M 1/1/2003 1/19/2004 3/29/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Migraine, Tic
4124849 4337040     F 1/15/2004 3/29/2004 74 OT PER Strattera Attention Deficit/Hyperactivity Disorder Vision Blurred
4124854 4337041 10 Years F 11/1/2003 1/19/2004 3/29/2004 70 MD PER Strattera Attention Deficit/Hyperactivity Disorder Weight Increased
4124856 4337014 7 Years M 1/19/2004 3/29/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Somnolence
4124857 4337042 41 Years M 1/1/2004 1/15/2004 3/29/2004 74 CN PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Palpitations
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124860 4337043 41 Years M 1/1/2004 1/19/2004 3/29/2004 70 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Sensation in Eye, Vision Blurred
4124863 4337015 7 Years F 1/19/2004 3/29/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Mania
4124865 4337044 28 Years F 1/15/2004 3/29/2004 74 CN PER Strattera Alopecia
4124867 4337045 7 Years F 1/1/2004 1/15/2004 3/29/2004 74 CN PER Strattera Tic
4124868 4337016 11 Years F 1/19/2004 3/29/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
4124870 4337046 6 Years M 1/1/2004 1/15/2004 3/29/2004 74 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Decreased Appetite, Drug Ineffective, Gastrointestinal Disorder, Nausea
4124874 4337047 24 Years F 1/1/2004 1/15/2004 3/29/2004 74 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Dry Mouth, Dysuria, Headache, Insomnia, Memory Impairment
4124875 4337397 7 Years M 1/16/2004 1/20/2004 3/29/2004 69 PER Strattera Disturbance in Attention Skin Discolouration, Vein Disorder
4124875 4440877 7 Years M 1/16/2004 4/1/2004 7/28/2004 118 MD PER Strattera Disturbance in Attention Skin Discolouration, Vein Disorder
4124877 4337399 8 Years M 1/1/2003 1/20/2004 3/29/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Lethargy, Nausea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124878 4337048 38 Years M 1/15/2004 3/29/2004 74 CN PER Strattera Vision Blurred Penis Disorder, Urinary Hesitation
4124879 4337402 12 Years F 1/1/2003 1/20/2004 3/29/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Expressive Language Disorder
4124880 4337407 16 Years M 1/20/2004 1/20/2004 3/29/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Panic Attack
4124881 4337410 5 Years M 1/16/2004 1/20/2004 3/29/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Emotional Distress, Retching
4124883 4337414 11 Years F 1/10/2004 1/20/2004 3/29/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Abnormal, Vision Blurred
4124884 4337416     F 1/20/2004 3/29/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Nausea, Visual Disturbance
4124887 4337422 33 Years F 1/1/2004 1/20/2004 3/29/2004 69 PER Strattera Blepharospasm
4124887 4580286 32 Years F 1/1/2004 9/8/2004 1/27/2005 141 CN PER Strattera Attention Deficit/Hyperactivity Disorder Blepharospasm, Psychomotor Hyperactivity
4124892 4337424 42 Years M 1/20/2004 3/29/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Male Orgasmic Disorder, Orgasm Abnormal, Somnolence
4124894 4337544 25 Years M 12/23/2003 3/29/2004 97 PH PER Strattera
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124896 4337552 10 Years M 1/19/2004 3/29/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Drug Interaction, Oppositional Defiant Disorder, Weight Increased
4124898 4337553 14 Years M 10/14/2003 12/23/2003 3/29/2004 97 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Tic
4124900 4337557 12 Years 12/23/2003 3/29/2004 97 MD PER Strattera Urinary Incontinence
4124901 4337566     M 12/23/2003 3/29/2004 97 MD PER Strattera Attention Deficit/Hyperactivity Disorder Pollakiuria, Urinary Retention
4124902 4337578 12 Years M 12/23/2003 3/29/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Epistaxis
4124903 4337581 10 Years F 12/1/2003 12/23/2003 3/29/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Blepharospasm, Decreased Appetite, Stomach Discomfort
4124905 4337588 12 Years M 1/1/2003 12/23/2003 3/29/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Retching, Weight Decreased
4124906 4337629     M 12/20/2003 12/24/2003 3/29/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Fatigue, Nausea, Yawning
4124913 4337886 15 Years M 1/29/2004 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Nausea, Nervousness
4124916 4337888 8 Years M 1/24/2004 1/29/2004 3/29/2004 60 PER Strattera Agitation, Anger, Crying, Decreased Appetite, Fatigue, Increased Appetite, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124916 4438561 8 Years M 1/24/2004 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Anger, Crying, Decreased Appetite, Drug Ineffective, Fatigue, Increased Appetite, Somnolence
4124918 4337890 10 Years M 1/28/2004 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Yawning
4124921 4337891 7 Years M 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Depressed Mood, Emotional Disorder
4124923 4337032 32 Years M 1/16/2004 3/29/2004 73 MD PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Pain
4124925 4337892 12 Years F 1/1/2004 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Disturbance in Attention, Dizziness, Fatigue, Nausea, Somnolence, Visual Disturbance
4124926 4337033     M 1/16/2004 3/29/2004 73 PER Strattera Excitability, Nervousness, Psychomotor Hyperactivity
4124927 4337894 8 Years F 1/1/2004 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4124928 4337895 8 Years M 9/1/2003 1/29/2004 3/29/2004 60 PER Strattera Hyperhidrosis, Mood Swings
4124930 4337896 9 Years M 1/1/2004 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Crying, Retching
4124931 4337034 7 Years M 1/1/2004 1/30/2004 3/29/2004 59 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anorexia, Fatigue, Hyperhidrosis, Influenza Like Illness, Irritability, Nausea, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124932 4337897 31 Years F 1/26/2004 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Renal Pain, Urine Abnormality, Urticaria
4124935 4337870     F 1/1/2004 2/20/2004 3/29/2004 38 PER Strattera Fatigue, Feeling Abnormal
4124936 4337035 9 Years F 1/5/2004 1/16/2004 3/29/2004 73 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
4124937 4337873 6 Years M 12/25/2003 2/20/2004 3/29/2004 38 PER Strattera Abdominal Pain Upper, Change of Bowel Habit
4124938 4337874 10 Years M 2/20/2004 3/29/2004 38 MD PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Thinking Abnormal
4124939 4337875 34 Years M 2/26/2004 3/29/2004 32 MD PER Strattera Abscess, Angioneurotic Oedema, Pyrexia, Rash Hospitalization - Initial or Prolonged
4124940 4337036 14 Years M 1/16/2004 1/16/2004 3/29/2004 73 PER Strattera Attention Deficit/Hyperactivity Disorder Blepharospasm, Vision Blurred
4124941 4337876 15 Years M 2/17/2004 2/20/2004 3/29/2004 38 PER Strattera Insomnia, Middle Insomnia, Sleep Disorder
4124942 4337877     M 2/19/2004 3/29/2004 39 MD PER Strattera Rectal Haemorrhage
4124943 4337879 51 Years M 2/1/2004 2/20/2004 3/29/2004 38 PER Strattera Attention Deficit/Hyperactivity Disorder Hypermetropia, Vision Blurred
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124946 4337884 9 Years F 11/21/2003 3/29/2004 129 MD PER Strattera Affect Lability, Crying, Insomnia
4124947 4337453 8 Years M 1/12/2004 3/29/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Drug Ineffective, Emotional Disorder, Insomnia, Irritability
4124948 4337455     M 1/1/2004 1/12/2004 3/29/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Abnormal, Somnolence
4124950 4337466 10 Years F 1/13/2004 3/29/2004 76 PH PER Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Irregular, Tachycardia
4124950 4440888 10 Years F 2/27/2004 7/28/2004 152 PH PER Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Irregular, Tachycardia
4124952 4337469     F 1/13/2004 3/29/2004 76 PH PER Strattera
4124953 4337474 12 Years M 1/13/2004 3/29/2004 76 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4124954 4337478     M 1/13/2004 3/29/2004 76 PER Strattera Psychomotor Hyperactivity Drug Ineffective
4124955 4337490     M 1/1/2004 1/13/2004 3/29/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Ejaculation Disorder, Erectile Dysfunction, Fatigue, Insomnia, Irritability, Restlessness
4124956 4337497 15 Years M 1/13/2004 3/29/2004 76 MD PER Strattera Anxiety, Panic Attack
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124958 4337503 10 Years M 1/13/2004 3/29/2004 76 PER Strattera
4124959 4337504 9 Years M 1/1/2003 1/13/2004 3/29/2004 76 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Crying, Dyspepsia, Emotional Disorder
4124961 4337646 7 Years F 1/1/2003 12/29/2003 3/29/2004 91 PER Strattera Nasopharyngitis, Pyrexia
4124962 4337650 13 Years M 12/29/2003 3/29/2004 91 PER Strattera Attention Deficit/Hyperactivity Disorder Malaise
4124963 4337659 25 Years M 12/1/2003 12/24/2003 3/29/2004 96 OT PER Strattera Drug Screen Positive
4124964 4337661 9 Years M 11/1/2003 12/24/2003 3/29/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dysuria, Pyrexia
4124965 4337664     M 12/22/2003 3/29/2004 98 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
4124966 4337665 49 Years F 12/1/2003 12/24/2003 3/29/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dry Mouth, Feeling Cold, Headache, Hot Flush, Influenza Like Illness, Insomnia
4124967 4337666 8 Years M 12/24/2003 3/29/2004 96 MD PER Strattera Feeling Abnormal, Mydriasis
4124968 4337667 10 Years M 12/28/2003 12/29/2003 3/29/2004 91 PER Strattera Decreased Appetite, Fatigue, Hyperhidrosis, Lethargy, Nausea, Pyrexia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124974 4337668 11 Years M 12/29/2003 1/19/2004 3/29/2004 70 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hypertension, Tachycardia, Vision Blurred
4124975 4337669     F 12/28/2003 12/29/2003 3/29/2004 91 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Feeling Cold, Hot Flush, Nausea, Tremor
4124977 4337319 13 Years M 1/1/2004 1/14/2004 3/29/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Disturbance in Attention
4124979 4337321 12 Years M 1/14/2004 3/29/2004 75 PER Strattera Abdominal Pain Upper, Disturbance in Attention
4124980 4337324 39 Years F 2/16/2004 3/29/2004 42 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Blood Pressure Increased, Chest Pain, Drug Ineffective, Feeling Abnormal, Migraine, Nervousness Other
4124982 4337328 14 Years F 1/13/2004 3/29/2004 76 OT PER Strattera Hepatic Enzyme Increased
4124982 4440891 14 Years F 4/6/2004 7/28/2004 113 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased
4124985 4337330     M 1/14/2004 1/14/2004 3/29/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Confusional State, Somnolence
4124990 4337333 17 Years M 1/1/2003 1/14/2004 3/29/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Hyperacusis, Somnolence, Tremor
4124995 4337335 44 Years M 1/13/2004 1/14/2004 3/29/2004 75 OT PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Diastolic Increased, Dry Mouth, Dysuria, Erectile Dysfunction, Headache, Paraesthesia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4124995 4440892 44 Years M 1/13/2004 4/6/2004 7/28/2004 113 OT PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Diastolic Increased, Dry Mouth, Dysuria, Erectile Dysfunction, Headache, Paraesthesia
4124996 4337337     M 1/14/2004 3/29/2004 75 MD PER Strattera Dysuria, Retrograde Ejaculation
4124997 4337339     M 1/14/2004 3/29/2004 75 MD PER Strattera Attention Deficit/Hyperactivity Disorder Burning Sensation, Drug Ineffective, Erythema, Eye Irritation
4124998 4337340     M 1/14/2004 3/29/2004 75 MD PER Strattera Blood Pressure Increased, Dyspnoea Exertional, Exercise Tolerance Decreased, Groin Pain, Heart Rate Increased
4124998 4440874     M 3/26/2004 7/28/2004 124 MD PER Strattera Blood Pressure Increased, Dyspnoea Exertional, Exercise Tolerance Decreased, Groin Pain, Heart Rate Increased
4124999 4337915 9 Years M 1/28/2004 3/29/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder Choking
4125000 4337917 17 Years M 1/28/2004 3/29/2004 61 MD PER Strattera Blood Bilirubin Increased
4125000 4501692 17 Years M 6/18/2004 9/27/2004 101 MD PER Strattera Blood Bilirubin Increased
4125002 4337918 40 Years M 1/23/2004 1/28/2004 3/29/2004 61 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Constipation, Disinhibition, Dry Mouth, Mood Swings, Nausea
4125003 4337919 8 Years M 1/28/2004 3/29/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125004 4337921 10 Years M 1/28/2004 3/29/2004 61 CN PER Strattera Attention Deficit/Hyperactivity Disorder Choking
4125005 4337929 30 Years F 1/24/2004 1/28/2004 3/29/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder Excitability, Insomnia
4125006 4337931 37 Years M 1/28/2004 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Decreased Appetite, Piloerection, Sleep Disorder
4125007 4337933     F 1/27/2004 3/29/2004 62 MD PER Strattera Panic Attack
4125008 4337935     M 1/28/2004 3/29/2004 61 MD PER Strattera Testicular Disorder
4125018 4337901 11 Years F 7/1/2003 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Fatigue, Hypersomnia, Weight Gain Poor
4125019 4337902 12 Years 1/29/2004 3/29/2004 60 MD PER Strattera Attention Deficit/Hyperactivity Disorder Muscle Cramp, Palpitations, Rash
4125019 4438559 7 Years F 1/25/2004 2/27/2004 7/28/2004 152 MD PER Strattera Attention Deficit/Hyperactivity Disorder Flushing, Headache, Pain, Pain in Extremity, Rash
4125021 4337903 10 Years M 1/27/2004 1/29/2004 3/29/2004 60 PER Strattera Decreased Appetite, Feeling Abnormal, Headache, Lethargy, Mood Altered, Nausea
4125022 4337904 11 Years M 1/28/2004 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Palpitations
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125022 4438560 11 Years M 1/28/2004 5/7/2004 7/28/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Palpitations, Stomach Discomfort
4125024 4337905 12 Years 1/28/2004 3/29/2004 61 MD PER Strattera Hyperhidrosis
4125025 4337906 12 Years M 1/1/2004 2/9/2004 3/29/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Headache
4125027 4337908 11 Years M 1/29/2004 3/29/2004 60 PH PER Strattera Choking
4125029 4337909     F 1/26/2004 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
4125030 4337911 23 Years M 1/23/2004 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Toothache
4125031 4337913 41 Years F 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Palpitations
4125032 4336989 50 Years F 1/13/2004 1/19/2004 3/29/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder, Mental Disorder Genital Pruritus Female, Vaginal Discharge
4125033 4336990 10 Years M 12/1/2003 1/19/2004 3/29/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Emotional Disorder, Irritability, Rebound Effect
4125034 4336991 23 Years M 1/15/2004 1/19/2004 3/29/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Feeling Abnormal, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125036 4336992 28 Years M 1/1/2004 1/19/2004 3/29/2004 70 PER Strattera Anxiety, Attention Deficit/Hyperactivity Disorder, Panic Attack Erythema, Heart Rate Increased, Insomnia, Mydriasis, Tremor
4125037 4336993 44 Years M 1/1/2004 1/20/2004 3/29/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Tremor, Urinary Hesitation
4125038 4336994 13 Years M 1/20/2004 3/29/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Nervousness
4125039 4336996 7 Years M 1/20/2004 3/29/2004 69 MD PER Strattera Autism, Disturbance in Attention Cough, Tic
4125040 4336997 22 Years M 12/1/2003 1/20/2004 3/29/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Testicular Pain, Testicular Swelling
4125041 4336998 10 Years M 1/20/2004 1/20/2004 3/29/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Pallor
4125042 4336999 8 Years M 1/20/2004 1/20/2004 3/29/2004 69 PER Strattera Retching, Vomiting
4125043 4336971 17 Years M 2/4/2004 2/5/2004 3/29/2004 53 CN PER Strattera Attention Deficit/Hyperactivity Disorder Nasal Discomfort, Sneezing
4125044 4336972 6 Years F 1/1/2003 2/5/2004 3/29/2004 53 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Decreased Appetite, Dizziness, Dyspepsia, Enuresis, Feeling Abnormal, Flushing, Food Craving, Herpes Simplex, Mood Swings, Nasal Discomfort, Nausea, Night Sweats, Pyrexia, Rash, Somnolence, Trichotillomania, Visual Disturbance, Vomiting, Weight Decreased
4125045 4336974 17 Years M 2/5/2004 2/5/2004 3/29/2004 53 PER Strattera Dizziness, Fatigue, Heart Rate Irregular
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125046 4336976 10 Years M 2/5/2004 3/29/2004 53 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Disturbance in Attention, Drug Ineffective, Fatigue, Mood Swings
4125047 4336978 37 Years M 1/1/2004 2/5/2004 3/29/2004 53 PER Strattera Attention Deficit/Hyperactivity Disorder Bronchitis, Folliculitis, Hepatic Enzyme Increased
4125050 4336980 9 Years M 11/2/2003 2/5/2004 3/29/2004 53 PER Strattera Vision Blurred Abnormal Behaviour, Agitation, Crying, Depression Suicidal, Suicidal Ideation
4125051 4336982 8 Years M 2/5/2004 3/29/2004 53 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Crying, Feeling Abnormal, Mood Swings, Psychomotor Hyperactivity
4125052 4336983 9 Years M 2/5/2004 3/29/2004 53 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anxiety, Drug Ineffective, Impulsive Behaviour, Mood Swings, Nausea
4125056 4336985 43 Years F 2/2/2004 2/5/2004 3/29/2004 53 PER Strattera Attention Deficit/Hyperactivity Disorder Depression
4125058 4336986 10 Years M 2/1/2004 2/5/2004 3/29/2004 53 PER Strattera Abnormal Behaviour, Nausea, Psychomotor Hyperactivity, Vomiting
4125059 4336952 18 Years M 2/5/2004 3/29/2004 53 PER Strattera Feeling Abnormal, Tinnitus
4125061 4336953     F 2/5/2004 3/29/2004 53 PER Strattera Anger
4125062 4336962 4 Years M 2/5/2004 3/29/2004 53 MD PER Strattera Retching, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125063 4336963 27 Years M 1/1/2004 2/5/2004 3/29/2004 53 PER Strattera Attention Deficit/Hyperactivity Disorder, Depression Erectile Dysfunction, Penile Size Reduced, Testicular Atrophy
4125064 4337086 7 Years M 1/1/2003 11/25/2003 3/29/2004 125 PER Strattera Pervasive Developmental Disorder Abnormal Behaviour, Aggression, Anger, Feeling Abnormal
4125065 4336964 7 Years 2/5/2004 3/29/2004 53 PER Strattera Retching
4125067 4336966 12 Years 2/6/2004 3/29/2004 52 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4125071 4336968     M 12/1/2003 2/6/2004 3/29/2004 52 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4125073 4336969 13 Years M 2/6/2004 3/29/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Mood Swings, Psychotic Disorder
4125074 4337088 11 Years M 11/25/2003 11/26/2003 3/29/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Body Temperature Decreased, Cold Sweat, Decreased Activity, Feeling Hot, Flushing
4125075 4336970 5 Years M 2/3/2004 2/6/2004 3/29/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Drug Interaction, Middle Insomnia, Psychomotor Hyperactivity, Somnolence
4125080 4336942     M 1/13/2004 3/29/2004 76 PER Strattera Asthenia, Drug Ineffective, Feeling Abnormal
4125081 4337147     M 2/17/2004 3/29/2004 41 PER Strattera Blepharospasm, Movement Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125082 4336943 12 Years M 1/13/2004 3/29/2004 76 OT PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4125085 4336944 7 Years M 12/1/2003 1/13/2004 3/29/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anxiety, Nervousness, Psychomotor Hyperactivity
4125086 4337089 13 Years M 1/1/2003 11/26/2003 3/29/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Somnolence
4125087 4336945 53 Years F 1/1/2004 1/13/2004 3/29/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Nausea, Somnolence
4125089 4337150 8 Years M 1/1/2004 2/14/2004 3/29/2004 44 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Mood Swings, Somnolence
4125090 4337090     F 11/1/2003 11/26/2003 3/29/2004 124 PER Strattera Gastritis, Weight Decreased
4125091 4336946 9 Years M 1/13/2004 1/13/2004 3/29/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Screaming
4125093 4336947 10 Years M 11/1/2003 1/13/2004 3/29/2004 76 PER Strattera Anger, Retching
4125095 4336948     F 1/13/2004 3/29/2004 76 MD PER Strattera Attention Deficit/Hyperactivity Disorder, Depression Psychomotor Hyperactivity
4125096 4337153 5 Years M 12/25/2003 2/17/2004 3/29/2004 41 PER Strattera Aggression, Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anorexia, Constipation, Dyspepsia, Insomnia, Pain, Weight Decreased Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125097 4337091 13 Years F 11/1/2003 11/26/2003 3/29/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Decreased Appetite, Dizziness, Eye Pain, Headache, Mydriasis, Nausea, Somnolence
4125098 4336729     M 1/8/2004 3/29/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria
4125099 4336949 5 Years M 1/5/2003 1/13/2004 3/29/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention
4125100 4336852 16 Years M 1/12/2004 1/12/2004 3/29/2004 77 PER Strattera Abnormal Behaviour, Pruritus, Swelling Face
4125101 4337092 53 Years F 11/26/2003 11/26/2003 3/29/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Somnolence
4125102 4336950 11 Years M 10/1/2003 1/13/2004 3/29/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Dysgeusia, Nausea
4125104 4336951 9 Years F 1/13/2004 1/14/2004 3/29/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Haematochezia, Weight Decreased
4125104 4440890 9 Years F 3/1/2004 4/1/2004 7/28/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder, Constipation, Ear Infection, Haematochezia, Weight Decreased
4125104 4501688 9 Years F 3/1/2004 7/21/2004 9/27/2004 68 CN PER Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder, Constipation, Ear Infection, Haematochezia, Weight Decreased
4125106 4336855 34 Years 1/12/2004 3/29/2004 77 PH PER Strattera
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125107 4336874 10 Years M 11/1/2003 1/12/2004 3/29/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4125109 4336730 7 Years M 1/8/2004 3/29/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Insomnia, Sleep Talking, Somnolence
4125110 4336875 53 Years F 1/12/2004 3/29/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder, Weight Control Menorrhagia
4125111 4337154 42 Years F 2/17/2004 3/29/2004 41 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Excitability, Feeling Abnormal, Motion Sickness
4125112 4336857 12 Years M 9/1/2003 1/12/2004 3/29/2004 77 PER Strattera Disturbance in Attention Drug Ineffective
4125113 4336876 7 Years M 1/12/2004 3/29/2004 77 PER Strattera Headache, Nausea, Weight Increased
4125115 4336735 45 Years M 2/10/2004 3/29/2004 48 PER Strattera Amnesia
4125116 4337155 8 Years F 2/1/2004 2/17/2004 3/29/2004 41 PER Strattera Attention Deficit/Hyperactivity Disorder Confusional State, Decreased Appetite, Dizziness, Feeling Abnormal, Mydriasis, Pallor, Somnolence, Weight Decreased
4125117 4336889     M 11/1/2003 1/12/2004 3/29/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Erectile Dysfunction, Fatigue, Urticaria, Viral Infection
4125118 4336858     M 1/12/2004 3/29/2004 77 MD PER Strattera Agitation, Irritability
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125120 4336890 13 Years M 1/12/2004 3/29/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Hypokinesia, Malaise, Vomiting
4125121 4336893     M 1/12/2004 3/29/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Insomnia
4125122 4336742 51 Years F 1/8/2004 1/8/2004 3/29/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
4125123 4337156 8 Years M 2/18/2004 2/18/2004 3/29/2004 40 PER Strattera Psychomotor Hyperactivity
4125124 4337094 35 Years F 11/1/2003 11/26/2003 3/29/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Insomnia
4125126 4336895     M 1/12/2004 3/29/2004 77 MD PER Strattera Attention Deficit/Hyperactivity Disorder Ear Pain
4125127 4336860 52 Years F 12/1/2003 1/12/2004 3/29/2004 77 PER Strattera Disturbance in Attention Asthenia, Cough, Disturbance in Attention, Hyperhidrosis, Memory Impairment, Nasopharyngitis, Nausea, Pyrexia
4125128 4336897 15 Years M 1/12/2004 3/29/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Mood Swings, Somnolence
4125129 4337157 7 Years F 2/18/2004 3/29/2004 40 PER Strattera Retching
4125131 4336912 10 Years M 1/13/2004 3/29/2004 76 PER Strattera Nightmare
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125132 4337095 25 Years M 8/1/2003 11/26/2003 3/29/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Hyperhidrosis, Rash, Skin Odour Abnormal
4125133 4336862     M 1/12/2004 3/29/2004 77 MD PER Strattera Agitation, Irritability
4125134 4336744 10 Years M 1/1/2003 1/8/2004 3/29/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder, Autism Abnormal Behaviour, Drug Ineffective, Fatigue, Mood Swings, Somnolence, Weight Increased
4125134 4501686 10 Years M 1/1/2003 7/8/2004 9/27/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder, Autism Abnormal Behaviour, Drug Ineffective, Fatigue, Mood Swings, Somnolence, Weight Increased
4125134 4726693 10 Years M 1/1/2003 4/11/2005 7/25/2005 105 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Fatigue, Mood Swings, Somnolence, Weight Increased
4125135 4336917 9 Years M 1/1/2004 1/12/2004 3/29/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Excitability, Fatigue, Feeling Abnormal, Irritability, Mood Swings
4125137 4336864     M 1/12/2004 3/29/2004 77 MD PER Strattera Agitation, Irritability
4125138 4337159 18 Years M 2/1/2004 2/18/2004 3/29/2004 40 PER Strattera Drug Interaction, Panic Attack
4125139 4337097 12 Years M 11/26/2003 3/29/2004 124 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Gastrooesophageal Reflux Disease
4125141 4337098 15 Years F 11/26/2003 11/26/2003 3/29/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Affect Lability, Agitation, Anxiety, Asthenia, Fatigue, Nervousness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125142 4336866 63 Years F 10/1/2003 1/12/2004 3/29/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Ear Infection, Increased Appetite, Muscle Tightness
4125144 4337160 15 Years M 12/1/2003 2/17/2004 3/29/2004 41 PER Strattera Disturbance in Attention Disturbance in Attention, Mood Swings, Personality Change, Somnolence, Thinking Abnormal
4125145 4336868 16 Years F 1/21/2004 3/29/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Anger
4125147 4337161 46 Years M 2/1/2004 2/17/2004 3/29/2004 41 PER Strattera Abnormal Behaviour, Dizziness, Dry Mouth, Headache, Insomnia, Weight Decreased
4125149 4336869 22 Years F 1/12/2004 1/12/2004 3/29/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Dyspnoea, Feeling Abnormal, Heart Rate Increased, Nausea, Pharyngolaryngeal Pain
4125149 4440887 22 Years F 1/12/2004 4/5/2004 7/28/2004 114 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Dyspnoea, Feeling Abnormal, Heart Rate Increased, Nausea, Pharyngolaryngeal Pain
4125150 4337111 9 Years F 1/21/2004 3/29/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Weight Increased
4125153 4336745     M 1/8/2004 3/29/2004 81 MD PER Strattera Tic
4125163 4337112 13 Years M 1/21/2004 3/29/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Affect Lability, Mania
4125164 4336787 9 Years M 1/1/2003 1/9/2004 3/29/2004 80 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Crying, Drug Ineffective, Mood Swings, Tic, Weight Increased Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125164 4369881 9 Years M 1/1/2003 3/16/2004 5/26/2004 71 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Crying, Drug Ineffective, Mood Swings, Tic, Weight Increased Hospitalization - Initial or Prolonged
4125164 4441542 9 Years M 1/1/2003 3/16/2004 7/28/2004 134 CN PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Crying, Drug Ineffective, Mood Swings, Tic, Weight Increased Hospitalization - Initial or Prolonged
4125165 4336792 14 Years M 1/9/2004 3/29/2004 80 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
4125166 4337113 53 Years F 1/21/2004 3/29/2004 68 PER Strattera Dry Mouth, Increased Appetite
4125170 4337114 10 Years M 1/20/2004 1/21/2004 3/29/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Somnolence
4125171 4336747 11 Years M 2/17/2004 3/29/2004 41 OT PER Strattera Drug Ineffective, Heart Rate Increased, Nausea, Pallor
4125176 4336750 7 Years M 1/9/2004 3/29/2004 80 PER Strattera Abnormal Behaviour
4125178 4336751 8 Years M 1/1/2004 1/9/2004 3/29/2004 80 PER Strattera Fatigue, Retching, Vomiting
4125180 4336794 50 Years M 12/1/2003 1/9/2004 3/29/2004 80 PER Strattera Attention Deficit/Hyperactivity Disorder, Depression Abnormal Dreams, Feeling Abnormal
4125183 4336752 10 Years M 1/9/2004 3/29/2004 80 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Belligerence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125184 4336797 12 Years M 1/12/2004 3/29/2004 77 OT PER Strattera Attention Deficit/Hyperactivity Disorder Skin Discolouration
4125187 4336798 24 Years M 1/11/2004 1/12/2004 3/29/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Erectile Dysfunction, Euphoric Mood, Fatigue, Libido Decreased, Mood Swings
4125193 4336839 10 Years F 1/1/2004 1/12/2004 3/29/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Feeling Abnormal
4125196 4336843 8 Years F 1/1/2003 1/12/2004 3/29/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Psychomotor Hyperactivity, Tic
4125198 4336845 9 Years M 1/12/2004 3/29/2004 77 MD PER Strattera Cough, Wheezing
4125201 4336847 67 Years M 10/1/2003 1/12/2004 3/29/2004 77 PER Strattera Obsessive-Compulsive Disorder Oedema Peripheral, Paraesthesia
4125202 4337115 16 Years F 1/16/2004 3/29/2004 73 OT PER Strattera Menstruation Irregular, Metrorrhagia
4125206 4337116 10 Years M 1/22/2004 3/29/2004 67 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Decreased Appetite, Diarrhoea, Stomatitis, Weight Decreased
4125208 4337117 9 Years F 1/17/2004 1/21/2004 3/29/2004 68 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4125210 4337118 13 Years M 1/22/2004 1/22/2004 3/29/2004 67 MD PER Strattera Attention Deficit/Hyperactivity Disorder Overdose
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125213 4337119 6 Years M 12/1/2003 1/22/2004 3/29/2004 67 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Disturbance in Attention
4125215 4336755 12 Years 1/9/2004 3/29/2004 80 PH PER Strattera Drug Ineffective
4125217 4337099 6 Years M 1/1/2004 1/14/2004 3/29/2004 75 CN PER Strattera Attention Deficit/Hyperactivity Disorder Social Avoidant Behaviour, Somnolence
4125218 4336758 12 Years M 1/8/2004 1/9/2004 3/29/2004 80 PER Strattera Affective Disorder, Anxiety, Attention Deficit/Hyperactivity Disorder Drug Ineffective, Psychomotor Hyperactivity, Somnolence
4125219 4336714 25 Years F 1/29/2004 3/29/2004 60 CN PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Feeling Abnormal, Feeling Jittery, Heart Rate Increased, Mydriasis
4125220 4336760 9 Years M 1/9/2004 3/29/2004 80 PER Strattera Attention Deficit/Hyperactivity Disorder Headache
4125221 4337101 6 Years M 1/14/2004 1/14/2004 3/29/2004 75 CN PER Strattera Psychomotor Hyperactivity Feeling Abnormal
4125224 4336762 7 Years M 1/9/2004 3/29/2004 80 PH PER Strattera Drug Ineffective, Mania
4125225 4336715 50 Years M 1/29/2004 3/29/2004 60 OT PER Strattera Testicular Pain, Urethral Pain, Urinary Retention
4125226 4337102 38 Years F 1/14/2004 3/29/2004 75 CN PER Strattera Dizziness, Hangover
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125227 4336716 12 Years M 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Dizziness, Headache, Throat Irritation
4125228 4337121 26 Years M 1/29/2004 2/2/2004 3/29/2004 56 PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Pain
4125229 4336764 11 Years M 1/9/2004 3/29/2004 80 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention
4125230 4337125 13 Years F 2/2/2004 3/29/2004 56 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4125235 4337126 63 Years F 2/1/2004 2/2/2004 3/29/2004 56 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Dyspepsia, Eructation, Flank Pain, Frequent Bowel Movements, Insomnia, Nausea, Pain, Personality Change
4125236 4336766 11 Years M 1/1/2003 1/27/2004 3/29/2004 62 PER Strattera Attention Deficit/Hyperactivity Disorder Pruritus Ani
4125237 4337128     F 1/26/2004 2/2/2004 3/29/2004 56 PER Strattera Crying, Food Craving, Headache, Hypersomnia
4125240 4337130     M 2/2/2004 3/29/2004 56 MD PER Strattera Suicidal Ideation
4125241 4336769 37 Years F 1/1/2004 1/9/2004 3/29/2004 80 MD PER Strattera Attention Deficit/Hyperactivity Disorder Gastritis, Gastrooesophageal Reflux Disease, Hypertension, Oesophagitis
4125242 4337103 12 Years 1/15/2004 3/29/2004 74 OT PER Strattera Pollakiuria
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125244 4336777 14 Years M 1/9/2004 1/9/2004 3/29/2004 80 PER Strattera Abdominal Pain, Back Pain, Dizziness, Dysuria, Feeling Abnormal, Loss of Control of Legs
4125245 4337134 10 Years F 2/1/2004 2/2/2004 3/29/2004 56 PER Strattera Attention Deficit/Hyperactivity Disorder Choking, Nausea
4125247 4336780     M 2/1/2003 1/9/2004 3/29/2004 80 PER Strattera Abnormal Behaviour, Decreased Appetite, Drug Ineffective, Insomnia, Weight Decreased
4125250 4337104 45 Years F 1/13/2004 1/15/2004 3/29/2004 74 CN PER Strattera Fatigue Depression, Hunger
4125254 4337135 28 Years F 1/1/2004 2/2/2004 3/29/2004 56 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Constipation, Feeling Abnormal, Feeling Hot, Headache, Hearing Impaired, Hyperhidrosis
4125256 4336719     F 1/29/2004 3/29/2004 60 PER Strattera Infection
4125256 4438562     F 4/15/2004 7/28/2004 104 MD PER Strattera Communication Disorder Infection
4125260 4337140 12 Years M 2/2/2004 3/29/2004 56 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic, Tourette's Disorder
4125267 4336721 16 Years M 1/29/2004 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Dysarthria, Fatigue, Feeling Abnormal, Lethargy, Somnolence
4125267 4438563 16 Years M 1/29/2004 1/29/2004 7/28/2004 181 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Dysarthria, Fatigue, Feeling Abnormal, Lethargy, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125268 4337141 11 Years M 2/2/2004 3/29/2004 56 PER Strattera Vision Blurred Anger
4125270 4337105 6 Years M 1/14/2004 1/15/2004 3/29/2004 74 PER Strattera Disturbance in Attention Conversion Disorder, Crying, Headache
4125271 4336722 8 Years F 1/16/2004 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Irritability, Weight Increased
4125271 4580291 9 Years F 10/1/2004 10/28/2004 1/27/2005 91 CN PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Crying, Drug Ineffective, Educational Problem, Emotional Disorder, Irritability, Weight Increased
4125273 4337144 10 Years F 1/31/2004 2/4/2004 3/29/2004 54 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Nausea, Psychomotor Hyperactivity, Vomiting
4125276 4336724 42 Years F 1/29/2004 1/30/2004 3/29/2004 59 CN PER Strattera Abnormal Behaviour Heart Rate Increased, Nervousness
4125276 4438564 42 Years F 1/29/2004 4/16/2004 7/28/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Increased, Nervousness
4125279 4336725 16 Years F 1/30/2004 3/29/2004 59 MD PER Strattera Attention Deficit/Hyperactivity Disorder Nightmare, Oppositional Defiant Disorder, Sleep Walking
4125284 4336726 10 Years M 1/1/2002 1/30/2004 3/29/2004 59 OT PER Strattera Attention Deficit/Hyperactivity Disorder
4125286 4336728 12 Years M 1/30/2004 3/29/2004 59 MD PER Strattera Abdominal Discomfort
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125456 4336967     F 2/6/2004 3/29/2004 52 PER Strattera Blood Iron Decreased, Hepatic Enzyme Increased
4125456 4501698     F 7/8/2004 9/27/2004 81 PER Strattera Disturbance in Attention Blood Iron Decreased, Hepatic Enzyme Increased
4125457 4336849 19 Years M 1/12/2004 3/29/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Mood Swings
4125458 4337421 13 Years F 1/1/2004 1/20/2004 3/29/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Crying, Educational Problem, Fear, Stress Symptoms
4125459 4337631 44 Years F 12/22/2003 12/24/2003 3/29/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Feeling Abnormal, Flushing, Headache, Nausea, Paraesthesia, Psychomotor Hyperactivity
4125461 4337898 10 Years M 1/1/2004 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Increased Appetite, Psychomotor Hyperactivity
4125462 4337166 5 Years F 2/17/2004 3/29/2004 41 PER Strattera Attention Deficit/Hyperactivity Disorder Change of Bowel Habit, Decreased Appetite, Drug Ineffective, Social Avoidant Behaviour, Somnolence
4125463 4337169 10 Years F 2/17/2004 2/17/2004 3/29/2004 41 PER Strattera Attention Deficit/Hyperactivity Disorder Body Temperature Increased, Cough, Nasopharyngitis, Rhinorrhoea
4125505 4337885 7 Years F 1/26/2004 1/27/2004 3/29/2004 62 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Nasopharyngitis, Nausea, Throat Irritation
4125511 4337887     F 1/27/2004 3/29/2004 62 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Nausea, Vision Blurred
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125518 4337889 36 Years F 1/27/2004 3/29/2004 62 MD PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Jittery, Hypertension, Insomnia, Rash
4125521 4337900 21 Years M 1/23/2004 1/27/2004 3/29/2004 62 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Aggression, Anger, Homicidal Ideation, Initial Insomnia, Mood Swings, Paranoia
4125524 4337916 9 Years M 1/27/2004 3/29/2004 62 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Feeling Abnormal
4125527 4337923 12 Years 1/28/2004 3/29/2004 61 MD PER Strattera Tic
4125529 4337924     1/28/2004 3/29/2004 61 MD PER Strattera Abdominal Pain Upper, Feeling Abnormal, Headache
4125532 4338071 8 Years M 1/27/2004 1/27/2004 3/29/2004 62 PER Strattera Drug Ineffective, Somnolence
4125533 4338072     F 1/28/2004 3/29/2004 61 PER Strattera Oral Discomfort
4125534 4337925 7 Years M 1/19/2004 1/28/2004 3/29/2004 61 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Belligerence, Weight Decreased
4125535 4338197 20 Years F 2/1/2004 2/9/2004 3/29/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Nausea
4125538 4337926 6 Years M 1/28/2004 1/28/2004 3/29/2004 61 CN PER Strattera Nausea, Retching, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125539 4338036 12 Years 12/10/2003 3/29/2004 110 MD PER Strattera
4125540 4338073 9 Years M 1/28/2004 3/29/2004 61 OT PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Nervousness
4125542 4338048     M 11/18/2003 3/29/2004 132 MD PER Strattera Feeling Abnormal, Sexual Dysfunction
4125543 4338037 16 Years M 1/13/2004 3/29/2004 76 MD PER Strattera Suicidal Ideation
4125544 4338049     M 11/18/2003 3/29/2004 132 MD PER Strattera Euphoric Mood
4125546 4337928 11 Years M 1/28/2004 3/29/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
4125547 4338074 47 Years M 1/28/2004 3/29/2004 61 PER Strattera Blood Pressure Increased, Feeling Abnormal, Headache, Hyperhidrosis, Somnolence
4125549 4338050 6 Years M 11/1/2003 11/25/2003 3/29/2004 125 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Mood Swings
4125550 4338075 38 Years F 1/28/2004 2/6/2004 3/29/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Fear, Heart Rate Increased, Nausea, Nightmare, Panic Attack, Paranoia, Somnolence, Vomiting
4125551 4338038 11 Years M 1/13/2004 3/29/2004 76 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Feeling Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125555 4338126 9 Years M 1/1/2004 2/18/2004 3/29/2004 40 PER Strattera Attention Deficit/Hyperactivity Disorder Haematuria
4125556 4338076 52 Years M 1/1/2004 1/28/2004 3/29/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Dysuria, Nausea, Prostatic Disorder, Rhinorrhoea, Urinary Tract Disorder
4125557 4338052 12 Years 12/3/2003 3/29/2004 117 MD PER Strattera Aggression, Mood Swings
4125560 4338053 12 Years 12/10/2003 3/29/2004 110 MD PER Strattera Urinary Hesitation
4125561 4338129 8 Years M 2/18/2004 2/18/2004 3/29/2004 40 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dyspepsia, Nausea, Somnolence, Vomiting
4125563 4338040 11 Years M 2/9/2004 3/29/2004 49 PER Strattera Abdominal Pain Lower, Dysuria
4125565 4338077 7 Years M 1/26/2004 2/12/2004 3/29/2004 46 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Anxiety, Crying, Decreased Appetite, Excitability, Impulsive Behaviour, Nausea
4125566 4338054 9 Years M 12/10/2003 3/29/2004 110 MD PER Strattera Muscle Twitching
4125568 4338055 10 Years M 3/29/2004 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4125569 4338056     12/5/2003 3/29/2004 115 MD PER Strattera Abdominal Discomfort
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125571 4338057 12 Years 12/8/2003 3/29/2004 112 MD PER Strattera Intentional Overdose
4125574 4338130     M 2/18/2004 3/29/2004 40 OT PER Strattera Weight Increased
4125574 4441368     M 4/5/2004 7/28/2004 114 OT PER Strattera Weight Increased
4125580 4338133 10 Years M 2/14/2004 2/18/2004 3/29/2004 40 OT PER Strattera Attention Deficit/Hyperactivity Disorder Muscle Spasms, Neck Pain, Pain in Extremity, Tension Headache
4125584 4338135 12 Years 2/12/2004 3/29/2004 46 MD PER Strattera Agitation, Nightmare, Psychomotor Hyperactivity
4125587 4338141 12 Years 2/12/2004 3/29/2004 46 MD PER Strattera Agitation, Nightmare, Psychomotor Hyperactivity
4125589 4338148 12 Years 2/12/2004 3/29/2004 46 MD PER Strattera Agitation, Nightmare, Psychomotor Hyperactivity
4125590 4338078 14 Years M 1/1/2004 1/28/2004 3/29/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder, Disturbance in Attention Blunted Affect, Decreased Appetite, Dizziness, Irritability
4125592 4338149 12 Years 2/12/2004 3/29/2004 46 MD PER Strattera Agitation, Nightmare, Psychomotor Hyperactivity
4125596 4338150 12 Years 2/12/2004 3/29/2004 46 MD PER Strattera Agitation, Nightmare, Psychomotor Hyperactivity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125597 4338154 12 Years 2/12/2004 3/29/2004 46 MD PER Strattera Agitation, Nightmare, Psychomotor Hyperactivity
4125611 4337932 42 Years F 1/26/2004 1/27/2004 3/29/2004 62 PER Strattera Coordination Abnormal, Feeling Abnormal, Hot Flush
4125629 4338198     M 1/1/2004 2/9/2004 3/29/2004 49 CN PER Strattera Abnormal Behaviour
4125631 4337937 9 Years M 1/27/2004 3/29/2004 62 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dizziness, Nausea, Weight Gain Poor
4125631 4440882 9 Years M 3/1/2004 7/28/2004 149 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dizziness, Nasopharyngitis, Nausea, Weight Gain Poor
4125635 4338199 30 Years M 2/9/2004 3/29/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Micturition Disorder
4125638 4337939 60 Years M 1/24/2004 2/2/2004 3/29/2004 56 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Hyperhidrosis, Nausea
4125640 4338200 7 Years M 2/7/2004 2/12/2004 3/29/2004 46 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Feeling Hot, Flushing
4125643 4338201 9 Years M 2/9/2004 3/29/2004 49 CN PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Drug Ineffective, Lack of Spontaneous Speech, Memory Impairment
4125645 4337940 54 Years F 1/27/2004 3/29/2004 62 CN PER Strattera
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125646 4338204 7 Years M 2/9/2004 3/29/2004 49 MD PER Strattera Muscle Cramp
4125647 4337942 14 Years M 7/1/2004 1/27/2004 3/29/2004 62 PER Strattera Agitation, Distractibility, Disturbance in Attention, Fatigue, Irritability
4125652 4337944 5 Years M 1/27/2004 3/29/2004 62 OT PER Strattera Abnormal Behaviour, Drug Ineffective, Pollakiuria, Weight Increased
4125653 4337962 11 Years F 12/1/2003 12/1/2003 3/29/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Feeling Abnormal, Somnolence
4125654 4337976 7 Years F 11/24/2003 12/1/2003 3/29/2004 119 PER Strattera Psychomotor Hyperactivity, Weight Decreased
4125655 4338213 9 Years M 2/9/2004 2/9/2004 3/29/2004 49 CN PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
4125656 4337946 9 Years M 1/27/2004 3/29/2004 62 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Drug Ineffective
4125665 4338215 7 Years M 2/9/2004 2/9/2004 3/29/2004 49 CN PER Strattera Decreased Appetite, Fatigue, Yawning
4125668 4337947 5 Years F 1/27/2004 3/29/2004 62 PER Strattera Foetal Alcohol Syndrome Early Morning Awakening, Mydriasis
4125669 4337978 44 Years F 12/1/2003 3/29/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Logorrhoea, Psychomotor Hyperactivity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125670 4337948 10 Years M 1/27/2004 3/29/2004 62 PER Strattera Drug Ineffective, Dysgraphia, Sensory Integrative Dysfunction
4125670 4438557 10 Years M 3/26/2004 7/28/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder Depressed Mood, Distractibility, Drug Ineffective, Dysgraphia, Emotional Disorder, Headache, Sensory Integrative Dysfunction, Suicidal Ideation, Suicide Attempt
4125672 4337980 10 Years F 1/1/2003 12/1/2003 3/29/2004 119 PER Strattera Nausea, Vomiting
4125675 4338041     M 1/14/2004 3/29/2004 75 MD PER Strattera Dysuria, Retrograde Ejaculation
4125677 4337982 40 Years F 11/1/2003 12/1/2003 3/29/2004 119 OT PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dyspepsia, Fatigue, Feeling Abnormal, Irritability, Malaise
4125678 4338043 18 Years M 1/18/2004 3/29/2004 71 PER Strattera Insomnia, Panic Attack
4125680 4338044 4 Years M 1/20/2004 3/29/2004 69 PER Strattera Hostility
4125681 4337984 8 Years F 12/1/2003 12/1/2003 3/29/2004 119 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Drooling
4125682 4338045 5 Years M 1/23/2004 3/29/2004 66 PER Strattera Crying, Dyskinesia, Headache, Nightmare, Pyrexia, Screaming, Somnolence
4125685 4337985     F 11/30/2003 12/1/2003 3/29/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Abnormal, Hypoacusis, Tinnitus
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125687 4338046 16 Years F 1/27/2004 1/28/2004 3/29/2004 61 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hypertension Other
4125687 4441566 16 Years F 1/27/2004 3/30/2004 7/28/2004 120 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hypertension Other
4125692 4338047 5 Years M 1/25/2004 3/29/2004 64 PER Strattera Somnolence, Staring
4125694 4337986     M 12/1/2003 3/29/2004 119 PER Strattera Anxiety, Mood Swings, Paranoia
4125695 4337995 40 Years F 9/1/2003 12/1/2003 3/29/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Drug Ineffective
4125704 4337996 10 Years M 10/1/2003 12/1/2003 3/29/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Mood Swings
4125719 4337106 10 Years M 1/13/2004 1/15/2004 3/29/2004 74 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Dyspepsia, Fatigue, Insomnia, Nausea, Somnolence, Vomiting
4125721 4337107 32 Years M 1/1/2004 1/15/2004 3/29/2004 74 CN PER Strattera Attention Deficit/Hyperactivity Disorder Erectile Dysfunction, Headache, Nausea, Pollakiuria, Urinary Hesitation
4125724 4337108 6 Years M 1/1/2004 1/15/2004 3/29/2004 74 CN PER Strattera Psychomotor Hyperactivity Anorexia, Apathy, Fatigue, Mydriasis, Tremor
4125726 4337109 31 Years F 1/15/2004 3/29/2004 74 MD PER Strattera Anxiety, Attention Deficit/Hyperactivity Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125738 4338080 21 Years M 1/8/2004 3/29/2004 81 PER Strattera Suicidal Ideation
4125741 4338081     F 1/5/2004 3/29/2004 84 OT PER Strattera Oligomenorrhoea
4125747 4338082 12 Years 2/3/2004 3/29/2004 55 MD PER Strattera Attention Deficit Hyperactivity Disorder
4125750 4338083 16 Years M 1/9/2004 3/29/2004 80 MD PER Strattera Scrotal Disorder
4125751 4338084 26 Years M 3/1/2003 1/12/2004 3/29/2004 77 MD PER Strattera Attention Deficit/Hyperactivity Disorder Palpitations, Tachycardia, Ventricular Extrasystoles
4125752 4338085 8 Years F 1/28/2004 3/29/2004 61 PER Strattera Hunger, Weight Increased
4125753 4338086     1/28/2004 3/29/2004 61 MD PER Strattera Psychomotor Hyperactivity
4125754 4338087 12 Years 1/29/2004 3/29/2004 60 MD PER Strattera Throat Irritation
4125755 4338088 12 Years 1/29/2004 3/29/2004 60 MD PER Strattera
4125764 4338170 6 Years M 2/1/2004 2/9/2004 3/29/2004 49 PER Strattera Abnormal Behaviour, Drug Ineffective
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125768 4338171     M 2/9/2004 3/29/2004 49 PH PER Strattera
4125769 4338172 10 Years M 2/9/2004 2/9/2004 3/29/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder, Depression, Tourette's Disorder Anorexia, Anxiety, Asthenia, Insomnia, Intentional Self-Injury, Malaise, Thinking Abnormal
4125770 4338174 16 Years M 11/1/2003 2/10/2004 3/29/2004 48 OT PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Decreased Appetite, Disturbance in Attention, Erectile Dysfunction, Fatigue, Somnolence, Weight Decreased
4125770 4440707 16 Years M 11/1/2003 5/21/2004 7/28/2004 68 OT PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Decreased Appetite, Disturbance in Attention, Erectile Dysfunction, Fatigue, Somnolence, Weight Decreased
4125771 4338175 9 Years M 2/10/2004 3/29/2004 48 PER Strattera Dyspepsia, Vomiting, Weight Decreased
4125774 4338177 43 Years F 2/10/2004 3/29/2004 48 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Psychomotor Hyperactivity
4125794 4338178 11 Years F 1/1/2004 2/10/2004 3/29/2004 48 PER Strattera Abdominal Pain Upper, Feeling Abnormal
4125797 4338179 41 Years M 2/10/2004 2/10/2004 3/29/2004 48 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Decreased
4125799 4338181 8 Years M 2/10/2004 3/29/2004 48 MD PER Strattera Chest Pain
4125802 4338182 9 Years F 2/10/2004 3/29/2004 48 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125856 4338155 6 Years M 2/10/2004 3/29/2004 48 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Drug Ineffective, Headache, Psychomotor Hyperactivity, Somnolence
4125859 4338156 10 Years M 1/27/2004 2/10/2004 3/29/2004 48 PER Strattera Drug Ineffective
4125861 4338157 43 Years M 2/1/2004 2/10/2004 3/29/2004 48 PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia, Hypotrichosis, Pruritus
4125863 4338158 16 Years M 2/10/2004 3/29/2004 48 MD PER Strattera Blood Pressure Increased, Chest Pain, Heart Rate Increased
4125863 4440708 16 Years M 2/9/2004 3/7/2004 7/28/2004 143 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Chest Pain, Palpitations
4125864 4338161     M 2/1/2004 2/10/2004 3/29/2004 48 PER Strattera Alopecia, Pruritus
4125869 4338163 12 Years M 2/17/2004 2/10/2004 3/29/2004 48 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Hot, Headache
4125870 4338164 2 Years F 2/10/2004 2/10/2004 3/29/2004 48 PER Strattera
4125872 4338165 27 Years M 2/9/2004 2/11/2004 3/29/2004 47 PER Strattera Paraesthesia, Piloerection, Testicular Pain
4125875 4338167 27 Years F 2/11/2004 3/29/2004 47 PER Strattera Bipolar I Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125875 4726695 27 Years F 9/20/2004 3/7/2005 7/25/2005 140 PER Strattera Bipolar Disorder Nerve Compression, Suppressed Lactation
4125876 4338168 6 Years F 2/1/2004 2/11/2004 3/29/2004 47 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Agitation, Crying, Emotional Disorder, Feeling Abnormal, Middle Insomnia
4125897 4338584     F 6/1/2003 2/6/2004 3/29/2004 52 PER Strattera Malaise
4125898 4338585 12 Years M 1/1/2004 2/6/2004 3/29/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Agitation, Dry Mouth, Sleep Disorder, Urinary Hesitation
4125899 4338587 13 Years M 2/6/2004 3/29/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
4125902 4338589     F 2/6/2004 3/29/2004 52 PH PER Strattera Panic Attack
4125903 4338590 50 Years M 2/6/2004 3/29/2004 52 MD PER Strattera Attention Deficit/Hyperactivity Disorder Thinking Abnormal
4125905 4338591     M 2/6/2004 3/29/2004 52 MD PER Strattera Attention Deficit/Hyperactivity Disorder Thinking Abnormal
4125906 4338593     M 2/5/2004 3/29/2004 53 MD PER Strattera Tic
4125907 4338595 46 Years F 2/6/2004 3/29/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Diarrhoea, Dry Mouth, Dysgeusia, Dyspepsia, Fatigue, Gastrointestinal Pain, Weight Decreased, Weight Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125908 4338596 40 Years F 2/6/2004 3/29/2004 52 OT PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Muscle Rigidity
4125909 4338559 6 Years M 1/30/2004 2/2/2004 3/29/2004 56 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Irritability
4125910 4338598     M 12/1/2003 2/6/2004 3/29/2004 52 PER Strattera Abnormal Behaviour, Disturbance in Attention, Feeling Abnormal, Nervousness, Somnolence
4125912 4338560     M 2/2/2004 3/29/2004 56 MD PER Strattera Attention Deficit/Hyperactivity Disorder Psychotic Disorder
4125915 4338563 12 Years M 2/2/2004 3/29/2004 56 PER Strattera Erythema, Urticaria
4125918 4338564 29 Years M 2/2/2004 3/29/2004 56 MD PER Strattera
4125920 4338566 5 Years M 1/1/2004 2/2/2004 3/29/2004 56 PER Strattera Attention Deficit/Hyperactivity Disorder
4125921 4338391 7 Years M 2/15/2004 2/19/2004 3/29/2004 39 PER Strattera Attention Deficit/Hyperactivity Disorder Back Pain, Neck Pain, Sleep Talking
4125922 4338571 15 Years M 2/2/2004 3/29/2004 56 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anxiety, Irritability, Mood Swings, Somnolence
4125924 4338392     M 2/19/2004 3/29/2004 39 MD PER Strattera Tic
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125926 4338572 18 Years F 2/2/2004 3/29/2004 56 MD PER Strattera Depression
4125939 4338575 12 Years F 1/30/2004 2/2/2004 3/29/2004 56 PER Strattera Disturbance in Attention Abdominal Pain Upper, Feeling Abnormal, Nausea
4125943 4338394 12 Years M 2/19/2004 3/29/2004 39 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Psychomotor Hyperactivity
4125945 4338578 19 Years F 1/1/2004 2/3/2004 3/29/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Irritability
4125949 4338529 12 Years 1/29/2004 3/29/2004 60 MD PER Strattera Drug Ineffective
4125950 4338579     F 1/1/2004 2/3/2004 3/29/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Retching, Vomiting
4125951 4338396     M 2/20/2004 2/20/2004 3/29/2004 38 PER Strattera
4125952 4338530 12 Years 1/29/2004 3/29/2004 60 MD PER Strattera Hyperhidrosis
4125954 4338531     M 2/18/2004 3/29/2004 40 PER Strattera Penile Discharge, Urinary Hesitation
4125955 4338397 32 Years M 2/18/2004 2/19/2004 3/29/2004 39 MD PER Strattera Dizziness, Dry Mouth, Dysarthria, Fatigue, Gait Disturbance, Headache, Lethargy, Nausea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125956 4338532 12 Years 2/4/2004 3/29/2004 54 MD PER Strattera Euphoric Mood
4125958 4338538 12 Years 2/4/2004 3/29/2004 54 MD PER Strattera Euphoric Mood
4125959 4338540 12 Years 2/4/2004 3/29/2004 54 MD PER Strattera Agitation, Mania
4125960 4338542 12 Years 2/4/2004 3/29/2004 54 MD PER Strattera Agitation, Mania
4125961 4338399 48 Years F 2/15/2004 2/19/2004 3/29/2004 39 PER Strattera Attention Deficit/Hyperactivity Disorder Dysphonia, Eye Pruritus, Nasopharyngitis, Pharyngolaryngeal Pain, Postnasal Drip, Rhinorrhoea
4125963 4338546     M 2/6/2004 3/29/2004 52 MD PER Strattera Orchitis Noninfective
4125964 4338413 26 Years M 2/18/2004 3/29/2004 40 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Prostatic Pain, Prostatitis
4125964 4441374 26 Years M 4/6/2004 7/28/2004 113 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Prostatic Pain, Prostatitis
4125964 4726697 26 Years M 5/25/2005 7/25/2005 61 PER Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder, Erectile Dysfunction, Feeling Abnormal, Prostatic Pain, Prostatitis
4125965 4338555 12 Years 2/13/2004 3/29/2004 45 MD PER Strattera Abdominal Pain Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125966 4338400 9 Years M 2/19/2004 3/29/2004 39 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Psychomotor Hyperactivity, Tic
4125966 4441393 9 Years M 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Increased Appetite, Psychomotor Hyperactivity, Somnolence, Tic, Weight Increased
4125971 4338414     M 2/17/2004 3/29/2004 41 MD PER Strattera Flushing, Hyperhidrosis
4125974 4338415 16 Years M 2/18/2004 3/29/2004 40 PER Strattera Anorexia, Dysphagia, Somnolence
4125974 4441378 16 Years M 2/18/2004 7/28/2004 161 PER Strattera Anorexia, Somnolence
4125975 4338401 8 Years M 2/19/2004 3/29/2004 39 PER Strattera Blood Pressure Increased, Drug Ineffective
4125979 4338422 9 Years F 2/18/2004 3/29/2004 40 CN PER Strattera Attention Deficit/Hyperactivity Disorder Trichotillomania
4125982 4338424 22 Years F 2/1/2004 2/19/2004 3/29/2004 39 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dry Mouth, Hyperhidrosis, Nausea, Rectal Haemorrhage
4125983 4338408 8 Years M 2/19/2004 3/29/2004 39 PER Strattera Abdominal Pain Upper, Abnormal Behaviour, Aggression, Irritability, Vomiting
4125985 4338425 6 Years F 2/1/2004 2/19/2004 3/29/2004 39 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Psychomotor Hyperactivity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4125986 4338409 10 Years F 2/17/2004 2/19/2004 3/29/2004 39 PER Strattera Attention Deficit/Hyperactivity Disorder Conjunctivitis, Pharyngeal Erythema, Retching, Vomiting
4125987 4338431 13 Years M 2/1/2004 2/19/2004 3/29/2004 39 PER Strattera Attention Deficit/Hyperactivity Disorder Diarrhoea, Disturbance in Attention, Dyspepsia, Fatigue
4125990 4338432 7 Years F 2/19/2004 3/29/2004 39 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Blood Glucose Increased, Bronchial Infection, Change of Bowel Habit, Hepatic Enzyme Increased, Ketonuria, Nausea, Vomiting
4125990 4441386 7 Years F 3/23/2004 7/28/2004 127 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Blood Glucose Increased, Bronchial Infection, Change of Bowel Habit, Hepatic Enzyme Increased, Ketonuria, Nausea, Vomiting
4125990 4500682 7 Years F 10/26/2004 11/9/2004 14 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Aspartate Aminotransferase Decreased, Blood Glucose Increased, Blood Ketone Body Increased, Bronchial Infection, Constipation, Hepatic Enzyme Increased, Nausea, Vomiting
4125990 4517474 7 Years F 11/11/2004 11/30/2004 19 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Alanine Aminotransferase Decreased, Blood Glucose Increased, Blood Ketone Body Increased, Bronchitis, Drug Ineffective, Faecaloma, Hepatic Enzyme Increased, Nausea, Vomiting
4125993 4338434 5 Years F 2/5/2004 2/19/2004 3/29/2004 39 PER Strattera Aspiration, Dysphagia
4125993 4441391 5 Years F 2/5/2004 4/20/2004 7/28/2004 99 PER Strattera Aspiration, Dysphagia
4125993 4501700 6 Years F 1/1/2004 7/9/2004 9/27/2004 80 MD PER Strattera Attention Deficit/Hyperactivity Disorder Cough, Drug Ineffective, Dysphagia, Pyrexia, Rhinorrhoea
4125996 4338435     F 8/3/2003 2/19/2004 3/29/2004 39 MD PER Strattera Nasal Congestion, Throat Irritation, Tic, Tremor
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4126023 4338441 12 Years 2/12/2004 3/29/2004 46 MD PER Strattera Agitation, Nightmare, Psychomotor Hyperactivity
4126026 4338445 12 Years 2/12/2004 3/29/2004 46 MD PER Strattera Agitation, Nightmare, Psychomotor Agitation
4126028 4338447 12 Years 2/12/2004 3/29/2004 46 MD PER Strattera Agitation, Nightmare, Psychomotor Hyperactivity
4126029 4338450 12 Years 2/12/2004 3/29/2004 46 MD PER Strattera Agitation, Nightmare, Psychomotor Hyperactivity
4126031 4338467 12 Years 2/12/2004 3/29/2004 46 MD PER Strattera Agitation, Nightmare, Psychomotor Agitation
4126033 4338471 11 Years M 2/1/2004 2/18/2004 3/29/2004 40 OT PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
4126034 4338474     M 2/18/2004 3/29/2004 40 MD PER Strattera Asthma, Tachycardia
4126036 4338476     F 2/18/2004 3/29/2004 40 MD PER Strattera Attention Deficit/Hyperactivity Disorder Mydriasis, Psychomotor Hyperactivity
4126037 4338477 12 Years M 2/18/2004 2/18/2004 3/29/2004 40 CN PER Strattera Appetite Disorder, Nausea, Rash
4126039 4338479 49 Years F 2/1/2004 2/18/2004 3/29/2004 40 CN PER Strattera Attention Deficit/Hyperactivity Disorder Body Temperature Decreased, Decreased Appetite, Feeling Cold, Mydriasis, Vision Blurred
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4126133 4338079 12 Years 12/24/2003 3/29/2004 96 MD PER Strattera Depression
4126134 4338556 12 Years 2/13/2004 3/29/2004 45 MD PER Strattera Tic
4126135 4338206 12 Years M 2/9/2004 3/29/2004 49 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4126137 4338212 7 Years M 2/26/2004 3/29/2004 32 MD PER Strattera Dyspnoea, Erythema, Urticaria Pigmentosa
4126254 4336525 12 Years 3/23/2004 4/7/2004 15 MD EXP Strattera Adrenal Neoplasm Other
4126268 4341953 16 Years F 3/23/2004 3/26/2004 4/15/2004 20 MD EXP Strattera Amnesia, Arrhythmia, Coma, Convulsion, Drug Screen Positive, Electrocardiogram QRS Complex Prolonged, Overdose, Suicide Attempt, Ventricular Tachycardia Hospitalization - Initial or Prolonged
4126273 4336528 12 Years M 3/22/2004 3/22/2004 4/7/2004 16 MD EXP Strattera Loss of Consciousness Other
4126294 4336529 61 Years F 3/22/2004 4/7/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dizziness, Drug Ineffective, Headache, Otitis Media, Vision Blurred, Weight Decreased Other
4126342 4336531 11 Years M 3/1/2004 3/23/2004 4/7/2004 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Optic Nerve Disorder, Tic, Vision Blurred, Weight Decreased Other
4126342 4341939 11 Years M 3/1/2004 3/31/2004 4/15/2004 15 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Optic Nerve Injury, Tic, Vision Blurred, Weight Decreased Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4126342 4351248 11 Years M 3/1/2004 4/12/2004 4/28/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Blindness, Fatigue, Nerve Injury, Tic, Tongue Disorder, Vision Blurred, Visual Acuity Reduced, Weight Decreased Other
4126354 4336533 45 Years M 2/1/2004 3/23/2004 3/24/2004 4/7/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alcohol Use, Cardiomegaly, Constipation, Hepatic Cirrhosis, Impaired Healing, Irritability, Toxicologic Test Abnormal Death
4126354 4359400 45 Years M 2/1/2004 3/23/2004 4/26/2004 5/12/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Cardiomegaly, Coma, Constipation, Feeling Cold, Hepatic Cirrhosis, Impaired Healing, Mitral Valve Disease, Obesity, Toxicologic Test Abnormal Death
4126358 4336534 16 Years M 3/23/2004 3/24/2004 4/7/2004 14 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Jaw Fracture, Road Traffic Accident Hospitalization - Initial or Prolonged
4126476 4338954 6 Years M 1/1/2004 2/4/2004 3/29/2004 54 PER Strattera Disturbance in Attention Cough, Fatigue, Rhinorrhoea, Somnolence
4126478 4338957 7 Years M 2/4/2004 3/29/2004 54 MD PER Strattera Suicidal Ideation
4126478 4501697 7 Years M 6/18/2004 9/27/2004 101 MD PER Strattera Suicidal Ideation
4126480 4338959 12 Years 2/4/2004 3/29/2004 54 MD PER Strattera Extrapyramidal Disorder
4126481 4338960     F 1/1/2004 2/12/2004 3/29/2004 46 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Hallucination (Auditory), Headache, Heart Rate Increased, Nausea, Paranoia
4126482 4338962 12 Years 2/4/2004 3/29/2004 54 MD PER Strattera Extrapyramidal Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4126484 4338963 8 Years M 1/1/2003 2/4/2004 3/29/2004 54 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
4126485 4338964 27 Years M 2/4/2004 3/29/2004 54 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Ejaculation Disorder, Libido Decreased, Residual Urine Volume, Semen Viscosity Increased, Sleep Disorder
4126487 4338966 52 Years M 1/25/2004 2/4/2004 3/29/2004 54 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Dizziness, Dry Mouth, Hyperchlorhydria
4126488 4338967     M 2/1/2003 2/6/2004 3/29/2004 52 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Mood Swings, Personality Change
4126489 4338936 42 Years F 12/22/2003 3/29/2004 98 OT PER Strattera Attention Deficit/Hyperactivity Disorder Migraine
4126490 4339088 33 Years F 12/1/2003 2/3/2004 3/29/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Breast Tenderness
4126491 4338938     F 12/22/2003 3/29/2004 98 OT PER Strattera Attention Deficit/Hyperactivity Disorder Migraine
4126492 4339089 8 Years F 2/3/2004 3/29/2004 55 PH PER Strattera Attention Deficit/Hyperactivity Disorder Fungal Infection
4126493 4338968 40 Years M 1/1/2004 2/4/2004 3/29/2004 54 PER Strattera Attention Deficit/Hyperactivity Disorder, Bipolar I Disorder
4126494 4338940 40 Years F 12/22/2003 3/29/2004 98 OT PER Strattera Attention Deficit/Hyperactivity Disorder Migraine
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4126495 4339091     F 2/3/2004 3/29/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Crying
4126496 4338985 7 Years M 2/3/2004 3/29/2004 55 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue
4126497 4338942 41 Years M 12/22/2003 3/29/2004 98 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Sensation in Eye, Headache, Hypoaesthesia
4126498 4338986 4 Years M 2/4/2004 3/29/2004 54 PER Strattera Anxiety Disorder Anxiety
4126499 4338944 44 Years M 12/22/2003 3/29/2004 98 OT PER Strattera Attention Deficit/Hyperactivity Disorder Migraine
4126501 4338946 16 Years M 12/22/2003 3/29/2004 98 OT PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Headache, Paraesthesia
4126502 4338988 8 Years M 2/4/2004 3/29/2004 54 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective
4126503 4338947 18 Years F 12/22/2003 3/29/2004 98 OT PER Strattera Attention Deficit/Hyperactivity Disorder Migraine
4126504 4338989     F 2/4/2004 3/29/2004 54 MD PER Strattera Drug Screen Positive
4126505 4339092     M 2/3/2004 3/29/2004 55 OT PER Strattera Anger, Emotional Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4126506 4338949 16 Years F 12/22/2003 3/29/2004 98 OT PER Strattera Attention Deficit/Hyperactivity Disorder Migraine, Vomiting
4126507 4338991 47 Years F 2/3/2004 3/29/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Muscle Rigidity, Myalgia
4126508 4338993 12 Years 2/4/2004 3/29/2004 54 MD PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain
4126509 4338950 17 Years F 12/22/2003 3/29/2004 98 OT PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Migraine, Nausea
4126511 4339093 35 Years M 2/18/2004 3/29/2004 40 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dry Mouth, Erectile Dysfunction, Insomnia, Pollakiuria
4126512 4338952 12 Years 12/19/2003 3/29/2004 101 MD PER Strattera Tic
4126513 4338994 17 Years F 2/4/2004 3/29/2004 54 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4126514 4338996 16 Years M 2/4/2004 3/29/2004 54 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Mood Swings
4126516 4338999     M 2/4/2004 3/29/2004 54 MD PER Strattera Tic
4126518 4339002 52 Years M 2/4/2004 3/29/2004 54 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Dry Mouth
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4126518 4440705 52 Years M 1/19/2004 3/31/2004 7/28/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Dry Mouth
4126519 4339094 12 Years M 2/3/2004 3/29/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Initial Insomnia, Nausea, Somnolence
4126521 4339095 14 Years F 2/3/2004 3/29/2004 55 MD PER Strattera Attention Deficit/Hyperactivity Disorder Contusion, Swelling
4126523 4338924 15 Years F 2/11/2004 3/29/2004 47 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4126525 4338925 52 Years M 2/1/2004 2/12/2004 3/29/2004 46 MD PER Strattera Dysuria
4126527 4338926 7 Years M 1/1/2004 2/12/2004 3/29/2004 46 MD PER Strattera Binocular Eye Movement Disorder
4126527 4440670 5 Years M 1/1/2004 3/29/2004 7/28/2004 121 MD PER Strattera Attention Deficit/Hyperactivity Disorder Binocular Eye Movement Disorder
4126530 4338927 8 Years M 2/11/2004 2/12/2004 3/29/2004 46 MD PER Strattera Binocular Eye Movement Disorder
4126530 4440671 10 Years M 2/11/2004 3/29/2004 7/28/2004 121 MD PER Strattera Attention Deficit/Hyperactivity Disorder Binocular Eye Movement Disorder
4126531 4338928 7 Years M 2/12/2004 3/29/2004 46 MD PER Strattera Binocular Eye Movement Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4126531 4440672 12 Years M 3/29/2004 7/28/2004 121 MD PER Strattera Attention Deficit/Hyperactivity Disorder Binocular Eye Movement Disorder
4126533 4338929 17 Years M 2/3/2004 2/12/2004 3/29/2004 46 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Disturbance in Attention
4126536 4338930 15 Years M 1/1/2004 2/12/2004 3/29/2004 46 PER Strattera Insomnia, Palpitations, Somnolence
4126539 4338931     M 2/12/2004 3/29/2004 46 PER Strattera Attention Deficit/Hyperactivity Disorder Lacrimation Increased, Paranasal Sinus Hypersecretion, Rhinorrhoea, Sneezing
4126543 4338933     M 2/12/2004 3/29/2004 46 MD PER Strattera Abnormal Behaviour
4126546 4338934 15 Years M 2/12/2004 2/12/2004 3/29/2004 46 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
4126564 4339096 13 Years M 2/3/2004 3/29/2004 55 MD PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia
4126565 4339097 40 Years F 2/23/2004 3/29/2004 35 PH PER Strattera Agitation, Palpitations, Tremor
4126565 4440702 40 Years F 2/24/2004 7/28/2004 155 PH PER Strattera Agitation, Palpitations, Tremor
4126569 4339099 15 Years M 2/2/2004 2/3/2004 3/29/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Catatonia, Dizziness, Feeling Abnormal, Hyperhidrosis, Vision Blurred, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4126609 4339052     M 2/3/2004 3/29/2004 55 OT PER Strattera Attention Deficit/Hyperactivity Disorder Urine Analysis Abnormal
4126611 4339053 7 Years M 1/31/2004 2/3/2004 3/29/2004 55 OT PER Strattera Contusion, Gingival Bleeding
4126613 4339054 13 Years M 2/3/2004 2/3/2004 3/29/2004 55 OT PER Strattera Abnormal Behaviour, Aggression
4126629 4339055 32 Years M 2/3/2004 2/24/2004 3/29/2004 34 CN PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Erectile Dysfunction, Paranoia
4126635 4339080 4 Years M 2/3/2004 2/3/2004 3/29/2004 55 CN PER Strattera Attention Deficit/Hyperactivity Disorder Cough, Viral Infection
4126638 4339082 12 Years F 2/3/2004 3/29/2004 55 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dysphagia, Nausea
4126654 4339083 7 Years F 2/3/2004 2/3/2004 3/29/2004 55 CN PER Strattera Attention Deficit/Hyperactivity Disorder Oral Discomfort
4126656 4339084     F 2/3/2004 3/29/2004 55 MD PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Drug Ineffective
4126657 4339085 6 Years F 2/3/2004 3/29/2004 55 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Nausea, Psychomotor Hyperactivity, Salivary Hypersecretion, Vomiting
4126658 4339086 15 Years M 1/1/2004 2/3/2004 3/29/2004 55 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Ear Infection, Fatigue, Sinusitis
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4126841 4336532     F 4/8/2004 DIR Strattera Agoraphobia, Psychotic Disorder Other
4127105 4336793     M 2/19/2004 3/22/2004 4/7/2004 16 MD EXP Strattera Syncope, Tachycardia Other
4127105 4364877 10 Years M 2/19/2004 5/4/2004 5/21/2004 17 MD EXP Strattera Syncope, Tachycardia Other
4127107 4336795     F 3/24/2004 4/7/2004 14 EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Alopecia, Bruxism, Decreased Appetite, Emotional Disorder, Flushing, Insomnia, Palpitations, Syncope Other
4127110 4336796 29 Years F 3/1/2004 3/23/2004 4/7/2004 15 MD EXP Strattera Pain, Pulmonary Embolism Other
4128034 4339753     M 4/14/2004 4/15/2004 OT DIR Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Insomnia, Personality Change
4128321 4342175 52 Years F 11/1/2003 12/4/2003 3/29/2004 116 CN PER Strattera Attention Deficit/Hyperactivity Disorder Contusion
4128327 4342176     F 12/5/2003 3/29/2004 115 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Feeling Abnormal, Food Craving, Tinnitus
4128337 4342177 13 Years M 12/4/2003 3/29/2004 116 CN PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Fatigue
4128337 4580280 13 Years M 8/1/2003 9/29/2004 1/27/2005 120 CN PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Decreased Appetite, Fatigue, Growth Retardation, Mood Swings, Weight Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4128340 4342179 32 Years M 12/4/2003 3/29/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Dyspepsia
4128341 4342180 6 Years M 12/4/2003 3/29/2004 116 CN PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity, Somnolence
4128343 4342181 8 Years M 12/4/2003 3/29/2004 116 CN PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Nausea, Vomiting
4128344 4342183 30 Years M 2/11/2004 3/29/2004 47 CN PER Strattera Attention Deficit/Hyperactivity Disorder Eating Disorder, Male Orgasmic Disorder, Throat Irritation
4128345 4342184     F 12/4/2003 12/4/2003 3/29/2004 116 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dry Throat, Hypersensitivity, Rash Papular, Throat Tightness, Tongue Disorder
4128349 4342186 16 Years M 12/3/2003 12/4/2003 3/29/2004 116 CN PER Strattera Attention Deficit/Hyperactivity Disorder Asthma
4128352 4342187 5 Years M 11/1/2003 12/4/2003 3/29/2004 116 CN PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Crying, Pain, Pollakiuria
4128377 4342189 10 Years F 12/4/2003 3/29/2004 116 CN PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Retention
4128383 4342190 9 Years M 12/1/2003 12/4/2003 3/29/2004 116 CN PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Increased Appetite, Nausea, Retching
4128384 4342191 38 Years M 11/1/2003 12/4/2003 3/29/2004 116 CN PER Strattera Attention Deficit/Hyperactivity Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4128389 4342192 8 Years M 1/1/2003 12/5/2003 3/29/2004 115 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
4128394 4342194 45 Years F 11/1/2003 12/5/2003 3/29/2004 115 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Early Morning Awakening, Insomnia
4128399 4342195 2 Years M 12/5/2003 3/29/2004 115 CN PER Strattera Autism Communication Disorder, Disturbance in Attention, Insomnia, Memory Impairment, Psychomotor Hyperactivity
4128400 4342196 9 Years M 12/3/2003 12/5/2003 3/29/2004 115 CN PER Strattera Abnormal Behaviour Eye Pain, Retching
4128402 4342198 13 Years M 12/5/2003 3/29/2004 115 CN PER Strattera Abnormal Behaviour, Crying, Depression, Emotional Disorder
4128403 4342199 24 Years F 12/5/2003 3/29/2004 115 CN PER Strattera
4128407 4342200 60 Years F 12/5/2003 3/29/2004 115 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disease Progression, Disturbance in Attention, Fatigue, Sinusitis
4128450 4342161 23 Years M 1/1/2003 12/18/2003 3/29/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort, Decreased Appetite, Dyspepsia, Weight Decreased
4128451 4342162 8 Years M 12/18/2003 3/29/2004 102 MD PER Strattera Drug Ineffective
4128453 4342163     M 12/18/2003 12/18/2003 3/29/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Urethral Discharge
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4128456 4342165 7 Years M 12/18/2003 3/29/2004 102 PER Strattera Arthralgia, Increased Tendency to Bruise
4128458 4342166     M 12/13/2003 12/18/2003 3/29/2004 102 PER Strattera Dry Throat, Fatigue, Feeling Abnormal, Lip Dry
4128460 4342167 14 Years M 12/1/2003 12/18/2003 3/29/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Retching, Vomiting, Weight Increased
4128462 4342170 10 Years F 12/18/2003 3/29/2004 102 OT PER Strattera Attention Deficit/Hyperactivity Disorder Enuresis, Urinary Incontinence
4128463 4342172 11 Years M 10/1/2003 12/18/2003 3/29/2004 102 PER Strattera Aggression, Disturbance in Attention, Headache, Nasopharyngitis, Somnolence, Weight Increased
4128464 4342173     M 12/18/2003 3/29/2004 102 OT PER Strattera Attention Deficit/Hyperactivity Disorder Enuresis, Incontinence
4128474 4342201     12/5/2003 3/29/2004 115 PER Strattera Mood Swings, Suicidal Ideation
4128476 4342202 12 Years M 1/1/2003 12/5/2003 3/29/2004 115 OT PER Strattera Abnormal Behaviour, Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dyspepsia
4128477 4342203 50 Years M 12/4/2003 12/5/2003 3/29/2004 115 PER Strattera Multiple Sclerosis Dysuria, Micturition Urgency, Urine Abnormality
4128479 4342204     M 11/1/2003 1/28/2004 3/29/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4128480 4342205 10 Years M 12/5/2003 3/29/2004 115 PER Strattera Attention Deficit/Hyperactivity Disorder Anger
4128482 4342206 9 Years M 3/1/2003 12/8/2003 3/29/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Gastrooesophageal Reflux Disease, Headache, Insomnia, Nausea, Somnolence
4128483 4342207 11 Years F 1/1/2003 12/8/2003 3/29/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Bipolar Disorder, Drug Ineffective
4128484 4342208 35 Years M 10/1/2003 12/8/2003 3/29/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Memory Impairment, Nausea, Somnolence
4128486 4342209 6 Years F 1/1/2003 12/8/2003 3/29/2004 112 PER Strattera Abdominal Pain Upper
4128489 4342210 6 Years M 12/6/2003 12/8/2003 3/29/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Logorrhoea, Psychomotor Hyperactivity, Somnolence
4128519 4340071 16 Years M 4/1/2004 4/15/2004 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Aggression, Irritability, Tic Other
4128563 4342169 12 Years M 12/18/2003 3/29/2004 102 MD PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Cold Sweat, Dyspepsia, Hyperhidrosis
4128563 4440543 12 Years M 3/8/2004 7/28/2004 142 MD PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Cold Sweat, Dyspepsia, Hyperhidrosis
4129790 4342233 5 Years M 11/1/2003 11/18/2003 3/29/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Crying, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4129791 4342234 45 Years M 10/1/2003 11/18/2003 3/29/2004 132 PER Strattera Musculoskeletal Stiffness, Neck Pain
4129793 4342680 7 Years M 11/1/2003 11/21/2003 3/29/2004 129 PER Strattera Asthma, Cough, Drug Interaction, Hyperhidrosis
4129802 4342692     M 11/17/2003 3/29/2004 133 MD PER Strattera Hallucination
4129847 4341865 12 Years M 3/30/2004 4/15/2004 16 MD EXP Strattera Suicide Attempt Other
4129847 4764241 12 Years M 3/20/2004 8/19/2005 9/6/2005 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Choking, Cough, Cyanosis, Hallucinations (Mixed), Incontinence, Injury Asphyxiation, Intentional Self-Injury, Loss of Consciousness, Mental Disorder, Suicide Attempt, Weight Increased Hospitalization - Initial or Prolonged, Life-Threatening, Other
4129865 4341911 25 Years M 3/26/2004 4/1/2004 4/15/2004 14 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Cervical Vertebral Fracture, Road Traffic Accident Hospitalization - Initial or Prolonged, Other
4129867 4341916 15 Years M 3/26/2004 4/15/2004 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Supraventricular Tachycardia Other
4129867 4411817 15 Years M 7/13/2004 7/28/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Electrocardiogram Poor R-Wave Progression, Electrocardiogram ST Segment Abnormal, Heart Rate Irregular, Sinus Arrhythmia, Sinus Tachycardia Other
4129938 4341910 17 Years M 1/1/2004 3/29/2004 4/15/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Bile Duct Stenosis, Cholangitis Sclerosing, Feeling Abnormal, Hepatic Cirrhosis, Night Sweats, Tremor Other
4129938 4432660 17 Years M 1/1/2004 8/2/2004 8/20/2004 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Cholangitis Sclerosing, Night Sweats, Tremor Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4129938 4501108 17 Years M 1/1/2004 10/26/2004 11/9/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Cholangitis Sclerosing, Feeling Abnormal, Gamma-Glutamyltransferase Increased, Hepatic Cirrhosis, Night Sweats, Tremor Other
4129938 4522480 16 Years M 1/1/2004 11/23/2004 12/7/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Cholangitis Sclerosing, Feeling Abnormal, Gamma-Glutamyltransferase Increased, Hepatic Cirrhosis, Night Sweats, Tremor Other
4130012 4341896 47 Years M 2/1/2004 3/31/2004 4/15/2004 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Dry Mouth, Nephrolithiasis, Paraesthesia Hospitalization - Initial or Prolonged
4130012 4401865 48 Years M 1/1/2004 6/23/2004 7/14/2004 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Dry Mouth, Nephrolithiasis, Paraesthesia, Psychomotor Hyperactivity Hospitalization - Initial or Prolonged
4130013 4341898 15 Years M 3/29/2004 3/31/2004 4/15/2004 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion, Hypoglycaemia Other
4130013 4381475 15 Years M 3/29/2004 3/31/2004 6/16/2004 77 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion, Hypoglycaemia, Somnolence, Somogyi Phenomenon Other
4130014 4341899 15 Years M 3/16/2004 3/31/2004 4/15/2004 15 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Anaemia, Blood Lactic Acid Increased, Chills, Headache, Leukopenia, Loss of Consciousness, Malaise, Neck Pain, Pyrexia, Viral Infection, Vomiting Other
4130014 4356797 15 Years M 3/16/2004 4/20/2004 5/7/2004 17 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Anaemia, Blood Lactic Acid Increased, Chills, Headache, Leukopenia, Loss of Consciousness, Malaise, Neck Pain, Pyrexia, Viral Infection, Vomiting, White Blood Cell Count Decreased Other
4130016 4341895 7 Years M 3/27/2004 4/6/2004 4/15/2004 9 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Anoxic Encephalopathy, Blood Urea Abnormal, Dehydration, Dysplasia, Headache, Nervous System Disorder, Tonic Convulsion Other
4130016 4348031 7 Years M 3/27/2004 4/6/2004 4/22/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Sleep-Related Event, Brain Scan Abnormal, Cyanosis, Dehydration, Headache, Loss of Consciousness, Tonic Convulsion Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4130016 4364879 7 Years M 3/27/2004 5/3/2004 5/21/2004 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Cyanosis, Dehydration, Dysplasia, Headache, Loss of Consciousness, Nervous System Disorder, Postictal State, Tonic Convulsion Other
4130321 4341873 26 Years M 3/28/2004 3/30/2004 4/15/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Decreased Other
4130391 4341954 7 Years F 3/1/2004 3/30/2004 4/15/2004 16 MD EXP Strattera Chest Pain, Dyspnoea, Electrocardiogram QT Corrected Interval Prolonged, Heart Rate Increased, Palpitations, Syncope Other
4130467 4342535     M 3/29/2004 4/19/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Cardiomegaly, Congestive Cardiomyopathy, Dyspnoea Exertional, Ejection Fraction Decreased
4132013 4347289 25 Years M 12/30/2003 3/29/2004 90 PH PER Strattera Obsessive-Compulsive Disorder
4132014 4347290 7 Years M 11/29/2003 1/21/2004 3/29/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Nausea, Weight Decreased
4132015 4347291     F 12/1/2003 12/30/2003 3/29/2004 90 PER Strattera Drug Screen Positive
4132017 4347292 7 Years M 12/15/2003 12/30/2003 3/29/2004 90 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Social Avoidant Behaviour, Somnolence, Weight Decreased
4132019 4347293 8 Years M 1/1/2003 12/30/2003 3/29/2004 90 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Weight Decreased
4132021 4347294 21 Years M 12/1/2003 12/30/2003 3/29/2004 90 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Fatigue, Mood Swings
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4132024 4347295 5 Years M 1/1/2003 12/30/2003 3/29/2004 90 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
4132026 4347296 10 Years F 12/1/2003 12/30/2003 3/29/2004 90 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Hallucination (Visual), Headache, Muscle Twitching, Nausea
4132028 4347297     F 12/30/2003 3/29/2004 90 PER Strattera Feeling Abnormal, Pallor, Tremor
4132036 4347298 12 Years M 12/28/2003 12/30/2003 3/29/2004 90 PER Strattera Attention Deficit/Hyperactivity Disorder Eye Redness
4132273 4347317 10 Years M 2/9/2004 3/29/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Mood Swings
4132278 4347318 28 Years F 2/6/2004 3/29/2004 52 OT PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Muscle Rigidity
4132290 4347344 51 Years M 12/27/2003 12/29/2003 3/29/2004 91 PER Strattera Attention Deficit/Hyperactivity Disorder Discomfort, Dysuria, Male Orgasmic Disorder, Premature Ejaculation
4132290 4440595 51 Years M 12/27/2003 3/23/2004 7/28/2004 127 MD PER Strattera Attention Deficit/Hyperactivity Disorder Discomfort, Dysuria, Male Orgasmic Disorder, Premature Ejaculation
4132291 4347319 8 Years M 1/20/2004 2/6/2004 3/29/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Nausea, Vomiting
4132293 4347345 7 Years M 12/1/2003 12/29/2003 3/29/2004 91 PER Strattera Choking, Retching
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4132297 4347347 40 Years M 1/1/2003 12/29/2003 3/29/2004 91 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Erectile Dysfunction, Male Orgasmic Disorder
4132300 4347348 13 Years M 12/21/2003 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Dyspepsia, Fatigue, Nausea, Vomiting
4132302 4347320 52 Years M 1/1/2004 2/6/2004 3/29/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Pollakiuria, Residual Urine Volume, Urinary Incontinence
4132303 4347349     F 12/30/2003 3/29/2004 90 MD PER Strattera
4132307 4347322 7 Years M 12/1/2004 2/6/2004 3/29/2004 52 CN PER Strattera Disturbance in Attention, Tremor
4132308 4347350 10 Years M 12/1/2003 12/30/2003 3/29/2004 90 PER Strattera Drug Interaction, Respiratory Tract Infection Viral
4132310 4347324     M 12/1/2003 2/6/2004 3/29/2004 52 PER Strattera Cough, Retching
4132313 4347352 11 Years M 12/1/2003 12/30/2003 3/29/2004 90 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Dyspepsia, Mood Swings, Mydriasis, Nausea, Psychomotor Hyperactivity, Tremor
4132314 4347330 55 Years M 1/1/2004 2/6/2004 3/29/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Night Sweats, Peripheral Coldness
4132317 4347325 42 Years M 2/9/2004 3/29/2004 49 MD PER Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder, Testicular Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4132318 4347332 13 Years M 2/9/2004 3/29/2004 49 MD PER Strattera Tic
4132320 4347353 45 Years M 12/1/2003 12/30/2003 3/29/2004 90 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Ejaculation Disorder, Erectile Dysfunction, Urine Analysis Abnormal
4132322 4347326 9 Years M 2/6/2004 3/29/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective
4132326 4347354 10 Years F 12/1/2003 12/30/2003 3/29/2004 90 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Dyspepsia, Headache
4132328 4347333 6 Years M 2/6/2004 3/29/2004 52 MD PER Strattera Attention Deficit/Hyperactivity Disorder Spontaneous Penile Erection
4132330 4347356     M 1/23/2004 3/29/2004 66 PER Strattera Libido Increased
4132330 4580284 45 Years M 12/18/2003 11/18/2004 1/27/2005 70 MD PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance In Sexual Arousal, Urinary Retention
4132330 4637478 45 Years M 12/18/2003 11/18/2004 3/28/2005 130 MD PER Strattera Disturbance In Sexual Arousal, Urinary Retention
4132333 4347328 12 Years M 2/9/2004 3/29/2004 49 MD PER Strattera Tic
4132334 4347334 14 Years F 2/2/2004 3/29/2004 56 MD PER Strattera Attention Deficit/Hyperactivity Disorder Weight Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4132338 4347329 13 Years M 2/9/2004 3/29/2004 49 OT PER Strattera Attention Deficit/Hyperactivity Disorder Mass
4132338 4440706 13 Years M 4/28/2004 7/28/2004 91 OT PER Strattera Attention Deficit/Hyperactivity Disorder Mass
4132339 4347335 13 Years M 1/25/2004 2/9/2004 3/29/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Anorexia, Feeling Abnormal, Mood Swings, Personality Change, Weight Decreased
4132344 4347337 15 Years M 2/9/2004 3/29/2004 49 PER Strattera Abnormal Behaviour, Aggression, Disturbance in Attention
4132346 4347338 61 Years F 2/2/2004 2/9/2004 3/29/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Cardiac Flutter
4132353 4347339 41 Years F 1/1/2004 2/9/2004 3/29/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder, Piloerection, Pruritus, Rash, Skin Burning Sensation
4132356 4347340 20 Years M 2/9/2004 3/29/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Somnolence
4132359 4347341 13 Years M 2/9/2004 3/29/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anorexia, Epigastric Discomfort, Flushing, Insomnia, Nausea, Somnolence
4132622 4348239 7 Years M 11/1/2003 11/24/2003 3/29/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Dizziness, Headache
4132624 4348241 9 Years M 11/25/2003 3/29/2004 125 MD PER Strattera Hallucination, Nightmare
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4132628 4348242 60 Years M 11/25/2003 3/29/2004 125 PER Strattera Aggression
4132633 4348244 9 Years F 8/1/2003 11/25/2003 3/29/2004 125 CN PER Strattera Attention Deficit/Hyperactivity Disorder Depressed Mood, Mood Swings, Weight Decreased
4132655 4348247 14 Years M 11/1/2003 12/1/2003 3/29/2004 119 CN PER Strattera Agitation, Anorexia, Constipation, Respiratory Tract Infection, Weight Decreased
4132662 4348248 5 Years F 11/25/2003 3/29/2004 125 OT PER Strattera Urinary Hesitation, Urinary Retention
4132670 4348249 8 Years M 11/1/2003 11/25/2003 3/29/2004 125 CN PER Strattera Asperger's Disorder, Impulsive Behaviour Tic
4132679 4348251 11 Years F 7/1/2003 11/25/2003 3/29/2004 125 CN PER Strattera Dysphagia, Fatigue, Middle Insomnia, Retching
4132704 4348252 7 Years F 11/24/2003 12/12/2003 3/29/2004 108 CN PER Strattera Attention Deficit/Hyperactivity Disorder Cough, Diarrhoea, Dyspepsia, Mood Swings, Nasopharyngitis, Nausea
4132709 4348254 8 Years M 10/27/2003 11/25/2003 3/29/2004 125 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Somnolence
4132807 4349657 8 Years M 1/21/2004 3/29/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4132812 4349658 8 Years F 1/1/2004 1/21/2004 3/29/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4132818 4349659 9 Years M 1/23/2004 3/29/2004 66 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Decreased Appetite, Fatigue, Mood Swings, Skin Discolouration, Weight Decreased
4132887 4349680 61 Years F 2/10/2004 2/18/2004 3/29/2004 40 PER Strattera Depression Fatigue, Insomnia, Nervousness, Pruritus, Rash
4132903 4349617     F 11/24/2003 11/24/2003 3/29/2004 126 PER Strattera
4132904 4349618 12 Years M 11/24/2003 3/29/2004 126 MD PER Strattera Psychomotor Hyperactivity
4132905 4349619 8 Years M 10/6/2003 12/15/2003 3/29/2004 105 OT PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Palpitations, Tachycardia
4132906 4349620 41 Years M 7/1/2003 11/24/2003 3/29/2004 126 OT PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Testicular Pain
4132907 4349621 10 Years F 11/24/2003 3/29/2004 126 PER Strattera Drug Ineffective
4132908 4349622 8 Years M 11/24/2003 3/29/2004 126 MD PER Strattera Crying, Depression, Mania
4132910 4349623     M 11/24/2003 3/29/2004 126 CN PER Strattera Attention Deficit/Hyperactivity Disorder
4132911 4349628 12 Years M 11/24/2003 3/29/2004 126 PER Strattera Abdominal Pain Upper, Dizziness, Mydriasis, Personality Change
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4132912 4349631     M 11/24/2003 3/29/2004 126 PER Strattera Abdominal Pain Upper, Anorexia, Feeling Abnormal, Vomiting
4132913 4349633 7 Years M 11/1/2003 11/24/2003 3/29/2004 126 OT PER Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder, Hallucination
4132914 4349563 8 Years M 11/1/2003 11/21/2003 3/29/2004 129 PER Strattera Retching
4132915 4349564 15 Years M 9/1/2003 11/21/2003 3/29/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia
4132916 4349565     M 11/21/2003 3/29/2004 129 PH PER Strattera Psychomotor Hyperactivity
4132918 4349570 15 Years F 1/22/2004 3/29/2004 67 MD PER Strattera Attention Deficit/Hyperactivity Disorder Paraesthesia
4132919 4349571 23 Years M 11/21/2003 11/21/2003 3/29/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Agitation, Impulse-Control Disorder
4132920 4349572 8 Years M 11/21/2003 3/29/2004 129 MD PER Strattera Hypokalaemia
4132920 4440867 8 Years M 11/21/2003 7/28/2004 250 MD PER Strattera Hypokalaemia
4132921 4349573 29 Years M 11/24/2003 3/29/2004 126 OT PER Strattera Testicular Pain, Urinary Retention
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4132922 4349575 8 Years M 11/1/2003 11/21/2003 3/29/2004 129 MD PER Strattera Attention Deficit/Hyperactivity Disorder Erection Increased, Painful Erection
4132923 4349576     M 1/1/2003 11/21/2003 3/29/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Nocturia
4132924 4349577 49 Years M 11/24/2003 3/29/2004 126 OT PER Strattera Dysuria, Testicular Pain, Urinary Retention
4132925 4349512 22 Years M 12/17/2003 3/29/2004 103 MD PER Strattera Dysuria, Urinary Hesitation
4132926 4349521 13 Years 12/17/2003 3/29/2004 103 MD PER Strattera Attention Deficit/Hyperactivity Disorder Trichotillomania
4132927 4349534 65 Years F 12/17/2003 3/29/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Urethral Spasm
4132929 4349540     M 12/9/2003 3/29/2004 111 MD PER Strattera Drug Screen Positive
4132930 4349543 8 Years M 12/17/2003 3/29/2004 103 PH PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Agitation, Anger, Drug Interaction
4132931 4349551     M 12/17/2003 3/29/2004 103 MD PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Pain
4132933 4349554     F 12/17/2003 3/29/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder, Depression Alopecia, Tremor
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4132934 4349556 4 Years F 8/1/2003 12/18/2003 3/29/2004 102 OT PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Fatigue, Mood Swings, Visual Disturbance
4132935 4349560 14 Years M 12/18/2003 3/29/2004 102 OT PER Strattera Visual Disturbance
4132937 4349562 11 Years F 12/18/2003 3/29/2004 102 OT PER Strattera Visual Disturbance
4133398 4349578 13 Years F 12/3/2003 3/29/2004 117 CN PER Strattera Attention Deficit/Hyperactivity Disorder
4133404 4349591     M 12/1/2003 3/29/2004 119 MD PER Strattera Depression
4133408 4349592 12 Years M 1/1/2003 12/2/2003 3/29/2004 118 OT PER Strattera Attention Deficit/Hyperactivity Disorder Arthralgia, Cough, Decreased Appetite, Hair Plucking, Nervousness, Pharyngolaryngeal Pain, Sinus Disorder
4133409 4349580 11 Years M 4/1/2003 12/4/2003 3/29/2004 116 PER Strattera Abnormal Behaviour Abdominal Pain Upper, Crying, Fatigue
4133410 4349594     F 12/1/2003 3/29/2004 119 MD PER Strattera Blepharospasm
4133413 4349595     M 12/1/2003 3/29/2004 119 MD PER Strattera Paraesthesia Oral
4133414 4349582     F 1/1/2003 12/4/2003 3/29/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Visual Disturbance
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4133416 4349597 51 Years M 11/1/2003 12/1/2003 3/29/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dizziness, Dysuria, Erectile Dysfunction, Feeling Abnormal, Headache, Hyperhidrosis, Initial Insomnia, Middle Insomnia, Somnolence
4133417 4349585 7 Years M 11/1/2003 12/4/2003 3/29/2004 116 MD PER Strattera Hallucination
4133418 4349598 15 Years M 12/1/2003 3/29/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Acne
4133421 4349586 9 Years F 12/4/2003 3/29/2004 116 MD PER Strattera Emotional Disorder
4133422 4349599 18 Years M 12/1/2003 3/29/2004 119 PER Strattera Antisocial Behaviour, Emotional Disorder
4133423 4349587 9 Years M 11/1/2003 12/4/2003 3/29/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Pallor, Somnolence
4133424 4349600 14 Years M 1/1/2003 12/1/2003 3/29/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Drug Ineffective, Fatigue, Mood Swings, Nausea, Somnolence
4133426 4349602     M 12/1/2003 3/29/2004 119 PER Strattera Antisocial Behaviour, Emotional Disorder
4133428 4349588 31 Years F 1/1/2003 12/4/2003 3/29/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Stomach Discomfort
4133429 4349604 10 Years F 12/22/2003 3/29/2004 98 PER Strattera Epistaxis, Heart Rate Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4133430 4349590 14 Years F 1/1/2003 12/4/2003 3/29/2004 116 MD PER Strattera Attention Deficit/Hyperactivity Disorder Menstruation Irregular
4133432 4349593     M 12/4/2003 3/29/2004 116 MD PER Strattera Erectile Dysfunction
4133436 4349596 14 Years M 11/15/2003 12/4/2003 3/29/2004 116 OT PER Strattera Attention Deficit/Hyperactivity Disorder Mydriasis, Psychotic Disorder
4133440 4349660 12 Years M 1/21/2004 2/11/2004 3/29/2004 47 OT PER Strattera Feeling Jittery, Mydriasis, Nausea
4133452 4349661 5 Years M 1/21/2004 3/29/2004 68 CN PER Strattera Attention Deficit/Hyperactivity Disorder
4133454 4349663 12 Years M 12/1/2003 1/21/2004 3/29/2004 68 CN PER Strattera Attention Deficit/Hyperactivity Disorder Epistaxis, Mood Swings
4133456 4349664 12 Years M 1/30/2004 3/29/2004 59 MD PER Strattera Visual Disturbance, Visual Field Defect
4133458 4349666 7 Years M 1/21/2004 3/29/2004 68 CN PER Strattera Keratoconjunctivitis Sicca
4133460 4349667 6 Years F 12/1/2003 1/21/2004 3/29/2004 68 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Eye Redness, Fatigue, Headache, Mood Swings, Somnolence, Weight Decreased
4133461 4349670 35 Years M 12/1/2003 1/21/2004 3/29/2004 68 CN PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Ligament Repair, Middle Insomnia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4133776 4349265 20 Years F 12/3/2003 3/29/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4133778 4349268 10 Years F 1/1/2003 11/24/2003 3/29/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Anorexia, Drug Ineffective, Fatigue, Feeling Abnormal, Mydriasis, Psychomotor Hyperactivity, Somnolence
4133780 4349270 15 Years M 1/1/2003 11/24/2003 3/1/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Anger
4133782 4349271 8 Years M 11/1/2003 11/24/2003 3/29/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Hyperchlorhydria
4133784 4349272 6 Years M 11/20/2003 11/24/2003 3/29/2004 126 MD PER Strattera Hallucination (Auditory), Nightmare
4133785 4349274     M 11/1/2003 11/24/2003 3/29/2004 126 OT PER Strattera Amnesia, Asthenia, Disturbance in Attention
4133787 4349275 48 Years M 8/1/2003 11/24/2003 3/29/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Arthralgia, Oedema Peripheral, Skin Disorder, Skin Warm
4133789 4349277 14 Years F 11/1/2003 11/24/2003 3/29/2004 126 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
4133790 4349278 16 Years 11/1/2003 11/24/2003 3/29/2004 126 OT PER Strattera Anorexia, Hallucination (Auditory)
4133791 4349279 13 Years M 11/24/2003 11/24/2003 3/29/2004 126 PER Strattera Disturbance in Attention, Feeling Abnormal, Headache
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134082 4348257 9 Years F 12/18/2003 3/29/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Constipation, Depressed Mood, Obsessive Thoughts
4134083 4348260 9 Years M 7/29/2003 1/20/2004 3/29/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Cold, Nausea, Pallor, Vomiting
4134084 4348267 18 Years M 8/1/2003 2/10/2004 3/29/2004 48 PER Strattera Asperger's Disorder, Attention Deficit/Hyperactivity Disorder Asthenia, Disturbance in Attention, Drug Ineffective, Headache, Logorrhoea, Weight Increased
4134086 4348270 14 Years M 12/1/2002 2/23/2004 3/29/2004 35 PER Strattera Attention Deficit/Hyperactivity Disorder, Bipolar Disorder Anger, Anorexia, Expressive Language Disorder, Eye Rolling, Fatigue, Juvenile Arthritis, Somnolence, Weight Decreased
4134086 4440481 14 Years M 12/1/2002 2/23/2004 7/28/2004 156 PER Strattera Attention Deficit/Hyperactivity Disorder, Bipolar Disorder Anger, Anorexia, Expressive Language Disorder, Eye Rolling, Fatigue, Juvenile Arthritis, Somnolence, Weight Decreased
4134087 4348274 14 Years M 12/1/2002 2/23/2004 3/29/2004 35 PER Strattera Attention Deficit/Hyperactivity Disorder, Bipolar Disorder Anger, Anorexia, Expressive Language Disorder, Eye Rolling, Fatigue, Juvenile Arthritis, Somnolence, Weight Decreased
4134087 4440495 14 Years M 12/1/2002 2/23/2004 7/28/2004 156 PER Strattera Attention Deficit/Hyperactivity Disorder, Bipolar Disorder Anger, Anorexia, Expressive Language Disorder, Eye Rolling, Fatigue, Juvenile Arthritis, Somnolence, Weight Decreased
4134088 4348276 9 Years F 8/6/2003 12/8/2003 3/29/2004 112 PER Strattera Somnolence
4134129 4349669 14 Years M 12/18/2003 3/29/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Withdrawal Syndrome, Dyskinesia, Heart Rate Increased, Insomnia, Tic
4134129 4440548 14 Years M 4/11/2003 4/21/2004 7/28/2004 98 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Dyskinesia, Heart Rate Increased, Hyperhidrosis, Insomnia, Tic, Urinary Incontinence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134132 4349677 6 Years F 12/19/2003 3/29/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Emotional Distress, Musculoskeletal Discomfort
4134133 4349682 48 Years F 12/1/2003 12/19/2003 3/29/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Feeling Abnormal, Heart Rate Increased, Hot Flush, Somnolence
4134133 4440567 48 Years F 12/1/2003 3/5/2004 7/28/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Feeling Abnormal, Heart Rate Increased, Hot Flush, Somnolence
4134134 4349684     M 12/19/2003 3/29/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety
4134136 4349687 42 Years F 1/1/2003 12/19/2003 3/29/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal
4134141 4349688 53 Years M 12/18/2003 12/19/2003 3/29/2004 101 PER Strattera Feeling Abnormal, Lethargy, Nervousness, Paranoia, Somnolence
4134145 4349690 12 Years M 12/19/2003 3/29/2004 101 PER Strattera Retching Abdominal Pain Upper, Decreased Appetite, Fatigue, Feeling Drunk, Mydriasis, Somnolence, Visual Acuity Reduced
4134148 4349691 7 Years M 11/1/2003 12/19/2003 3/29/2004 101 PER Strattera Retching Agitation, Anger, Crying, Insomnia
4134151 4349692     F 12/19/2003 3/29/2004 101 PER Strattera Mood Swings
4134156 4349693 10 Years M 4/1/2003 12/19/2003 3/29/2004 101 PER Strattera Anorexia, Apathy, Dyspepsia, Food Aversion, Retching, Somnolence, Vomiting, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134200 4350203 6 Years M 1/26/2004 3/29/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4134201 4350205 5 Years M 1/26/2004 3/29/2004 63 PER Strattera Abnormal Behaviour, Decreased Appetite
4134204 4350206 13 Years M 1/23/2004 1/26/2004 3/29/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Angina Pectoris, Decreased Appetite, Weight Decreased
4134208 4350207 39 Years F 12/13/2003 1/26/2004 3/29/2004 63 PER Strattera Disturbance in Attention, Headache, Nausea, Somnolence, Vomiting
4134208 4440881 39 Years F 12/13/2003 3/10/2004 7/28/2004 140 PER Strattera Disturbance in Attention, Headache, Nausea, Somnolence, Vomiting
4134209 4350209 8 Years F 1/25/2004 1/26/2004 3/29/2004 63 PER Strattera Belligerence, Feeling Abnormal, Mood Swings
4134212 4350211 9 Years M 9/1/2003 1/26/2004 3/29/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, School Refusal
4134213 4350213     M 1/26/2004 3/29/2004 63 MD PER Strattera Testicular Pain
4134214 4350215 14 Years M 1/1/2004 1/26/2004 3/29/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Body Temperature Increased, Feeling Abnormal
4134215 4350216 14 Years M 1/26/2004 3/29/2004 63 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Heart Rate Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134218 4350217     M 1/27/2004 3/29/2004 62 MD PER Strattera Tremor
4134219 4349149 45 Years M 8/23/2003 1/5/2004 3/29/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Fatigue, Hypoaesthesia, Nausea, Paraesthesia, Sexual Dysfunction, Somnolence
4134235 4349524 46 Years F 11/1/2003 11/21/2003 3/29/2004 129 PER Strattera Sinus Disorder
4134236 4349525 9 Years M 11/3/2003 11/21/2003 3/29/2004 129 MD PER Strattera Attention Deficit/Hyperactivity Disorder Precocious Puberty
4134238 4349526 12 Years F 11/1/2003 11/21/2003 3/29/2004 129 PH PER Strattera Tic
4134240 4349527     F 11/20/2003 3/29/2004 130 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Anxiety, Nervousness
4134241 4349538     M 11/21/2003 3/29/2004 129 PER Strattera
4134244 4349541 55 Years M 11/1/2003 11/21/2003 3/29/2004 129 OT PER Strattera Attention Deficit/Hyperactivity Disorder Psychosomatic Disease
4134245 4349544 38 Years M 10/1/2003 11/21/2003 3/29/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Feeling Abnormal, Nervousness
4134247 4349545 12 Years M 10/1/2003 11/21/2003 3/29/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Impulsive Behaviour, Nausea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134248 4349546     M 11/23/2003 11/24/2003 3/29/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Agitation, Anxiety, Dyspnoea, Fatigue, Feeling Abnormal, Hyperventilation, Insomnia, Nausea, Psychomotor Hyperactivity, Rash, Tongue Disorder
4134252 4349547     F 11/24/2003 11/24/2003 3/29/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Euphoric Mood, Hypervigilance
4134256 4349548 17 Years M 12/3/2003 3/29/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Feeling Abnormal, Nausea
4134257 4349549 40 Years M 1/1/2003 12/2/2003 3/29/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Erectile Dysfunction, Nausea, Penis Disorder, Urinary Hesitation
4134258 4349550 11 Years M 11/25/2003 12/2/2003 3/29/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anorexia, Fatigue, Headache, Irritability, Mood Swings
4134259 4349552 17 Years M 11/1/2003 12/2/2003 3/29/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Dyspnoea, Haemoptysis
4134260 4349553 8 Years M 11/1/2003 12/3/2003 3/29/2004 117 PER Strattera Abnormal Behaviour, Crying, Drug Ineffective, Emotional Disorder
4134261 4349555 7 Years M 11/25/2003 12/3/2003 3/29/2004 117 PER Strattera Psychomotor Hyperactivity
4134262 4349557 59 Years M 12/2/2003 12/3/2003 3/29/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Decreased Appetite, Dizziness, Dry Mouth, Dysuria, Insomnia, Pharyngolaryngeal Pain
4134263 4349558 24 Years M 1/1/2003 12/3/2003 3/29/2004 117 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Irritability, Libido Decreased, Night Sweats, Serotonin Syndrome
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134264 4349559 10 Years M 11/22/2003 12/3/2003 3/29/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Crying, Dyspepsia, Fatigue, Feeling Abnormal, Insomnia, Irritability, Sleep Disorder, Sleep Talking, Somnolence, Vomiting
4134265 4349561 35 Years M 12/3/2003 3/29/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Urinary Retention
4134601 4349718 7 Years F 1/1/2004 1/26/2004 3/29/2004 63 PER Strattera Psychomotor Hyperactivity Feeling Abnormal, Skin Discolouration
4134603 4349719 10 Years M 1/1/2004 1/26/2004 3/29/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Dyspepsia, Fatigue, Gastroenteritis Viral, Vomiting
4134605 4349720 11 Years M 1/26/2004 3/29/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Decreased Appetite, Feeling Abnormal
4134606 4349721 8 Years F 1/1/2004 1/26/2004 3/29/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Blepharospasm, Eye Pain, Fatigue, Headache
4134607 4349722 10 Years F 1/26/2004 3/29/2004 63 PER Strattera Disturbance in Attention Drug Ineffective, Early Morning Awakening, Fatigue, Headache
4134610 4349723 20 Years F 1/1/2004 1/26/2004 3/29/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Disorientation
4134611 4349724 8 Years F 1/26/2004 3/29/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Feeling Abnormal
4134612 4349725 8 Years M 2/18/2004 3/29/2004 40 PER Strattera Attention Deficit/Hyperactivity Disorder, Sensory Disturbance Abnormal Behaviour, Drug Ineffective, Fight In School, Suicidal Ideation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134612 4440880 8 Years M 4/21/2004 7/28/2004 98 OT PER Strattera Attention Deficit/Hyperactivity Disorder, Sensory Integrative Dysfunction Abnormal Behaviour, Drug Ineffective, Fight In School, Suicidal Ideation
4134613 4349726 37 Years M 1/23/2004 1/26/2004 3/29/2004 63 PER Strattera Disturbance in Attention Dizziness, Insomnia, Thinking Abnormal
4134614 4349727 10 Years M 1/26/2004 1/26/2004 3/29/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Pyrexia
4134642 4349700 10 Years M 1/1/2004 2/18/2004 3/29/2004 40 PER Strattera Retching Abnormal Behaviour, Affect Lability, Crying, Drug Ineffective
4134642 4580287 10 Years M 1/1/2004 8/30/2004 1/27/2005 150 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Affect Lability, Crying, Drug Ineffective, Insomnia
4134643 4349702 43 Years M 4/1/2003 1/23/2004 3/29/2004 66 PER Strattera Alopecia
4134644 4349705 13 Years M 1/23/2004 3/29/2004 66 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Dysuria, Mydriasis, Urinary Hesitation
4134648 4349706 12 Years 1/23/2004 3/29/2004 66 MD PER Strattera Tic
4134651 4349710 13 Years M 1/26/2004 3/29/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
4134652 4349713 14 Years M 1/26/2004 3/29/2004 63 OT PER Strattera Abnormal Behaviour
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134653 4349714 7 Years M 1/23/2004 1/26/2004 3/29/2004 63 PER Strattera Emotional Disorder Mydriasis, Pruritus, Pyrexia
4134655 4349715 8 Years F 1/24/2004 1/26/2004 3/29/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Choking
4134661 4349716 21 Years M 1/26/2004 3/29/2004 63 PER Strattera Drug Screen Positive
4134667 4349717 7 Years M 1/20/2004 1/28/2004 3/29/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Learning Disorder, Psychomotor Hyperactivity
4134684 4346728 6 Years F 1/27/2004 1/28/2004 3/29/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Retching
4134685 4346729     M 1/28/2004 3/29/2004 61 CN PER Strattera Drug Screen Positive
4134686 4346731 19 Years M 1/28/2004 3/29/2004 61 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Heart Rate Increased, Heart Rate Irregular
4134686 4438558 20 Years M 1/28/2004 7/28/2004 182 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Heart Rate Increased, Heart Rate Irregular
4134688 4346733 7 Years M 1/24/2004 1/28/2004 3/29/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder Dyskinesia
4134689 4346735 10 Years M 1/28/2004 3/29/2004 61 MD PER Strattera Attention Deficit/Hyperactivity Disorder Wheezing
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134690 4346738 34 Years F 1/26/2004 1/28/2004 3/29/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Initial Insomnia, Paraesthesia
4134690 4726694 34 Years F 1/26/2004 3/10/2005 7/25/2005 137 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Fatigue, Feeling Abnormal, Initial Insomnia, Paraesthesia, Therapeutic Response Decreased
4134692 4346739 7 Years M 11/1/2003 1/28/2004 3/29/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder, Disturbance in Attention Abnormal Behaviour
4134695 4346811 16 Years M 11/26/2003 3/29/2004 124 MD PER Strattera Urethral Discharge
4134698 4346812 6 Years M 12/1/2003 12/10/2003 3/29/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Gastroenteritis Viral, Psychomotor Hyperactivity, Stomach Discomfort, Vomiting
4134699 4346814 8 Years F 11/1/2003 12/10/2003 3/29/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Psychomotor Hyperactivity
4134701 4346815 11 Years M 12/10/2003 3/29/2004 110 MD PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Nightmare
4134703 4346816 8 Years F 12/9/2003 12/10/2003 3/29/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
4134704 4346818 30 Years M 12/1/2003 12/10/2003 3/29/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Erectile Dysfunction, Male Orgasmic Disorder, Weight Decreased
4134707 4346821 12 Years M 1/1/2003 12/10/2003 3/29/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Impulsive Behaviour, Sleep Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134708 4346822 16 Years F 12/12/2003 3/29/2004 108 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Dystonia
4134708 4440871 16 Years F 12/6/2003 3/11/2004 7/28/2004 139 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blepharospasm, Dizziness, Drug Interaction, Dysarthria, Dystonia, Hypokinesia, Tremor
4134710 4346823 28 Years F 12/12/2003 3/29/2004 108 MD PER Strattera Dysgeusia
4134712 4346824 8 Years M 9/1/2003 12/12/2003 3/29/2004 108 PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Appetite Disorder, Drug Ineffective
4134754 4350226 10 Years F 1/1/2004 1/20/2004 3/29/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Head Banging, Headache, Hot Flush, Nausea, Photophobia
4134755 4350228 14 Years M 1/19/2004 1/20/2004 3/29/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Hyperhidrosis, Nausea, Vomiting
4134756 4350231 11 Years F 8/1/2003 1/21/2004 3/29/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Dysgeusia, Insomnia
4134758 4350232 9 Years M 10/1/2003 1/20/2004 3/29/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Feeling Abnormal, Mood Swings, Somnolence, Vomiting
4134759 4350233 9 Years M 1/20/2004 3/29/2004 69 PER Strattera Dysgeusia
4134761 4350234 8 Years M 1/1/2004 1/21/2004 3/29/2004 68 PER Strattera Disturbance in Attention Disturbance in Attention
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134762 4350235     M 10/1/2003 1/21/2004 3/29/2004 68 PER Strattera Depression Cardiac Flutter
4134762 4440878     M 10/1/2003 3/31/2004 7/28/2004 119 PER Strattera Depression Cardiac Flutter
4134763 4350236 8 Years M 1/1/2004 1/21/2004 3/29/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Headache
4134764 4350237 7 Years M 1/1/2004 1/21/2004 3/29/2004 68 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Disturbance in Attention, Drug Ineffective, Ear Infection, Feeling Abnormal, Insomnia, Nausea, Vomiting, Weight Decreased
4134765 4350238 29 Years M 1/21/2004 3/29/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Mood Swings, Testicular Pain, Urinary Retention
4134766 4346742 62 Years F 1/1/2004 1/22/2004 3/29/2004 67 CN PER Strattera Attention Deficit/Hyperactivity Disorder Diarrhoea, Gastroenteritis Viral, Nausea, Vomiting
4134774 4346744 7 Years M 1/22/2004 3/29/2004 67 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Fatigue, Somnolence
4134779 4346746 16 Years M 1/1/2003 1/22/2004 3/29/2004 67 CN PER Strattera Abnormal Behaviour, Dizziness, Drug Ineffective, Mood Altered, Negativism, Weight Decreased
4134784 4346712 19 Years F 11/1/2003 12/3/2003 3/29/2004 117 PER Strattera Gingival Swelling, Weight Decreased
4134786 4346714 6 Years F 6/1/2003 12/3/2003 3/29/2004 117 MD PER Strattera Overdose
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134788 4346715 16 Years M 12/1/2003 12/3/2003 3/29/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Myalgia, Pallor, Pharyngolaryngeal Pain, Somnolence
4134790 4346716     F 12/1/2003 3/29/2004 119 MD PER Strattera Agitation
4134791 4346718 17 Years M 12/3/2003 3/29/2004 117 CN PER Strattera Attention Deficit/Hyperactivity Disorder Amnesia, Loss of Consciousness
4134793 4346719     M 12/1/2003 12/3/2003 3/29/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria
4134794 4346720 42 Years F 11/22/2003 12/3/2003 3/29/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Dry Mouth, Fatigue, Feeling Abnormal, Feeling Drunk, Insomnia, Paraesthesia, Sedation
4134797 4346722 12 Years M 12/3/2003 3/29/2004 117 MD PER Strattera Tic
4134799 4346723 17 Years M 12/3/2003 12/16/2003 3/29/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Epistaxis, Fatigue, Feeling Abnormal, Headache, Pharyngolaryngeal Pain, Pulse Pressure Increased
4134800 4346724 53 Years F 12/3/2003 12/3/2003 3/29/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Disease Progression, Dizziness, Feeling Abnormal, Pupils Unequal
4134805 4346747 24 Years M 1/1/2004 1/23/2004 3/29/2004 66 CN PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Dry Mouth, Irritability, Tearfulness
4134811 4346749 8 Years F 1/23/2004 3/29/2004 66 CN PER Strattera Attention Deficit/Hyperactivity Disorder Change In Sustained Attention, Drug Ineffective
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134821 4346750 13 Years M 1/22/2004 1/23/2004 3/29/2004 66 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Crying, Depressed Mood, Insomnia, Somnolence
4134830 4346752 73 Years M 1/22/2004 1/23/2004 3/29/2004 66 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fatigue, Heart Rate Increased, Middle Insomnia, Restlessness, Somnolence
4134830 4440879 73 Years M 1/22/2004 3/16/2004 7/28/2004 134 OT PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Dizziness, Fatigue, Heart Rate Increased, Loss of Libido, Micturition Disorder, Middle Insomnia, Restlessness, Somnolence
4134835 4346754 10 Years M 1/20/2004 1/23/2004 3/29/2004 66 CN PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Disturbance in Attention, Fatigue, Sluggishness
4134845 4346756 50 Years F 1/23/2004 3/29/2004 66 CN PER Strattera Depression Abdominal Pain, Aggression, Crying, Disturbance in Attention, Dizziness, Fatigue, Mood Swings
4134849 4346758 49 Years M 1/22/2004 1/23/2004 3/29/2004 66 CN PER Strattera Attention Deficit/Hyperactivity Disorder Gastroenteritis Viral, Heart Rate Increased, Insomnia, Nausea, Sexual Dysfunction, Vision Blurred
4134869 4347617 7 Years M 3/31/2004 4/1/2004 4/22/2004 21 EXP Strattera Autism Tremor Other
4134879 4347622 15 Years M 4/12/2004 4/22/2004 10 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Anxiety, Blood Alkaline Phosphatase Increased, Blood Chloride Decreased, Blood Urea Decreased, Depression, Dry Mouth, Electrocardiogram QT Prolonged, Grand Mal Convulsion, Heart Rate Increased, Intentional Overdose, Tremor, Ventricular Hypertrophy, White Blood Cell Count Increased Hospitalization - Initial or Prolonged, Other
4134879 4455038 15 Years M 8/30/2004 9/17/2004 18 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Anxiety, Arrhythmia, Blood Alkaline Phosphatase Increased, Blood Chloride Decreased, Blood Glucose Increased, Blood Urea Nitrogen/Creatinine Ratio Decreased, Conduction Disorder, Confusional State, Convulsion, Depression, Dry Mouth, Electrocardiogram QT Corrected Interval Prolonged, Heart Rate Increased, Intentional Overdose, Neurological Examination Abnormal, Postictal State, QRS Axis Abnormal, Tremor, Ventricular Hypertrophy, White Blood Cell Count Increased Hospitalization - Initial or Prolonged, Other
4134882 4346855     F 12/9/2003 3/29/2004 111 MD PER Strattera Tremor
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134885 4346857 7 Years F 11/1/2003 12/9/2003 3/29/2004 111 PER Strattera Bipolar Disorder Mydriasis, Tremor
4134886 4346956 50 Years F 12/12/2003 12/15/2003 3/29/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder, Fatigue Fatigue, Hypersomnia, Nausea
4134888 4346858     F 12/1/2003 12/9/2003 3/29/2004 111 PER Strattera Abnormal Faeces, Constipation, Somnolence
4134889 4346958 9 Years M 12/10/2003 12/15/2003 3/29/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Psychomotor Hyperactivity
4134890 4346941     F 12/16/2003 3/29/2004 104 MD PER Strattera Aggression, Feeling Abnormal, Mood Swings
4134891 4346959 12 Years M 12/15/2003 3/29/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Psychomotor Hyperactivity
4134892 4346907     M 2/9/2004 3/29/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
4134893 4346943 6 Years M 12/16/2003 3/29/2004 104 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination (Auditory)
4134894 4346859 11 Years M 12/8/2003 12/9/2003 3/29/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Fatigue, Headache, Nausea
4134895 4346860     M 11/1/2003 1/14/2004 3/29/2004 75 PER Strattera Aggression, Crying, Emotional Disorder, Mood Swings, Suicidal Ideation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134896 4346963 12 Years M 10/1/2003 12/16/2003 3/29/2004 104 MD PER Strattera Ciliary Body Disorder, Visual Disturbance
4134897 4346944 6 Years M 12/16/2003 3/29/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder, Bipolar Disorder Dyspepsia, Eye Swelling, Lactose Intolerance, Multiple Allergies, Pruritus
4134898 4346964     M 12/12/2003 3/29/2004 108 MD PER Strattera Attention Deficit/Hyperactivity Disorder Penile Discharge
4134900 4346862 14 Years M 12/9/2003 3/29/2004 111 MD PER Strattera Pharyngitis Streptococcal, Wheezing
4134901 4346946 7 Years M 1/1/2003 12/16/2003 3/29/2004 104 PER Strattera Cough, Feeling Abnormal, Phobia, Vomiting
4134902 4346965 9 Years F 12/16/2003 3/29/2004 104 MD PER Strattera Autism Blepharospasm
4134904 4346966 8 Years M 12/16/2003 3/29/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4134905 4346947 14 Years M 12/8/2003 3/29/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Impulsive Behaviour
4134906 4346967 31 Years F 12/19/2003 3/29/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Insomnia, Irritability, Nail Disorder
4134907 4346969     M 12/16/2003 3/29/2004 104 MD PER Strattera Aggression, Feeling Abnormal, Mood Swings
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134908 4346970     M 12/16/2003 3/29/2004 104 MD PER Strattera Aggression, Feeling Abnormal, Mood Swings
4134909 4346948 49 Years M 12/16/2003 3/29/2004 104 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Disturbance in Attention
4134913 4346949 33 Years M 12/1/2003 1/29/2004 3/29/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Feeling Abnormal, Feeling Drunk, Heart Rate Increased, Insomnia, Irritability, Muscle Atrophy, Nervousness
4134914 4346951 14 Years M 12/8/2003 12/16/2003 3/29/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Headache, Oppositional Defiant Disorder, Psychomotor Hyperactivity, Somnolence, Vision Blurred
4134916 4346952 17 Years M 12/9/2003 12/16/2003 3/29/2004 104 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
4134917 4346909 5 Years M 2/9/2004 3/29/2004 49 PER Strattera Disturbance in Attention, Restlessness Blood Galactose Increased
4134919 4346863 12 Years F 12/9/2003 12/9/2003 3/29/2004 111 PER Strattera Dizziness, Fatigue, Feeling Abnormal
4134920 4346837     F 1/1/2003 12/10/2003 3/29/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Depression, Irritability, Migraine, Nausea, Negative Thoughts, Pain, Road Traffic Accident, Weight Decreased
4134921 4346953 9 Years M 12/15/2003 12/16/2003 3/29/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Impulsive Behaviour, Irritability
4134922 4346910 9 Years M 2/8/2004 2/9/2004 3/29/2004 49 PER Strattera Anorexia, Dizziness, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134923 4346864 12 Years M 12/6/2003 12/9/2003 3/29/2004 111 PER Strattera Blood Pressure Increased, Erythema, Fatigue, Feeling Abnormal, Feeling Hot, Heart Rate Increased, Insomnia, Pyrexia
4134925 4346911 54 Years F 2/4/2004 2/9/2004 3/29/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Dyspepsia, Headache, Nausea
4134926 4346866 5 Years M 11/5/2003 12/9/2003 3/29/2004 111 OT PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Feeling Abnormal, Sedation
4134927 4346839 41 Years M 1/1/2003 12/9/2003 3/29/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Blunted Affect, Constipation, Feeling Abnormal, Formication, Headache, Nausea, Pruritus, Social Avoidant Behaviour
4134928 4346912 34 Years F 1/1/2004 2/9/2004 3/29/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Sinus Congestion, Skin Discolouration, Somnolence, Thirst
4134929 4346867 16 Years M 11/1/2003 12/9/2003 3/29/2004 111 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4134930 4346793 7 Years M 12/1/2003 12/15/2003 3/29/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Insomnia, Tachycardia
4134930 4501319 7 Years M 12/1/2003 6/29/2004 9/27/2004 90 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Insomnia, Tachycardia
4134930 4580282 7 Years M 12/1/2003 11/18/2004 1/27/2005 70 MD PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Insomnia, Tachycardia
4134930 4637476 7 Years M 12/1/2003 11/18/2004 3/28/2005 130 MD PER Strattera Chest Pain, Insomnia, Tachycardia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134931 4346913     M 1/1/2004 2/9/2004 3/29/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Irritability, Nasal Dryness
4134932 4346843 6 Years M 11/1/2003 12/9/2003 3/29/2004 111 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Growth Accelerated, Nasopharyngitis
4134934 4346844 7 Years M 12/10/2003 3/29/2004 110 OT PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
4134935 4346796 10 Years M 12/9/2003 12/12/2003 3/29/2004 108 PER Strattera Attention Deficit/Hyperactivity Disorder Pruritus, Restlessness
4134937 4346845 42 Years M 12/10/2003 3/29/2004 110 MD PER Strattera Attention Deficit/Hyperactivity Disorder Disorientation, Nausea, Vomiting
4134938 4346914 8 Years M 2/9/2004 3/29/2004 49 OT PER Strattera Decreased Appetite, Hair Colour Changes, Headache, Nausea
4134940 4346846 8 Years M 12/1/2003 2/18/2004 3/29/2004 40 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Eructation, Flatulence, Muscle Cramp, Nervousness, Vomiting
4134940 4440870 8 Years M 12/1/2003 4/27/2004 7/28/2004 92 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Asthma, Decreased Appetite, Eructation, Fear, Flatulence, Muscle Cramp, Nervousness, Paranoia, Vomiting
4134940 4637507 8 Years M 12/1/2003 1/12/2005 3/28/2005 75 PER Strattera Aggression, Anxiety, Asthma, Decreased Appetite, Dry Skin, Dyspnoea, Eructation, Fear, Flatulence, Insomnia, Muscle Spasms, Nervousness, Paranoia, Somnolence, Stomach Discomfort, Vomiting
4134941 4346848     F 11/27/2003 12/10/2003 3/29/2004 110 MD PER Strattera Overdose, Tremor
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134943 4346915     F 1/1/2003 2/9/2004 3/29/2004 49 PER Strattera Dizziness
4134944 4346849 59 Years F 12/6/2003 12/10/2003 3/29/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Hypoaesthesia, Lacrimation Increased, Sinus Disorder
4134946 4346850     M 12/15/2003 3/29/2004 105 MD PER Strattera Abnormal Behaviour
4134947 4346916 21 Years F 2/9/2004 3/29/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Eye Pain, Vision Blurred, Visual Disturbance
4134948 4346917     M 2/2/2004 3/29/2004 56 MD PER Strattera Suicidal Ideation
4134949 4346852 6 Years M 11/1/2003 12/10/2003 3/29/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Fatigue, Impulsive Behaviour
4134951 4346797 10 Years F 12/1/2003 12/15/2003 3/29/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder, Autism, Obsessive-Compulsive Disorder Impulse-Control Disorder
4134954 4346798 8 Years F 1/1/2003 12/15/2003 3/29/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence, Viral Infection, Weight Decreased
4134955 4346799 7 Years F 12/15/2003 3/29/2004 105 MD PER Strattera Eye Swelling
4134957 4347708 5 Years M 4/1/2003 4/6/2004 4/22/2004 16 EXP Strattera Homicidal Ideation, Pharmaceutical Product Complaint Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4134958 4347713 6 Years M 4/3/2004 4/6/2004 4/22/2004 16 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Pyrexia Other
4134958 4399442 6 Years M 4/3/2004 6/21/2004 7/12/2004 21 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion, Pyrexia, White Blood Cell Count Increased Other
4134959 4347720 12 Years M 5/1/2003 4/6/2004 4/22/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Homicidal Ideation, Impulse-Control Disorder, Insomnia, Pharmaceutical Product Complaint, Suicidal Ideation Hospitalization - Initial or Prolonged
4134960 4347725     M 4/6/2004 4/22/2004 16 MD EXP Strattera Neuroleptic Malignant Syndrome Other
4134961 4347730 6 Years M 3/28/2004 4/2/2004 4/22/2004 20 MD EXP Strattera Loss of Consciousness, Pharyngitis Streptococcal Other
4134962 4347735 18 Years M 1/1/2004 4/1/2004 4/22/2004 21 MD EXP Strattera Blood Pressure Diastolic Decreased, Blood Pressure Increased, Disturbance in Attention, Dizziness, Heart Rate Increased, Loss of Consciousness Other
4135087 4346889     M 4/1/2003 12/19/2003 3/29/2004 101 PER Strattera Coeliac Disease, Dyspnoea, Weight Decreased
4135090 4346890 11 Years M 12/22/2003 12/22/2003 3/29/2004 98 PER Strattera
4135091 4346892 35 Years M 12/1/2003 12/22/2003 3/29/2004 98 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation
4135094 4346893 12 Years F 8/1/2003 12/22/2003 3/29/2004 98 MD PER Strattera Attention Deficit/Hyperactivity Disorder Amenorrhoea, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4135098 4346895 45 Years F 12/1/2003 12/22/2003 3/29/2004 98 PER Strattera Somnolence Abnormal Behaviour, Apathy, Chills, Myalgia, Nervousness, Tremor, Yawning
4135100 4346896 8 Years M 12/1/2003 12/22/2003 3/29/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dyspepsia, Eye Swelling, Flushing
4135105 4346899 6 Years M 1/1/2003 12/22/2003 3/29/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder, Pervasive Developmental Disorder Abdominal Pain Upper, Muscle Cramp, Pneumonia, Psychomotor Hyperactivity, Somnolence
4135106 4346900 37 Years F 12/22/2003 3/29/2004 98 OT PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
4135109 4346902 18 Years M 12/1/2003 12/22/2003 3/29/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Crying, Depression
4135110 4346904     1/13/2004 3/29/2004 76 PH PER Strattera Coordination Abnormal
4135147 4346918 66 Years M 12/16/2003 3/29/2004 104 PER Strattera Sleep Apnoea Syndrome Aggression, Anxiety, Feeling Abnormal
4135154 4346919 17 Years M 12/17/2003 3/29/2004 103 MD PER Strattera Palpitations
4135157 4346920 45 Years M 12/1/2003 12/17/2003 3/29/2004 103 PER Strattera Anxiety, Nervousness
4135164 4346921 59 Years M 12/1/2003 12/17/2003 3/29/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Confusional State, Dizziness, Feeling Abnormal, Nervousness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4135169 4346922 15 Years M 12/16/2003 3/29/2004 104 MD PER Strattera Headache, Tinnitus
4135172 4346923 42 Years F 12/1/2003 12/17/2003 3/29/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Pruritus
4135182 4346924 8 Years M 12/17/2003 3/29/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder
4135187 4346927     M 12/17/2003 3/29/2004 103 CN PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Irritability, Pallor, Psychomotor Skills Impaired
4135191 4346928 6 Years M 12/1/2003 12/17/2003 3/29/2004 103 PER Strattera Psychomotor Hyperactivity Crying, Excitability, Fatigue, Feeling Abnormal, Initial Insomnia, Middle Insomnia, Nervousness, Restlessness, Somnolence
4135193 4346930 13 Years F 12/9/2003 1/14/2004 3/29/2004 75 OT PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Suicidal Ideation
4135311 4346800 8 Years F 12/14/2003 12/15/2003 3/29/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity
4135313 4346802 6 Years M 11/1/2003 12/15/2003 3/29/2004 105 PER Strattera Disturbance in Attention, Restlessness Decreased Appetite, Dry Mouth, Emotional Distress, Eye Disorder, Eye Irritation, Lacrimation Increased, Mood Swings, Weight Decreased
4135315 4346803 55 Years M 1/1/2003 12/15/2003 3/29/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Erythema, Hot Flush, Hyperhidrosis, Weight Decreased
4135315 4440872 55 Years M 1/1/2003 3/10/2004 7/28/2004 140 CN PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Erythema, Hot Flush, Hyperhidrosis, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4135316 4346805 39 Years F 1/1/2003 12/15/2003 3/29/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Drug Ineffective, Somnolence
4135317 4346807     F 1/7/2004 3/29/2004 82 MD PER Strattera Mania
4135526 4348741     M 1/1/2003 12/8/2003 3/29/2004 112 MD PER Strattera Abnormal Behaviour, Priapism
4135526 4476586 7 Years M 1/1/2003 9/24/2004 10/13/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Priapism
4135529 4348742 60 Years M 12/4/2003 12/17/2003 3/29/2004 103 PH PER Strattera Attention Deficit/Hyperactivity Disorder Arthralgia, Chest Pain, Prostatic Pain
4135533 4348743 8 Years M 12/7/2003 12/8/2003 3/29/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Depression, Fatigue, Feeling Abnormal, Irritability
4135536 4348744 10 Years M 1/1/2003 12/8/2003 3/29/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
4135540 4348746 8 Years M 12/7/2003 12/8/2003 3/29/2004 112 PER Strattera Insomnia, Mydriasis, Visual Acuity Reduced
4135545 4348747 6 Years M 11/24/2003 12/8/2003 3/29/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Haematochezia, Vomiting
4135551 4348772 19 Years M 6/1/2003 12/8/2003 3/29/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Malaise
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4135556 4348788 7 Years M 12/9/2003 3/29/2004 111 OT PER Strattera Attention Deficit/Hyperactivity Disorder Erection Increased
4135560 4348791     F 12/1/2003 12/8/2003 3/29/2004 112 PER Strattera Constipation, Fatigue, Insomnia, Rectal Haemorrhage
4135563 4348794 9 Years M 12/1/2003 12/8/2003 3/29/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
4135566 4346773 14 Years M 1/1/2004 1/23/2004 3/29/2004 66 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Dyspepsia, Increased Appetite, Vomiting
4135567 4346775 9 Years M 1/22/2004 1/23/2004 3/29/2004 66 OT PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Feeling Abnormal, Somnolence
4135570 4346776 10 Years M 1/22/2004 1/23/2004 3/29/2004 66 PER Strattera Retching
4135572 4346780 12 Years F 1/23/2004 3/29/2004 66 PER Strattera Attention Deficit/Hyperactivity Disorder Choking, Retching
4135574 4346781 6 Years M 1/22/2004 2/5/2004 3/29/2004 53 OT PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Dyspepsia, Erythema, Feeling Hot, Heart Rate Increased, Hypersomnia, Nausea, Psychomotor Hyperactivity
4135574 4501690 7 Years M 1/22/2004 6/3/2004 9/27/2004 116 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Dizziness, Erythema, Feeling Hot, Heart Rate Increased, Hyperhidrosis, Hypersomnia, Nausea, Psychomotor Hyperactivity, Screaming, Stomach Discomfort
4135577 4346782 8 Years M 1/22/2004 1/23/2004 3/29/2004 66 PER Strattera Attention Deficit/Hyperactivity Disorder Tic
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4135580 4346786 7 Years M 11/1/2003 1/23/2004 3/29/2004 66 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Logorrhoea, Psychomotor Hyperactivity
4135582 4346787 14 Years M 1/23/2004 3/29/2004 66 PER Strattera Abnormal Behaviour, Sinusitis, Somnolence
4135584 4346789 6 Years M 1/23/2004 1/23/2004 3/29/2004 66 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Fatigue, Lethargy
4135586 4349566 7 Years M 11/1/2003 12/2/2003 3/29/2004 118 PER Strattera Impulse-Control Disorder Emotional Disorder, Feeling Jittery, Pruritus, Psychomotor Hyperactivity, Tremor
4135587 4346791 13 Years M 1/1/2004 2/10/2004 3/29/2004 48 PER Strattera Attention Deficit/Hyperactivity Disorder, Obsessive-Compulsive Disorder Chest Discomfort, Dyspnoea
4135590 4349567 18 Years M 11/25/2003 12/2/2003 3/29/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Viral Infection, Vomiting
4135592 4349568 83 Years M 2/21/2003 12/2/2003 3/29/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Incontinence, Urinary Retention
4135595 4349569 12 Years M 12/2/2003 3/29/2004 118 PER Strattera Hepatic Enzyme Increased
4135595 4419763 10 Years M 7/12/2004 8/4/2004 23 OT EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Albumin Increased, Blood Alkaline Phosphatase Increased, Hepatic Fibrosis Other
4135600 4349579 11 Years M 11/1/2003 12/4/2003 3/29/2004 116 OT PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Headache, Pallor
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4135601 4349581 14 Years F 12/2/2003 3/29/2004 118 CN PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Vomiting
4135603 4349583 12 Years 1/1/2003 12/2/2003 3/29/2004 118 MD PER Strattera Attention Deficit/Hyperactivity Disorder Cyanopsia
4135604 4349584     M 12/2/2003 3/29/2004 118 CN PER Strattera Feeling Abnormal
4135609 4349589     M 12/9/2003 12/2/2003 3/29/2004 118 PER Strattera Abnormal Behaviour Abnormal Behaviour, Asthenopia, Back Pain, Migraine, Nausea, Neck Pain, Panic Attack, Somnolence, Tension, Tremor, Vision Blurred
4135641 4346869 8 Years M 10/1/2003 12/10/2003 3/29/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anger, Drug Ineffective, Headache, Irritability, Nervousness
4135642 4346870     M 6/1/2003 12/8/2003 3/29/2004 112 PER Strattera Disturbance in Attention Depressed Mood
4135643 4346872 18 Years M 12/9/2003 3/29/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
4135644 4346873 6 Years M 12/9/2003 3/29/2004 111 MD PER Strattera Attention Deficit/Hyperactivity Disorder Compulsions, Tic
4135645 4346875 5 Years M 1/1/2003 12/10/2003 3/29/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Antisocial Behaviour, Crying, Drug Interaction, Fatigue, Hypersomnia, Pallor, Skin Discolouration, Social Avoidant Behaviour
4135646 4346876 12 Years 12/9/2003 3/29/2004 111 MD PER Strattera Anxiety
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4135647 4346878 8 Years M 12/7/2003 12/9/2003 3/29/2004 111 PER Strattera Abdominal Pain Upper, Anxiety, Increased Upper Airway Secretion, Phagophobia, Sensation of Foreign Body, Throat Irritation
4135648 4346879     M 12/9/2003 3/29/2004 111 PH PER Strattera Drug Screen Positive
4135649 4346880 9 Years F 12/9/2003 3/29/2004 111 OT PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
4135650 4346881 9 Years M 12/9/2003 3/29/2004 111 PER Strattera Tic, Weight Decreased
4135941 4347160     F 12/29/2003 3/29/2004 91 PER Strattera Gastrointestinal Haemorrhage
4135941 4440589     F 3/18/2004 7/28/2004 132 PER Strattera Gastrointestinal Haemorrhage
4135944 4347161 12 Years M 12/29/2003 3/29/2004 91 PER Strattera Gastrointestinal Haemorrhage
4135944 4440592 12 Years M 3/18/2004 7/28/2004 132 PER Strattera Gastrointestinal Haemorrhage
4135946 4347162 6 Years M 1/1/2003 12/29/2003 3/29/2004 91 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Drug Ineffective, Dysgraphia, Memory Impairment, Nervousness
4135947 4347163 29 Years M 12/1/2003 12/29/2003 3/29/2004 91 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Nervousness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4135949 4347165 7 Years M 12/1/2003 12/29/2003 3/29/2004 91 PER Strattera Psychomotor Hyperactivity Decreased Appetite, Fatigue, Psychomotor Hyperactivity
4135950 4347166 3 Years F 12/25/2003 12/29/2003 3/29/2004 91 PER Strattera Attention Deficit/Hyperactivity Disorder Labyrinthitis, Lethargy, Pyrexia
4135954 4347168 8 Years F 9/1/2003 12/29/2003 3/29/2004 91 OT PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Growth Retardation, Weight Decreased
4135955 4347169 9 Years F 11/1/2003 12/29/2003 3/29/2004 91 PER Strattera Drug Ineffective, Fatigue
4135960 4347170 6 Years F 2/3/2004 2/10/2004 3/29/2004 48 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Hypersomnia, Psychomotor Hyperactivity
4135961 4347171     F 12/1/2003 12/29/2003 3/29/2004 91 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Abnormal, Nausea
4135976 4347150 8 Years M 1/7/2004 1/8/2004 3/29/2004 81 PER Strattera Headache, Pain in Extremity
4135982 4347151 12 Years F 12/1/2003 1/8/2004 3/29/2004 81 PER Strattera Abnormal Behaviour, Disturbance in Attention, Emotional Disorder, Mood Swings
4135989 4347152     F 1/7/2004 3/29/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Hyperhidrosis
4135998 4347153 11 Years M 12/1/2003 1/7/2004 3/29/2004 82 PH PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fatigue, Hypersomnia Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4136006 4347154 18 Years M 1/6/2004 1/7/2004 3/29/2004 82 MD PER Strattera Fatigue, Feeling Abnormal, Nausea
4136011 4347155 6 Years M 1/7/2004 3/29/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
4136018 4347156 9 Years F 1/8/2004 3/29/2004 81 PER Strattera Abdominal Pain, Eructation, Gastrooesophageal Reflux Disease
4136029 4347157 5 Years M 12/1/2003 1/8/2004 3/29/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Dysphonia, Nervousness
4136037 4347158 8 Years F 1/8/2004 3/29/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Back Pain, Decreased Appetite, Fatigue, Mood Swings, Nausea, Tendon Injury, Weight Decreased
4136045 4347159 16 Years F 1/8/2004 3/29/2004 81 MD PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Emotional Distress
4136357 4347108     F 2/11/2004 3/29/2004 47 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased
4136357 4440684 15 Years M 9/29/2003 4/7/2004 7/28/2004 112 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased
4136358 4347133 15 Years M 2/18/2004 3/29/2004 40 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
4136359 4347134     F 2/11/2004 3/29/2004 47 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Feeling Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4136360 4347135 34 Years F 2/11/2004 3/29/2004 47 MD PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Tachycardia
4136361 4347109 13 Years M 2/16/2004 3/29/2004 42 PER Strattera Attention Deficit/Hyperactivity Disorder Protein Urine
4136361 4440682 13 Years M 4/8/2004 7/28/2004 111 CN PER Strattera Attention Deficit/Hyperactivity Disorder Protein Urine
4136362 4347136     F 1/26/2004 3/29/2004 63 MD PER Strattera Oedema Peripheral, Peripheral Coldness, Raynaud's Phenomenon
4136363 4347036 18 Years M 2/12/2004 2/13/2004 3/29/2004 45 PER Strattera Feeling Abnormal
4136364 4347112 7 Years M 2/16/2004 3/29/2004 42 MD PER Strattera Vision Blurred
4136365 4347113     F 2/16/2004 3/29/2004 42 PER Strattera Feeling Abnormal, Pyrexia, Tremor, Weight Decreased
4136366 4347137 13 Years M 2/1/2004 2/11/2004 3/29/2004 47 OT PER Strattera Attention Deficit/Hyperactivity Disorder Epistaxis
4136368 4347037 10 Years M 2/1/2004 2/13/2004 3/29/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Sleep Disorder, Somnolence
4136368 4440673 10 Years M 1/1/2003 5/5/2004 7/28/2004 84 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Anorexia, Fatigue, Personality Change, Sleep Disorder, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4136369 4347138 4 Years M 1/30/2004 2/11/2004 3/29/2004 47 CN PER Strattera Retching
4136369 4440712 4 Years M 1/30/2004 3/8/2004 7/28/2004 142 PER Strattera Decreased Appetite, Retching, Somnolence, Weight Decreased
4136370 4347114 16 Years F 2/17/2004 2/24/2004 3/29/2004 34 PER Strattera Dizziness, Somnolence, Vomiting
4136372 4346971     F 12/1/2003 12/18/2003 3/29/2004 102 CN PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Somnolence
4136373 4347040 33 Years F 1/1/2004 2/16/2004 3/29/2004 42 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Influenza Like Illness
4136373 4440678 33 Years F 1/1/2004 2/16/2004 7/28/2004 163 CN PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Influenza Like Illness
4136374 4347139 11 Years M 2/1/2003 2/11/2004 3/29/2004 47 CN PER Strattera Anxiety, Depression, Drug Ineffective, Fatigue
4136375 4347120 31 Years M 2/11/2004 3/29/2004 47 MD PER Strattera Feeling Abnormal, Testicular Injury, Testicular Pain
4136376 4347115 23 Years F 2/9/2004 2/16/2004 3/29/2004 42 OT PER Strattera Dysmenorrhoea, Panic Attack
4136377 4347140 15 Years M 2/12/2004 3/29/2004 46 MD PER Strattera Dysphemia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4136379 4347015 6 Years F 2/1/2004 2/13/2004 3/29/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder, Disturbance in Attention
4136380 4347041 8 Years M 2/16/2004 3/29/2004 42 PER Strattera Attention Deficit/Hyperactivity Disorder Cyanosis
4136381 4347123 4 Years M 2/10/2004 2/11/2004 3/29/2004 47 PER Strattera Aggression, Anger, Anxiety, Vomiting
4136382 4347116 11 Years M 2/16/2004 3/29/2004 42 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Drug Ineffective
4136383 4347142 6 Years M 2/6/2004 2/12/2004 3/29/2004 46 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Decreased Appetite, Dyskinesia
4136384 4346972     F 12/18/2003 3/29/2004 102 MD PER Strattera Suicidal Ideation
4136385 4347016     F 2/13/2004 2/13/2004 3/29/2004 45 PER Strattera Feeling Abnormal, Somnolence
4136386 4347124 19 Years F 1/1/2003 2/11/2004 3/29/2004 47 PER Strattera Depression, Fatigue
4136388 4347042 35 Years M 1/1/2004 2/16/2004 3/29/2004 42 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Somnolence
4136389 4347144     M 2/1/2004 2/12/2004 3/29/2004 46 CN PER Strattera Attention Deficit/Hyperactivity Disorder Chest Discomfort, Feeling Abnormal, Insomnia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4136390 4346974 33 Years M 12/18/2003 12/18/2003 3/29/2004 102 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Stomach Discomfort
4136391 4347018 51 Years F 2/13/2004 3/29/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Tremor
4136392 4347001 18 Years M 2/19/2004 3/29/2004 39 CN PER Strattera Attention Deficit/Hyperactivity Disorder Chromaturia, Scrotal Pain, Somnolence
4136394 4346975 12 Years M 12/18/2003 3/29/2004 102 CN PER Strattera Drug Ineffective
4136395 4347043 5 Years M 2/16/2004 3/29/2004 42 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Fatigue, Irritability, Pain in Extremity, Polydipsia
4136397 4347122 53 Years M 2/8/2004 2/11/2004 3/29/2004 47 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance In Sexual Arousal, Dysuria, Insomnia, Micturition Urgency, Urine Flow Decreased
4136398 4347019     F 2/1/2004 2/13/2004 3/29/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Palpitations
4136400 4347046 6 Years M 2/14/2004 2/16/2004 3/29/2004 42 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Feeling Abnormal, Somnolence
4136401 4346976 8 Years M 12/18/2003 3/29/2004 102 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective
4136402 4347002 12 Years 2/12/2004 3/29/2004 46 MD PER Strattera Agitation, Nightmare, Psychomotor Hyperactivity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4136403 4347020 26 Years M 2/1/2004 2/13/2004 3/29/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder, Erectile Dysfunction, Muscle Twitching
4136405 4347003 11 Years M 2/9/2004 2/12/2004 3/29/2004 46 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Fear, Somnolence
4136406 4346977     M 12/18/2003 3/29/2004 102 MD PER Strattera Enuresis
4136408 4347048 11 Years F 2/16/2004 3/29/2004 42 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
4136409 4347022 12 Years M 2/13/2004 3/29/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Fatigue, Grimacing
4136410 4347004 9 Years F 9/1/2003 2/12/2004 3/29/2004 46 PER Strattera Attention Deficit/Hyperactivity Disorder Ear Infection, Educational Problem, Impulsive Behaviour
4136411 4346978 7 Years F 1/1/2003 12/19/2003 3/29/2004 101 CN PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Decreased Appetite, Excitability
4136414 4347054 15 Years M 1/1/2004 2/16/2004 3/29/2004 42 PER Strattera Attention Deficit/Hyperactivity Disorder Coeliac Disease
4136414 4440680 15 Years M 1/1/2004 4/2/2004 7/28/2004 117 CN PER Strattera Attention Deficit/Hyperactivity Disorder Coeliac Disease
4136415 4347055 37 Years M 2/16/2004 3/29/2004 42 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Nervousness, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4136415 4440681 37 Years M 2/16/2004 7/28/2004 163 CN PER Strattera Attention Deficit/Hyperactivity Disorder Nervousness, Somnolence, Stomach Discomfort
4136417 4347029 18 Years M 2/11/2004 2/13/2004 3/29/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Anxiety, Depressed Mood, Dysuria, Excitability, Infrequent Bowel Movements, Paraesthesia
4136420 4346979     12/17/2003 3/29/2004 103 MD PER Strattera Somnolence
4136421 4347005     M 2/12/2004 3/29/2004 46 PER Strattera
4136422 4347032 11 Years M 1/26/2004 2/13/2004 3/29/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Dyskinesia, Muscle Twitching
4136424 4346982 11 Years M 12/1/2003 12/19/2003 3/29/2004 101 CN PER Strattera Attention Deficit/Hyperactivity Disorder Agitation
4136427 4347006     F 2/12/2004 2/12/2004 3/29/2004 46 PER Strattera Feeling Abnormal, Nausea, Somnolence
4136431 4347007     F 2/23/2004 3/29/2004 35 PER Strattera Attention Deficit/Hyperactivity Disorder Dysgeusia, Mood Swings, Nausea, Somnolence
4136434 4347009 12 Years 2/6/2004 3/29/2004 52 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4136435 4346983 10 Years M 12/1/2003 12/18/2003 3/29/2004 102 CN PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4136437 4347011 11 Years M 2/13/2004 3/29/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Fatigue, Feeling of Despair, Insomnia, Mood Swings
4136442 4347012 28 Years M 2/1/2004 2/13/2004 3/29/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
4136458 4347126 16 Years M 2/1/2004 2/11/2004 3/29/2004 47 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Feeling Abnormal, Indifference
4136462 4347127 6 Years M 1/1/2004 2/11/2004 3/29/2004 47 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4136466 4347128 11 Years M 1/1/2004 2/11/2004 3/29/2004 47 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Aggression, Delusion of Grandeur, Headache, Logorrhoea, Negativism
4136468 4347129 9 Years M 12/1/2003 2/11/2004 3/29/2004 47 PER Strattera Attention Deficit/Hyperactivity Disorder Tourette's Disorder
4136471 4347130 12 Years 2/4/2004 3/29/2004 54 MD PER Strattera Extrapyramidal Disorder
4136474 4347132 22 Years M 2/11/2004 3/29/2004 47 PER Strattera Attention Deficit/Hyperactivity Disorder, Disturbance in Attention Drug Ineffective, Dysuria
4136474 4440710 22 Years M 6/2/2004 7/28/2004 56 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Dysuria, Penile Discharge
4136474 4501699 22 Years M 6/2/2004 9/27/2004 117 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Dysuria, Penile Discharge
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4136580 4347030 19 Years M 2/13/2004 3/29/2004 45 PER Strattera Anger
4136798 4351215 12 Years M 5/1/2003 4/6/2004 4/28/2004 22 EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Homicidal Ideation, Insomnia, Pharmaceutical Product Complaint, Suicidal Ideation Hospitalization - Initial or Prolonged
4136879 4351415 7 Years M 4/13/2004 4/28/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion Other
4136881 4351417 13 Years M 3/29/2004 4/12/2004 4/28/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Cardiomegaly, Cardiomyopathy, Dyspnoea Hospitalization - Initial or Prolonged
4136881 4373146 13 Years M 3/29/2004 5/18/2004 6/3/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Carnitine Increased, Chromosome Abnormality, Congestive Cardiomyopathy, Ejection Fraction Decreased, Hepatitis C Positive, Urine Analysis Abnormal Hospitalization - Initial or Prolonged, Other
4136884 4351418 25 Years F 4/1/2004 4/12/2004 4/28/2004 16 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Impulsive Behaviour, Loss of Consciousness Other
4137151 4327487 11 Years M 2/2/2003 3/29/2004 PH DIR Strattera Attention Deficit/Hyperactivity Disorder Drooling, Dysphagia, Extrapyramidal Disorder, Gait Disturbance, Gaze Palsy Hospitalization - Initial or Prolonged
4137269 4349148     M 4/1/2003 12/4/2003 3/29/2004 116 OT PER Strattera Attention Deficit/Hyperactivity Disorder Lethargy, Mydriasis, Nausea, Palpitations
4137863 4347117 12 Years M 2/16/2004 3/29/2004 42 MD PER Strattera Tic
4137866 4347118     M 2/1/2004 2/10/2004 3/29/2004 48 PER Strattera Alopecia, Pruritus
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4137870 4347119 11 Years M 2/17/2004 3/29/2004 41 PER Strattera Fatigue, Mood Altered, Personality Change
4139539 4355781 11 Years M 12/1/2003 5/10/2004 OT DIR Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Heart Rate Increased, QRS Axis Abnormal, Ventricular Hypertrophy Other
4139691 4355746 11 Years F 11/18/2003 5/10/2004 OT DIR Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dizziness, Fall, Feeling Abnormal, Loss of Consciousness, Stomach Discomfort, Vomiting Other
4140320 4356979 12 Years M 1/6/2004 4/19/2004 5/7/2004 18 EXP Strattera Psychomotor Hyperactivity Convulsion, Eye Rolling, Faecal Incontinence, Insomnia, Intentional Self-Injury, Urinary Incontinence Other
4140322 4356980     M 4/15/2004 5/7/2004 22 MD EXP Strattera Supraventricular Tachycardia Other
4140327 4356981 8 Years M 1/29/2004 4/15/2004 5/7/2004 22 EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion Hospitalization - Initial or Prolonged, Other
4140327 4381490 9 Years M 1/1/2004 5/26/2004 6/16/2004 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Faecal Incontinence, Grand Mal Convulsion, Psychomotor Hyperactivity, Somnolence, Urinary Incontinence Hospitalization - Initial or Prolonged, Other
4140327 4433958 9 Years M 1/1/2004 8/9/2004 8/25/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Grand Mal Convulsion, Incontinence, Psychomotor Hyperactivity Hospitalization - Initial or Prolonged, Other
4140327 4474255 9 Years M 1/1/2004 9/17/2004 10/8/2004 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Depressed Level of Consciousness, Drug Ineffective, Electroencephalogram Abnormal, Faecal Incontinence, Hypotonia, Partial Seizures with Secondary Generalisation, Postictal State, Psychomotor Hyperactivity, Somnolence, Urinary Incontinence Hospitalization - Initial or Prolonged, Other
4140329 4356982     M 4/15/2004 5/7/2004 22 MD EXP Strattera Supraventricular Tachycardia Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4141339 4356939 16 Years F 4/1/2004 4/15/2004 5/7/2004 22 EXP Strattera Attention Deficit/Hyperactivity Disorder Anger, Fatigue, Feeling Abnormal, Headache, Impulsive Behaviour, Intentional Self-Injury, Irritability, Mood Swings, Nausea, Weight Increased Hospitalization - Initial or Prolonged
4141341 4356941 7 Years F 4/19/2004 4/21/2004 5/7/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion Other
4141341 4381487 7 Years F 4/19/2004 5/27/2004 6/16/2004 20 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion Other
4141396 4356944 45 Years F 4/19/2004 5/7/2004 18 EXP Strattera Convulsion, Feeling Abnormal, Insomnia, Nervous System Disorder Other
4141399 4356945 61 Years F 1/1/2003 4/19/2004 5/7/2004 18 EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Loss of Consciousness Other
4141401 4356942 35 Years M 4/1/2004 3/8/2004 4/20/2004 5/7/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Completed Suicide, Intentional Overdose Death
4141401 4956847 35 Years M 3/8/2004 3/8/2004 3/9/2006 3/23/2006 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Bronchopneumonia, Completed Suicide, Hepatic Steatosis, Intentional Drug Misuse, Multiple Drug Overdose Intentional Death, Other
4143539 4359920 25 Years F 6/30/2003 5/18/2004 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Brain Damage, Depression, Headache, Hyperhidrosis, Irritability, Nausea, Nervous System Disorder, Panic Attack, Stress Symptoms Other
4143619 4359170 23 Years M 4/21/2004 4/26/2004 5/12/2004 16 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Dizziness, Drug Effect Increased, Drug Toxicity, Loss of Consciousness Other
4143620 4359174 11 Years F 4/25/2004 4/26/2004 5/12/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion, Postictal State Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4143621 4359175 43 Years M 4/1/2004 4/24/2004 5/12/2004 18 MD EXP Strattera Heart Rate Irregular, Loss of Consciousness, Nausea, Syncope Other
4143629 4359182     M 4/27/2004 5/12/2004 15 MD EXP Strattera Convulsion Other
4143635 4359176 11 Years M 1/1/2004 4/26/2004 5/12/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Electrocardiogram QT Corrected Interval Prolonged, Electrocardiogram QT Prolonged Other
4143693 4359178 11 Years M 1/1/2004 4/26/2004 5/12/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Electrocardiogram QT Corrected Interval Prolonged, Electrocardiogram QT Prolonged Other
4143700 4359180 12 Years M 1/1/2004 4/26/2004 5/12/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Electrocardiogram QT Corrected Interval Prolonged, Electrocardiogram QT Prolonged Other
4143998 4359161     M 4/27/2004 5/12/2004 15 MD EXP Strattera Convulsion Other
4144003 4359162 12 Years 4/1/2004 4/22/2004 5/12/2004 20 MD EXP Strattera Convulsion Other
4144003 4399440 8 Years F 1/1/2004 6/21/2004 7/12/2004 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Loss of Consciousness Other
4144003 4413799 8 Years F 1/1/2004 7/8/2004 7/28/2004 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Loss of Consciousness Other
4144006 4359163 16 Years M 1/1/2003 4/23/2004 5/12/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Anger, Decreased Appetite, Depression, Drug Interaction, Feeling Abnormal, Insomnia, Loss of Consciousness, Loss of Employment, Paranoia, Psychotic Disorder, Road Traffic Accident, Tearfulness, Theft Hospitalization - Initial or Prolonged, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4144007 4359164 14 Years M 4/23/2004 5/12/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Atrioventricular Block Second Degree, Condition Aggravated Other
4144162 4361049     M 3/29/2004 5/19/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Cardiomegaly, Dyspnoea Exertional
4144237 4359218 12 Years M 8/24/2003 4/23/2004 5/12/2004 19 EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Confusional State, Electroencephalogram Abnormal, Eye Pain, Fall, Feeling Hot, Head Injury, Migraine, Paraesthesia, Somnolence, Vomiting Hospitalization - Initial or Prolonged
4144272 4359179 13 Years M 1/1/2004 4/26/2004 5/12/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Electrocardiogram QT Prolonged Other
4144358 4361363 7 Years M 4/23/2004 5/19/2004 OT DIR Strattera Attention Deficit/Hyperactivity Disorder Photosensitivity Reaction Other
4147803 4364649 11 Years F 5/4/2004 5/21/2004 17 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion Other
4147813 4364650 36 Years M 4/21/2004 5/4/2004 5/21/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Pancreatitis Hospitalization - Initial or Prolonged
4147813 4421799 36 Years M 4/21/2004 7/21/2004 8/6/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Lymphoma, Pancreatitis Hospitalization - Initial or Prolonged, Other
4147949 4364847 9 Years F 5/6/2004 5/10/2004 5/21/2004 11 EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Abdominal Pain Upper, Dyspepsia, Eating Disorder, Gastric Haemorrhage, Haematochezia, Stomach Discomfort Hospitalization - Initial or Prolonged
4147949 4456277 9 Years F 5/6/2004 8/27/2004 9/17/2004 21 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Abdominal Pain Upper, Dyspepsia, Eating Disorder, Gastric Haemorrhage, Screaming, Stomach Discomfort, Vomiting Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4147949 4476731 9 Years F 5/6/2004 10/1/2004 10/13/2004 12 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Abdominal Pain Upper, Dyspepsia, Ear Pain, Eating Disorder, Faeces Discoloured, Gastritis, Gastritis Viral, Gastrointestinal Haemorrhage, Irritable Bowel Syndrome, Loose Stools, Nasal Congestion, Pharyngolaryngeal Pain, Pyrexia, Screaming, Viral Infection, Vomiting
4147953 4364848 12 Years M 4/12/2004 4/30/2004 5/21/2004 21 OT EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Appendicitis Hospitalization - Initial or Prolonged
4147953 4501086 12 Years M 4/7/2004 10/21/2004 11/9/2004 19 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Appendicitis, Nausea, Vomiting Hospitalization - Initial or Prolonged
4148328 4364658 12 Years 5/3/2004 5/21/2004 18 MD EXP Strattera Glaucoma Other
4148333 4364659 46 Years F 5/3/2004 5/21/2004 18 OT EXP Strattera Multiple Drug Overdose Intentional Other
4148333 4373149 46 Years F 5/19/2004 6/3/2004 15 OT EXP Strattera Alcohol Use, Drug Screen Positive, Intentional Overdose, Multiple Drug Overdose Hospitalization - Initial or Prolonged
4148345 4364662     5/3/2004 5/21/2004 18 MD EXP Strattera Anencephaly, Intra-Uterine Death, Transmission of Drug via Semen Congenital Anomaly, Death
4148345 4464694     4/1/2004 9/10/2004 9/29/2004 19 MD EXP Strattera Abortion Induced, Anencephaly, Drug Exposure During Pregnancy, Transmission of Drug via Semen Congenital Anomaly
4148360 4364664 45 Years F 4/26/2004 4/26/2004 4/29/2004 5/21/2004 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Agitation, Anxiety, Brain Death, Cardiac Arrest, Loss of Consciousness Death, Hospitalization - Initial or Prolonged, Life-Threatening
4148360 4449074 45 Years F 4/26/2004 8/24/2004 9/9/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Agitation, Anoxic Encephalopathy, Anxiety, Brain Death, Cardiac Arrest, Loss of Consciousness Death, Hospitalization - Initial or Prolonged, Life-Threatening
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4148360 4456279 45 Years F 4/26/2004 8/31/2004 9/17/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Agitation, Anoxic Encephalopathy, Anxiety, Brain Death, Cardiac Arrest Death, Hospitalization - Initial or Prolonged, Life-Threatening
4148364 4364666 27 Years M 4/29/2004 5/21/2004 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion, Impaired Driving Ability Other
4148364 4413801 27 Years M 7/7/2004 7/28/2004 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alcohol Poisoning, Grand Mal Convulsion, Impaired Driving Ability, Imprisonment Other
4150787 4369173 13 Years M 5/11/2004 5/11/2004 5/27/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Hemiparesis Other
4150787 4381485 13 Years M 5/11/2004 5/31/2004 6/16/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Hemiparesis, Therapy Non-Responder Other
4150834 4369177 36 Years F 5/11/2004 5/27/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Drug Intolerance, Dyspnoea, Fatigue, Haematemesis, Mood Altered, Nausea, Tremor, Weight Decreased Other
4150842 4369182     5/7/2004 5/27/2004 20 OT EXP Strattera Heat Stroke Other
4150862 4369185 61 Years F 12/1/2003 5/10/2004 5/27/2004 17 EXP Strattera Attention Deficit/Hyperactivity Disorder Cartilage Injury, Leg Crushing, Road Traffic Accident, Strabismus, Vith Nerve Paralysis Hospitalization - Initial or Prolonged
4150872 4369188 17 Years M 5/7/2004 5/27/2004 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive, Mania Hospitalization - Initial or Prolonged
4150872 4378772 17 Years M 5/25/2004 6/9/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive, Mania Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4151041 4369419 20 Years F 2/1/2004 5/10/2004 5/27/2004 17 EXP Strattera Convulsion, Drug Interaction Other
4151041 4399407 20 Years F 2/1/2004 6/21/2004 7/12/2004 21 EXP Strattera Drug Interaction, Electroencephalogram Abnormal, Grand Mal Convulsion Other
4151041 4421752 20 Years F 2/1/2004 7/16/2004 8/6/2004 21 MD EXP Strattera Convulsion, Drug Interaction, Electroencephalogram Abnormal, Exposure to Toxic Agent, Tonic Clonic Movements Other
4151133 4372239 10 Years M 5/20/2004 6/3/2004 CN DIR Strattera Asperger's Disorder, Attention Deficit/Hyperactivity Disorder, Developmental Delay Mood Altered, Tic Other
4151180 4369196 7 Years M 5/20/2004 6/2/2004 PH DIR Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Disturbance in Attention, Personality Change Other
4152401 4368784 12 Years M 5/6/2004 5/27/2004 21 MD EXP Strattera Convulsion Other
4152456 4369175     5/10/2004 5/27/2004 17 MD EXP Strattera Stevens-Johnson Syndrome Other
4152635 4368792 14 Years M 3/9/2004 5/12/2004 5/27/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Agitation, Anxiety, Burns First Degree, Burns Second Degree, Psychomotor Hyperactivity, Self Injurious Behaviour, Self-Injurious Ideation Other
4152690 4371050 13 Years F 10/1/2003 5/6/2004 5/27/2004 21 EXP Strattera Attention Deficit/Hyperactivity Disorder Constipation, Decreased Appetite, Educational Problem, Mood Altered, Nausea, Nephrolithiasis, Pain Other
4152701 4371051 7 Years M 5/3/2004 5/13/2004 5/27/2004 14 EXP Strattera Blindness Transient, Eye Pain, Photopsia Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4152701 4399438 7 Years M 5/3/2004 6/21/2004 7/12/2004 21 MD EXP Strattera Blindness Transient, Eye Pain, Photopsia Other
4152711 4371054 17 Years M 4/1/2004 4/1/2004 5/6/2004 5/27/2004 21 OT EXP Strattera Completed Suicide Death
4152711 4456276 17 Years M 4/1/2004 4/1/2004 8/31/2004 9/17/2004 17 MD EXP Strattera Completed Suicide, Injury Asphyxiation, Intentional Self-Injury Death
4154007 4372976     M 5/19/2004 6/3/2004 15 MD EXP Strattera Abdominal Discomfort, Dizziness, Syncope Other
4154008 4372977 14 Years M 5/19/2004 6/3/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Heart Rate Increased, Loss of Consciousness Other
4154009 4372978     F 5/14/2004 6/3/2004 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Kawasaki's Disease Other
4154010 4372979 16 Years M 4/1/2004 5/14/2004 6/3/2004 20 PH EXP Strattera Abnormal Behaviour, Drug Screen Positive Hospitalization - Initial or Prolonged
4154011 4372980 12 Years F 3/25/2004 5/18/2004 6/3/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Feeling Abnormal, Gait Disturbance, Hallucination (Visual), Psychotic Disorder, Vomiting Hospitalization - Initial or Prolonged
4154011 4444633 12 Years F 3/25/2004 8/17/2004 9/2/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Gait Disturbance, Hallucination (Visual), Psychotic Disorder, Sensory Disturbance, Vomiting Hospitalization - Initial or Prolonged
4154012 4372981 12 Years 5/18/2004 6/3/2004 16 EXP Strattera Psychotic Disorder Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4154023 4372986 14 Years M 5/19/2004 6/3/2004 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Chromaturia, Psychotic Disorder, Somnolence, Tremor, Urinary Tract Infection, Urine Odour Abnormal Hospitalization - Initial or Prolonged
4154034 4372987 30 Years F 5/1/2004 5/18/2004 6/3/2004 16 PH EXP Strattera Hospitalisation Hospitalization - Initial or Prolonged
4154430 4373033 21 Years M 5/11/2004 5/13/2004 6/3/2004 21 OT EXP Strattera Bipolar Disorder Convulsion, Fall, Loss of Consciousness Other
4154431 4373035     F 5/12/2004 5/13/2004 6/3/2004 21 MD EXP Strattera Agitation, Feeling Jittery, Overdose Hospitalization - Initial or Prolonged
4154433 4373036 6 Years M 5/18/2004 6/3/2004 16 OT EXP Strattera Pervasive Developmental Disorder Petit Mal Epilepsy Other
4154433 4427061 6 Years M 1/29/2004 7/27/2004 8/11/2004 15 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Body Temperature Decreased, Eye Movement Disorder, Lethargy, Muscle Twitching, Petit Mal Epilepsy, Vomiting Other
4157575 4378183 10 Years M 5/26/2004 6/9/2004 14 OT EXP Strattera Glaucoma Other
4157575 4381484 10 Years M 4/8/2004 6/2/2004 6/16/2004 14 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort, Glaucoma Other
4157588 4378206 41 Years M 12/19/2003 12/19/2003 6/2/2004 6/9/2004 7 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Myocardial Infarction Death
4157599 4378208 6 Years M 5/24/2004 6/9/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Condition Aggravated, Convulsion Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4157608 4378209 40 Years F 5/1/2004 5/24/2004 6/9/2004 16 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Atrial Fibrillation Hospitalization - Initial or Prolonged
4157627 4378210 9 Years F 5/1/2004 5/21/2004 6/9/2004 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Disturbance In Social Behaviour, Homicidal Ideation, Oppositional Defiant Disorder Hospitalization - Initial or Prolonged
4157627 4444632 9 Years F 5/1/2004 8/16/2004 9/2/2004 17 EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Human Bite, Personality Change, Physical Assault Hospitalization - Initial or Prolonged
4157638 4378211 11 Years M 5/19/2004 5/20/2004 6/9/2004 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Pallor, Somnolence, Syncope Other
4157762 4378732 25 Years M 5/20/2004 6/9/2004 20 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased Other
4157762 4407874 25 Years M 7/8/2004 7/21/2004 13 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Hepatitis C Other
4157762 4413802 25 Years M 7/8/2004 7/28/2004 20 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatitis C Other
4160137 4381188 12 Years F 4/19/2004 6/17/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Pruritus, Urticaria Other
4160360 4381310 24 Years M 6/4/2004 6/17/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Bladder Distension, Dysuria Hospitalization - Initial or Prolonged, Other
4160431 4381315 14 Years M 6/30/2003 6/17/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Irritability, Mood Altered Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4161335 4383336 8 Years M 5/22/2004 5/27/2004 6/18/2004 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Drug Ineffective Other
4161335 4391971 8 Years M 5/22/2004 6/10/2004 7/1/2004 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Agitation, Blood Pressure Diastolic Decreased, Drug Ineffective, Heart Rate Increased, Loss of Consciousness, Partial Seizures with Secondary Generalisation, Postictal State, Tonic Clonic Movements Other
4161338 4383338     M 6/2/2004 6/18/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fall, Loss of Consciousness Hospitalization - Initial or Prolonged
4161338 4391970 45 Years M 6/14/2004 7/1/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fall, Loss of Consciousness, Nasopharyngitis, Orthostatic Hypotension Hospitalization - Initial or Prolonged
4161341 4383342     M 6/2/2004 6/18/2004 16 MD EXP Strattera Suicidal Ideation Hospitalization - Initial or Prolonged
4161343 4383343     M 6/2/2004 6/18/2004 16 MD EXP Strattera Suicidal Ideation Hospitalization - Initial or Prolonged
4161364 4383379     M 5/27/2004 6/18/2004 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Syncope Other
4161370 4383381     M 5/26/2004 5/27/2004 6/18/2004 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Cardiac Fibrillation Other
4161373 4383382 11 Years M 5/26/2004 6/18/2004 23 MD EXP Strattera Electrocardiogram QT Corrected Interval Prolonged Hospitalization - Initial or Prolonged, Other
4161373 4455092 11 Years M 8/31/2004 9/17/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Electrocardiogram QT Corrected Interval Prolonged, Loss of Consciousness Hospitalization - Initial or Prolonged, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4161373 4545551 11 Years M 12/15/2004 1/3/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Electrocardiogram QT Corrected Interval Prolonged, Electrocution, Loss of Consciousness Hospitalization - Initial or Prolonged, Other
4161612 4383703 9 Years M 2/14/2003 6/2/2004 6/18/2004 16 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Chest Pain, Heart Rate Increased, Loss of Consciousness, Muscle Cramp Other
4161612 4399441 9 Years M 2/14/2003 6/21/2004 7/12/2004 21 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Abnormal Behaviour, Chest Pain, Heart Rate Increased, Loss of Consciousness Other
4163333 4385799 12 Years M 6/2/2004 6/4/2004 6/23/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Palpitations, Tachycardia Other
4163333 4399879 12 Years M 6/2/2004 6/24/2004 7/14/2004 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Palpitations, Tachycardia Other
4165040 4388078 12 Years M 6/4/2004 6/23/2004 19 MD EXP Strattera Loss of Consciousness Other
4165046 4388080 10 Years F 1/1/2004 6/4/2004 6/23/2004 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Choking, Convulsion, Loss of Consciousness, Salivary Hypersecretion, Tremor Other
4165046 4449076 10 Years F 1/1/2004 8/19/2004 9/9/2004 21 EXP Strattera Attention Deficit/Hyperactivity Disorder Apnoea, Choking, Convulsion, Loss of Consciousness Other
4165051 4388081 57 Years M 4/1/2004 6/9/2004 6/23/2004 14 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Neuroleptic Malignant Syndrome Hospitalization - Initial or Prolonged, Other
4165051 4457402 57 Years M 4/1/2004 9/8/2004 9/22/2004 14 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Chloride Increased, Blood Potassium Decreased, Cerebral Atrophy, Disease Recurrence, Electroencephalogram Abnormal, Foreign Body Trauma, Haematocrit Decreased, Haemoglobin Decreased, Neuroleptic Malignant Syndrome, Platelet Count Increased, Pleural Effusion, Post Procedural Complication, Rhabdomyolysis, Serotonin Syndrome, Sputum Culture Positive, Staphylococcal Infection Hospitalization - Initial or Prolonged, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4165051 4530762 57 Years M 4/1/2004 9/8/2004 11/29/2004 82 PH PER Strattera Attention Deficit/Hyperactivity Disorder Neuroleptic Malignant Syndrome, Staphylococcal Infection Hospitalization - Initial or Prolonged, Other
4165053 4388082 35 Years M 11/1/2003 6/9/2004 6/23/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder, Joint Swelling, Viral Vasculitis Other
4165055 4388083 14 Years 6/1/2004 6/9/2004 6/23/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Overdose, Suicide Attempt Hospitalization - Initial or Prolonged, Other
4168406 4393260 10 Years 4/4/2004 6/11/2004 7/1/2004 20 EXP Atomoxetine Attention Deficit/Hyperactivity Disorder, Oppositional Defiant Disorder Anorexia, Apathy, Depression, Fatigue, Hypersomnia, Weight Decreased Other
4168734 4302946 7 Years F 9/25/2003 1/26/2004 123 MD PER Strattera Dysphemia
4168736 4301779 11 Years M 1/1/2003 10/2/2003 1/26/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Blepharospasm, Fatigue, Headache
4168738 4296875 10 Years M 8/1/2003 8/27/2003 1/26/2004 152 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Irritability, Stool Analysis Abnormal
4168847 4392009 14 Years M 6/1/2003 6/11/2004 7/1/2004 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion Hospitalization - Initial or Prolonged, Other
4168848 4392010 19 Years M 6/10/2004 7/1/2004 21 EXP Strattera Oesophageal Disorder, Scar, Throat Irritation Other
4168987 4392012 18 Years M 6/16/2004 7/1/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Completed Suicide, Depression, Disturbance in Attention, Emotional Disorder, Gun Shot Wound Death
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4169000 4392013 13 Years F 6/12/2004 6/15/2004 7/1/2004 16 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anger, Attention-Seeking Behaviour, Fatigue, Headache, Impulsive Behaviour, Overdose, Somnolence Other
4169000 4399433 13 Years F 6/12/2004 6/22/2004 7/12/2004 20 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Blood Glucose Increased, Body Temperature Decreased, Emotional Disorder, Fatigue, Headache, Intentional Overdose, Vomiting Other
4169054 4391998 21 Years M 6/11/2004 7/1/2004 20 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Disease Recurrence, Fall Other
4169054 4413537 21 Years M 7/13/2004 7/28/2004 15 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Respiratory Arrest, Syncope Vasovagal Other
4169054 4493308 21 Years M 10/19/2004 11/2/2004 14 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Apnoea, Convulsion, Cyanosis, Fall, Muscle Twitching, Syncope Vasovagal Other
4169056 4391999     F 1/1/2004 6/11/2004 7/1/2004 20 EXP Strattera Fall, Loss of Consciousness Other
4171103 4394134 65 Years M 7/4/2004 7/8/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Atrial Fibrillation Hospitalization - Initial or Prolonged, Life-Threatening, Required Intervention to Prevent Permanent Impairment/Damage
4173237 4398235     7/14/2004 MD DIR Strattera Aggression, Agitation, Hypomania, Mania
4173631 4398812 58 Years F 1/1/2004 6/17/2004 7/12/2004 25 MD EXP Strattera Fatigue, General Physical Health Deterioration, Red Blood Cell Count Decreased Hospitalization - Initial or Prolonged
4173633 4398813 12 Years 6/18/2004 7/12/2004 24 MD EXP Strattera Thrombocytopenia Hospitalization - Initial or Prolonged, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4173633 4413539 14 Years M 7/12/2004 7/28/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Contusion, Thrombocytopenia Hospitalization - Initial or Prolonged, Other
4173633 4518205 14 Years M 11/12/2004 11/30/2004 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Contusion, Thrombocytopenia Hospitalization - Initial or Prolonged, Other
4176470 4402051     M 8/1/2003 7/19/2004 OT DIR Strattera Attention Deficit/Hyperactivity Disorder Condition Aggravated, Dysgraphia, Tremor Other
4176768 4404614 38 Years M 3/1/2004 7/21/2004 DIR Strattera Attention Deficit/Hyperactivity Disorder Penile Discharge, Rhinorrhoea Other
4176796 4401751 12 Years F 6/1/2004 6/28/2004 7/14/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Decreased Appetite, Dizziness, Face Injury, Fall, Loss of Consciousness, Mental Impairment, Somnolence Other
4176806 4401755 35 Years F 4/19/2004 6/29/2004 7/14/2004 15 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased Hospitalization - Initial or Prolonged
4176813 4401756 7 Years M 6/29/2004 7/14/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Mania Hospitalization - Initial or Prolonged
4176820 4401760 10 Years M 6/28/2004 7/14/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Cardiac Valve Disease Other
4176820 4538839 10 Years M 12/6/2004 12/22/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aortic Valve Incompetence, Aortic Valve Stenosis, Cardiac Valve Disease, Cardiac Valve Replacement Complication, Echocardiogram Abnormal, Ejection Fraction Decreased, Headache, Ventricular Hypertrophy Other
4176833 4401761     F 5/24/2004 6/29/2004 7/14/2004 15 EXP Strattera Aphonia, Burn Oesophageal, Burning Sensation, Drug Ineffective, Ear Pain, Foreign Body Trauma, Pharmaceutical Product Complaint, Pharyngolaryngeal Pain, Sputum Discoloured, Throat Irritation Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4176833 4407752     F 5/24/2004 7/7/2004 7/21/2004 14 CN EXP Strattera Aphonia, Burn Oesophageal, Burning Sensation, Drug Ineffective, Ear Pain, Fear, Foreign Body Trauma, Markedly Reduced Dietary Intake, Oral Mucosal Blistering, Pharmaceutical Product Complaint, Sputum Discoloured Other
4179889 4407336 57 Years F 7/1/2004 7/21/2004 20 EXP Strattera Inflammation, Liver Disorder Other
4179889 4421784 57 Years F 7/20/2004 8/6/2004 17 CN EXP Strattera Condition Aggravated, Hepatitis C Other
4179889 4449070 57 Years F 8/20/2004 9/9/2004 20 MD EXP Strattera Hepatitis Other
4179894 4407337 44 Years M 6/26/2004 7/8/2004 7/21/2004 13 EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Abnormal, Disorientation, Dizziness, Drug Ineffective, Dysarthria, Dyspnoea, Dysstasia, Eye Swelling, Head Injury, Laceration, Loss of Consciousness, Malaise, Nausea, Post Procedural Complication, Rash, Tremor, Urticaria, Vomiting Other
4179894 4425562 44 Years M 6/26/2004 7/20/2004 8/10/2004 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Adverse Drug Reaction, Disorientation, Dizziness, Dysarthria, Dyspnoea, Eating Disorder, Eye Swelling, Feeling Abnormal, Head Injury, Labile Blood Pressure, Laceration, Loss of Consciousness, Movement Disorder, Rash, Tremor, Urticaria Other
4179895 4407340 53 Years M 6/26/2004 7/6/2004 7/21/2004 15 OT EXP Strattera Atrial Fibrillation, Conduction Disorder, Ventricular Tachycardia Hospitalization - Initial or Prolonged
4179898 4407341     F 7/1/2004 7/21/2004 20 MD EXP Strattera Loss of Consciousness Other
4179922 4407225 10 Years F 7/2/2004 7/2/2004 7/21/2004 19 MD EXP Strattera Erythema Multiforme Other
4179924 4407227 28 Years F 6/8/2004 7/2/2004 7/21/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Gastrooesophageal Reflux Disease, Hyperlipidaemia, Peptic Ulcer
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4179924 4419736 28 Years F 6/8/2004 7/15/2004 8/4/2004 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Gastrooesophageal Reflux Disease, Hyperlipidaemia, Low Density Lipoprotein Increased, Peptic Ulcer
4179936 4407236 9 Years M 1/1/2004 7/2/2004 7/21/2004 19 MD EXP Strattera Grand Mal Convulsion Other
4179936 4425566 9 Years M 6/29/2004 7/20/2004 8/10/2004 21 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Agitation, Asthenia, Confusional State, Fatigue, Gastroenteritis, Grand Mal Convulsion, Myalgia, Postictal Headache Other
4180851 4407748 14 Years M 5/1/2004 6/25/2004 7/21/2004 26 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Chest Discomfort, Haematemesis, Nipple Oedema, Nipple Pain, Weight Increased Other
4180851 4546103 14 Years M 11/12/2003 11/24/2004 1/3/2005 40 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Chest Pain, Haematemesis, Haemoptysis, Nasopharyngitis, Nipple Pain, Nipple Swelling, Somnolence, Weight Increased Other
4180851 4684442 14 Years M 11/12/2003 1/11/2005 5/31/2005 140 MD PER Strattera Anorexia, Breast Tenderness, Chest Pain, Feeling Cold, Gynaecomastia, Haemoptysis, Hyperphagia, Hypersomnia, Hypertension, Nausea, Rhinitis Allergic, Weight Increased Other
4182863 4409679     7/27/2004 MD DIR Strattera Mania
4191129 4419740 13 Years M 7/8/2004 8/4/2004 27 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Activated Partial Thromboplastin Time Prolonged, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Hepatic Steatosis, Hepatomegaly, Low Density Lipoprotein Increased, Splenomegaly Other
4191129 4441418 13 Years 4/27/2004 7/28/2004 92 MD PER Strattera Hepatic Enzyme Increased
4191129 4474511 13 Years M 9/21/2004 10/8/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Activated Partial Thromboplastin Time Prolonged, Hepatic Steatosis, Hepatomegaly, Low Density Lipoprotein Increased, Splenomegaly Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4191129 4509520 13 Years M 10/28/2004 11/19/2004 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Activated Partial Thromboplastin Time Prolonged, Hepatic Steatosis, Hepatomegaly, Low Density Lipoprotein Increased, Splenomegaly Other
4191129 4512532 13 Years M 11/8/2004 11/24/2004 16 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatic Steatosis, Hepatomegaly, Splenomegaly Other
4191129 4517482 13 Years M 11/10/2004 11/30/2004 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatic Steatosis, Hepatosplenomegaly, Low Density Lipoprotein Increased Other
4191203 4422405     F 7/16/2004 8/6/2004 21 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Electroencephalogram Abnormal Other
4191203 4449072 25 Years F 8/23/2004 9/9/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Electroencephalogram Abnormal, Fatigue, Feeling Abnormal, Grand Mal Convulsion, Headache, Intervertebral Disc Protrusion, Loss of Consciousness, Malaise, Nausea, Neutrophil Count Decreased, PCO2 Decreased, Postictal State, Venous Angioma of Brain, White Blood Cell Count Increased Other
4191208 4422408 38 Years M 7/5/2004 7/15/2004 8/6/2004 22 EXP Strattera Anorexia, Hallucination (Auditory), Psychotic Disorder, Weight Decreased Hospitalization - Initial or Prolonged
4191208 4444631 38 Years M 7/5/2004 8/17/2004 9/2/2004 16 OT EXP Strattera Decreased Appetite, Hallucination (Auditory), Psychotic Disorder, Weight Decreased Hospitalization - Initial or Prolonged
4191215 4422410 15 Years M 7/16/2004 8/6/2004 21 EXP Strattera Cardiac Murmur Other
4191215 4642263 15 Years M 4/6/2005 4/20/2005 14 MD EXP Strattera Arterial Bruit, Cardiac Murmur
4191282 4419772 10 Years M 7/9/2004 7/9/2004 8/4/2004 26 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Obsessive-Compulsive Disorder Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4191812 4421766 7 Years M 1/1/2004 7/20/2004 8/6/2004 17 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Eye Disorder, Headache, Mydriasis, Optic Atrophy, Photosensitivity Reaction, Tardive Dyskinesia Other
4191812 4493299 7 Years M 7/13/2004 10/19/2004 11/2/2004 14 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Condition Aggravated, Headache, Impulsive Behaviour, Mydriasis, Ophthalmological Examination Abnormal, Optic Atrophy, Photophobia, Psychomotor Hyperactivity, Tardive Dyskinesia, Visual Field Defect Other
4191812 4538838 6 Years M 7/13/2004 12/3/2004 12/22/2004 19 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Headache, Impulsive Behaviour, Intraocular Pressure Test Abnormal, Mydriasis, Obsessive-Compulsive Personality Disorder, Optic Atrophy, Optic Nerve Cup/Disc Ratio Increased, Photophobia, Psychomotor Hyperactivity, Pupils Unequal, Tardive Dyskinesia, Visual Field Defect Other
4191812 4684419 6 Years M 7/13/2004 2/8/2005 5/31/2005 112 OT PER Strattera Eye Pain, Headache, Mydriasis, Obsessive-Compulsive Disorder, Ophthalmological Examination Abnormal, Optic Atrophy, Photophobia, Tardive Dyskinesia Other
4191818 4421764 65 Years M 7/19/2004 8/6/2004 18 EXP Strattera Attention Deficit/Hyperactivity Disorder Atrial Fibrillation, Blood Pressure Abnormal, Heart Rate Irregular, Hypoaesthesia, Pallor, Sinus Tachycardia, Ventricular Tachycardia Hospitalization - Initial or Prolonged, Other
4191818 4474154 65 Years M 9/20/2004 10/8/2004 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Atrial Fibrillation, Heart Rate Irregular, Hypoaesthesia, Skin Discolouration Hospitalization - Initial or Prolonged, Other
4191928 4421801 48 Years M 6/10/2004 7/20/2004 8/6/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Atrial Fibrillation, Atrial Flutter, Myocardial Ischaemia, Sinus Tachycardia, Syncope, Therapy Non-Responder Hospitalization - Initial or Prolonged
4191942 4421698 10 Years M 7/16/2004 8/6/2004 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Atrioventricular Block Second Degree Other
4191966 4421982 13 Years M 7/12/2004 8/4/2004 23 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Priapism Hospitalization - Initial or Prolonged
4191966 4474074 13 Years M 9/24/2004 10/8/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Priapism
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4191970 4421984 7 Years M 7/9/2004 8/4/2004 26 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Disturbance in Attention, Impulsive Behaviour, Mood Swings, Physical Assault Other
4193361 4425571 12 Years M 7/19/2004 8/10/2004 22 MD EXP Strattera Psychotic Disorder Other
4193746 4424336 11 Years F 11/11/2003 8/6/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Accommodation Disorder, Glare, Hypermetropia, Photopsia, Vision Blurred, Visual Disturbance Disability
4193751 4424339 16 Years F 7/29/2004 8/6/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Visual Acuity Reduced Disability
4194450 4426714 20 Years M 7/1/2004 7/28/2004 8/11/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Depression, Insomnia, Psychotic Disorder Hospitalization - Initial or Prolonged
4194450 4457400 20 Years M 7/1/2004 9/8/2004 9/22/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Depression, Insomnia, Nightmare, Psychotic Disorder Hospitalization - Initial or Prolonged
4197721 4431798 35 Years F 7/29/2004 8/18/2004 20 MD EXP Strattera Convulsion Other
4197756 4431809 14 Years F 1/1/2004 7/30/2004 8/18/2004 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Muscle Cramp, Muscle Spasms, Weight Decreased Hospitalization - Initial or Prolonged
4198214 4432675 11 Years M 7/27/2004 8/20/2004 24 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased, Blood Lactate Dehydrogenase Increased
4198214 4517477 11 Years M 11/16/2004 11/30/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased, Blood Lactate Dehydrogenase Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4199197 4432619 8 Years M 8/9/2004 8/9/2004 8/9/2004 8/20/2004 11 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aspiration, Cardiac Arrest, Cough, Dyspnoea, Faecal Incontinence, Food Allergy, Sudden Death, Urinary Incontinence Death, Other
4199197 4433960 8 Years M 8/9/2004 8/9/2004 8/10/2004 8/25/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aspiration, Cardiac Arrest, Cough, Faecal Incontinence, Food Allergy, Respiratory Arrest, Sudden Death, Urinary Incontinence Death, Other
4199197 4455032 8 Years M 8/9/2004 8/9/2004 8/31/2004 9/17/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aspiration, Cardiac Arrest, Cough, Dyskinesia, Faecal Incontinence, Food Allergy, Respiration Abnormal, Sudden Death, Urinary Incontinence Death, Other
4199197 4476508 8 Years M 8/9/2004 8/9/2004 9/23/2004 10/13/2004 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aspiration, Cardio-Respiratory Arrest, Cough, Faecal Incontinence, Food Allergy, Respiratory Disorder, Sepsis, Sudden Death, Urinary Incontinence, Viral Infection Death, Other
4199197 4512534 8 Years 8/9/2004 8/9/2004 11/5/2004 11/24/2004 19 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Aspiration, Cardio-Respiratory Arrest, Faecal Incontinence, Food Allergy, Pneumonia, Sepsis, Sudden Death, Urinary Incontinence, Victim of Child Abuse, Viral Infection Death, Other
4199197 4517495 8 Years M 8/9/2004 8/9/2004 11/16/2004 11/30/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aspiration, Bronchitis Chronic, Cardio-Respiratory Arrest, Dyspnoea, Faecal Incontinence, Food Allergy, Lung Infection, Pneumonia, Sepsis, Sudden Death, Urinary Incontinence, Viral Infection Death, Other
4199197 4572167 8 Years M 8/9/2004 8/9/2004 1/18/2005 2/2/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aspiration, Cardio-Respiratory Arrest, Cough, Drug Toxicity, Dyskinesia, Dyspnoea, Faecal Incontinence, Pneumonia, Sepsis, Somnolence, Sudden Death, Urinary Incontinence, Viral Infection Death, Other
4199201 4432626 10 Years M 8/7/2003 7/27/2004 8/20/2004 24 MD EXP Strattera Abnormal Behaviour, Anger, Anorexia, Anxiety, Drug Toxicity, Dysgraphia, Educational Problem, Fatigue, Flat Affect, Grand Mal Convulsion, Hyperacusis, Irritability, Lethargy, Nausea, Perseveration, Personality Change, Social Avoidant Behaviour, Somnolence, Stomach Discomfort Other
4199217 4433699     F 1/1/2004 8/25/2004 PH DIR Atomoxetine Attention Deficit/Hyperactivity Disorder Ill-Defined Disorder, Stomach Discomfort Other
4199220 4433701     F 1/1/2004 8/25/2004 PH DIR Atomoxetine Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Hair Plucking, Physical Abuse Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4199529 4431330     M 6/23/2003 8/20/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Thrombocytopenia Other
4199557 4431347 35 Years M 8/23/2004 DIR Strattera Attention Deficit/Hyperactivity Disorder Anger, Irritability Other
4199823 4431985 16 Years M 7/29/2004 8/18/2004 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Bilirubin Increased, Haematocrit Increased, Haemoglobin Increased
4199823 4434409 16 Years M 8/6/2004 8/25/2004 19 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Gilbert's Syndrome, Haematocrit Increased, Haemoglobin Increased, Weight Decreased
4199823 4473971 16 Years M 9/1/2004 9/16/2004 10/8/2004 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Appendicitis, Gilbert's Syndrome, Haematocrit Increased, Haemoglobin Increased, Weight Decreased Hospitalization - Initial or Prolonged
4199823 4487894 16 Years M 8/29/2004 10/12/2004 10/26/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Appendicitis, Gilbert's Syndrome, Haematocrit Increased, Haemoglobin Increased, Weight Decreased Hospitalization - Initial or Prolonged
4199823 4687163 16 Years M 8/9/2004 5/24/2005 6/7/2005 14 MD EXP Strattera Appendicitis, Gilbert's Syndrome, Haematocrit Increased, Haemoglobin Increased, Weight Decreased Hospitalization - Initial or Prolonged
4199826 4432005 5 Years F 4/1/2004 8/2/2004 8/18/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Coma, Somnolence Hospitalization - Initial or Prolonged, Other
4199826 4449067 5 Years F 4/1/2004 8/23/2004 9/9/2004 17 EXP Strattera Attention Deficit/Hyperactivity Disorder Coma, Overdose, Somnolence Hospitalization - Initial or Prolonged
4199891 4432021 16 Years F 3/1/2004 7/30/2004 8/18/2004 19 MD EXP Strattera Cystitis Haemorrhagic, Urinary Tract Infection Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4199892 4432024 12 Years 7/30/2004 8/18/2004 19 MD EXP Strattera Supraventricular Tachycardia Life-Threatening, Other
4199893 4432026 11 Years 7/30/2004 8/18/2004 19 MD EXP Strattera Liver Function Test Abnormal Other
4199893 4464696 11 Years M 9/14/2004 9/29/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased, Developmental Delay Other
4199893 4522463 11 Years M 11/18/2004 12/7/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Acid Phosphatase Increased Other
4199893 4565499 11 Years M 1/10/2005 1/26/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased Other
4199893 4631296 11 Years M 3/18/2005 4/6/2005 19 MD EXP Strattera Alanine Aminotransferase Decreased, Aspartate Aminotransferase Decreased, Blood Alkaline Phosphatase Increased, Developmental Delay Other
4199900 4432028     M 6/1/2004 7/29/2004 8/18/2004 20 MD EXP Strattera Insomnia, Psychotic Disorder Hospitalization - Initial or Prolonged, Other
4200025 4431266     M 7/9/2004 8/23/2004 MD DIR Strattera Major Depression Atrial Fibrillation, Atrial Flutter, Dizziness, Palpitations Hospitalization - Initial or Prolonged, Life-Threatening, Required Intervention to Prevent Permanent Impairment/Damage
4200028 4433611 13 Years M 3/25/2004 8/25/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Tic Other
4200229 4433705     M 2/1/2004 8/25/2004 PH DIR Atomoxetine Aggression, Anger Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4200238 4433706     M 4/13/2004 8/25/2004 PH DIR Atomoxetine Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Anger, Hallucination, Hallucination (Auditory), Screaming, Verbal Abuse Other
4200242 4433708     M 3/3/2004 8/25/2004 PH DIR Atomoxetine Attention Deficit/Hyperactivity Disorder Physical Abuse
4201139 4434135 7 Years M 7/16/2004 8/10/2004 8/25/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Crying, Depression, Dysphoria, Heart Rate Increased, Palpitations, Tachycardia, Vomiting Other
4201290 4433070 16 Years M 5/1/2004 8/2/2004 8/23/2004 21 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Blindness, Mydriasis, Reading Disorder Other
4201290 4444689 16 Years M 8/23/2004 9/2/2004 10 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Accommodation Disorder, Vision Blurred, Visual Disturbance
4201466 4433940 7 Years F 8/1/2004 8/11/2004 8/25/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Anuria, Cough, Hepatitis, Lethargy, Pyrexia, Vomiting, Wheezing Hospitalization - Initial or Prolonged, Other
4201466 4487897 7 Years F 8/1/2004 10/12/2004 10/26/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Blood Albumin Increased, Blood Immunoglobulin G Decreased, Cough, Dehydration, Hepatitis, Laboratory Test Abnormal, Lethargy, Platelet Count Decreased, Rhinorrhoea, Urine Output Decreased, Viral Infection, Vomiting, Wheezing, White Blood Cell Count Increased Hospitalization - Initial or Prolonged, Other
4201466 4501107 7 Years F 8/1/2004 10/22/2004 11/9/2004 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Mass, Abdominal Pain, Band Neutrophil Count Increased, Cough, Dehydration, Diarrhoea, Epstein-Barr Virus Antibody Positive, Gastroenteritis, Hepatitis Viral, Lethargy, Lymphocyte Percentage Decreased, Pharyngolaryngeal Pain, Platelet Count Increased, Urinary Tract Infection, Urine Output Decreased, Viral Infection, Vomiting, Wheezing, White Blood Cell Count Increased Hospitalization - Initial or Prolonged
4201466 4614224 7 Years F 8/1/2004 2/25/2005 3/15/2005 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Mass, Abdominal Pain, Band Neutrophil Percentage Increased, Blood Immunoglobulin G Increased, Cough, Dehydration, Diarrhoea, Flatulence, Gastroenteritis, Hepatitis, Lethargy, Lymphocyte Count Decreased, Pharyngolaryngeal Pain, Platelet Count Increased, Urinary Tract Infection, Urine Leukocyte Esterase Positive, Urine Output Decreased, Viral Infection, Vomiting, Wheezing, White Blood Cell Count Increased, White Blood Cells Urine Positive Hospitalization - Initial or Prolonged
4201487 4433950 16 Years M 8/11/2004 8/11/2004 8/25/2004 14 MD EXP Strattera Leukaemia Hospitalization - Initial or Prolonged, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4201487 4487888 15 Years M 8/11/2004 10/12/2004 10/26/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Anaemia, Fatigue, Leukaemia, Pallor Hospitalization - Initial or Prolonged, Other
4201496 4433952 12 Years 8/5/2004 8/25/2004 20 MD EXP Strattera Convulsion Other
4201515 4433954 4 Years M 6/1/2004 8/11/2004 8/25/2004 14 EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Cyanosis, Dizziness, Electroencephalogram Abnormal, Mydriasis, Trance, Vomiting Other
4201515 4474072 4 Years M 6/1/2004 9/21/2004 10/8/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Complex Partial Seizures, Cyanosis, Faecal Incontinence, Mydriasis, Urinary Incontinence, Vomiting Other
4201564 4433778     F 7/1/2003 8/4/2004 8/25/2004 21 OT EXP Strattera Blood Glucose Increased, Diarrhoea
4201564 4445244     F 7/1/2003 8/19/2004 9/2/2004 14 EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Increased, Diarrhoea, Glucose Urine Present, Pollakiuria
4201877 4434097 14 Years M 8/3/2004 8/25/2004 22 MD EXP Strattera Bipolar Disorder, Mania Other
4201877 4538837 13 Years M 6/1/2004 12/9/2004 12/22/2004 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Mania Other
4201877 4546032 13 Years M 6/1/2004 12/15/2004 1/3/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Bipolar I Disorder, Mania Other
4202132 4434109     8/5/2004 8/25/2004 20 MD EXP Strattera Convulsion Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4202145 4434110 7 Years M 6/24/2004 8/10/2004 8/25/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Agitation, Hallucination (Auditory), Mania, Psychotic Disorder Hospitalization - Initial or Prolonged
4202153 4434111 8 Years F 8/10/2004 8/25/2004 15 EXP Strattera Fall, Grand Mal Convulsion Other
4202153 4487889 8 Years F 10/8/2004 10/26/2004 18 CN EXP Strattera Fall, Grand Mal Convulsion Other
4202153 4538836 8 Years F 12/2/2004 12/22/2004 20 EXP Strattera Epilepsy, Fall, Grand Mal Convulsion, Weight Increased Other
4203618 4439422 7 Years M 3/16/2004 7/28/2004 134 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Fatigue, Mood Swings
4203620 4439423 7 Years F 3/14/2004 4/21/2004 7/28/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Flushing, Rash Erythematous, Skin Discolouration, Somnolence
4203622 4439424 7 Years M 3/10/2004 3/25/2004 7/28/2004 125 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Agitation, Fatigue, Headache, Hypertension, Lethargy, Oxygen Saturation Decreased, Psychomotor Hyperactivity
4203623 4439425 10 Years M 3/11/2004 3/16/2004 7/28/2004 134 MD PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Tonsillectomy
4203625 4439426 14 Years M 3/18/2004 7/28/2004 132 MD PER Strattera Mydriasis, Somnolence, Speech Disorder
4203626 4439427 15 Years M 3/1/2004 3/17/2004 7/28/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anger, Mood Swings, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4203627 4439428 10 Years M 3/22/2004 7/28/2004 128 OT PER Strattera Chest Pain, Heart Rate Irregular, Tachycardia
4203628 4439429 12 Years M 3/17/2004 7/28/2004 133 PER Strattera Disturbance in Attention Disturbance in Attention
4203630 4439430 35 Years M 3/17/2004 7/28/2004 133 PER Strattera Erectile Dysfunction, Eye Pain, Insomnia, Libido Decreased
4203631 4439431 35 Years F 3/1/2004 3/17/2004 7/28/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Migraine
4203636 4439412 12 Years M 1/1/2004 3/2/2004 7/28/2004 148 PER Strattera Aggression
4203639 4439432 42 Years F 3/1/2004 3/12/2004 7/28/2004 138 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Cold Sweat, Hot Flush, Mydriasis, Nausea
4203640 4439413 12 Years M 3/3/2004 7/28/2004 147 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Educational Problem, Feeling Abnormal, Headache, Somnolence
4203641 4439433 8 Years F 3/11/2004 3/12/2004 7/28/2004 138 CN PER Strattera Abdominal Pain Upper, Feeling Abnormal, Vomiting
4203642 4439414 12 Years M 3/3/2004 7/28/2004 147 CN PER Strattera Retching
4203644 4439434 17 Years F 3/12/2004 7/28/2004 138 CN PER Strattera Anxiety, Attention Deficit/Hyperactivity Disorder Aggression, Decreased Appetite, Fatigue, Headache, Mood Swings, Nausea, Pain in Extremity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4203645 4439415 11 Years M 3/3/2004 7/28/2004 147 PER Strattera Disturbance in Attention Drug Ineffective, Fatigue
4203646 4439435 17 Years M 8/1/2003 3/12/2004 7/28/2004 138 CN PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Personality Change, Weight Decreased
4203647 4439416 9 Years F 3/3/2004 7/28/2004 147 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Impulsive Behaviour, Pharyngitis Streptococcal
4203648 4439417 50 Years M 2/27/2004 3/3/2004 7/28/2004 147 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Bruxism, Depressed Mood, Disorientation, Fatigue, Feeling Abnormal, Irritability, Mood Swings, Pain in Jaw, Paraesthesia, Vertigo
4203651 4439418 10 Years M 3/3/2004 7/28/2004 147 PER Strattera Attention Deficit/Hyperactivity Disorder Enuresis, Somnolence
4203652 4439419 15 Years M 3/3/2004 7/28/2004 147 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Educational Problem
4203654 4439420 5 Years M 3/3/2004 7/28/2004 147 PH PER Strattera Retching
4203657 4439436 7 Years M 3/1/2004 3/12/2004 7/28/2004 138 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Drug Ineffective, Emotional Disorder, Gastrointestinal Disorder
4203658 4439421 8 Years M 3/3/2004 3/3/2004 7/28/2004 147 PER Strattera Pyrexia
4203660 4439437 18 Years F 2/23/2004 3/12/2004 7/28/2004 138 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Insomnia, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4203661 4439402     F 4/21/2004 7/28/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder
4203663 4439438 14 Years F 1/1/2003 3/12/2004 7/28/2004 138 PER Strattera Attention Deficit/Hyperactivity Disorder Initial Insomnia, Nausea, Nightmare, Oral Discomfort, Somnolence
4203665 4439403     F 4/21/2004 7/28/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia, Drug Withdrawal Syndrome, Irritability
4203666 4439439 7 Years M 2/1/2004 3/12/2004 7/28/2004 138 CN PER Strattera Disturbance in Attention Aggression, Crying, Hostility, Irritability
4203667 4439404 8 Years M 4/21/2004 7/28/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dizziness, Feeling Hot, Insomnia
4203668 4439440 5 Years M 2/1/2004 3/12/2004 7/28/2004 138 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Drug Ineffective, Vomiting
4203669 4439405 12 Years F 4/21/2004 7/28/2004 98 MD PER Strattera Breast Discharge
4203670 4439441 10 Years M 3/15/2004 7/28/2004 135 MD PER Strattera Attention Deficit/Hyperactivity Disorder Initial Insomnia, Vision Blurred, Weight Decreased
4203671 4439406 12 Years M 4/21/2004 7/28/2004 98 OT PER Strattera Aggression
4203672 4439407 45 Years F 4/21/2004 4/21/2004 7/28/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Distractibility, Tremor
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4203673 4439408 6 Years M 3/1/2004 4/21/2004 7/28/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Excitability, Insomnia, Psychomotor Hyperactivity
4203674 4439409     M 4/21/2004 7/28/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder
4203675 4439410     M 4/21/2004 7/28/2004 98 MD PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Hesitation, Urinary Tract Infection
4203676 4439411     M 4/21/2004 7/28/2004 98 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety
4203677 4439389 54 Years F 4/1/2004 4/22/2004 7/28/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity
4203678 4439390 10 Years M 4/18/2004 4/20/2004 7/28/2004 99 OT PER Strattera Attention Deficit/Hyperactivity Disorder Angina Pectoris, Diarrhoea, Drug Withdrawal Syndrome, Feeling Abnormal, Flatulence, Pallor, Vomiting
4203680 4439391 24 Years F 3/10/2004 4/20/2004 7/28/2004 99 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Hot and Cold, Insomnia, Mood Swings, Somnolence
4203681 4439392 10 Years F 4/20/2004 7/28/2004 99 PH PER Strattera Retching
4203684 4439393 21 Years M 4/20/2004 4/20/2004 7/28/2004 99 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
4203685 4439394 16 Years M 4/19/2004 5/28/2004 7/28/2004 61 CN PER Strattera Intentional Overdose, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4203685 4497058 16 Years M 4/19/2004 5/28/2004 9/27/2004 122 CN PER Strattera Intentional Overdose, Vomiting
4203689 4439398 21 Years M 4/20/2004 4/21/2004 7/28/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Hot Flush, Insomnia, Vomiting
4203691 4439399 12 Years 4/20/2004 7/28/2004 99 MD PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain
4203693 4439400     4/20/2004 7/28/2004 99 MD PER Strattera Tic
4203695 4439401 12 Years F 4/20/2004 7/28/2004 99 MD PER Strattera Tic
4203712 4439377 7 Years F 3/1/2004 4/20/2004 7/28/2004 99 PER Strattera Attention Deficit/Hyperactivity Disorder Enuresis, Sleep Walking, Weight Decreased
4203714 4439379     F 4/20/2004 7/28/2004 99 PER Strattera Hot Flush
4203717 4439381     M 4/17/2004 4/20/2004 7/28/2004 99 PER Strattera Anxiety, Attention Deficit/Hyperactivity Disorder, Depression Affect Lability, Anger, Fatigue, Insomnia, Irritability
4203718 4439382 33 Years F 4/20/2004 4/22/2004 7/28/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Communication Disorder, Decreased Interest, Dysgeusia, Fatigue, Feeling Abnormal, Lip Dry
4203719 4439383     F 4/17/2004 4/20/2004 7/28/2004 99 PER Strattera Drug Ineffective, Musculoskeletal Stiffness, Myalgia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4203723 4439385 7 Years M 1/1/2004 4/20/2004 7/28/2004 99 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Belligerence, Disturbance in Attention
4203728 4439386 7 Years F 4/19/2004 5/13/2004 7/28/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Crying, Depressed Mood, Educational Problem, Mood Swings, Regressive Behaviour
4203730 4439387 16 Years 4/20/2004 7/28/2004 99 PH PER Strattera Drug Screen Positive
4203733 4439388 8 Years M 2/1/2004 4/20/2004 7/28/2004 99 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Hallucination, Somnolence
4203734 4439219 16 Years 3/12/2004 7/28/2004 138 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Feeling Abnormal, Feeling Drunk, Personality Change
4203735 4439358 12 Years 3/9/2004 7/28/2004 141 PH PER Strattera
4203736 4439220 10 Years M 3/1/2004 3/12/2004 7/28/2004 138 MD PER Strattera Serum Sickness
4203737 4439360     F 3/9/2004 7/28/2004 141 MD PER Strattera Sluggishness
4203738 4439361 8 Years M 3/9/2004 3/9/2004 7/28/2004 141 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Drug Ineffective, Skin Discolouration
4203739 4439363 7 Years M 3/9/2004 7/28/2004 141 PH PER Strattera Flatulence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4203740 4439365 12 Years 3/10/2004 7/28/2004 140 MD PER Strattera Anger, Anxiety, Emotional Disorder
4203741 4439366 14 Years F 3/10/2004 7/28/2004 140 MD PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia
4203742 4439221     M 3/1/2004 3/22/2004 7/28/2004 128 PER Strattera Psychomotor Hyperactivity Abdominal Pain, Chest Discomfort, Constipation, Eosinophil Count Increased, Pallor, Peripheral Coldness, Pruritus, Rash, Skin Discolouration, Stomach Discomfort, Viral Infection, Vomiting
4203743 4439368 12 Years M 3/11/2004 3/10/2004 7/28/2004 140 MD PER Strattera Endodontic Procedure
4203744 4439370 6 Years F 2/1/2004 3/10/2004 7/28/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4203746 4439222 14 Years M 2/1/2004 5/3/2004 7/28/2004 86 MD PER Strattera Attention Deficit/Hyperactivity Disorder Faecaloma, Urinary Tract Infection
4203747 4439372 58 Years F 6/10/2003 3/10/2004 7/28/2004 140 PER Strattera Fatigue Drug Interaction, Heart Rate Increased
4203749 4439224 11 Years M 3/15/2004 7/28/2004 135 PER Strattera Contusion, Erythema, Rash Papular
4203750 4439374 59 Years F 3/10/2004 7/28/2004 140 PER Strattera Apathy, Asthenia
4203752 4439331 48 Years F 4/1/2004 4/23/2004 7/28/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Cardiovascular Disorder, Constipation, Depression, Irritability, Mania, Tinnitus, Urinary Incontinence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4203752 4497060 48 Years F 4/1/2004 8/17/2004 9/27/2004 41 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Constipation, Gastrooesophageal Reflux Disease, Increased Appetite, Irritability, Urinary Incontinence, Weight Decreased
4203753 4439225 8 Years M 2/28/2004 3/15/2004 7/28/2004 135 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Crying, Hostility
4203754 4439332 64 Years M 4/1/2004 4/23/2004 7/28/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Disturbance in Attention
4203756 4439227 14 Years M 3/15/2004 7/28/2004 135 OT PER Strattera Aggression, Drug Ineffective, Drug Withdrawal Syndrome, Feeling Abnormal, Vomiting
4203757 4439340 22 Years M 4/1/2004 4/23/2004 7/28/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Libido Decreased, Mood Swings, Paraesthesia, Personality Change
4203759 4439229 5 Years M 3/14/2004 3/15/2004 7/28/2004 135 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Psychomotor Hyperactivity, Somnolence
4203760 4439231 21 Years M 2/1/2004 3/15/2004 7/28/2004 135 PER Strattera Disturbance in Attention Hallucination (Auditory), Insomnia
4203761 4439343 38 Years F 4/22/2004 4/23/2004 7/28/2004 96 PER Strattera Memory Impairment Headache, Hyperhidrosis, Insomnia, Paraesthesia
4203762 4439346 14 Years M 1/1/2002 4/23/2004 7/28/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Feeling Abnormal, Headache, Increased Appetite, Insomnia, Nausea, Vomiting
4203762 4497061 14 Years M 1/1/2002 7/9/2004 9/27/2004 80 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Feeling Abnormal, Headache, Increased Appetite, Insomnia, Nausea, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4203762 4580290 14 Years M 1/1/2002 8/23/2004 1/27/2005 157 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Feeling Abnormal, Headache, Increased Appetite, Insomnia, Nausea, Vomiting
4203763 4439233     M 3/15/2004 3/15/2004 7/28/2004 135 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Epistaxis
4203765 4439347 25 Years M 7/1/2003 4/26/2004 7/28/2004 93 PER Strattera Attention Deficit/Hyperactivity Disorder Thirst
4203767 4439349 36 Years M 4/26/2004 7/28/2004 93 OT PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Hesitation, Urinary Retention
4203779 4439237 7 Years M 3/15/2004 3/15/2004 7/28/2004 135 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Fatigue, Jaw Disorder
4203781 4439238 9 Years M 3/13/2004 3/15/2004 7/28/2004 135 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Fatigue
4203782 4439239 8 Years M 3/1/2004 3/15/2004 7/28/2004 135 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4203783 4439241 12 Years M 3/15/2004 7/28/2004 135 PER Strattera Disturbance in Attention, Drug Ineffective, Psychomotor Hyperactivity
4203784 4439242 6 Years M 3/15/2004 7/28/2004 135 PER Strattera Attention Deficit/Hyperactivity Disorder Neck Injury, Psychomotor Hyperactivity
4203785 4439244 8 Years M 3/15/2004 7/28/2004 135 PER Strattera Disturbance in Attention Disturbance in Attention, Fatigue, Restlessness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4203786 4439247     F 1/1/2004 3/15/2004 7/28/2004 135 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Coeliac Disease
4203788 4439249 6 Years M 1/1/2004 3/15/2004 7/28/2004 135 OT PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Fatigue, Tremor
4203791 4439251 12 Years F 11/1/2003 4/5/2004 7/28/2004 114 MD PER Strattera Attention Deficit/Hyperactivity Disorder Suicidal Ideation
4203793 4439252 6 Years M 3/15/2004 7/28/2004 135 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Nausea, Vomiting
4203794 4437728 45 Years F 3/1/2004 3/18/2004 7/28/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder, Depression Dizziness, Feeling Hot and Cold, Headache, Nausea, Urinary Hesitation
4203795 4437731 58 Years F 12/1/2003 3/18/2004 7/28/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4203796 4437732     M 1/1/2004 3/18/2004 7/28/2004 132 PER Strattera Dizziness, Urine Flow Decreased
4203797 4437733 7 Years M 3/1/2004 3/18/2004 7/28/2004 132 PER Strattera Crying, Emotional Disorder, Mood Swings, Retching, Vomiting
4203799 4437735     M 3/18/2004 7/28/2004 132 PER Strattera Bacteriuria, Dysuria, Pollakiuria, Urinary Hesitation
4203801 4437736     F 3/18/2004 3/18/2004 7/28/2004 132 PER Strattera Anxiety, Dizziness, Drug Interaction, Dyspnoea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4203802 4437739 7 Years M 3/1/2004 3/18/2004 7/28/2004 132 MD PER Strattera Obsessive-Compulsive Disorder
4203803 4437741 8 Years M 2/1/2004 3/18/2004 7/28/2004 132 OT PER Strattera Disturbance in Attention, Drug Ineffective, Impulsive Behaviour, Psychomotor Hyperactivity
4203804 4437745     3/18/2004 7/28/2004 132 MD PER Strattera
4203805 4437750 5 Years M 3/15/2004 3/18/2004 7/28/2004 132 PER Strattera Retching
4203806 4438067 10 Years M 1/1/2004 3/3/2004 7/28/2004 147 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anxiety, Crying, Depression, Disturbance in Attention, Drug Ineffective, Fatigue, Fear, Flatulence, Gastroenteritis Viral, Insomnia, Nervousness, Personality Change, Somnolence, Stomach Discomfort
4203808 4438091     M 3/2/2004 3/3/2004 7/28/2004 147 PER Strattera Abdominal Pain Upper, Dizziness, Nausea
4203809 4438147 9 Years M 1/1/2004 3/3/2004 7/28/2004 147 PER Strattera Psychomotor Hyperactivity Abdominal Pain Upper, Fatigue, Feeling Abnormal, Somnolence
4203811 4438247 10 Years M 3/4/2004 7/28/2004 146 PER Strattera Attention Deficit/Hyperactivity Disorder, Depression Agitation, Educational Problem, Weight Decreased
4203812 4438297 6 Years F 4/13/2004 7/28/2004 106 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Depressed Mood, Disturbance in Attention, Drug Ineffective, Headache, Tension
4203813 4438386 42 Years M 3/3/2004 7/28/2004 147 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4203814 4438400 12 Years F 3/4/2004 7/28/2004 146 PH PER Strattera Choking, Hoarseness, Throat Irritation
4203815 4438411 13 Years M 3/4/2004 7/28/2004 146 PER Strattera Attention Deficit/Hyperactivity Disorder Distractibility, Somnolence
4203816 4438414 8 Years M 3/3/2004 7/28/2004 147 PER Strattera Impulsive Behaviour Drug Ineffective, Somnolence, Stomach Discomfort
4203817 4438416 9 Years M 1/1/2004 3/4/2004 7/28/2004 146 PER Strattera Disturbance in Attention, Malaise, Mydriasis, Restlessness
4203818 4437920 46 Years F 3/18/2004 3/19/2004 7/28/2004 131 PER Strattera Feeling Jittery, Heart Rate Increased, Insomnia, Nervousness
4203819 4437922 38 Years F 3/19/2004 7/28/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Euphoric Mood, Middle Insomnia
4203820 4437923 44 Years F 3/1/2004 3/19/2004 7/28/2004 131 PER Strattera Dysgeusia, Nausea
4203822 4437925 15 Years M 3/18/2004 7/28/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression
4203823 4437926 12 Years 3/15/2004 7/28/2004 135 MD PER Strattera Nightmare
4203824 4437927 11 Years M 3/19/2004 7/28/2004 131 PER Strattera Fear, Feeling Abnormal, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4203825 4439351 37 Years F 4/1/2004 5/12/2004 7/28/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Ageusia, Drug Ineffective, Hypoaesthesia
4203827 4437931 10 Years F 1/1/2004 3/19/2004 7/28/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Abdominal Pain Upper, Decreased Appetite, Hunger, Sleep Disorder, Somnolence
4203828 4437965 35 Years F 3/19/2004 3/19/2004 7/28/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Jittery
4203829 4439353 16 Years F 4/26/2004 7/28/2004 93 OT PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Pharyngolaryngeal Pain, Viral Infection
4203830 4437972 8 Years M 3/18/2004 7/28/2004 132 MD PER Strattera Suicidal Ideation
4203831 4437981 42 Years F 3/19/2004 3/19/2004 7/28/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Pruritus, Swelling Face
4203833 4437812 56 Years F 3/5/2004 7/28/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
4203834 4437813 12 Years M 6/21/2004 7/28/2004 37 OT PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Headache, Lethargy, Somnolence, Weight Increased
4203834 4501702 12 Years M 6/21/2004 9/27/2004 98 OT PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Headache, Lethargy, Somnolence, Weight Increased
4203835 4437814     F 1/1/2004 3/5/2004 7/28/2004 145 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hypoaesthesia, Peripheral Coldness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4203836 4437815 3 Years M 2/1/2004 3/5/2004 7/28/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Vomiting
4203837 4437816 10 Years M 3/5/2004 7/28/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Abnormal, Nausea, Weight Decreased
4203838 4439354 11 Years M 4/26/2004 7/28/2004 93 PER Strattera Drug Ineffective, Suicidal Ideation
4203839 4437817 12 Years M 3/3/2004 3/5/2004 7/28/2004 145 PER Strattera Aggression, Anger, Nervousness
4203841 4437819 11 Years F 3/3/2004 3/5/2004 7/28/2004 145 PER Strattera Disturbance in Attention Feeling Hot, Photosensitivity Reaction, Rash Macular, Scab, Swelling Face, Wound Secretion
4203842 4437820 9 Years M 3/5/2004 7/28/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Yawning
4203845 4437821 26 Years M 3/1/2004 3/5/2004 7/28/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Micturition Urgency, Scrotal Disorder, Urinary Hesitation
4203846 4437822 16 Years M 3/5/2004 7/28/2004 145 MD PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Drug Ineffective
4203848 4439316 6 Years M 8/1/2003 4/26/2004 7/28/2004 93 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Disturbance in Attention, Drug Ineffective, Pallor, Stomach Discomfort, Vomiting
4203848 4637490 6 Years M 8/1/2003 2/1/2005 3/28/2005 55 PER Strattera Crying, Disturbance in Attention, Drug Ineffective, Pallor, Stomach Discomfort, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4203850 4439317 48 Years F 4/23/2004 4/26/2004 7/28/2004 93 PER Strattera Menorrhagia, Menstruation Irregular
4203851 4439319 35 Years F 3/1/2004 4/26/2004 7/28/2004 93 PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia, Headache, Pain of Skin
4203853 4439321 50 Years F 4/26/2004 7/28/2004 93 OT PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Decreased Appetite, Dizziness, Hyperhidrosis, Irritability, Nausea, Palpitations, Psychomotor Hyperactivity, Sleep Disorder, Weight Decreased
4203854 4439322 34 Years F 1/1/2004 5/14/2004 7/28/2004 75 PER Strattera Disturbance in Attention Dry Mouth, Fatigue, Nausea, Yawning
4203855 4439323     F 5/20/2004 7/28/2004 69 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tachycardia Other
4203856 4439325 9 Years M 5/20/2004 7/28/2004 69 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tachycardia Other
4203858 4439326 11 Years F 5/20/2004 7/28/2004 69 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tachycardia Other
4203859 4439328 14 Years F 4/26/2004 7/28/2004 93 OT PER Strattera Menstruation Irregular
4203862 4439329 39 Years M 4/26/2004 7/28/2004 93 MD PER Strattera Urinary Incontinence
4204161 4438547     F 3/4/2004 7/28/2004 146 CN PER Strattera Hallucination (Auditory) Alopecia, Hair Growth Abnormal, Trichorrhexis
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4204164 4439255 9 Years F 3/29/2004 4/19/2004 7/28/2004 100 PER Strattera Attention Deficit/Hyperactivity Disorder Developmental Delay, Dyspnoea, Heart Rate Increased, Vision Blurred, Weight Decreased
4204166 4438548 52 Years M 3/4/2004 4/30/2004 7/28/2004 89 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Urinary Tract Disorder
4204167 4439256 35 Years M 4/19/2004 7/28/2004 100 PER Strattera Attention Deficit/Hyperactivity Disorder Nervousness
4204169 4438549     F 3/4/2004 7/28/2004 146 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Insomnia, Somnolence
4204170 4439257 11 Years M 4/1/2004 4/19/2004 7/28/2004 100 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Disturbance in Attention, Hyperhidrosis, Insomnia, Pruritus, Urticaria
4204174 4439260 10 Years F 4/17/2004 4/19/2004 7/28/2004 100 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Headache, Hypertension, Memory Impairment
4204176 4438550 6 Years M 2/1/2004 3/4/2004 7/28/2004 146 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Gastrointestinal Disorder, Nausea
4204177 4439262 9 Years M 4/19/2004 7/28/2004 100 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression
4204179 4439264 25 Years M 4/19/2004 7/28/2004 100 MD PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity
4204180 4438551 33 Years M 5/6/2004 7/28/2004 83 CN PER Strattera Attention Deficit/Hyperactivity Disorder Prostate Tenderness, Urinary Hesitation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4204183 4439266 16 Years M 1/1/2004 4/19/2004 7/28/2004 100 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Fatigue, Increased Appetite, Irritability
4204184 4438552     F 3/2/2004 3/4/2004 7/28/2004 146 CN PER Strattera Anger
4204186 4439273 6 Years M 4/19/2004 7/28/2004 100 OT PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Emotional Distress, Lethargy, Somnolence
4204189 4439276 42 Years F 4/1/2004 4/19/2004 7/28/2004 100 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Headache
4204190 4438553 8 Years M 3/1/2004 3/5/2004 7/28/2004 145 PH PER Strattera Attention Deficit/Hyperactivity Disorder Daydreaming, Disturbance in Attention, Drug Ineffective, Dysarthria
4204192 4439278 18 Years M 4/1/2004 4/19/2004 7/28/2004 100 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Depression, Fatigue, Insomnia
4204193 4438554 13 Years M 3/4/2004 7/28/2004 146 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
4204194 4437793 6 Years M 2/1/2004 3/5/2004 7/28/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4204197 4437796 9 Years M 3/5/2004 7/28/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder, Impulsive Behaviour Anger, Drug Ineffective, Pneumonia
4204198 4438555 6 Years F 3/4/2004 3/4/2004 7/28/2004 146 CN PER Strattera Attention Deficit/Hyperactivity Disorder Depressed Mood, Fatigue
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4204199 4437798 36 Years F 3/1/2004 3/5/2004 7/28/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Heart Rate Increased
4204200 4438556     F 3/3/2004 7/28/2004 147 OT PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Emotional Disorder, Mood Swings
4204202 4437803 10 Years M 3/5/2004 7/28/2004 145 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4204204 4437806 7 Years M 3/5/2004 7/28/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Emotional Distress
4204205 4437807 7 Years M 3/5/2004 3/5/2004 7/28/2004 145 PER Strattera Attention Deficit/Hyperactivity Disorder, Depression, Post-Traumatic Stress Disorder Psychomotor Hyperactivity, Suicide Attempt
4204231 4437808 26 Years F 3/8/2004 7/28/2004 142 PER Strattera Amenorrhoea, Feeling Abnormal
4204238 4437809 6 Years M 3/8/2004 7/28/2004 142 PH PER Strattera Anger, Drug Ineffective, Personality Change
4204240 4437810 11 Years M 3/8/2004 3/10/2004 7/28/2004 140 OT PER Strattera Chest Pain
4204241 4437811 5 Years M 3/24/2004 7/28/2004 126 PER Strattera Psychomotor Hyperactivity Abdominal Pain Upper, Decreased Appetite, Eating Disorder Symptom
4204268 4438648 13 Years M 2/1/2004 2/26/2004 7/28/2004 153 OT PER Strattera Attention Deficit/Hyperactivity Disorder Raynaud's Phenomenon
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4204270 4438649 10 Years M 2/26/2004 7/28/2004 153 CN PER Strattera Anger, Diarrhoea, Mood Swings, Stomach Discomfort
4204272 4438650 4 Years M 2/27/2004 2/26/2004 7/28/2004 153 CN PER Strattera Psychomotor Hyperactivity Chromaturia
4204273 4438651 9 Years M 2/27/2004 7/28/2004 152 CN PER Strattera Attention Deficit/Hyperactivity Disorder Keratoconjunctivitis Sicca, Mononucleosis Syndrome, Pallor, Weight Decreased
4204274 4437753 44 Years F 5/1/2004 5/25/2004 7/28/2004 64 PER Strattera Attention Deficit/Hyperactivity Disorder Diarrhoea, Dizziness, Influenza Like Illness, Nausea, Sleep Disorder, Weight Decreased
4204274 4501706 44 Years F 5/1/2004 5/25/2004 9/27/2004 125 PER Strattera Attention Deficit/Hyperactivity Disorder Diarrhoea, Dizziness, Influenza Like Illness, Nausea, Sleep Disorder, Weight Decreased
4204276 4439442 18 Years M 3/10/2004 7/28/2004 140 MD PER Strattera Paranoia
4204277 4438652     M 2/27/2004 7/28/2004 152 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
4204281 4439443 14 Years F 3/8/2004 3/10/2004 7/28/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anxiety, Dizziness, Feeling Abnormal, Paranoia, Somnolence
4204282 4438653 10 Years M 2/27/2004 7/28/2004 152 PH PER Strattera Dyspepsia, Eructation
4204283 4437768 14 Years M 3/14/2004 6/11/2004 7/28/2004 47 MD PER Strattera Attention Deficit/Hyperactivity Disorder Bone Pain, Bundle Branch Block Right, Dyspnoea, Feeling Abnormal, Headache, Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4204283 4501707 14 Years M 3/14/2004 7/27/2004 9/27/2004 62 MD PER Strattera Attention Deficit/Hyperactivity Disorder Bone Pain, Bundle Branch Block Right, Dyspnoea, Feeling Abnormal, Headache, Pain
4204284 4439444 8 Years F 3/10/2004 7/28/2004 140 CN PER Strattera Psychomotor Hyperactivity Abnormal Behaviour, Chapped Lips, Dry Mouth
4204285 4437770 13 Years M 3/15/2004 3/16/2004 7/28/2004 134 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Drug Ineffective
4204286 4438654 11 Years F 2/27/2004 7/28/2004 152 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Insomnia, Weight Decreased
4204287 4439445 9 Years F 3/10/2004 7/28/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4204288 4437774 30 Years M 1/1/2004 3/16/2004 7/28/2004 134 MD PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Pain, Urethral Discharge
4204289 4439446 11 Years M 2/29/2004 3/10/2004 7/28/2004 140 PH PER Strattera Disturbance in Attention Dyslexia, Fatigue, Panic Reaction, Somnolence
4204290 4438655 14 Years M 2/27/2004 7/28/2004 152 MD PER Strattera Gingival Hyperplasia
4204291 4437776 7 Years M 8/1/2003 3/16/2004 7/28/2004 134 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Abnormal Dreams, Feeling Hot and Cold, Hyperhidrosis
4204292 4439447 20 Years M 3/8/2004 3/10/2004 7/28/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4204294 4437777 6 Years F 3/16/2004 7/28/2004 134 MD PER Strattera Attention Deficit/Hyperactivity Disorder Nasal Congestion, Wheezing
4204295 4438656 10 Years M 1/1/2004 2/27/2004 7/28/2004 152 PH PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Hyperhidrosis
4204297 4437788 26 Years F 3/16/2004 7/28/2004 134 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Drug Interaction, Panic Reaction
4204298 4438657 10 Years M 2/16/2004 2/27/2004 7/28/2004 152 CN PER Strattera Abdominal Pain Upper, Abnormal Behaviour, Dizziness, Ear Infection
4204300 4437789 16 Years M 3/14/2004 3/16/2004 7/28/2004 134 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Fatigue, Insomnia
4204303 4437790 10 Years M 3/16/2004 7/28/2004 134 OT PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Sleep Disorder
4204305 4437643 21 Years M 4/19/2004 7/28/2004 100 MD PER Strattera Attention Deficit/Hyperactivity Disorder Mania
4204306 4437644 10 Years M 3/19/2004 3/18/2004 7/28/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Dyspnoea, Fatigue, Heart Rate Increased, Psychomotor Hyperactivity
4204307 4437646 12 Years M 3/18/2004 7/28/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Decreased Appetite, Sleep Disorder, Trance
4204308 4437647 6 Years M 1/1/2004 3/18/2004 7/28/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Salivary Hypersecretion
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4204309 4437650 13 Years M 3/1/2004 4/2/2004 7/28/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Confusional State, Heart Rate Increased, Lethargy, Mydriasis, Somnolence
4204311 4437652 19 Years F 3/18/2004 7/28/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Nasal Dryness, Nasopharyngitis, Sinusitis
4204312 4437653 70 Years M 3/16/2004 3/18/2004 7/28/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fatigue, Hyperhidrosis, Nausea, Pain, Tinnitus
4204313 4437654     M 3/15/2004 3/19/2004 7/28/2004 131 PER Strattera Drug Interaction, Headache, Nausea, Vision Blurred
4204314 4437658 14 Years M 2/1/2004 3/19/2004 7/28/2004 131 PER Strattera Gynaecomastia, Swelling
4204315 4438638 12 Years M 3/1/2004 7/28/2004 149 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Nervousness
4204316 4437672 13 Years 3/18/2004 7/28/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Weight Decreased
4204317 4439448 67 Years F 3/1/2004 3/10/2004 7/28/2004 140 PER Strattera Cough, Dry Mouth, Hoarseness, Hypertrophy Breast, Weight Increased
4204319 4438639 14 Years M 11/1/2003 3/1/2004 7/28/2004 149 MD PER Strattera Epistaxis
4204320 4439449 15 Years M 2/27/2004 3/9/2004 7/28/2004 141 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination (Visual)
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4204321 4438640 6 Years M 2/29/2004 3/1/2004 7/28/2004 149 CN PER Strattera Retching
4204322 4439450 12 Years 3/10/2004 7/28/2004 140 MD PER Strattera Tic
4204323 4439455 34 Years F 3/10/2004 3/10/2004 7/28/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Feeling Abnormal, Flushing
4204331 4438641 8 Years M 4/7/2004 7/28/2004 112 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anorexia, Communication Disorder, Constipation, Contusion, Hyperphagia, Overdose, Sleep Disorder, Staring, Weight Decreased
4204333 4438642 11 Years M 3/1/2004 7/28/2004 149 CN PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Restlessness
4204349 4437752 8 Years M 3/15/2004 3/16/2004 7/28/2004 134 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
4204350 4438643     F 3/1/2004 7/28/2004 149 CN PER Strattera Disturbance in Attention Headache, Pollakiuria, Somnolence
4204351 4438644 7 Years M 3/11/2004 7/28/2004 139 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Drug Ineffective, Mood Swings, Tic
4204353 4438645     F 3/1/2004 7/28/2004 149 CN PER Strattera Feeling Abnormal, Initial Insomnia, Piloerection
4204356 4438646 46 Years M 3/1/2004 7/28/2004 149 CN PER Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder, Headache
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4204360 4438647 7 Years M 3/1/2004 7/28/2004 149 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Gastrooesophageal Reflux Disease
4204793 4440405 10 Years M 2/1/2004 3/19/2004 7/28/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective
4204795 4440406 55 Years M 3/17/2004 3/19/2004 7/28/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder
4204799 4440407 11 Years M 3/17/2004 3/19/2004 7/28/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Headache, Stomach Discomfort, Vomiting
4204800 4440408     F 3/17/2004 3/19/2004 7/28/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Lethargy
4204804 4440409 15 Years M 3/19/2004 7/28/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Asthma, Viral Infection, Weight Decreased
4204805 4440410 33 Years M 3/22/2004 7/28/2004 128 PER Strattera Erectile Dysfunction, Fatigue, Sluggishness
4204808 4440411     F 3/1/2004 4/19/2004 7/28/2004 100 PER Strattera Attention Deficit/Hyperactivity Disorder, Depression Anorexia, Constipation, Drug Ineffective, Dysgeusia, Feeling Abnormal, Middle Insomnia, Nausea, Throat Irritation, Viral Infection
4204815 4440412 11 Years M 3/1/2004 3/22/2004 7/28/2004 128 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Dizziness
4204817 4440413 5 Years M 3/1/2004 3/22/2004 7/28/2004 128 PER Strattera Disturbance in Attention, Psychomotor Hyperactivity Abdominal Pain, Anorexia, Diarrhoea, Insomnia, Mood Swings
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4204830 4440414 45 Years F 3/17/2004 3/22/2004 7/28/2004 128 PER Strattera Attention Deficit/Hyperactivity Disorder Initial Insomnia, Pruritus, Rash, Somnolence
4205714 4441653 14 Years F 3/1/2004 5/10/2004 7/28/2004 79 MD PER Strattera Attention Deficit/Hyperactivity Disorder Breast Discharge
4205725 4441692 14 Years M 4/1/2004 5/10/2004 7/28/2004 79 MD PER Strattera Attention Deficit/Hyperactivity Disorder Impulsive Behaviour
4205730 4441693 4 Years M 5/10/2004 7/28/2004 79 PH PER Strattera Attention Deficit/Hyperactivity Disorder
4205739 4441696 10 Years M 1/1/2004 5/10/2004 7/28/2004 79 OT PER Strattera Tic
4205743 4441699     M 5/10/2004 7/28/2004 79 PER Strattera Eye Disorder, Psychomotor Hyperactivity
4205749 4441701     M 5/1/2004 5/10/2004 7/28/2004 79 PER Strattera Nausea, Paraesthesia, Piloerection
4205751 4441702 24 Years M 5/7/2004 7/28/2004 82 MD PER Strattera Intentional Overdose
4205752 4441703 7 Years 5/10/2004 7/28/2004 79 OT PER Strattera Haematuria
4205755 4441707     M 5/11/2004 7/28/2004 78 OT PER Strattera Thermal Burn
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205756 4440533 11 Years F 8/1/2003 4/16/2004 7/28/2004 103 MD PER Strattera Attention Deficit/Hyperactivity Disorder Gastritis
4205758 4441709 14 Years M 5/11/2004 7/28/2004 78 PER Strattera Attention Deficit/Hyperactivity Disorder Stomach Discomfort
4205764 4440343 8 Years M 2/5/2004 3/5/2004 7/28/2004 145 MD PER Strattera Attention Deficit/Hyperactivity Disorder
4205768 4440380 9 Years M 3/8/2004 3/8/2004 7/28/2004 142 OT PER Strattera Blood Pressure Systolic Increased, Body Temperature Increased, Chest Pain, Emotional Distress, Headache, Heart Rate Increased, Tremor
4205769 4440385 9 Years M 2/1/2004 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Depressed Mood, Drug Ineffective, Major Depression
4205770 4440386 6 Years M 3/8/2004 7/28/2004 142 PER Strattera Retching
4205771 4440389 14 Years M 1/1/2004 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder, Depression Acne, Fatigue, Feeling Abnormal, Somnolence
4205772 4440392     F 3/5/2004 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder, Depression Apathy, Depressed Mood, Fatigue, Somnolence
4205773 4440397 33 Years M 3/8/2004 7/28/2004 142 MD PER Strattera Genital Disorder Male
4205774 4440400 9 Years M 3/1/2004 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205775 4440403 15 Years F 2/22/2004 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Migraine, Somnolence, Weight Decreased
4205778 4440649     M 2/20/2004 7/28/2004 159 PER Strattera Abnormal Behaviour
4205779 4440650 8 Years M 2/20/2004 7/28/2004 159 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
4205780 4440651 9 Years F 2/20/2004 7/28/2004 159 OT PER Strattera Diarrhoea, Stool Analysis Abnormal
4205781 4440652 8 Years M 2/20/2004 7/28/2004 159 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Impulse-Control Disorder
4205782 4440653 10 Years M 2/20/2004 7/28/2004 159 MD PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Thinking Abnormal
4205783 4440654 7 Years M 2/20/2004 7/28/2004 159 PER Strattera Attention Deficit/Hyperactivity Disorder, Bipolar Disorder Abnormal Behaviour, Aggression, Headache, Insomnia, Irritability, Psychomotor Hyperactivity
4205785 4440655 9 Years M 2/20/2004 7/28/2004 159 PER Strattera Attention Deficit/Hyperactivity Disorder Motion Sickness, Vomiting
4205786 4440658 10 Years F 2/1/2004 3/17/2004 7/28/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Nausea, Retching, Vomiting
4205787 4440661 37 Years F 2/3/2004 2/20/2004 7/28/2004 159 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dizziness, Feeling Hot and Cold, Hot Flush, Nausea, Stomach Discomfort
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205791 4440698 8 Years M 3/11/2004 7/28/2004 139 PER Strattera Logorrhoea
4205792 4440709 9 Years M 3/11/2004 7/28/2004 139 PER Strattera Condition Aggravated
4205794 4440711 11 Years M 3/11/2004 7/28/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Conversion Disorder, Crying, Fear
4205797 4440713 9 Years M 3/10/2004 3/11/2004 7/28/2004 139 PH PER Strattera Abdominal Pain, Headache, Hyperhidrosis, Nausea, Vomiting
4205798 4440715 16 Years M 3/11/2004 7/28/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Weight Decreased
4205799 4440723 53 Years F 3/1/2004 3/10/2004 7/28/2004 140 PER Strattera Arthralgia, Muscle Tightness
4205801 4440718 9 Years M 10/1/2003 3/11/2004 7/28/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Feeling Hot, Nausea, Vomiting
4205803 4440719 38 Years F 3/10/2004 3/11/2004 7/28/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Restlessness
4205805 4440724 41 Years M 3/10/2004 7/28/2004 140 PER Strattera Attention Deficit/Hyperactivity Disorder Communication Disorder, Constipation, Dry Mouth, Erectile Dysfunction, Heart Rate Increased, Insomnia, Libido Increased, Orgasmic Sensation Decreased, Premature Ejaculation, Sexual Dysfunction
4205806 4440720 13 Years F 3/11/2004 3/11/2004 7/28/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205807 4440721 9 Years M 3/11/2004 7/28/2004 139 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hypomania, Mania
4205810 4440722 33 Years F 3/10/2004 3/11/2004 7/28/2004 139 PER Strattera Dizziness, Feeling Abnormal, Heart Rate Increased, Psychomotor Hyperactivity
4205812 4440726 29 Years M 1/1/2004 5/28/2004 7/28/2004 61 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Erectile Dysfunction, Hyperhidrosis, Sexual Dysfunction, Vomiting, Weight Decreased
4205812 4501704 29 Years M 1/1/2004 5/28/2004 9/27/2004 122 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Erectile Dysfunction, Hyperhidrosis, Sexual Dysfunction, Vomiting, Weight Decreased
4205813 4440418 7 Years F 3/16/2004 7/28/2004 134 PER Strattera Attention Deficit/Hyperactivity Disorder Erythema, Feeling Hot
4205814 4440434 12 Years 3/15/2004 7/28/2004 135 MD PER Strattera Nightmare
4205815 4440436 78 Years F 3/16/2004 7/28/2004 134 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Somnolence
4205818 4440440 12 Years 3/1/2004 3/15/2004 7/28/2004 135 PER Strattera Decreased Appetite, Dry Mouth, Fatigue, Mood Swings, Social Avoidant Behaviour, Tinnitus
4205822 4440443 7 Years M 3/15/2004 7/28/2004 135 PER Strattera Abnormal Behaviour
4205823 4440727 8 Years M 3/11/2004 7/28/2004 139 PER Strattera Retching
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205825 4440448 42 Years F 3/14/2004 3/15/2004 7/28/2004 135 PER Strattera Attention Deficit/Hyperactivity Disorder Euphoric Mood, Fatigue, Feeling Abnormal, Heart Rate Increased, Insomnia
4205830 4440451 44 Years F 3/12/2004 3/15/2004 7/28/2004 135 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Tension
4205831 4440453 7 Years F 3/15/2004 3/15/2004 7/28/2004 135 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour
4205832 4440460 48 Years M 2/18/2004 3/15/2004 7/28/2004 135 PER Strattera Attention Deficit/Hyperactivity Disorder Nasopharyngitis, Rhinorrhoea, Sneezing
4205833 4440476 34 Years F 3/16/2004 7/28/2004 134 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Feeling Abnormal, Mood Altered, Somnolence
4205834 4440729 6 Years M 3/10/2004 7/28/2004 140 PER Strattera Haematochezia, Irritability
4205835 4440679 11 Years F 5/3/2004 7/28/2004 86 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fatigue, Nausea, Retching, Vomiting
4205836 4440731 9 Years M 3/11/2004 3/11/2004 7/28/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Headache, Middle Insomnia, Pollakiuria
4205839 4440737     M 2/1/2004 3/11/2004 7/28/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Disturbance in Attention, Drug Ineffective, Fatigue, Psychomotor Hyperactivity, Sluggishness
4205841 4440760 43 Years F 1/1/2004 3/30/2004 7/28/2004 120 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205843 4440762 10 Years M 3/30/2004 3/30/2004 7/28/2004 120 PER Strattera Attention Deficit/Hyperactivity Disorder Vomiting
4205844 4440742 7 Years M 2/1/2003 3/11/2004 7/28/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Headache, Lethargy, Nausea, Psychomotor Hyperactivity, Weight Decreased
4205847 4440764 15 Years F 3/2/2004 6/10/2004 7/28/2004 48 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dyskinesia, Insomnia
4205847 4501713 15 Years F 3/2/2004 6/10/2004 9/27/2004 109 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dyskinesia, Insomnia
4205848 4440766 7 Years F 4/8/2004 7/28/2004 111 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination (Auditory), Insomnia
4205849 4440744 11 Years M 3/11/2004 7/28/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Irritability, Respiratory Tract Infection, Retching
4205850 4440768     F 3/30/2004 3/30/2004 7/28/2004 120 PER Strattera Attention Deficit/Hyperactivity Disorder Dissociation, Fatigue, Irritability
4205852 4440770 10 Years F 5/25/2004 7/28/2004 64 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tachycardia
4205852 4501714 10 Years F 5/25/2004 9/27/2004 125 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tachycardia
4205855 4440748 25 Years M 3/11/2004 3/18/2004 7/28/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Ejaculation Disorder, Nausea, Testicular Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205856 4440772 9 Years M 5/27/2004 7/28/2004 62 PER Strattera Attention Deficit/Hyperactivity Disorder Contusion, Weight Decreased
4205856 4501715 9 Years M 5/27/2004 9/27/2004 123 PER Strattera Attention Deficit/Hyperactivity Disorder Contusion, Weight Decreased
4205857 4440773 9 Years M 3/1/2004 3/31/2004 7/28/2004 119 OT PER Strattera Attention Deficit/Hyperactivity Disorder Contusion, Weight Decreased
4205858 4440775 44 Years M 3/30/2004 3/31/2004 7/28/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Heart Rate Increased, Thinking Abnormal
4205860 4440777 11 Years F 3/24/2004 3/31/2004 7/28/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Halitosis
4205861 4440700 15 Years M 4/1/2004 5/12/2004 7/28/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anxiety, Chest Pain, Dyspnoea, Feeling Abnormal, Irritability, Mood Swings, Somnolence, Stomach Discomfort
4205861 4501695 15 Years M 4/1/2004 7/21/2004 9/27/2004 68 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anxiety, Chest Pain, Drug Ineffective, Dyspnoea, Feeling Abnormal, Irritability, Mood Swings, Somnolence, Stomach Discomfort
4205862 4440496 6 Years M 8/14/2003 5/18/2004 7/28/2004 71 PER Strattera Autism Aggression, Anger, Growth Retardation, Increased Appetite, Screaming, Somnolence, Tic, Weight Increased
4205865 4441452 40 Years M 4/5/2004 7/28/2004 114 PER Strattera Drug Ineffective, Feeling Abnormal
4205869 4440500 7 Years M 8/1/2003 3/15/2004 7/28/2004 135 PER Strattera Attention Deficit/Hyperactivity Disorder Impulsive Behaviour
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205871 4440501     F 1/1/2003 8/18/2003 7/28/2004 345 MD PER Strattera Decreased Appetite, Dizziness, Hyperhidrosis, Insomnia, Mood Swings
4205872 4440512 9 Years M 8/1/2003 4/15/2004 7/28/2004 104 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Irritability
4205874 4440521 9 Years M 3/8/2004 7/28/2004 142 CN PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Depressed Mood, Disturbance in Attention, Fatigue, Mood Swings, Somnolence, Upper Limb Fracture, Weight Decreased, Weight Increased
4205875 4441455 12 Years M 4/2/2004 4/5/2004 7/28/2004 114 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Anorexia, Crying, Flatulence, Self Injurious Behaviour
4205876 4440503 14 Years F 7/1/2003 3/24/2004 7/28/2004 126 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction
4205877 4441457 37 Years M 3/1/2004 4/5/2004 7/28/2004 114 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Agitation, Drug Ineffective
4205879 4441459 6 Years F 4/1/2004 4/5/2004 7/28/2004 114 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Somnolence
4205880 4441384 55 Years M 2/19/2004 7/28/2004 160 PER Strattera Muscle Spasms, Myalgia
4205881 4441462 54 Years F 3/6/2004 4/5/2004 7/28/2004 114 PER Strattera Attention Deficit/Hyperactivity Disorder Pigmentation Disorder
4205882 4440454 6 Years F 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Emotional Distress
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205883 4440522 5 Years F 6/1/2003 3/2/2004 7/28/2004 148 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Drug Ineffective, Fatigue
4205884 4440456 12 Years F 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Weight Increased
4205885 4441463 28 Years M 4/5/2004 7/28/2004 114 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Decreased Appetite, Dysuria
4205886 4440457 7 Years M 3/1/2004 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4205887 4440463 10 Years F 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective
4205888 4440523 22 Years F 7/3/2003 3/22/2004 7/28/2004 128 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dysphemia, Fatigue, Hyperhidrosis, Nausea
4205889 4441466 7 Years M 4/5/2004 7/28/2004 114 PER Strattera Belligerence, Crying, Drug Ineffective, Fatigue, Mood Swings
4205891 4440466 32 Years M 3/5/2004 3/8/2004 7/28/2004 142 OT PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Insomnia
4205892 4441395 7 Years M 2/16/2004 2/19/2004 7/28/2004 160 MD PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Retention
4205893 4441468 55 Years F 4/3/2004 4/13/2004 7/28/2004 106 PER Strattera Disturbance in Attention Abdominal Pain Upper, Decreased Appetite, Fatigue, Gastrooesophageal Reflux Disease, Sinus Headache, Tension, Tension Headache
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205894 4441398 20 Years M 2/18/2004 2/19/2004 7/28/2004 160 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Headache, Nervousness
4205895 4441403 10 Years M 2/20/2004 7/28/2004 159 MD PER Strattera Tic
4205896 4441470 13 Years F 3/29/2004 4/5/2004 7/28/2004 114 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Pruritus, Tic, Urticaria
4205897 4440528 13 Years M 8/5/2003 3/16/2004 7/28/2004 134 CN PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Attention Deficit Hyperactivity Disorder, Decreased Appetite, Disturbance in Attention, Educational Problem, Fatigue, Therapeutic Response Decreased
4205898 4441465 8 Years M 5/1/2004 5/12/2004 7/28/2004 77 MD PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Tic
4205899 4441525 8 Years M 3/1/2004 7/28/2004 149 MD PER Strattera Abnormal Behaviour, Drug Ineffective
4205900 4441469 27 Years M 5/12/2004 7/28/2004 77 MD PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Swelling
4205901 4440469 57 Years M 2/1/2004 4/6/2004 7/28/2004 113 PER Strattera Attention Deficit/Hyperactivity Disorder Infection, Testicular Pain
4205902 4441527 9 Years M 4/6/2004 7/28/2004 113 MD PER Strattera Drooling
4205904 4441471 8 Years F 3/1/2004 5/12/2004 7/28/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Drug Ineffective
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205905 4441472 12 Years F 4/1/2004 4/5/2004 7/28/2004 114 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Nausea
4205906 4441474 43 Years M 5/11/2004 5/12/2004 7/28/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Dizziness, Feeling Abnormal, Nausea, Paranoia
4205907 4441528 12 Years 3/5/2004 7/28/2004 145 MD PER Strattera Abdominal Discomfort
4205908 4441421 34 Years F 3/1/2004 3/29/2004 7/28/2004 121 PER Strattera Attention Deficit/Hyperactivity Disorder Menorrhagia, Oligomenorrhoea
4205909 4441475 58 Years F 4/1/2004 5/12/2004 7/28/2004 77 MD PER Strattera Raynaud's Phenomenon
4205910 4440470 34 Years M 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Orgasm Abnormal
4205911 4441554 43 Years M 8/2/2003 3/19/2004 7/28/2004 131 PER Strattera Drug Interaction, Dysgeusia, Weight Decreased
4205912 4441477 6 Years M 5/3/2004 5/12/2004 7/28/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4205913 4441555     2/19/2004 7/28/2004 160 PER Strattera Agitation, Anxiety
4205914 4441424 37 Years F 3/1/2004 3/29/2004 7/28/2004 121 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Excitability
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205915 4441479 11 Years M 5/12/2004 5/12/2004 7/28/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Body Temperature Increased, Vomiting
4205916 4441530 12 Years 3/5/2004 7/28/2004 145 OT PER Strattera Aggression, Agitation
4205917 4440473 33 Years F 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Hypotension, Nervousness
4205918 4441557 17 Years F 2/23/2004 7/28/2004 156 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Increased Appetite, Mydriasis
4205919 4440477 16 Years F 3/8/2004 7/28/2004 142 OT PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Logorrhoea, Memory Impairment, Somnolence, Thinking Abnormal
4205920 4441482 49 Years F 2/1/2004 5/12/2004 7/28/2004 77 CN PER Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased
4205921 4441427 44 Years M 3/1/2004 3/29/2004 7/28/2004 121 PER Strattera Attention Deficit/Hyperactivity Disorder Micturition Urgency
4205922 4441558 7 Years M 2/23/2004 7/28/2004 156 PER Strattera Attention Deficit/Hyperactivity Disorder Eructation, Gastrooesophageal Reflux Disease, Initial Insomnia, Pruritus, Rash Papular
4205923 4441532 12 Years 3/5/2004 7/28/2004 145 OT PER Strattera Aggression, Agitation
4205924 4440480 16 Years M 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205925 4441484 17 Years M 5/12/2004 7/28/2004 77 PER Strattera Abdominal Pain Upper, Constipation, Flatulence
4205926 4441537 34 Years M 2/26/2004 7/28/2004 153 MD PER Strattera Abscess, Hypersensitivity Hospitalization - Initial or Prolonged
4205927 4441431 11 Years M 3/1/2004 3/29/2004 7/28/2004 121 PER Strattera Attention Deficit/Hyperactivity Disorder Conversion Disorder, Decreased Appetite, Hunger, Mood Swings, Somnolence
4205928 4441533 12 Years 3/5/2004 7/28/2004 145 OT PER Strattera Weight Increased
4205929 4441496     F 1/1/2002 5/12/2004 7/28/2004 77 PER Strattera Depression Feeling Hot, Hyperhidrosis, Temperature Intolerance
4205930 4440415 34 Years M 3/5/2004 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Back Pain, Dizziness, Headache, Tinnitus
4205931 4441561 14 Years M 2/1/2004 3/16/2004 7/28/2004 134 MD PER Strattera Abnormal Behaviour, Acute Stress Disorder, Blood Pressure Increased
4205932 4441433 6 Years M 1/1/2004 3/30/2004 7/28/2004 120 PER Strattera Attention Deficit/Hyperactivity Disorder Vomiting, Weight Gain Poor
4205933 4441372 40 Years M 1/1/2004 5/6/2004 7/28/2004 83 OT PER Strattera Attention Deficit/Hyperactivity Disorder Atrophy
4205934 4441535 12 Years 3/8/2004 7/28/2004 142 MD PER Strattera Chest Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205935 4440416 7 Years M 1/1/2003 3/8/2004 7/28/2004 142 PER Strattera Asthma, Cough, Dyspnoea, Wheezing
4205936 4441376 8 Years M 3/1/2004 5/7/2004 7/28/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anorexia, Weight Decreased
4205937 4441562 8 Years M 2/21/2004 2/23/2004 7/28/2004 156 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Decreased Appetite, Nausea, Pyrexia, Vomiting
4205938 4440419 9 Years M 1/1/2004 3/8/2004 7/28/2004 142 MD PER Strattera Attention Deficit/Hyperactivity Disorder Haemorrhage Urinary Tract
4205939 4441435     M 3/1/2004 3/30/2004 7/28/2004 120 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Fatigue
4205940 4441564 7 Years M 3/18/2004 7/28/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Arthralgia, Chest Pain, Stomach Discomfort
4205941 4441379 12 Years M 4/16/2004 5/7/2004 7/28/2004 82 MD PER Strattera Attention Deficit/Hyperactivity Disorder Disorientation, Hypersensitivity, Vomiting
4205942 4440433 49 Years F 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Menorrhagia
4205943 4441565 17 Years M 2/1/2004 2/23/2004 7/28/2004 156 PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Disorder
4205944 4441380 47 Years M 5/7/2004 5/7/2004 7/28/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Increased, Nervousness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205945 4440435 13 Years M 7/1/2003 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anxiety, Crying, Fatigue, Headache, Irritability, Mood Swings
4205946 4441436 30 Years M 2/24/2004 5/18/2004 7/28/2004 71 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hypoglycaemia
4205947 4441568 9 Years M 2/21/2004 2/23/2004 7/28/2004 156 PER Strattera Irritability, Nasal Congestion, Nasopharyngitis, Rhinorrhoea
4205948 4441381 7 Years M 5/7/2004 7/28/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder, Tourette's Disorder Drug Ineffective, Epistaxis, Lethargy
4205949 4441560 6 Years M 4/1/2004 4/15/2004 7/28/2004 104 PH PER Strattera Attention Deficit/Hyperactivity Disorder Angioneurotic Oedema Hospitalization - Initial or Prolonged
4205950 4440437 48 Years M 3/8/2004 4/8/2004 7/28/2004 111 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Ejaculation Disorder, Urine Abnormality
4205951 4441437 13 Years M 3/30/2004 7/28/2004 120 MD PER Strattera Ejaculation Disorder, Epididymitis
4205952 4441382 40 Years M 5/7/2004 5/7/2004 7/28/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Jittery, Nervousness, Stomach Discomfort, Tension
4205953 4441569 10 Years M 2/1/2004 2/23/2004 7/28/2004 156 PER Strattera Abnormal Behaviour, Fatigue, Somnolence, Thirst
4205954 4441409 10 Years M 4/22/2004 4/27/2004 7/28/2004 92 MD PER Strattera Cough, Mydriasis, Pyrexia, Viral Infection
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205955 4441385 48 Years M 5/7/2004 7/28/2004 82 PH PER Strattera Drug Ineffective
4205956 4441536 9 Years F 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Decreased Appetite, Disturbance in Attention
4205957 4441497 10 Years F 3/24/2004 5/5/2004 7/28/2004 84 MD PER Strattera Attention Deficit/Hyperactivity Disorder Back Pain, Chest Pain, Palpitations
4205958 4441500     F 5/5/2004 7/28/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Abortion Spontaneous
4205959 4441387 13 Years M 5/5/2004 5/7/2004 7/28/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Muscle Twitching, Vomiting
4205960 4441538 12 Years 2/19/2004 7/28/2004 160 MD PER Strattera Irritability
4205961 4441503 13 Years M 5/6/2004 7/28/2004 83 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Educational Problem
4205962 4441438 30 Years F 3/29/2004 3/30/2004 7/28/2004 120 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Emotional Disorder, Fatigue, Feeling Jittery, Headache, Hypoaesthesia Oral
4205963 4441571 12 Years M 5/20/2004 7/28/2004 69 MD PER Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Increased Other
4205964 4441389 12 Years M 10/1/2003 5/7/2004 7/28/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Disturbance in Attention
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205965 4441551 9 Years F 4/1/2004 5/6/2004 7/28/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Ear Pain, Eye Allergy, Fatigue, Pharyngolaryngeal Pain, Rhinitis Allergic
4205966 4440438 6 Years M 3/1/2004 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Somnolence
4205967 4441414 12 Years 4/27/2004 7/28/2004 92 MD PER Strattera Extrasystoles, Hypertension, Hypotension, Ventricular Arrhythmia
4205968 4441439 8 Years F 3/30/2004 3/30/2004 7/28/2004 120 OT PER Strattera Attention Deficit/Hyperactivity Disorder
4205969 4441540     M 3/10/2004 7/28/2004 140 MD PER Strattera Testicular Pain
4205970 4441573 15 Years M 1/1/2004 6/8/2004 7/28/2004 50 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tachycardia Other
4205970 4495976 15 Years M 1/1/2004 6/8/2004 9/27/2004 111 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tachycardia Other
4205971 4441556     F 4/1/2004 5/6/2004 7/28/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety
4205972 4441392 15 Years M 7/1/2003 5/10/2004 7/28/2004 79 PER Strattera Malaise, Nausea, Vomiting, Weight Increased
4205973 4441473     4/5/2004 7/28/2004 114 MD PER Strattera Drug Dependence, Drug Interaction
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205974 4440439 44 Years M 1/1/2004 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Sexual Dysfunction
4205975 4440441 12 Years F 3/8/2004 7/28/2004 142 MD PER Strattera Anxiety
4205976 4441394 12 Years 4/2/2004 7/28/2004 117 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Psychomotor Hyperactivity
4205977 4441476     4/5/2004 7/28/2004 114 MD PER Strattera Drug Dependence, Drug Interaction
4205978 4440444 30 Years F 3/8/2004 7/28/2004 142 PER Strattera Dizziness, Feeling Abnormal
4205979 4441574 26 Years M 5/7/2004 7/28/2004 82 MD PER Strattera Blood Pressure Increased, Headache, Intentional Overdose Other
4205980 4441481     4/5/2004 7/28/2004 114 MD PER Strattera Drug Dependence, Drug Interaction
4205981 4441397 12 Years F 4/5/2004 7/28/2004 114 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
4205982 4441486 11 Years F 1/1/2004 4/7/2004 7/28/2004 112 PER Strattera Disturbance in Attention Anxiety, Crying, Emotional Disorder, Obsessive-Compulsive Disorder
4205983 4441400     4/5/2004 7/28/2004 114 MD PER Strattera Drug Dependence, Drug Interaction
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205984 4441489 8 Years M 4/7/2004 7/28/2004 112 OT PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4205985 4441576 7 Years M 5/20/2004 7/28/2004 69 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tachycardia Other
4205986 4440746 17 Years F 3/27/2004 5/4/2004 7/28/2004 85 OT PER Strattera Attention Deficit/Hyperactivity Disorder Prolonged Labour
4205987 4441416 42 Years F 12/24/2003 4/27/2004 7/28/2004 92 PER Strattera Impulsive Behaviour, Psychomotor Hyperactivity Dizziness, Drug Ineffective, Headache, Middle Insomnia, Visual Disturbance
4205988 4441491 20 Years M 4/26/2004 7/28/2004 93 MD PER Strattera Attention Deficit/Hyperactivity Disorder Urine Analysis Abnormal
4205989 4441494 4 Years M 4/7/2004 7/28/2004 112 MD PER Strattera Hallucination (Visual)
4205991 4441402 56 Years F 4/1/2004 4/5/2004 7/28/2004 114 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Dizziness Postural, Dry Mouth, Dysphonia, Nervousness, Tremor, Weight Decreased
4205992 4441499 40 Years M 4/7/2004 7/28/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Anxiety, Disturbance in Attention, Dry Mouth, Feeling Abnormal, Feeling Jittery, Headache, Insomnia, Paraesthesia
4205993 4441404     F 4/1/2004 4/5/2004 7/28/2004 114 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Crying
4205994 4441504     M 4/7/2004 7/28/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder, Bipolar Disorder Testicular Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4205995 4441407 11 Years M 2/1/2004 4/5/2004 7/28/2004 114 MD PER Strattera Attention Deficit/Hyperactivity Disorder
4205996 4441559 12 Years M 5/6/2004 7/28/2004 83 MD PER Strattera Decreased Appetite, Neck Pain, Somnolence
4205996 4495962 12 Years M 6/28/2004 9/27/2004 91 MD PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Nausea, Neck Pain, Somnolence, Vomiting
4205997 4441506     F 3/29/2004 4/7/2004 7/28/2004 112 PER Strattera Dysgeusia
4205998 4440753 13 Years M 5/11/2004 7/28/2004 78 PER Strattera Anxiety, Chest Pain, Electrocardiogram Abnormal, Heart Rate Increased, Hypoaesthesia
4205999 4441408 23 Years F 4/6/2004 7/28/2004 113 PER Strattera Attention Deficit/Hyperactivity Disorder Sedation, Somnolence
4206000 4441441 61 Years M 4/2/2004 4/2/2004 7/28/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Abnormal, Memory Impairment, Vision Blurred
4206001 4440756 7 Years M 11/1/2003 3/25/2004 7/28/2004 125 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anger, Communication Disorder, Disturbance in Attention, Drug Ineffective, Psychomotor Hyperactivity
4206002 4441411 10 Years F 4/5/2004 4/5/2004 7/28/2004 114 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Impulsive Behaviour
4206003 4441444 15 Years M 4/1/2004 4/2/2004 7/28/2004 117 PER Strattera Decreased Appetite, Headache, Lacrimation Increased, Rhinorrhoea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206004 4441412     M 3/29/2004 7/28/2004 121 MD PER Strattera Paraesthesia, Pruritus, Rash
4206005 4441446 17 Years M 4/2/2004 7/28/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Adjustment Disorder, Drug Ineffective, Somnolence
4206006 4441415 7 Years M 4/5/2004 4/5/2004 7/28/2004 114 PER Strattera Feeling Abnormal, Nausea, Vomiting
4206007 4441449 52 Years F 4/2/2004 7/28/2004 117 MD PER Strattera Attention Deficit/Hyperactivity Disorder Skin Odour Abnormal
4206008 4441563 14 Years M 5/6/2004 7/28/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Erythema, Insomnia, Peripheral Coldness
4206010 4441606 74 Years F 3/31/2004 7/28/2004 119 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort, Haemorrhage Hospitalization - Initial or Prolonged
4206011 4441567 11 Years F 1/1/2004 5/6/2004 7/28/2004 83 OT PER Strattera Attention Deficit/Hyperactivity Disorder Blood Thyroid Stimulating Hormone Increased, Enuresis
4206013 4441570 9 Years M 5/6/2004 5/6/2004 7/28/2004 83 PER Strattera Hypoaesthesia Oral, Nausea, Pharyngeal Hypoaesthesia, Vomiting
4206014 4439456 52 Years F 1/1/2004 3/31/2004 7/28/2004 119 CN PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Constipation, Dizziness, Eye Pruritus, Fatigue, Impatience, Nasopharyngitis, Nausea, Peripheral Coldness, Urticaria
4206015 4439457 30 Years F 2/1/2004 3/9/2004 7/28/2004 141 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Increased Appetite, Menstrual Disorder, Premenstrual Syndrome, Psychomotor Hyperactivity, Thinking Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206016 4439458 4 Years M 3/1/2004 3/5/2004 7/28/2004 145 CN PER Strattera Attention Deficit/Hyperactivity Disorder Eye Irritation
4206017 4439459 19 Years M 3/8/2004 7/28/2004 142 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression
4206018 4441420 7 Years F 4/27/2004 7/28/2004 92 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
4206019 4441422 10 Years F 4/27/2004 7/28/2004 92 OT PER Strattera Alopecia
4206020 4439460     M 3/9/2004 7/28/2004 141 CN PER Strattera Attention Deficit/Hyperactivity Disorder Emotional Distress
4206021 4441425 36 Years F 6/16/2004 7/28/2004 42 PER Strattera Attention Deficit/Hyperactivity Disorder Nasopharyngitis, Pharyngolaryngeal Pain, Pruritus, Rash
4206021 4497063 36 Years F 6/16/2004 9/27/2004 103 CN PER Strattera Attention Deficit/Hyperactivity Disorder Nasopharyngitis, Pharyngolaryngeal Pain, Pruritus, Rash
4206022 4441428     F 4/28/2004 7/28/2004 91 MD PER Strattera Constipation, Drug Ineffective
4206023 4441572 19 Years F 5/6/2004 7/28/2004 83 OT PER Strattera
4206024 4441429 61 Years M 4/28/2004 7/28/2004 91 PH PER Strattera Attention Deficit/Hyperactivity Disorder Depressed Mood, Drug Ineffective
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206025 4439461 16 Years M 3/9/2004 7/28/2004 141 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4206027 4441432 5 Years M 4/26/2004 4/28/2004 7/28/2004 91 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Stomatitis, Swelling Face
4206028 4439463 6 Years M 3/9/2004 7/28/2004 141 CN PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity
4206029 4439464 31 Years M 3/1/2004 3/9/2004 7/28/2004 141 CN PER Strattera Attention Deficit/Hyperactivity Disorder Nasopharyngitis
4206030 4439465 5 Years M 3/9/2004 7/28/2004 141 CN PER Strattera Drug Ineffective, Psychomotor Hyperactivity
4206031 4441541     M 2/1/2004 2/23/2004 7/28/2004 156 PER Strattera Depression
4206032 4439466     M 3/10/2004 7/28/2004 140 MD PER Strattera Tic
4206033 4441543 31 Years M 2/23/2004 7/28/2004 156 OT PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Feeling Jittery, Middle Insomnia, Nervousness
4206034 4441544 17 Years F 2/23/2004 7/28/2004 156 PER Strattera Attention Deficit/Hyperactivity Disorder Nightmare
4206035 4441545 5 Years M 2/23/2004 7/28/2004 156 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Oppositional Defiant Disorder, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206036 4439467 12 Years M 3/10/2004 7/28/2004 140 MD PER Strattera Crohn's Disease
4206037 4439468 55 Years M 3/10/2004 7/28/2004 140 MD PER Strattera Cardiovascular Disorder
4206038 4441498 15 Years F 5/1/2004 5/11/2004 7/28/2004 78 MD PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Flushing, Muscle Spasms, Tachycardia
4206039 4439469 9 Years M 3/9/2004 3/10/2004 7/28/2004 140 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Ear Pain, Headache, Stomach Discomfort, Vomiting
4206040 4439470 9 Years M 3/10/2004 7/28/2004 140 CN PER Strattera Aggression, Psychomotor Hyperactivity
4206041 4441546 14 Years M 2/1/2004 3/16/2004 7/28/2004 134 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Blood Cholesterol Increased, Hypertension
4206042 4439471 13 Years F 1/1/2004 3/26/2004 7/28/2004 124 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blood Thyroid Stimulating Hormone
4206043 4441547 38 Years M 2/23/2004 7/28/2004 156 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dry Mouth, Dysuria, Groin Pain, Hyperhidrosis, Irritability, Memory Impairment, Pain
4206044 4441501 11 Years M 5/11/2004 7/28/2004 78 PER Strattera Weight Increased
4206045 4439472 25 Years M 3/9/2004 3/10/2004 7/28/2004 140 CN PER Strattera Anxiety, Disturbance in Attention Fatigue, Feeling Abnormal, Panic Disorder, Pruritus
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206047 4441502 10 Years M 5/11/2004 7/28/2004 78 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Drug Ineffective, Insomnia, Tic
4206048 4441505     M 5/11/2004 7/28/2004 78 PER Strattera Attention Deficit/Hyperactivity Disorder Amnesia, Apathy
4206050 4439473 13 Years M 3/10/2004 7/28/2004 140 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Palpitations
4206051 4439474 9 Years M 2/20/2004 3/29/2004 7/28/2004 121 OT PER Strattera Attention Deficit/Hyperactivity Disorder Family Stress, Suicidal Ideation
4206052 4439475 8 Years M 3/10/2004 7/28/2004 140 CN PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4206055 4441548 8 Years F 2/1/2004 2/23/2004 7/28/2004 156 PER Strattera Abnormal Behaviour, Drug Ineffective, Mood Swings, Psychomotor Hyperactivity, Stomach Discomfort, Weight Decreased
4206056 4441549 8 Years M 2/23/2004 7/28/2004 156 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Somnolence
4206057 4441550 16 Years F 12/1/2003 2/23/2004 7/28/2004 156 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Lethargy
4206060 4441552 54 Years M 3/1/2004 7/28/2004 149 MD PER Strattera Attention Deficit/Hyperactivity Disorder Defaecation Urgency, Micturition Urgency
4206063 4441507 68 Years M 5/1/2004 5/21/2004 7/28/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Libido Decreased, Urine Flow Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206063 4495964 68 Years M 5/1/2004 7/2/2004 9/27/2004 87 PER Strattera Attention Deficit/Hyperactivity Disorder Erectile Dysfunction, Feeling Abnormal, Libido Decreased, Urine Flow Decreased
4206065 4441508 11 Years F 5/12/2004 7/28/2004 77 PER Strattera Dysgeusia, Sensation of Foreign Body
4206069 4441509 6 Years M 4/1/2004 5/12/2004 7/28/2004 77 PER Strattera Nausea, Tic, Vomiting
4206071 4441510 9 Years M 5/12/2004 7/28/2004 77 MD PER Strattera Dyspnoea, Tachycardia
4206077 4441511 16 Years M 5/12/2004 7/28/2004 77 MD PER Strattera Dyspnoea, Tachycardia
4206081 4441512 46 Years 4/1/2004 5/12/2004 7/28/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Malaise
4206095 4441478 9 Years M 5/4/2004 5/6/2004 7/28/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Blepharospasm
4206096 4441480 62 Years F 5/5/2004 7/28/2004 84 MD PER Strattera Anxiety, Blood Pressure Increased, Emotional Distress, Fall
4206097 4441483 12 Years M 12/1/2003 5/6/2004 7/28/2004 83 OT PER Strattera Apathy, Depressed Mood, Disturbance in Attention, Dizziness, Fatigue, Irritability, Stomach Discomfort
4206099 4441485 16 Years F 3/1/2004 5/4/2004 7/28/2004 85 PER Strattera Attention Deficit/Hyperactivity Disorder Appetite Disorder, Oedema Peripheral
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206100 4441487 5 Years M 5/6/2004 7/28/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4206102 4441488 12 Years 5/6/2004 7/28/2004 83 MD PER Strattera Aggression, Anger, Mood Swings
4206103 4441490 46 Years F 5/6/2004 7/28/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Dysmenorrhoea
4206104 4441492 16 Years M 5/6/2004 7/28/2004 83 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Tic
4206105 4441493 12 Years F 5/7/2004 7/28/2004 82 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Crying, Depression
4206106 4441495 16 Years M 5/7/2004 7/28/2004 82 PER Strattera Abnormal Behaviour, Depression, Dysphonia
4206107 4441405 43 Years M 4/3/2004 4/7/2004 7/28/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Bruxism, Chills, Drug Ineffective, Feeling Drunk, Piloerection, Yawning
4206108 4441406 33 Years M 4/7/2004 7/28/2004 112 MD PER Strattera Fatigue Anosmia, Parosmia
4206109 4441410 6 Years M 4/7/2004 7/28/2004 112 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anger
4206111 4441413 6 Years M 4/4/2004 4/7/2004 7/28/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Initial Insomnia, Irritability, Lethargy, Psychomotor Hyperactivity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206112 4441417 26 Years F 4/7/2004 4/14/2004 7/28/2004 105 MD PER Strattera White Blood Cell Count Abnormal
4206113 4441419     M 4/14/2004 7/28/2004 105 OT PER Strattera Exercise Tolerance Decreased, Fatigue
4206114 4441423 12 Years F 4/8/2004 7/28/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Apathy
4206115 4441426 53 Years M 4/8/2004 7/28/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Pollakiuria, Urinary Hesitation
4206116 4441430 33 Years M 1/1/2004 4/8/2004 7/28/2004 111 PER Strattera Fatigue Ageusia, Parosmia, Yawning
4206118 4441434 16 Years F 4/8/2004 7/28/2004 111 MD PER Strattera Migraine
4206184 4441451 9 Years M 1/1/2003 4/2/2004 7/28/2004 117 CN PER Strattera Attention Deficit/Hyperactivity Disorder
4206192 4441456 13 Years M 4/2/2004 7/28/2004 117 OT PER Strattera Anger, Depression, Mood Swings
4206210 4441458 7 Years M 4/2/2004 7/28/2004 117 CN PER Strattera Fatigue, Headache
4206223 4441460 12 Years 4/2/2004 7/28/2004 117 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Psychomotor Hyperactivity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206232 4441464     F 1/1/2003 4/5/2004 7/28/2004 114 OT PER Strattera Abdominal Pain Upper, Headache, Malaise, Vomiting
4206234 4441467 7 Years M 1/1/2004 5/13/2004 7/28/2004 76 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Headache, Malaise, Somnolence, Vomiting
4206259 4438608     F 2/25/2004 7/28/2004 154 MD PER Strattera Aggression
4206265 4438609 8 Years F 1/1/2004 2/25/2004 7/28/2004 154 CN PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Somnolence, Stomach Discomfort, Weight Decreased
4206267 4438610 9 Years F 2/25/2004 7/28/2004 154 CN PER Strattera Attention Deficit/Hyperactivity Disorder
4206298 4438628 11 Years M 2/1/2004 3/1/2004 7/28/2004 149 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Eye Disorder, Fatigue, Mydriasis, Pallor, Stomach Discomfort
4206301 4438629 5 Years M 3/1/2004 3/1/2004 7/28/2004 149 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4206304 4438630 13 Years M 3/1/2004 7/28/2004 149 OT PER Strattera Attention Deficit/Hyperactivity Disorder Dyskinesia, Headache
4206308 4438631 18 Years F 2/28/2004 3/1/2004 7/28/2004 149 PER Strattera Erythema, Feeling Hot, Heat Rash, Rash Papular
4206310 4438632 44 Years F 1/1/2004 3/1/2004 7/28/2004 149 PER Strattera Obsessive-Compulsive Disorder Disturbance in Attention, Fall, Skin Laceration
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206311 4438633 12 Years F 3/1/2004 7/28/2004 149 MD PER Strattera Chronic Sinusitis, Ear Infection, Hypersensitivity
4206313 4438634 6 Years M 3/1/2004 7/28/2004 149 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anorexia, Dizziness, Drug Ineffective, Flatulence, Nausea, Nervousness, Psychomotor Hyperactivity, Vomiting, Weight Decreased
4206315 4438635 7 Years M 3/1/2004 7/28/2004 149 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
4206316 4438636 6 Years M 3/1/2004 7/28/2004 149 PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Retching
4206324 4438618 14 Years M 5/3/2004 5/4/2004 7/28/2004 85 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Nausea, Somnolence
4206326 4438619 46 Years F 3/1/2004 5/4/2004 7/28/2004 85 PER Strattera Thinking Abnormal Oedema Peripheral
4206329 4438620 11 Years M 4/13/2004 5/4/2004 7/28/2004 85 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fatigue, Somnolence
4206335 4438621     F 5/4/2004 7/28/2004 85 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Drug Interaction, Feeling Abnormal, Headache, Nausea
4206336 4438622 53 Years M 1/1/2004 5/4/2004 7/28/2004 85 PER Strattera Disorientation, Middle Insomnia, Nausea, Somnolence
4206340 4438623 56 Years F 5/4/2004 5/4/2004 7/28/2004 85 PER Strattera Attention Deficit/Hyperactivity Disorder Hyperhidrosis, Nausea, Paranoia, Psychomotor Hyperactivity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206342 4438624 6 Years F 12/1/2003 5/4/2004 7/28/2004 85 PER Strattera Attention Deficit/Hyperactivity Disorder Lymphadenopathy, Pharyngolaryngeal Pain
4206344 4438625 8 Years M 1/1/2004 5/5/2004 7/28/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Crying, Decreased Appetite, Irritability
4206346 4438626 10 Years M 5/5/2004 5/5/2004 7/28/2004 84 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination
4206346 4495956 10 Years M 5/5/2004 5/5/2004 9/27/2004 145 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination
4206361 4438627 52 Years M 5/5/2004 7/28/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Indifference
4206364 4438611 12 Years F 2/25/2004 7/28/2004 154 MD PER Strattera Vision Blurred Vision Blurred
4206364 4580299 11 Years F 11/11/2003 8/24/2004 1/27/2005 156 MD PER Strattera Attention Deficit/Hyperactivity Disorder Accommodation Disorder, Hypermetropia
4206366 4438612 10 Years M 2/25/2004 7/28/2004 154 OT PER Strattera Attention Deficit/Hyperactivity Disorder Self-Injurious Ideation, Suicidal Ideation
4206370 4438613 48 Years M 4/14/2004 7/28/2004 105 MD PER Strattera Attention Deficit/Hyperactivity Disorder Libido Increased, Orgasm Abnormal
4206373 4438614     M 2/26/2004 7/28/2004 153 PER Strattera Feeling Abnormal, Nausea, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206377 4438615 8 Years M 2/26/2004 7/28/2004 153 PER Strattera Educational Problem, Somnolence
4206380 4438616 12 Years M 2/6/2004 2/24/2004 7/28/2004 155 PER Strattera Asthenopia, Fatigue, Irritability, Somnolence
4206381 4438617     M 2/20/2004 7/28/2004 159 MD PER Strattera Anger
4206411 4438448 12 Years F 3/1/2004 3/24/2004 7/28/2004 126 PER Strattera Disturbance in Attention Decreased Appetite, Feeling Cold, Feeling Hot, Nausea, Pallor
4206415 4438449 47 Years F 3/1/2004 3/24/2004 7/28/2004 126 PER Strattera Dizziness, Headache, Nausea, Tremor, Vomiting
4206418 4438450 26 Years M 3/1/2004 3/24/2004 7/28/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Dysphagia, Headache, Initial Insomnia, Pruritus, Urticaria
4206420 4438451 4 Years F 3/1/2004 3/24/2004 7/28/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Dysphagia, Infection, Pyrexia
4206425 4438565 20 Years M 4/19/2004 7/28/2004 100 OT PER Strattera Attention Deficit/Hyperactivity Disorder Libido Decreased, Retrograde Ejaculation, Spermatozoa Abnormal
4206427 4438566 12 Years M 10/27/2003 2/24/2004 7/28/2004 155 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Hypertension
4206428 4438452 12 Years M 3/1/2004 3/24/2004 7/28/2004 126 PER Strattera Disturbance in Attention Decreased Appetite, Headache, Pharyngitis Streptococcal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206430 4438453 12 Years 3/24/2004 7/28/2004 126 MD PER Strattera Blepharospasm
4206436 4438454 48 Years M 3/1/2004 3/31/2004 7/28/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Chapped Lips, Constipation, Drug Ineffective, Dry Mouth, Dysuria, Malaise, Nausea, Piloerection, Psychomotor Hyperactivity, Rash Macular, Stomatitis
4206438 4438455 12 Years M 3/1/2004 3/24/2004 7/28/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Somnolence, Weight Increased
4206439 4438567     F 3/1/2004 3/1/2004 7/28/2004 149 PER Strattera Anxiety, Dizziness, Heart Rate Increased
4206440 4438568 22 Years M 2/27/2004 3/2/2004 7/28/2004 148 PER Strattera Anxiety, Attention Deficit/Hyperactivity Disorder Anxiety, Dizziness, Somnolence
4206441 4438456 53 Years F 3/1/2004 3/24/2004 7/28/2004 126 PER Strattera Asthenia, Fatigue, Feeling Abnormal
4206443 4438569 4 Years M 3/2/2004 7/28/2004 148 PER Strattera Oral Mucosal Blistering, Retching, Vomiting
4206446 4438457 35 Years M 3/1/2004 3/24/2004 7/28/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Gastrooesophageal Reflux Disease
4206448 4438570 7 Years M 2/25/2004 3/2/2004 7/28/2004 148 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Nasopharyngitis, Psychomotor Hyperactivity
4206452 4438571 9 Years M 11/1/2003 3/2/2004 7/28/2004 148 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Decreased Appetite, Distractibility, Drug Ineffective
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206468 4438572 18 Years M 1/1/2004 3/8/2004 7/28/2004 142 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Amnesia, Drug Dependence, Drug Screen Positive, Fatigue
4206486 4438573 13 Years F 3/2/2004 7/28/2004 148 MD PER Strattera Attention Deficit/Hyperactivity Disorder Sedation
4206490 4438574 26 Years M 2/29/2004 3/2/2004 7/28/2004 148 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Lower, Difficulty in Walking, Dysuria, Genital Pain Male, Oedema Genital, Rash Macular, Scab, Urinary Hesitation, Urine Output Decreased
4206494 4438576 8 Years F 2/1/2004 3/2/2004 7/28/2004 148 PER Strattera Attention Deficit/Hyperactivity Disorder, Memory Impairment Retching
4206507 4438578 11 Years M 1/1/2004 3/2/2004 7/28/2004 148 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4206510 4438579 25 Years F 3/2/2004 3/2/2004 7/28/2004 148 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Feeling Abnormal, Nausea
4206515 4438580 52 Years M 5/1/2003 3/2/2004 7/28/2004 148 PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Hesitation, Urine Flow Decreased
4206516 4438581 8 Years F 9/1/2003 3/2/2004 7/28/2004 148 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Diarrhoea, Vomiting
4206517 4438582     M 3/2/2004 7/28/2004 148 PER Strattera Attention Deficit/Hyperactivity Disorder Erectile Dysfunction, Male Orgasmic Disorder, Visual Disturbance
4206569 4438478 51 Years F 3/22/2004 3/22/2004 7/28/2004 128 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Cold Sweat, Dizziness, Fatigue, Influenza Like Illness, Nausea, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206571 4438479 5 Years F 3/22/2004 7/28/2004 128 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4206572 4438480     F 3/16/2004 7/28/2004 134 MD PER Strattera Bruxism
4206576 4438598 7 Years M 2/23/2004 7/28/2004 156 PER Strattera Abnormal Behaviour Anorexia, Drug Ineffective, Weight Decreased
4206579 4438482 12 Years 3/17/2004 7/28/2004 133 MD PER Strattera Motion Sickness
4206582 4438483 22 Years F 3/22/2004 7/28/2004 128 OT PER Strattera Alopecia
4206583 4438583 44 Years F 3/2/2004 7/28/2004 148 CN PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Heart Rate Increased, Insomnia, Tremor, Weight Decreased
4206584 4438484 17 Years M 3/19/2004 3/22/2004 7/28/2004 128 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Irritability, Nasopharyngitis
4206585 4438584 6 Years M 3/1/2004 4/6/2004 7/28/2004 113 CN PER Strattera Asthma, Chest Discomfort, Cough, Dyspnoea, Wheezing
4206587 4438485 7 Years M 3/22/2004 7/28/2004 128 PER Strattera Agitation, Retching, Vomiting
4206588 4438585 20 Years M 3/3/2004 7/28/2004 147 CN PER Strattera Attention Deficit/Hyperactivity Disorder Euphoric Mood, Feeling Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206589 4438586 38 Years M 12/1/2002 3/2/2004 7/28/2004 148 CN PER Strattera Erectile Dysfunction, Loss of Libido, Urinary Hesitation
4206592 4438486 43 Years F 3/21/2004 3/26/2004 7/28/2004 124 PER Strattera Anxiety, Attention Deficit/Hyperactivity Disorder Chills, Feeling Abnormal, Formication, Insomnia, Sleep Disorder
4206595 4438487 38 Years F 3/20/2004 3/22/2004 7/28/2004 128 PER Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased, Malaise
4206595 4637481 38 Years F 3/20/2004 3/1/2005 3/28/2005 27 PER Strattera Hepatic Enzyme Increased, Malaise
4206595 4726698 38 Years F 3/20/2004 3/1/2005 7/25/2005 146 PER Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased, Malaise
4206596 4438599 10 Years M 2/23/2004 2/23/2004 7/28/2004 156 PER Strattera Abnormal Behaviour
4206598 4438587     M 3/2/2004 7/28/2004 148 MD PER Strattera Chest Pain, Dizziness, Feeling Abnormal
4206599 4438600 9 Years F 1/12/2004 4/12/2004 7/28/2004 107 OT PER Strattera Abnormal Behaviour Crying, Depression, Drug Ineffective, Fatigue, Irritability, Nausea, Suicidal Ideation
4206601 4438601 12 Years F 2/1/2004 2/24/2004 7/28/2004 155 PER Strattera Vision Blurred Heart Rate Increased, Overdose
4206602 4438602 7 Years M 2/24/2004 7/28/2004 155 PER Strattera Feeling Abnormal Drug Ineffective, Impulsive Behaviour, Weight Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206604 4438603 8 Years M 2/21/2004 2/24/2004 7/28/2004 155 PER Strattera Abnormal Behaviour Abnormal Behaviour
4206607 4438604     M 2/1/2004 2/24/2004 7/28/2004 155 MD PER Strattera Abnormal Behaviour Oral Surgery
4206608 4438458     F 3/23/2004 7/28/2004 127 PER Strattera
4206610 4438605     M 2/24/2004 2/24/2004 7/28/2004 155 PER Strattera Nausea
4206611 4438606     F 2/24/2004 7/28/2004 155 PER Strattera Feeling Abnormal
4206612 4442911 4 Years M 5/13/2004 7/28/2004 76 MD PER Strattera Autism Aggression, Nightmare, Tachycardia
4206614 4442912 8 Years F 4/1/2004 5/11/2004 7/28/2004 78 PER Strattera Abnormal Behaviour
4206616 4442914 14 Years M 4/1/2004 5/10/2004 7/28/2004 79 PER Strattera Apathy, Fatigue, Heart Rate Increased
4206617 4438607 14 Years M 12/25/2003 3/4/2004 7/28/2004 146 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Agitation, Anxiety, Delusion, Drug Ineffective, Drug Interaction, Insomnia, Paranoia, Psychotic Disorder, Social Avoidant Behaviour, Stress Symptoms, Suicidal Ideation
4206619 4442915 47 Years M 5/10/2004 7/28/2004 79 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Urinary Retention
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206621 4442917 12 Years 5/13/2004 7/28/2004 76 MD PER Strattera Drug Ineffective
4206623 4442919     M 5/20/2004 7/28/2004 69 MD PER Strattera Testicular Pain
4206625 4442920 9 Years M 5/17/2004 7/28/2004 72 PER Strattera Compulsions, Tic
4206626 4438468 31 Years M 3/1/2004 3/22/2004 7/28/2004 128 PER Strattera Attention Deficit/Hyperactivity Disorder Depressed Mood, Feeling Abnormal, Headache, Somnolence
4206627 4438469 14 Years F 1/1/2004 3/22/2004 7/28/2004 128 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Menstruation Irregular
4206628 4442922 12 Years M 9/30/2003 5/19/2004 7/28/2004 70 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Irritability, Mood Swings
4206630 4442924 12 Years 5/19/2004 7/28/2004 70 MD PER Strattera Disturbance in Attention, Educational Problem
4206631 4438470 6 Years M 3/1/2004 6/15/2004 7/28/2004 43 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Cyanosis, Decreased Appetite, Dry Mouth, Feeling Abnormal, Feeling Cold, Mydriasis, Somnolence, Weight Decreased
4206631 4501708 6 Years M 3/1/2004 6/15/2004 9/27/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Cyanosis, Decreased Appetite, Dry Mouth, Feeling Abnormal, Feeling Cold, Mydriasis, Somnolence, Weight Decreased
4206633 4438471 53 Years M 1/1/2004 3/22/2004 7/28/2004 128 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Insomnia, Loss of Libido, Pollakiuria, Urinary Retention, Urine Flow Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206635 4438472 9 Years M 3/23/2004 7/28/2004 127 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Increased Appetite
4206637 4438459 13 Years F 12/1/2003 3/23/2004 7/28/2004 127 MD PER Strattera Acne
4206638 4438473 35 Years M 3/23/2004 7/28/2004 127 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Burning Sensation, Chills, Feeling Abnormal, Hyperhidrosis, Sleep Disorder
4206644 4438488 15 Years M 3/17/2004 7/28/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Mood Swings, Personality Change
4206645 4438460 60 Years F 3/1/2004 5/13/2004 7/28/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Blood Pressure Decreased, Drug Ineffective, Drug Interaction, Fatigue, Increased Appetite, Insomnia, Mood Swings, Nausea, Vomiting
4206646 4438489 12 Years 5/17/2004 7/28/2004 72 MD PER Strattera Motion Sickness
4206647 4438475 57 Years F 3/1/2004 3/23/2004 7/28/2004 127 PER Strattera Aggression, Constipation, Depression, Fatigue, Feeling Abnormal, Hot Flush, Impatience, Libido Decreased, Memory Impairment, Weight Decreased
4206649 4438476     F 3/1/2004 3/23/2004 7/28/2004 127 MD PER Strattera Attention Deficit/Hyperactivity Disorder Palpitations, Peripheral Coldness, Piloerection
4206650 4438490 12 Years M 3/17/2004 3/24/2004 7/28/2004 126 OT PER Strattera Gastroenteritis, Gastroenteritis Viral, Pruritus, Rash, Urticaria, Viral Infection
4206651 4438461 9 Years M 11/1/2003 3/24/2004 7/28/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Headache, Lymphadenopathy, Sinusitis
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206652 4438491 6 Years M 3/17/2004 7/28/2004 133 PER Strattera Abnormal Behaviour
4206654 4438492 32 Years F 3/17/2004 3/17/2004 7/28/2004 133 OT PER Strattera Dermatitis Contact, Pruritus, Rash Macular
4206655 4438462 5 Years M 3/23/2004 3/24/2004 7/28/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
4206656 4438493     M 3/18/2004 7/28/2004 132 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Tremor
4206657 4438494 6 Years M 3/13/2004 3/18/2004 7/28/2004 132 OT PER Strattera Abdominal Pain, Headache, Lethargy, Loose Stools, Retching, Vomiting
4206658 4438496 25 Years M 1/1/2004 3/18/2004 7/28/2004 132 MD PER Strattera Semen Abnormal
4206659 4438463     M 3/23/2004 3/24/2004 7/28/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Cough, Dry Mouth, Dyspnoea, Parosmia
4206661 4438464 14 Years M 3/19/2004 3/24/2004 7/28/2004 126 PER Strattera Abnormal Behaviour, Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Drug Ineffective, Intentional Self-Injury, Panic Reaction, Sleep Disorder, Somnolence
4206662 4438465 7 Years M 3/23/2004 3/24/2004 7/28/2004 126 PER Strattera Retching, Vomiting
4206663 4438588 12 Years 3/17/2004 7/28/2004 133 MD PER Strattera Motion Sickness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206664 4438466 7 Years F 3/24/2004 7/28/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Emotional Distress, Fatigue, Mood Altered, Stomach Discomfort, Urinary Incontinence, Urine Odour Abnormal
4206665 4438467 10 Years M 3/24/2004 5/5/2004 7/28/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Hypersomnia, Skin Desquamation
4206666 4438589 8 Years M 3/17/2004 7/28/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation
4206669 4438477 53 Years F 3/23/2004 7/28/2004 127 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Hot, Hot Flush, Insomnia, Somnolence
4206671 4438498 9 Years F 3/18/2004 7/28/2004 132 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Insomnia, Psychomotor Hyperactivity
4206673 4438499     F 3/15/2004 3/18/2004 7/28/2004 132 PER Strattera Dizziness, Dyspnoea, Erythema, Tremor, Urticaria
4206675 4441011 40 Years F 4/14/2004 4/14/2004 7/28/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Amnesia, Disturbance in Attention, Stress Symptoms, Thinking Abnormal
4206677 4441012 7 Years F 2/20/2004 5/21/2004 7/28/2004 68 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Drug Withdrawal Syndrome, Headache, Irritability
4206678 4441013 8 Years F 2/1/2004 4/14/2004 7/28/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia
4206681 4438590     M 3/1/2004 3/17/2004 7/28/2004 133 PER Strattera Drug Ineffective, Euphoric Mood
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206684 4438591 13 Years M 1/12/2004 5/11/2004 7/28/2004 78 MD PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Palpitations, Tachycardia
4206685 4438592 5 Years M 3/14/2004 3/17/2004 7/28/2004 133 PER Strattera Vision Blurred Abdominal Pain Upper, Drug Ineffective, Feeling Drunk, Lethargy, Somnolence
4206687 4438593 7 Years M 3/17/2004 7/28/2004 133 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4206689 4438594 27 Years F 3/17/2004 7/28/2004 133 PH PER Strattera Memory Impairment
4206690 4438595     M 3/17/2004 7/28/2004 133 MD PER Strattera Throat Irritation
4206693 4438596 44 Years M 3/17/2004 7/28/2004 133 MD PER Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder, Testicular Swelling
4206695 4438597     F 1/1/2004 3/17/2004 7/28/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Mood Swings
4206698 4441014 40 Years M 1/1/2004 4/14/2004 7/28/2004 105 MD PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Suicidal Ideation
4206701 4441015 10 Years M 1/1/2004 4/14/2004 7/28/2004 105 MD PER Strattera Dyspnoea, Panic Attack
4206702 4441016 21 Years F 4/10/2004 4/14/2004 7/28/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Depression
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206704 4441017 40 Years M 4/14/2004 7/28/2004 105 MD PER Strattera Attention Deficit/Hyperactivity Disorder Disorientation, Dizziness, Euphoric Mood
4206706 4441018 25 Years 1/1/2004 4/14/2004 7/28/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Hypersomnia, Nightmare
4206708 4441019     F 2/7/2004 4/14/2004 7/28/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Adjustment Disorder, Drug Ineffective, Somnolence
4206710 4441020 42 Years F 4/9/2004 4/14/2004 7/28/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Arthralgia, Dizziness, Feeling Abnormal, Insomnia, Pain, Paraesthesia, Somnolence
4206749 4440973 22 Years F 4/27/2004 7/28/2004 92 OT PER Strattera Attention Deficit/Hyperactivity Disorder Neutropenia
4206751 4440974     M 4/16/2004 7/28/2004 103 MD PER Strattera Abnormal Behaviour
4206757 4440975 36 Years F 6/1/2004 7/28/2004 57 PER Strattera Eating Disorder, Fibromyalgia Affective Disorder, Confusional State, Drug Ineffective, Dysgeusia, Dyspnoea, Fatigue, Feeling Abnormal, Nervousness, Rash, Urticaria
4206757 4497057 36 Years F 6/1/2004 9/27/2004 118 CN PER Strattera Eating Disorder, Fibromyalgia Affective Disorder, Confusional State, Drug Ineffective, Dysgeusia, Dyspnoea, Fatigue, Feeling Abnormal, Nervousness, Rash, Urticaria
4206758 4440976 40 Years F 4/16/2004 7/28/2004 103 MD PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Irritability, Psychomotor Hyperactivity, Somnolence
4206759 4440977 5 Years F 4/15/2004 5/10/2004 7/28/2004 79 PER Strattera Attention Deficit/Hyperactivity Disorder Flushing, Nausea, Piloerection, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206762 4440978 39 Years F 4/13/2004 5/3/2004 7/28/2004 86 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Nasopharyngitis, Pharyngolaryngeal Pain, Rhinorrhoea
4206770 4440979 18 Years M 1/1/2003 4/16/2004 7/28/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Stomach Discomfort, Stress Symptoms
4206773 4440980 18 Years M 4/15/2004 4/16/2004 7/28/2004 103 OT PER Strattera Attention Deficit/Hyperactivity Disorder Depersonalisation, Formication, Insomnia, Panic Attack, Stress Symptoms
4206776 4440981 12 Years 4/15/2004 7/28/2004 104 OT PER Strattera Chest Pain
4206781 4440982     F 4/16/2004 4/16/2004 7/28/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Insomnia, Piloerection
4206783 4440933     M 4/12/2004 7/28/2004 107 MD PER Strattera Disturbance in Attention, Drug Interaction
4206784 4440934 13 Years M 3/1/2004 4/12/2004 7/28/2004 107 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Heart Rate Increased, Nausea
4206785 4440935 44 Years M 1/1/2004 4/12/2004 7/28/2004 107 PER Strattera Nervousness, Nightmare
4206790 4440983 23 Years M 4/10/2004 4/27/2004 7/28/2004 92 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Confusional State, Hyperhidrosis, Nasopharyngitis, Tachycardia, Tremor, Urinary Retention
4206792 4440984 12 Years 4/15/2004 7/28/2004 104 OT PER Strattera Chest Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206793 4440985 8 Years M 4/15/2004 7/28/2004 104 MD PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Hallucination (Auditory), Insomnia, Suicidal Ideation
4206795 4440986 48 Years F 4/15/2004 7/28/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Apathy
4206799 4440987 12 Years M 4/15/2004 7/28/2004 104 MD PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity, Tic
4206801 4440936 12 Years M 4/12/2004 7/28/2004 107 PER Strattera Attention Deficit/Hyperactivity Disorder Tinnitus
4206802 4440988 6 Years M 3/1/2004 4/15/2004 7/28/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria
4206806 4440937     M 4/1/2004 4/13/2004 7/28/2004 106 PER Strattera Abnormal Behaviour, Dry Mouth, Dysuria, Erectile Dysfunction, Malaise, Nervousness, Sleep Disorder
4206807 4440989 17 Years M 4/15/2004 7/28/2004 104 MD PER Strattera Attention Deficit/Hyperactivity Disorder Chest Discomfort, Feeling Abnormal
4206808 4440938     M 2/18/2004 4/12/2004 7/28/2004 107 MD PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Depression, Disturbance in Attention, Drug Ineffective, Lethargy, Urinary Hesitation
4206809 4440990 16 Years F 4/15/2004 7/28/2004 104 MD PER Strattera Amenorrhoea
4206810 4440939     M 4/12/2004 7/28/2004 107 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Depression
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206812 4440991 33 Years F 4/1/2004 4/16/2004 7/28/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Formication, Insomnia, Paraesthesia, Piloerection, Pruritus
4206813 4440940 17 Years M 3/1/2004 4/12/2004 7/28/2004 107 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Enuresis
4206814 4440992 49 Years F 1/1/2004 4/16/2004 7/28/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Confusional State, Disturbance in Attention, Drug Ineffective, Thinking Abnormal
4206815 4440941 7 Years M 4/13/2004 7/28/2004 106 PH PER Strattera Attention Deficit/Hyperactivity Disorder Epistaxis
4206818 4442898 8 Years M 5/20/2004 7/28/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Weight Increased
4206819 4442899 15 Years M 5/20/2004 7/28/2004 69 PER Strattera Drug Ineffective
4206820 4442900 12 Years M 5/20/2004 7/28/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Weight Increased
4206822 4442901 4 Years M 5/20/2004 7/28/2004 69 MD PER Strattera Attention Deficit/Hyperactivity Disorder Postictal State
4206822 4495930 4 Years M 8/5/2004 9/27/2004 53 MD PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity, Somnolence
4206827 4442902 6 Years M 5/21/2004 7/28/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Flushing, Initial Insomnia, Insomnia, Psychomotor Hyperactivity, Thirst, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206832 4440942 9 Years F 4/13/2004 7/28/2004 106 PER Strattera Mydriasis, Palpitations
4206833 4442904 28 Years F 5/21/2004 5/21/2004 7/28/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Euphoric Mood, Fear, Somnolence
4206836 4442905 8 Years M 5/21/2004 5/21/2004 7/28/2004 68 PER Strattera Abnormal Behaviour, Hypersomnia
4206840 4442907 8 Years M 5/21/2004 5/21/2004 7/28/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Choking, Vomiting
4206841 4442908 53 Years F 5/1/2004 6/3/2004 7/28/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Amnesia, Diarrhoea, Dry Mouth, Dyspepsia, Eructation, Headache, Hypotension, Nausea, Oral Discomfort, Sleep Disorder, Urinary Hesitation, Vomiting, Weight Increased
4206841 4495924 53 Years F 5/1/2004 8/11/2004 9/27/2004 47 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Amnesia, Diarrhoea, Drug Ineffective, Dry Mouth, Dyspepsia, Eructation, Headache, Hypotension, Nausea, Oral Discomfort, Sleep Disorder, Urinary Hesitation, Vomiting, Weight Increased
4206844 4442909 14 Years 5/20/2004 7/28/2004 69 PER Strattera Affect Lability, Psychomotor Hyperactivity
4206903 4440943 52 Years M 1/1/2003 4/9/2004 7/28/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Peripheral Coldness, Raynaud's Phenomenon
4206905 4440944     M 4/9/2004 4/9/2004 7/28/2004 110 PER Strattera Asthenia, Feeling Abnormal, Hypotension, Middle Insomnia, Paraesthesia
4206909 4440945     M 4/9/2004 7/28/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Fatigue, Nervousness, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206914 4440946 8 Years M 4/8/2004 7/28/2004 111 PER Strattera Abdominal Distension, Constipation, Headache, Micturition Urgency, Urinary Hesitation, Urinary Retention, Weight Decreased
4206915 4440947 11 Years M 9/1/2003 4/21/2004 7/28/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Nausea, Tic
4206918 4440948 7 Years M 4/1/2004 5/7/2004 7/28/2004 82 PER Strattera Anorexia, Feeling Abnormal, Social Avoidant Behaviour, Staring, Weight Decreased, Yawning
4206920 4440949 18 Years M 3/1/2004 4/12/2004 7/28/2004 107 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Decreased Appetite, Insomnia, Irritability
4206923 4440950 17 Years M 4/10/2004 4/12/2004 7/28/2004 107 PER Strattera Attention Deficit/Hyperactivity Disorder Boredom, Fatigue, Irritability, Stress Symptoms, Yawning
4206927 4440951 48 Years M 1/1/2004 4/12/2004 7/28/2004 107 OT PER Strattera Dysuria, Ejaculation Disorder
4206930 4440952 30 Years M 4/12/2004 7/28/2004 107 MD PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Interaction
4206932 4440913 3 Years M 4/21/2004 4/21/2004 7/28/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity
4206935 4440914 10 Years M 4/21/2004 7/28/2004 98 MD PER Strattera Attention Deficit/Hyperactivity Disorder Trichotillomania
4206937 4441052 15 Years M 1/1/2004 3/31/2004 7/28/2004 119 CN PER Strattera Decreased Appetite, Disturbance In Social Behaviour, Educational Problem, Emotional Disorder, Negativism, Tearfulness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206938 4440915 10 Years F 3/1/2004 4/22/2004 7/28/2004 97 PER Strattera Anxiety, Attention Deficit/Hyperactivity Disorder Hunger
4206940 4440916 10 Years M 4/22/2004 7/28/2004 97 PER Strattera Crying, Suicidal Ideation
4206944 4440917 34 Years F 4/1/2004 4/22/2004 7/28/2004 97 MD PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia, Anorexia, Dehydration, Dizziness, Fatigue, Hot Flush, Nausea, Vomiting, Weight Decreased
4206946 4440918 37 Years M 4/16/2004 7/28/2004 103 LW PER Strattera Attention Deficit/Hyperactivity Disorder Sleep Apnoea Syndrome
4206947 4441053 7 Years M 1/1/2004 3/30/2004 7/28/2004 120 OT PER Strattera Attention Deficit/Hyperactivity Disorder Sexual Inhibition
4206953 4440919 10 Years M 4/22/2004 7/28/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Emotional Disorder, Mood Swings, Somnolence
4206954 4441054 5 Years M 3/31/2004 7/28/2004 119 PER Strattera Disturbance in Attention Bowel Sounds Abnormal
4206965 4441055 10 Years M 3/25/2004 3/31/2004 7/28/2004 119 MD PER Strattera Tic
4206966 4441056 5 Years M 4/1/2004 7/28/2004 118 OT PER Strattera Somnolence
4206968 4440920 7 Years M 4/26/2004 7/28/2004 93 PER Strattera Attention Deficit/Hyperactivity Disorder Gastrointestinal Disorder, Increased Appetite, Psychomotor Hyperactivity, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4206971 4441057 24 Years M 3/31/2004 7/28/2004 119 OT PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Irritability
4206972 4441058 8 Years M 3/31/2004 4/1/2004 7/28/2004 118 OT PER Strattera Attention Deficit/Hyperactivity Disorder Drooling, Glossodynia, Hypoaesthesia Oral, Retching
4206974 4440921 12 Years M 4/1/2004 5/13/2004 7/28/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Hyperphagia, Nervousness, Weight Increased
4206975 4441059 7 Years M 3/1/2004 4/1/2004 7/28/2004 118 PER Strattera Decreased Appetite Crying, Decreased Appetite, Fatigue, Headache, Insomnia, Mood Swings, Pain in Extremity, Psychomotor Hyperactivity, Weight Decreased
4206978 4441060 20 Years M 3/1/2004 4/1/2004 7/28/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation
4206979 4440922 7 Years M 4/1/2004 4/22/2004 7/28/2004 97 OT PER Strattera Abnormal Behaviour, Impulse-Control Disorder, Somnolence
4206989 4441061 9 Years M 4/1/2004 7/28/2004 118 MD PER Strattera Attention Deficit/Hyperactivity Disorder Chest Discomfort
4206991 4443233 7 Years M 5/1/2004 5/13/2004 7/28/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Crying, Decreased Appetite, Impulsive Behaviour, Insomnia, Irritability, Mood Swings, Psychomotor Hyperactivity
4207032 4441353 7 Years M 2/1/2004 4/28/2004 7/28/2004 91 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Drug Ineffective, Psychomotor Hyperactivity, Weight Decreased
4207038 4441358 9 Years F 3/8/2004 4/28/2004 7/28/2004 91 PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207066 4441361 37 Years F 4/29/2004 4/29/2004 7/28/2004 90 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Feeling Abnormal, Heart Rate Increased, Orthostatic Hypotension
4207067 4441363 13 Years M 4/28/2004 7/28/2004 91 OT PER Strattera Psychotic Disorder
4207073 4441364 13 Years M 4/28/2004 7/28/2004 91 OT PER Strattera Psychotic Disorder
4207101 4441365 15 Years F 4/1/2004 4/29/2004 7/28/2004 90 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Hypersomnia, Nausea, Stomach Discomfort
4207102 4441366     M 4/1/2004 4/29/2004 7/28/2004 90 MD PER Strattera Fight In School, Irritability
4207104 4441367     F 1/1/2004 4/29/2004 7/28/2004 90 MD PER Strattera Abnormal Behaviour, Feeling Abnormal
4207107 4441369 10 Years M 4/28/2004 7/28/2004 91 OT PER Strattera Sleep Walking
4207110 4441370 13 Years F 4/28/2004 4/29/2004 7/28/2004 90 PER Strattera Intentional Overdose
4207178 4440923 9 Years F 4/5/2004 7/28/2004 114 PER Strattera Retching, Vomiting
4207180 4440924 7 Years M 4/6/2004 7/28/2004 113 PER Strattera Attention Deficit/Hyperactivity Disorder Compulsions, Crying, Emotional Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207181 4440893 9 Years M 4/1/2004 4/23/2004 7/28/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Depression, Emotional Distress, Fatigue, Feeling Abnormal, Insomnia, Nervousness, Psychiatric Symptom
4207182 4440925 9 Years F 1/1/2003 4/6/2004 7/28/2004 113 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Blister, Haemangioma
4207184 4440926 7 Years F 1/1/2004 4/6/2004 7/28/2004 113 MD PER Strattera Attention Deficit/Hyperactivity Disorder Formication
4207185 4440927 4 Years M 4/6/2004 7/28/2004 113 PER Strattera Drug Interaction, Excitability, Nasopharyngitis
4207188 4440928 46 Years F 4/4/2004 4/6/2004 7/28/2004 113 PER Strattera Chills, Fatigue, Insomnia, Somnolence
4207189 4440873 7 Years M 3/16/2004 7/28/2004 134 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Drug Interaction, Headache, Respiratory Disorder, Respiratory Tract Infection
4207189 4782216 7 Years M 7/5/2005 9/27/2005 84 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Drug Interaction, Headache, Nausea, Respiratory Disorder, Respiratory Tract Infection
4207191 4440929 47 Years 4/6/2004 4/6/2004 7/28/2004 113 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Somnolence
4207192 4440930 11 Years 4/1/2004 4/6/2004 7/28/2004 113 PER Strattera Vision Blurred Chest Discomfort, Cough, Dyspnoea, Fatigue
4207193 4440931     F 4/6/2004 7/28/2004 113 PER Strattera Amphetamines Positive
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207194 4440894     F 4/23/2004 7/28/2004 96 MD PER Strattera Agitation, Fatigue, Insomnia
4207195 4440895 16 Years M 4/1/2004 4/23/2004 7/28/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder, Impulsive Behaviour Dizziness, Feeling Abnormal
4207197 4440932 6 Years F 1/1/2004 4/6/2004 7/28/2004 113 PH PER Strattera Blood Glucose Increased
4207204 4443237     M 5/13/2004 5/13/2004 7/28/2004 76 CN PER Strattera
4207205 4443239 12 Years F 10/1/2003 5/13/2004 7/28/2004 76 MD PER Strattera Weight Increased
4207209 4443241 10 Years M 3/1/2004 5/13/2004 7/28/2004 76 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Mood Swings, Psychomotor Hyperactivity
4207215 4440896 25 Years M 6/17/2003 4/23/2004 7/28/2004 96 OT PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Eructation, Gastrooesophageal Reflux Disease, Nausea, Vomiting
4207216 4443243 15 Years F 1/1/2004 5/13/2004 7/28/2004 76 MD PER Strattera Weight Increased
4207218 4443295 62 Years F 1/1/2004 5/19/2004 7/28/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Disturbance in Attention, Dizziness, Nausea, Somnolence
4207223 4440897     F 4/21/2004 4/23/2004 7/28/2004 96 PER Strattera Excitability, Fatigue, Feeling Jittery
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207224 4443297 12 Years M 5/19/2004 7/28/2004 70 MD PER Strattera Cognitive Disorder, Feeling Abnormal, Somnolence
4207225 4443298     F 5/6/2004 5/19/2004 7/28/2004 70 PER Strattera Drug Ineffective, Nausea, Somnolence
4207228 4440898 26 Years F 4/23/2004 4/23/2004 7/28/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Feeling Cold
4207229 4443300 9 Years M 4/9/2004 5/19/2004 7/28/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Weight Decreased
4207233 4443302 11 Years M 5/1/2004 5/19/2004 7/28/2004 70 PER Strattera Feeling Hot, Initial Insomnia
4207235 4443304 8 Years M 5/20/2004 7/28/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Drug Ineffective, Early Morning Awakening, Memory Impairment
4207236 4440899 8 Years M 4/23/2004 7/28/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dysgeusia, Stomach Discomfort, Weight Decreased
4207239 4443309 50 Years F 5/20/2004 7/28/2004 69 OT PER Strattera Feeling Abnormal, Headache
4207241 4443244 4 Years 5/13/2004 7/28/2004 76 PH PER Strattera
4207242 4443312 28 Years M 5/20/2004 7/28/2004 69 MD PER Strattera Attention Deficit/Hyperactivity Disorder Groin Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207244 4443246     F 4/1/2004 5/13/2004 7/28/2004 76 CN PER Strattera Attention Deficit/Hyperactivity Disorder Hypokinesia, Insomnia, Migraine, Somnolence
4207245 4443323 41 Years M 5/1/2004 5/20/2004 7/28/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Drug Ineffective
4207246 4440900 12 Years 4/22/2004 7/28/2004 97 MD PER Strattera Attention Deficit/Hyperactivity Disorder Psychotic Disorder, Tic
4207247 4443325 18 Years M 5/13/2004 7/28/2004 76 MD PER Strattera Anger
4207248 4443248 25 Years M 6/4/2004 7/28/2004 54 MD PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Pain
4207248 4495965 25 Years M 6/4/2004 9/27/2004 115 OT PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Pain
4207250 4443250 8 Years F 5/13/2004 7/28/2004 76 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Haematemesis, Headache, Nausea
4207251 4443251     M 5/13/2004 7/28/2004 76 PH PER Strattera
4207253 4443253 45 Years F 5/12/2004 7/28/2004 77 CN PER Strattera
4207256 4443255 10 Years F 5/9/2004 5/13/2004 7/28/2004 76 CN PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Decreased Appetite, Irritability, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207258 4443256 38 Years F 5/11/2004 5/13/2004 7/28/2004 76 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Bruxism, Somnolence, Tremor
4207260 4440901 6 Years M 12/1/2003 4/23/2004 7/28/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Headache, Malaise, Nausea, Vomiting
4207262 4443257 45 Years F 5/13/2004 5/13/2004 7/28/2004 76 CN PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Dizziness, Drug Ineffective, Dry Mouth, Fatigue, Feeling Abnormal, Paraesthesia
4207264 4443258 4 Years M 4/1/2004 5/13/2004 7/28/2004 76 CN PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Retching
4207265 4443259 6 Years F 3/1/2004 5/13/2004 7/28/2004 76 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Feeling Abnormal
4207267 4443260 5 Years M 5/13/2004 7/28/2004 76 CN PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4207268 4443261     F 5/12/2004 5/13/2004 7/28/2004 76 CN PER Strattera Disturbance in Attention Formication, Piloerection, Psychomotor Hyperactivity
4207271 4443265 11 Years M 10/1/2003 5/13/2004 7/28/2004 76 MD PER Strattera Attention Deficit/Hyperactivity Disorder Weight Decreased
4207274 4440864 10 Years F 3/1/2004 6/8/2004 7/28/2004 50 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Acne, Chest Pain, Crying, Diarrhoea, Disturbance in Attention, Dizziness, Drug Ineffective, Dyskinesia, Fatigue, Feeling Abnormal, Feeling Hot, Haematochezia, Headache, Hyperhidrosis, Insomnia, Irritability
4207274 4501311 10 Years F 3/1/2004 6/8/2004 9/27/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Acne, Chest Pain, Crying, Diarrhoea, Disturbance in Attention, Dizziness, Drug Ineffective, Dyskinesia, Fatigue, Feeling Abnormal, Feeling Hot, Haematochezia, Headache, Hyperhidrosis, Insomnia, Irritability
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207275 4440902 64 Years M 4/1/2004 5/4/2004 7/28/2004 85 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Drug Ineffective, Dry Mouth, Hypotension, Muscle Spasms, Nervousness, Pallor, Restless Legs Syndrome, Tremor
4207277 4440868 16 Years M 10/1/2003 3/29/2004 7/28/2004 121 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dermatitis Contact
4207278 4440869 15 Years F 12/7/2003 5/25/2004 7/28/2004 64 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Nausea, Vomiting, Weight Increased
4207278 4501318 15 Years F 12/7/2003 5/25/2004 9/27/2004 125 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Nausea, Vomiting, Weight Increased
4207280 4443327 39 Years F 5/18/2004 5/18/2004 7/28/2004 71 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Jittery, Hot Flush, Nausea, Nervousness, Tremor, Vomiting
4207281 4443330 10 Years M 5/1/2004 5/18/2004 7/28/2004 71 PER Strattera Attention Deficit/Hyperactivity Disorder Glossodynia
4207284 4443334 14 Years M 5/12/2004 5/18/2004 7/28/2004 71 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Dizziness, Pruritus, Rash Macular
4207292 4442925 6 Years M 5/1/2004 5/14/2004 7/28/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Agitation, Fatigue, Retching, Vomiting, Yawning
4207294 4440889 6 Years M 4/27/2004 7/28/2004 92 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Somnolence, Thirst
4207296 4442926 40 Years M 5/12/2004 5/14/2004 7/28/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Urethral Discharge, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207297 4442927 36 Years F 5/14/2004 7/28/2004 75 PER Strattera Disturbance in Attention Jaw Disorder
4207298 4442928 49 Years F 5/1/2004 5/20/2004 7/28/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Dry Mouth, Dysmenorrhoea, Heart Rate Increased, Menstrual Disorder, Nausea
4207298 4495966 49 Years F 5/1/2004 7/27/2004 9/27/2004 62 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Dry Mouth, Dysmenorrhoea, Dysuria, Heart Rate Increased, Menstrual Disorder, Nausea, Pollakiuria
4207302 4442929 11 Years M 4/1/2004 5/14/2004 7/28/2004 75 PER Strattera Disturbance in Attention Abnormal Behaviour, Aggression, Decreased Appetite, Insomnia, Rash
4207304 4442930 8 Years M 5/14/2004 7/28/2004 75 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dysphemia
4207305 4443338 3 Years M 1/1/2003 5/18/2004 7/28/2004 71 PER Strattera Psychomotor Hyperactivity Abnormal Behaviour, Constipation, Faecal Incontinence, Insomnia, Irritability, Mood Altered, Mood Swings, Negativism, Psychomotor Hyperactivity
4207306 4442932 11 Years M 3/1/2003 5/14/2004 7/28/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Hyperphagia, Weight Increased
4207307 4443340 55 Years F 5/14/2004 5/18/2004 7/28/2004 71 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Lower, Chills, Feeling Hot and Cold, Heart Rate Increased, Hot Flush, Hyperhidrosis, Tinnitus
4207308 4442933 18 Years M 5/14/2004 7/28/2004 75 CN PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Somnolence
4207309 4443342 57 Years F 1/1/2004 5/18/2004 7/28/2004 71 PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Disturbance in Attention, Drug Ineffective, Feeling Cold, Memory Impairment, Reading Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207311 4442934 20 Years F 5/14/2004 7/28/2004 75 PER Strattera Hypersomnia, Somnolence
4207314 4442935 53 Years M 5/10/2004 5/14/2004 7/28/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Anorgasmia, Feeling Abnormal, Head Discomfort, Headache, Nausea, Sedation
4207315 4443345 48 Years F 5/11/2004 5/18/2004 7/28/2004 71 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Insomnia, Tremor
4207316 4443347 10 Years M 1/1/2004 5/19/2004 7/28/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Decreased Appetite, Fatigue, Mood Swings, Oppositional Defiant Disorder
4207317 4442937 49 Years M 1/1/2004 5/4/2004 7/28/2004 85 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Jittery, Psychomotor Hyperactivity
4207318 4443349 9 Years M 5/19/2004 7/28/2004 70 MD PER Strattera Abnormal Behaviour
4207320 4442943 63 Years M 7/1/2003 5/4/2004 7/28/2004 85 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tremor
4207321 4442945 7 Years M 5/4/2004 7/28/2004 85 PER Strattera Alopecia
4207322 4440903     F 4/22/2004 7/28/2004 97 MD PER Strattera Oligomenorrhoea
4207323 4442946 14 Years M 4/1/2004 6/18/2004 7/28/2004 40 PER Strattera Attention Deficit/Hyperactivity Disorder Cyst, Dysuria
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207323 4495952 14 Years M 4/1/2004 6/18/2004 9/27/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Cyst, Dysuria
4207326 4443353 8 Years 5/19/2004 7/28/2004 70 MD PER Strattera Emotional Disorder
4207327 4442948 13 Years M 4/19/2004 5/4/2004 7/28/2004 85 OT PER Strattera Attention Deficit/Hyperactivity Disorder Contusion, Nausea, Somnolence, Vomiting, Weight Increased
4207330 4440904 13 Years M 3/29/2004 5/12/2004 7/28/2004 77 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Delirium, Intentional Self-Injury, Vomiting
4207333 4440905 7 Years M 4/21/2004 4/22/2004 7/28/2004 97 OT PER Strattera Retching, Vomiting
4207334 4442951 5 Years M 8/1/2003 5/4/2004 7/28/2004 85 PER Strattera Tic
4207336 4440906 52 Years F 4/1/2004 4/22/2004 7/28/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Disturbance in Attention, Drug Ineffective
4207339 4440907 8 Years M 4/22/2004 7/28/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective
4207341 4440908 33 Years F 4/22/2004 4/22/2004 7/28/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
4207343 4440909 7 Years F 4/20/2004 6/2/2004 7/28/2004 56 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Crying, Delusion, Depression, Formication, Social Avoidant Behaviour
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207343 4497059 7 Years F 4/20/2004 6/2/2004 9/27/2004 117 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Crying, Delusion, Depression, Formication, Social Avoidant Behaviour
4207344 4440910 10 Years M 4/22/2004 7/28/2004 97 MD PER Strattera Platelet Count Decreased, White Blood Cell Count Decreased
4207346 4440911 16 Years F 4/14/2004 4/23/2004 7/28/2004 96 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anger, Decreased Appetite, Depression, Dizziness, Hypoaesthesia, Nausea, Oppositional Defiant Disorder, Suicidal Ideation, Weight Decreased
4207349 4440912 6 Years M 4/23/2004 7/28/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dyspepsia, Psychomotor Hyperactivity, Weight Decreased
4207356 4442952 10 Years M 4/1/2004 5/4/2004 7/28/2004 85 PER Strattera Disturbance in Attention Dysgeusia, Retching
4207358 4443279 7 Years M 5/1/2004 5/20/2004 7/28/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anger
4207360 4442954 10 Years M 5/1/2004 5/4/2004 7/28/2004 85 PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4207363 4443281 24 Years F 5/20/2004 7/28/2004 69 MD PER Strattera Tremor
4207364 4442956 12 Years M 1/1/2004 5/4/2004 7/28/2004 85 OT PER Strattera Attention Deficit/Hyperactivity Disorder Sinusitis, Tic
4207366 4443283 56 Years F 5/1/2004 5/20/2004 7/28/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Constipation, Thyroid Function Test Abnormal, Weight Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207367 4443284     F 5/1/2004 5/20/2004 7/28/2004 69 MD PER Strattera Menorrhagia
4207371 4443285 18 Years M 1/1/2004 5/20/2004 7/28/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Fatigue, Feeling Abnormal, Somnolence
4207374 4443286 55 Years M 5/1/2004 5/20/2004 7/28/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Headache, Pollakiuria, Sleep Disorder, Vision Blurred
4207375 4443288 10 Years M 1/1/2004 5/20/2004 7/28/2004 69 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Irritability
4207376 4443289 8 Years M 5/18/2004 5/20/2004 7/28/2004 69 PER Strattera Diplopia
4207378 4443291 7 Years M 1/1/2004 5/20/2004 7/28/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Emotional Disorder
4207381 4443294 17 Years F 5/20/2004 7/28/2004 69 PER Strattera Drug Ineffective, Fatigue, Mood Swings, Negativism
4207382 4441440 10 Years F 5/3/2004 5/3/2004 7/28/2004 86 OT PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4207385 4441442 10 Years M 4/28/2004 5/3/2004 7/28/2004 86 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Asthenia, Nausea, Pallor, Tremor
4207386 4442958 31 Years M 1/1/2004 5/4/2004 7/28/2004 85 PER Strattera Attention Deficit/Hyperactivity Disorder Anorgasmia, Micturition Urgency, Somnolence, Urinary Incontinence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207389 4441443 22 Years M 5/3/2004 7/28/2004 86 PH PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Pain
4207399 4441445 34 Years F 1/1/2004 5/3/2004 7/28/2004 86 PER Strattera Attention Deficit/Hyperactivity Disorder Bradyphrenia, Drug Ineffective, Dysgeusia, Thinking Abnormal
4207399 4580292 34 Years F 1/1/2004 11/30/2004 1/27/2005 58 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Bradyphrenia, Chest Pain, Crying, Drug Ineffective, Dysgeusia, Dysphemia, Dyspnoea, Emotional Disorder, Fatigue, Headache, Heart Rate Irregular, Irritability, Memory Impairment, Menstrual Disorder, Social Phobia, Thirst
4207399 4637494 34 Years F 1/1/2004 11/30/2004 3/28/2005 118 PER Strattera Anxiety, Bradyphrenia, Chest Pain, Crying, Drug Ineffective, Dysgeusia, Dysphemia, Dyspnoea, Emotional Disorder, Fatigue, Headache, Heart Rate Irregular, Irritability, Memory Impairment, Menstrual Disorder, Social Phobia, Thirst
4207400 4441447 7 Years M 4/30/2004 7/28/2004 89 OT PER Strattera Hot Flush, Peripheral Coldness
4207411 4441448 35 Years M 2/1/2004 5/3/2004 7/28/2004 86 PER Strattera Disturbance in Attention
4207412 4441221 8 Years M 3/1/2004 4/1/2004 7/28/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia
4207414 4441262 11 Years M 3/1/2004 3/29/2004 7/28/2004 121 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective
4207416 4441223 6 Years F 4/23/2004 7/28/2004 96 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Constipation, Rheumatoid Arthritis
4207417 4441450 3 Years M 5/3/2004 7/28/2004 86 PH PER Strattera Abnormal Behaviour, Convulsion Feeling Abnormal, Mydriasis
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207419 4441265 11 Years M 3/29/2004 7/28/2004 121 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety
4207422 4441271 15 Years M 8/1/2003 3/29/2004 7/28/2004 121 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Disturbance in Attention, Educational Problem, Fatigue, Mood Swings, Therapeutic Response Decreased
4207423 4441226 54 Years F 3/1/2004 4/1/2004 7/28/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Nausea, Sleep Disorder, Visual Acuity Reduced
4207426 4441228 7 Years M 1/1/2004 4/1/2004 7/28/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity, Somnolence
4207427 4441453 40 Years M 1/1/2004 5/3/2004 7/28/2004 86 PER Strattera Breath Odour, Dry Mouth, Dysgeusia, Increased Upper Airway Secretion, Sensory Disturbance
4207428 4441244 43 Years M 4/1/2004 4/1/2004 7/28/2004 118 PER Strattera Anxiety, Depression Anxiety, Feeling Cold
4207430 4441246     M 4/1/2004 7/28/2004 118 MD PER Strattera Chest Pain
4207431 4441250 17 Years F 4/1/2003 4/1/2004 7/28/2004 118 OT PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Drug Ineffective, Somnolence, Weight Increased
4207433 4441252     M 3/1/2004 4/1/2004 7/28/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Mental Impairment
4207434 4441454 7 Years M 5/3/2004 7/28/2004 86 PER Strattera Autism Drug Ineffective, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207436 4441254 9 Years M 4/1/2004 4/1/2004 7/28/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Suicidal Ideation
4207437 4441461 6 Years F 5/3/2004 7/28/2004 86 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Decreased Appetite, Heart Rate Increased, Lethargy, Nausea
4207438 4441257 6 Years M 3/1/2004 4/1/2004 7/28/2004 118 PER Strattera Psychomotor Hyperactivity, Retching, Vomiting
4207441 4441199 10 Years M 4/6/2004 7/28/2004 113 PER Strattera Disturbance in Attention Decreased Appetite, Thirst
4207442 4441274 6 Years M 11/1/2003 3/29/2004 7/28/2004 121 PER Strattera Depression Anorexia, Constipation, Emotional Disorder, Erythema, Hunger, Oedema Peripheral, Peripheral Coldness, Weight Decreased
4207445 4441201 57 Years M 4/5/2004 4/6/2004 7/28/2004 113 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Headache, Nervousness
4207448 4441277 27 Years 4/1/2004 7/28/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dizziness, Dry Mouth, Fatigue, Headache, Nausea, Stomach Discomfort, Vasodilatation
4207449 4441280 10 Years M 3/29/2004 6/2/2004 7/28/2004 56 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Crying, Muscular Weakness
4207449 4501711 10 Years M 3/29/2004 6/2/2004 9/27/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Crying, Muscular Weakness, Somnolence
4207450 4441283 6 Years M 3/29/2004 7/28/2004 121 PER Strattera Retching
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207452 4441285 10 Years M 3/20/2004 3/29/2004 7/28/2004 121 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Fatigue, Mydriasis
4207453 4441286 46 Years F 3/15/2004 3/29/2004 7/28/2004 121 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Feeling Abnormal, Feeling Jittery, Formication
4207457 4441288 16 Years F 3/29/2004 7/28/2004 121 MD PER Strattera Attention Deficit/Hyperactivity Disorder Paranoia
4207458 4441160 8 Years M 3/1/2004 3/24/2004 7/28/2004 126 PER Strattera Nightmare, Psychomotor Hyperactivity, Somnolence
4207460 4441161 35 Years F 3/23/2004 3/24/2004 7/28/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Insomnia, Nausea
4207461 4441162 9 Years F 3/7/2004 3/24/2004 7/28/2004 126 PER Strattera Learning Disability Disturbance in Attention, Dysgraphia, Nervousness, Psychomotor Hyperactivity, Weight Decreased
4207463 4441203 50 Years F 12/1/2003 4/6/2004 7/28/2004 113 PER Strattera Disturbance in Attention Drug Ineffective, Heart Rate Increased, Insomnia, Somnolence
4207463 4726699 50 Years F 12/1/2003 5/13/2005 7/25/2005 73 PER Strattera Disturbance in Attention Drug Ineffective, Heart Rate Increased, Insomnia, Somnolence
4207464 4441163 5 Years M 1/1/2004 3/24/2004 7/28/2004 126 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Fear
4207467 4441164 9 Years M 3/20/2004 4/23/2004 7/28/2004 96 PER Strattera Disturbance in Attention, Learning Disability Suicidal Ideation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207468 4441205     F 4/6/2004 7/28/2004 113 MD PER Strattera Hallucination
4207469 4441165 50 Years M 12/1/2003 3/24/2004 7/28/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Ejaculation Disorder, Libido Decreased, Sexual Dysfunction
4207471 4441166 16 Years F 3/24/2004 7/28/2004 126 PER Strattera Eye Pain, Mydriasis
4207473 4441167     3/24/2004 7/28/2004 126 PER Strattera Nightmare
4207475 4441168 10 Years M 3/24/2004 3/24/2004 7/28/2004 126 OT PER Strattera Disturbance in Attention
4207476 4441207 5 Years M 4/6/2004 7/28/2004 113 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Disturbance in Attention, Drug Ineffective, Vomiting
4207479 4441169 49 Years F 3/1/2004 5/3/2004 7/28/2004 86 OT PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Heart Rate Increased, Nausea, Photopsia
4207481 4441209 13 Years M 6/1/2003 4/6/2004 7/28/2004 113 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Agitation, Disturbance in Attention, Drug Ineffective, Irritability, Mood Swings, Psychomotor Hyperactivity
4207483 4441210     4/5/2004 7/28/2004 114 MD PER Strattera Drug Dependence, Drug Interaction
4207485 4441212     4/5/2004 7/28/2004 114 MD PER Strattera Drug Dependence, Drug Interaction
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207487 4441213 19 Years M 4/6/2004 7/28/2004 113 MD PER Strattera Erectile Dysfunction, Scrotal Disorder, Testicular Pain
4207489 4441216 13 Years F 4/7/2004 7/28/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Acne, Hirsutism
4207497 4441170 60 Years M 4/1/2004 7/28/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria
4207503 4441172 11 Years F 3/30/2004 4/2/2004 7/28/2004 117 PER Strattera Disturbance in Attention, Impulsive Behaviour, Insomnia Anxiety, Insomnia, Panic Reaction
4207505 4441174 42 Years F 3/26/2004 4/2/2004 7/28/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Cardiac Flutter, Dizziness, Head Discomfort, Hot Flush, Hyperhidrosis, Nausea, Palpitations, Tinnitus, Vomiting
4207506 4441176 10 Years M 2/1/2004 4/2/2004 7/28/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Aphthous Stomatitis, Diarrhoea, Gastrooesophageal Reflux Disease, Mouth Haemorrhage, Pain in Jaw, Pyrexia, Testicular Pain, Vomiting
4207508 4441178     M 4/2/2004 7/28/2004 117 PER Strattera Oesophageal Ulcer, Overgrowth Bacterial
4207509 4441181 8 Years M 3/1/2004 4/2/2004 7/28/2004 117 OT PER Strattera Attention Deficit/Hyperactivity Disorder Wrist Deformity
4207510 4441371 34 Years F 2/1/2004 4/28/2004 7/28/2004 91 PER Strattera Attention Deficit/Hyperactivity Disorder Hyperventilation, Nightmare, Paraesthesia, Peripheral Coldness, Screaming
4207512 4441373 5 Years F 1/1/2004 4/28/2004 7/28/2004 91 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207513 4441193     M 4/2/2004 7/28/2004 117 MD PER Strattera Testicular Pain
4207514 4441375 24 Years M 4/1/2004 4/28/2004 7/28/2004 91 MD PER Strattera Depression, Mood Altered
4207515 4441194 36 Years M 4/2/2004 7/28/2004 117 PER Strattera Disturbance in Attention Micturition Disorder
4207517 4441377 38 Years M 3/1/2004 4/28/2004 7/28/2004 91 PER Strattera Amnesia Difficulty in Walking, Dyspnoea, Testicular Pain
4207518 4441195     F 3/1/2004 4/2/2004 7/28/2004 117 PER Strattera Diarrhoea, Migraine
4207521 4441196 70 Years F 3/1/2004 6/15/2004 7/28/2004 43 PER Strattera Drug Ineffective, Hypertension, Intraocular Pressure Increased
4207521 4497054 70 Years F 3/1/2004 8/11/2004 9/27/2004 47 CN PER Strattera Drug Ineffective, Hypertension, Intraocular Pressure Increased
4207525 4441383 9 Years M 6/7/2004 7/28/2004 51 PH PER Strattera Hallucination (Auditory), Hallucination (Visual)
4207525 4495949 9 Years M 6/7/2004 9/27/2004 112 PH PER Strattera Hallucination (Auditory), Hallucination (Visual)
4207527 4441388 57 Years F 4/28/2004 7/28/2004 91 PER Strattera Alopecia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207533 4441390 26 Years M 4/28/2004 7/28/2004 91 OT PER Strattera Attention Deficit/Hyperactivity Disorder Eye Haemorrhage, Migraine
4207535 4441396 55 Years M 1/1/2004 6/28/2004 7/28/2004 30 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Dry Mouth, Dysuria, Rash, Red Blood Cells Semen
4207535 4495950 55 Years M 1/1/2004 6/20/2004 9/27/2004 99 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Dry Mouth, Dysuria, Rash, Red Blood Cells Semen
4207539 4441266 7 Years F 4/1/2004 5/6/2004 7/28/2004 83 PER Strattera Alopecia
4207540 4441268 14 Years M 4/1/2004 5/5/2004 7/28/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Somnolence, Vomiting
4207541 4441270 11 Years M 1/1/2004 5/5/2004 7/28/2004 84 OT PER Strattera Abnormal Behaviour
4207542 4441273 33 Years F 5/1/2004 5/5/2004 7/28/2004 84 PER Strattera Anxiety, Eyelid Disorder, Hallucination, Insomnia, Stress Symptoms
4207543 4441276 7 Years M 1/1/2003 5/5/2004 7/28/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Diarrhoea, Hyperphagia, Weight Increased
4207544 4441279 9 Years F 5/4/2004 7/28/2004 85 MD PER Strattera Alopecia
4207545 4441282 44 Years M 4/27/2004 5/12/2004 7/28/2004 77 MD PER Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder, Penile Pain, Penis Disorder, Retrograde Ejaculation, Urinary Hesitation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207545 4495959 44 Years M 4/27/2004 5/12/2004 9/27/2004 138 MD PER Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder, Penile Pain, Penis Disorder, Retrograde Ejaculation, Urinary Hesitation
4207546 4441284 11 Years M 5/5/2004 7/28/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Balance Disorder, Dizziness, Headache, Tremor, Weight Increased
4207547 4441287 12 Years M 5/4/2004 5/4/2004 7/28/2004 85 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fatigue, Headache, Increased Appetite, Somnolence, Thirst
4207548 4441289 6 Years F 5/5/2004 7/28/2004 84 PH PER Strattera Pollakiuria, Urinary Incontinence
4207548 4495961 6 Years F 5/5/2004 9/27/2004 145 PH PER Strattera Pollakiuria, Urinary Incontinence
4207549 4441290 5 Years M 4/12/2004 5/3/2004 7/28/2004 86 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Agitation, Weight Decreased
4207550 4441291 36 Years F 5/5/2004 7/28/2004 84 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Blepharospasm, Depression, Dizziness, Drug Ineffective, Feeling Drunk, Pruritus, Sensation of Heaviness, Stomach Discomfort, Urticaria, Vision Blurred
4207551 4441292 8 Years M 4/12/2004 5/3/2004 7/28/2004 86 PER Strattera Attention Deficit/Hyperactivity Disorder Skin Discolouration
4207552 4441293 15 Years M 4/1/2004 5/3/2004 7/28/2004 86 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Confusional State, Heart Rate Increased, Pharyngolaryngeal Pain, Vision Blurred, Weight Fluctuation
4207553 4441294 7 Years M 5/1/2004 5/3/2004 7/28/2004 86 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Sleep Talking, Sleep Walking
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207554 4441295 21 Years M 5/2/2004 7/28/2004 87 MD PER Strattera Attention Deficit/Hyperactivity Disorder Bipolar I Disorder
4207555 4441299 11 Years M 1/1/2004 4/27/2004 7/28/2004 92 PER Strattera Attention Deficit/Hyperactivity Disorder Acute Stress Disorder, Drug Ineffective
4207556 4441302     M 5/1/2004 5/3/2004 7/28/2004 86 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Dizziness, Fatigue, Hyperhidrosis, Nausea, Thirst
4207557 4441305 15 Years F 5/2/2004 7/28/2004 87 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Bipolar I Disorder, Irritability
4207558 4441307 8 Years M 4/1/2003 4/30/2004 7/28/2004 89 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Drug Ineffective, Fatigue
4207559 4441312 10 Years F 4/29/2004 7/28/2004 90 OT PER Strattera Attention Deficit/Hyperactivity Disorder Emotional Distress, Insomnia
4207560 4441315 7 Years M 4/29/2004 7/28/2004 90 PER Strattera Attention Deficit/Hyperactivity Disorder
4207561 4441316 14 Years M 10/1/2003 4/29/2004 7/28/2004 90 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Depressed Mood, Feeling Abnormal
4207562 4441319 14 Years M 4/22/2004 4/29/2004 7/28/2004 90 MD PER Strattera Attention Deficit/Hyperactivity Disorder Muscle Spasms
4207563 4441320 60 Years F 4/8/2004 4/29/2004 7/28/2004 90 PER Strattera Blood Pressure Decreased, Dizziness, Ear Infection, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207564 4441337     M 4/29/2004 7/28/2004 90 MD PER Strattera Muscle Spasms
4207565 4441339 44 Years F 4/12/2004 4/30/2004 7/28/2004 89 OT PER Strattera Disturbance in Attention Anhedonia, Fatigue, Lethargy
4207566 4441343 7 Years F 4/30/2004 4/30/2004 7/28/2004 89 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
4207567 4441345 14 Years F 4/30/2004 6/16/2004 7/28/2004 42 MD PER Strattera Attention Deficit/Hyperactivity Disorder Pulse Pressure Increased, Tachycardia
4207567 4495951 14 Years F 4/30/2004 6/16/2004 9/27/2004 103 MD PER Strattera Attention Deficit/Hyperactivity Disorder Pulse Pressure Increased, Tachycardia
4207568 4441348 7 Years F 4/30/2004 7/28/2004 89 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Mydriasis, Nervousness
4207624 4441329 8 Years M 3/11/2004 7/28/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Headache, Overdose
4207625 4441331 9 Years F 3/8/2004 3/11/2004 7/28/2004 139 PER Strattera Choking, Fatigue, Retching, Vomiting
4207626 4441333 11 Years F 3/11/2004 7/28/2004 139 MD PER Strattera Personality Change
4207627 4441336 13 Years M 3/11/2004 7/28/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Fatigue, Restlessness, Somnolence, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207629 4441341 9 Years F 3/11/2004 7/28/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Disturbance in Attention, Hunger, Weight Increased
4207630 4441346 11 Years M 3/6/2004 3/11/2004 7/28/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder, Drug Ineffective, Paraesthesia, Somnolence
4207631 4441349     M 3/11/2004 7/28/2004 139 PER Strattera Drug Interaction, Vomiting
4207632 4441351     F 3/11/2004 7/28/2004 139 MD PER Strattera Mania
4207633 4441354 9 Years M 2/1/2004 3/11/2004 7/28/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Constipation, Decreased Appetite, Fatigue, Mood Swings, Painful Respiration, Somnolence
4207634 4441357 8 Years M 3/11/2004 7/28/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective
4207653 4441215 17 Years M 4/27/2004 7/28/2004 92 OT PER Strattera
4207655 4441217 6 Years M 4/16/2004 4/27/2004 7/28/2004 92 CN PER Strattera Aggression, Disturbance in Attention, Irritability, Mood Swings
4207656 4441218 13 Years M 4/27/2004 7/28/2004 92 MD PER Strattera Tic
4207657 4441220 10 Years M 4/27/2004 7/28/2004 92 PER Strattera Tic
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207659 4441224 40 Years M 4/27/2004 7/28/2004 92 MD PER Strattera Attention Deficit/Hyperactivity Disorder Painful Erection
4207664 4441227 11 Years M 4/1/2004 4/27/2004 7/28/2004 92 PER Strattera Belligerence, Fatigue, Mood Swings
4207668 4441230 12 Years M 4/22/2004 7/28/2004 97 MD PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Retention
4207670 4441231 7 Years M 4/25/2004 4/27/2004 7/28/2004 92 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4207671 4441232 11 Years M 10/1/2002 4/27/2004 7/28/2004 92 MD PER Strattera Abdominal Mass, Gynaecomastia
4207674 4441233 9 Years M 4/27/2004 4/27/2004 7/28/2004 92 MD PER Strattera Attention Deficit/Hyperactivity Disorder Pharyngolaryngeal Pain
4207705 4441235 11 Years F 4/23/2004 4/26/2004 7/28/2004 93 PER Strattera Attention Deficit/Hyperactivity Disorder Malaise, Somnolence
4207708 4441236 9 Years M 4/1/2004 4/26/2004 7/28/2004 93 PER Strattera Attention Deficit/Hyperactivity Disorder Malaise, Somnolence
4207710 4441243 13 Years F 2/1/2104 4/26/2004 7/28/2004 93 PER Strattera Crying
4207711 4441247 35 Years F 1/1/2004 4/27/2004 7/28/2004 92 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Constipation, Dizziness, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207714 4441253 54 Years F 4/26/2004 4/27/2004 7/28/2004 92 PER Strattera Dry Mouth, Dyspnoea, Heart Rate Increased, Hyperhidrosis, Nausea
4207727 4441256 61 Years F 4/26/2004 7/28/2004 93 PER Strattera Depression Affect Lability, Bronchitis, Crying, Hyperhidrosis
4207729 4441259 23 Years F 4/1/2004 4/27/2004 7/28/2004 92 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Jittery, Paraesthesia, Somnolence
4207733 4441261 43 Years F 4/27/2004 7/28/2004 92 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Dry Mouth, Hypoaesthesia, Paraesthesia
4207736 4441263 36 Years M 5/27/2004 7/28/2004 62 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased
4207736 4448961 36 Years M 8/25/2004 9/9/2004 15 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Blood Cholesterol Increased, Hepatic Enzyme Increased, Therapeutic Response Decreased
4207736 4497062 36 Years M 8/25/2004 9/27/2004 33 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased
4207736 4821684 36 Years M 10/13/2005 11/3/2005 21 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Depression, Metabolic Disorder
4207803 4443266 11 Years M 3/24/2004 3/24/2004 7/28/2004 126 CN PER Strattera
4207804 4443267 9 Years M 3/24/2004 7/28/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Agitation, Drug Ineffective
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207808 4443268     3/24/2004 7/28/2004 126 PER Strattera Psychomotor Hyperactivity
4207810 4440963 12 Years F 1/1/2004 4/8/2004 7/28/2004 111 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Pyrexia, Sleep Disorder
4207812 4443269 10 Years M 3/24/2004 3/31/2004 7/28/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Lacrimation Increased, Sneezing, Somnolence
4207814 4440964 5 Years F 4/8/2004 7/28/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4207815 4443270 31 Years M 3/25/2004 3/30/2004 7/28/2004 120 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Decreased Appetite, Dry Mouth, Feeling Abnormal, Headache
4207816 4440965 9 Years M 1/1/2004 4/8/2004 7/28/2004 111 OT PER Strattera Attention Deficit/Hyperactivity Disorder Emotional Distress, Nausea, Sleep Disorder
4207817 4440966 14 Years F 4/8/2004 7/28/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia
4207818 4443272 10 Years M 12/1/2003 3/25/2004 7/28/2004 125 PER Strattera Abdominal Pain Upper, Decreased Appetite, Weight Decreased
4207820 4443274 20 Years M 3/25/2004 7/28/2004 125 MD PER Strattera Attention Deficit/Hyperactivity Disorder
4207821 4440967 8 Years F 4/6/2004 4/8/2004 7/28/2004 111 PER Strattera Dizziness, Stomach Discomfort, Vision Blurred
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207822 4443275 14 Years M 3/25/2004 7/28/2004 125 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
4207823 4440968 9 Years M 1/1/2004 4/8/2004 7/28/2004 111 PER Strattera Abnormal Behaviour, Drug Ineffective, Logorrhoea, Vomiting
4207825 4440969 11 Years M 2/1/2004 4/8/2004 7/28/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Decreased Appetite, Drug Ineffective, Fatigue, Stomach Discomfort, Weight Decreased
4207827 4443276 9 Years M 3/25/2004 7/28/2004 125 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Increased
4207828 4440970     M 4/8/2004 7/28/2004 111 PER Strattera Agitation
4207831 4443278 33 Years M 3/25/2004 7/28/2004 125 PER Strattera Libido Decreased, Nausea, Thinking Abnormal
4207832 4440971 30 Years F 4/7/2004 4/8/2004 7/28/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Feeling Abnormal, Feeling Jittery, Insomnia
4207833 4440972 9 Years M 3/1/2004 6/22/2004 7/28/2004 36 PER Strattera Disturbance in Attention Tic
4207833 4497055 9 Years M 3/1/2004 6/22/2004 9/27/2004 97 CN PER Strattera Disturbance in Attention Tic
4207837 4440953     F 4/6/2004 7/28/2004 113 MD PER Strattera Disturbance in Attention
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207842 4440954 40 Years F 4/3/2004 4/8/2004 7/28/2004 111 MD PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence, Tinnitus
4207844 4440955     F 3/30/2004 4/9/2004 7/28/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Malaise, Nausea
4207845 4440956 9 Years M 4/9/2004 7/28/2004 110 PER Strattera Asperger's Disorder Abnormal Behaviour, Disturbance in Attention
4207848 4440957     F 4/9/2004 7/28/2004 110 MD PER Strattera Drug Ineffective, Drug Interaction
4207850 4440958 15 Years M 2/1/2004 4/9/2004 7/28/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Educational Problem, Memory Impairment
4207851 4440959 7 Years M 4/9/2004 7/28/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Urinary Hesitation, Urine Analysis Abnormal
4207852 4440960 9 Years M 4/9/2004 7/28/2004 110 PER Strattera Mood Swings
4207854 4440961 4 Years M 4/9/2004 7/28/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anger
4207857 4440962 10 Years M 11/1/2003 4/9/2004 7/28/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Mood Swings, Weight Decreased
4207857 4726700 10 Years M 11/1/2003 3/22/2005 7/25/2005 125 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Mood Swings, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4207859 4440993 9 Years M 4/14/2004 7/28/2004 105 MD PER Strattera Attention Deficit/Hyperactivity Disorder Intentional Self-Injury, Priapism
4207861 4440994 9 Years F 4/15/2004 7/28/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Rash
4207862 4440995 48 Years F 4/6/2004 4/15/2004 7/28/2004 104 PER Strattera Abnormal Dreams, Insomnia, Thinking Abnormal
4207864 4440996 7 Years M 4/13/2004 4/15/2004 7/28/2004 104 PER Strattera Disturbance in Attention Insomnia, Nightmare
4207867 4440997 6 Years M 4/15/2004 4/15/2004 7/28/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Pyrexia, Rash
4207869 4440998 12 Years M 4/15/2004 7/28/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Dizziness, Pallor, Somnolence, Vomiting
4207871 4440999 7 Years M 1/1/2004 4/15/2004 7/28/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Choking, Vomiting
4207872 4441000 16 Years M 4/1/2004 4/15/2004 7/28/2004 104 MD PER Strattera Drug Interaction
4207874 4441001 43 Years F 3/1/2004 4/15/2004 7/28/2004 104 PER Strattera Insomnia, Somnolence
4207875 4441002 10 Years M 8/1/2003 5/7/2004 7/28/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Eructation, Faecaloma
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4208244 4438637 8 Years M 3/1/2004 7/28/2004 149 OT PER Strattera Attention Deficit/Hyperactivity Disorder Visual Disturbance
4208387 4444434 17 Years M 8/17/2004 9/2/2004 16 MD EXP Strattera Gilbert's Syndrome
4208396 4444435 11 Years M 8/10/2004 8/16/2004 9/2/2004 17 EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Affective Disorder, Amnesia, Confusional State, Constipation, Convulsion, Crying, Decreased Appetite, Disorientation, Drug Hypersensitivity, Dry Mouth, Dyspnoea, Fatigue, Hyperhidrosis, Hyperventilation, Insomnia, Irritability, Restlessness, Tremor, Yawning Other
4208396 4464692 11 Years M 8/10/2004 9/9/2004 9/29/2004 20 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Amnesia, Confusional State, Constipation, Convulsion, Crying, Decreased Appetite, Disorientation, Drug Hypersensitivity, Dry Mouth, Dyspnoea, Eating Disorder, Fatigue, Hyperhidrosis, Hyperventilation, Insomnia, Irritability, Paranoia, Restlessness, Staring, Tremor, Yawning Other
4208396 4566629 11 Years M 8/10/2004 1/6/2005 1/26/2005 20 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Confusional State, Constipation, Convulsion, Crying, Decreased Activity, Decreased Appetite, Depressed Level of Consciousness, Disorientation, Drug Hypersensitivity, Dry Mouth, Dyspnoea, Fatigue, Hyperhidrosis, Hyperventilation, Insomnia, Irritability, Loss of Consciousness, Memory Impairment, Mood Altered, Oral Intake Reduced, Restlessness, Staring, Thinking Abnormal, Tonic Clonic Movements, Tremor, Yawning Other
4208539 4441399 6 Years M 4/27/2004 4/28/2004 7/28/2004 91 CN PER Strattera Aggression, Emotional Distress, Nervousness
4208540 4441401 6 Years M 4/28/2004 7/28/2004 91 PH PER Strattera Retching
4208775 4443290 6 Years M 9/2/2004 9/7/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Condition Aggravated, Vomiting Other
4209157 4444436     M 8/16/2004 9/2/2004 17 OT EXP Strattera Hospitalization - Initial or Prolonged
4209157 4512527 36 Years M 8/1/2004 11/15/2004 11/24/2004 9 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Agitation, Physical Assault, Thinking Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4209159 4444437 12 Years F 8/17/2004 8/18/2004 9/2/2004 15 MD EXP Strattera Convulsion Other
4209159 4509500 12 Years F 8/17/2004 11/3/2004 11/19/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased, Complex Partial Seizures, Confusional State, Eosinophil Percentage Increased, Grand Mal Convulsion, Heart Rate Increased, Loss of Consciousness, Postictal State, Respiratory Rate Increased Other
4209161 4444438     F 8/17/2004 9/2/2004 16 MD EXP Strattera Convulsion Other
4209177 4444439 51 Years F 8/16/2004 8/16/2004 9/2/2004 17 OT EXP Strattera Dizziness, Dyskinesia, Dyspnoea, Myalgia Other
4209177 4455036 51 Years F 8/16/2004 8/30/2004 9/17/2004 18 OT EXP Strattera Dizziness, Dyskinesia, Dyspnoea, Myalgia, Overdose Other
4209546 4448125 18 Years M 1/1/2004 6/18/2004 8/12/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Erectile Dysfunction, Suicidal Ideation, Therapeutic Response Decreased
4209546 4498710 18 Years M 1/1/2004 6/18/2004 9/27/2004 101 PER Strattera Drug Ineffective, Erectile Dysfunction, Suicidal Ideation, Therapeutic Response Decreased
4210236 4446551 49 Years F 8/18/2004 9/2/2004 15 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Depression, Drug Ineffective, Speech Disorder, Vision Blurred Other
4212047 4449497     M 9/9/2004 9/13/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Aggression Required Intervention to Prevent Permanent Impairment/Damage
4212251 4448967 14 Years M 8/19/2004 9/9/2004 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Cardiotoxicity Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4212254 4448847 12 Years M 8/17/2004 9/9/2004 23 MD EXP Strattera Alanine Aminotransferase Increased, Stomach Discomfort, Viral Infection
4212254 4476734 9 Years M 8/6/2004 9/23/2004 10/13/2004 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Stomach Discomfort
4212254 4501063 9 Years M 8/6/2004 10/29/2004 11/9/2004 11 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Stomach Discomfort
4212254 4503970 12 Years M 8/17/2004 9/27/2004 41 MD PER Strattera Alanine Aminotransferase Increased, Stomach Discomfort
4212267 4448969 12 Years F 8/20/2004 9/9/2004 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Leukopenia, Neutrophil Count Decreased Other
4212267 4509514 12 Years F 10/29/2004 11/19/2004 21 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Leukopenia Other
4212294 4448971 57 Years F 8/1/2004 8/23/2004 9/9/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Drug Dependence, Drug Interaction, Early Morning Awakening, Hot Flush, Insomnia, Obsessive Thoughts, Suicidal Ideation Other
4212370 4441132 46 Years F 4/12/2004 4/13/2004 7/28/2004 106 PER Strattera Attention Deficit/Hyperactivity Disorder Hot Flush, Keratoconjunctivitis Sicca, Nausea
4212375 4441134 7 Years 4/7/2004 4/13/2004 7/28/2004 106 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Agitation
4212377 4441136 10 Years M 4/1/2004 4/13/2004 7/28/2004 106 PER Strattera Attention Deficit/Hyperactivity Disorder Rash Pruritic
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4212378 4441139 9 Years M 4/13/2004 7/28/2004 106 MD PER Strattera Epistaxis
4212380 4441140 12 Years M 4/1/2004 4/13/2004 7/28/2004 106 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anorexia, Fatigue, Nausea
4212381 4441142 5 Years M 4/13/2004 7/28/2004 106 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Agitation, Homicidal Ideation
4212382 4448947 20 Years M 8/23/2004 8/25/2004 9/9/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Arrhythmia, Depression, Multiple Drug Overdose Intentional Hospitalization - Initial or Prolonged, Other
4212382 4509499 20 Years M 8/23/2004 11/2/2004 11/19/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Attention-Seeking Behaviour, Depression, Intentional Self-Injury, Loss of Employment, Multiple Drug Overdose, Relationship Breakdown, Sinus Arrhythmia, Sinus Tachycardia Hospitalization - Initial or Prolonged
4212384 4441156 15 Years F 4/13/2004 7/28/2004 106 PER Strattera Galactorrhoea
4212389 4441157     M 4/1/2004 4/13/2004 7/28/2004 106 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
4212397 4441158 15 Years F 4/11/2004 4/14/2004 7/28/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Flushing, Insomnia, Vomiting
4212400 4441159 9 Years M 4/14/2004 4/14/2004 7/28/2004 105 PER Strattera Stomach Discomfort, Vomiting
4212403 4442960 8 Years F 5/13/2004 7/28/2004 76 PER Strattera Gaze Palsy, Vision Blurred
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4212405 4442962 17 Years F 5/15/2004 5/17/2004 7/28/2004 72 PER Strattera Attention Deficit/Hyperactivity Disorder
4212408 4442963 12 Years F 5/1/2004 5/17/2004 7/28/2004 72 PER Strattera Attention Deficit/Hyperactivity Disorder Ear Infection, Rash
4212421 4442966     M 5/17/2004 7/28/2004 72 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Pruritus
4212423 4442967 14 Years M 5/17/2004 7/28/2004 72 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anger, Antisocial Behaviour, Somnolence
4212432 4448950 16 Years F 8/24/2004 9/9/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Von Willebrand's Disease Hospitalization - Initial or Prolonged
4212432 4464693 16 Years F 9/10/2004 9/29/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Contusion, Menorrhagia, Von Willebrand's Disease, Weight Decreased Hospitalization - Initial or Prolonged
4212433 4442968 10 Years M 3/1/2004 5/17/2004 7/28/2004 72 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Educational Problem, Emotional Disorder
4212435 4442969 7 Years M 1/1/2004 5/14/2004 7/28/2004 75 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria
4212435 4495971 10 Years M 1/1/2004 8/17/2004 9/27/2004 41 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria
4212444 4442970     M 5/17/2004 7/28/2004 72 PER Strattera Disturbance in Attention, Initial Insomnia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4212446 4442971 7 Years M 5/15/2004 5/17/2004 7/28/2004 72 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Drug Ineffective
4212447 4442972 7 Years M 5/1/2004 5/17/2004 7/28/2004 72 PER Strattera Attention Deficit/Hyperactivity Disorder Excitability, Somnolence
4212447 4495973 7 Years M 5/1/2004 6/24/2004 9/27/2004 95 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Excitability, Somnolence, Weight Decreased
4212455 4442974     F 5/14/2004 7/28/2004 75 CN PER Strattera Agitation
4212461 4442976 41 Years M 5/16/2004 7/28/2004 73 PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Hesitation
4212462 4442977 25 Years M 5/1/2004 5/12/2004 7/28/2004 77 OT PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Incontinence
4212472 4442979 3 Years M 5/14/2004 7/28/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Hypersomnia
4212483 4442981 7 Years M 5/14/2004 7/28/2004 75 PER Strattera Drug Ineffective
4212491 4442982 51 Years F 5/14/2004 5/27/2004 7/28/2004 62 OT PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Feeling Abnormal, Psychomotor Hyperactivity, Somnolence, Stomach Discomfort
4212491 4495967 51 Years F 5/14/2004 5/27/2004 9/27/2004 123 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Feeling Abnormal, Psychomotor Hyperactivity, Somnolence, Stomach Discomfort
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4212494 4442985 18 Years F 6/4/2004 7/28/2004 54 MD PER Strattera Attention Deficit/Hyperactivity Disorder Increased Appetite, Weight Increased
4212494 4495970 18 Years F 6/4/2004 9/27/2004 115 MD PER Strattera Attention Deficit/Hyperactivity Disorder Increased Appetite, Weight Increased
4212497 4442986 54 Years F 5/14/2004 7/28/2004 75 OT PER Strattera Dizziness, Flushing, Hyperhidrosis, Tachycardia Other
4212499 4442987 23 Years F 5/8/2004 5/13/2004 7/28/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Exophthalmos, Gaze Palsy, Vision Blurred
4212501 4442988     F 3/1/2004 5/14/2004 7/28/2004 75 PER Strattera Stomach Discomfort
4212502 4441171 35 Years 4/21/2004 7/28/2004 98 MD PER Strattera Sedation
4212504 4441173 12 Years 3/23/2004 7/28/2004 127 MD PER Strattera Tic
4212506 4441175 12 Years 3/23/2004 7/28/2004 127 MD PER Strattera Tic
4212507 4441177     M 4/27/2004 7/28/2004 92 PER Strattera Thirst
4212508 4441179 12 Years 4/26/2004 7/28/2004 93 MD PER Strattera Contusion
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4212509 4441180 12 Years 5/3/2004 7/28/2004 86 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4212510 4441182 53 Years F 5/3/2004 5/4/2004 7/28/2004 85 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Chills, Fatigue, Insomnia, Nausea, Tremor
4212511 4441183 12 Years 5/4/2004 7/28/2004 85 MD PER Strattera
4212512 4441184 12 Years 5/5/2004 7/28/2004 84 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety
4212513 4441185 13 Years M 4/13/2004 5/6/2004 7/28/2004 83 MD PER Strattera Somnolence, Urinary Incontinence
4212515 4441234     M 2/18/2004 2/20/2004 7/28/2004 159 PER Strattera Testicular Disorder, Testicular Pain
4212517 4441237     M 2/10/2004 2/20/2004 7/28/2004 159 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Feeling Abnormal, Feeling Hot, Sexual Dysfunction, Stomach Discomfort, Urinary Hesitation
4212518 4441238 55 Years M 2/20/2004 7/28/2004 159 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Erectile Dysfunction, Feeling Abnormal, Male Orgasmic Disorder
4212520 4441239 41 Years F 2/20/2004 7/28/2004 159 OT PER Strattera Hot Flush, Rash, Sleep Disorder
4212521 4441241 14 Years M 2/23/2004 7/28/2004 156 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4212522 4441242 42 Years F 2/1/2004 2/23/2004 7/28/2004 156 PER Strattera Attention Deficit/Hyperactivity Disorder Amenorrhoea, Hormone Level Abnormal
4212524 4441245 13 Years F 6/1/2004 7/28/2004 57 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Activity, Disturbance in Attention, Dyspepsia, Fatigue, Feeling Abnormal, Hearing Impaired, Hypokinesia, Irritability, Social Avoidant Behaviour, Somnolence
4212524 4501701 13 Years F 6/1/2004 9/27/2004 118 CN PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Activity, Disturbance in Attention, Dyspepsia, Fatigue, Feeling Abnormal, Hearing Impaired, Hypokinesia, Irritability, Social Avoidant Behaviour, Somnolence
4212527 4441248 42 Years F 2/1/2004 2/23/2004 7/28/2004 156 PER Strattera Nausea, Paraesthesia, Somnolence
4212530 4441249 14 Years M 2/21/2004 2/23/2004 7/28/2004 156 PER Strattera Decreased Appetite, Feeling Abnormal, Stomach Discomfort
4212532 4441251 4 Years M 2/23/2004 7/28/2004 156 PER Strattera
4212536 4441255 28 Years F 3/10/2004 3/11/2004 7/28/2004 139 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Feeling Hot, Heart Rate Increased, Insomnia, Nausea, Paraesthesia
4212544 4441258 62 Years M 8/1/2003 3/12/2004 7/28/2004 138 PER Strattera Attention Deficit/Hyperactivity Disorder Contusion, Diarrhoea, Drug Ineffective, Vomiting
4212546 4441260 9 Years M 1/1/2004 3/12/2004 7/28/2004 138 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hypoaesthesia
4212548 4441264 17 Years F 1/20/2004 4/13/2004 7/28/2004 106 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Dizziness, Dyspnoea, Flushing, Heart Rate Increased, Nervousness, Panic Attack, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4212552 4441267 39 Years M 3/1/2004 3/12/2004 7/28/2004 138 PER Strattera Attention Deficit/Hyperactivity Disorder Nasopharyngitis
4212557 4441269 33 Years M 1/1/2004 3/12/2004 7/28/2004 138 PER Strattera Blood Glucose Decreased, Erectile Dysfunction, Feeling Drunk
4212558 4441272 45 Years F 1/1/2004 3/12/2004 7/28/2004 138 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Hypersomnia, Insomnia, Weight Decreased
4212559 4441275 44 Years M 3/12/2004 3/12/2004 7/28/2004 138 PER Strattera Epistaxis
4212561 4441278 6 Years M 1/1/2004 3/12/2004 7/28/2004 138 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Feeling Abnormal, Speech Disorder
4212563 4441281 12 Years M 3/12/2004 7/28/2004 138 MD PER Strattera Drug Ineffective, Weight Decreased
4212565 4441297 11 Years M 4/16/2004 4/16/2004 7/28/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder
4212567 4441301 6 Years M 4/6/2004 4/16/2004 7/28/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Choking
4212568 4441304     F 1/1/2004 4/16/2004 7/28/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Eye Pruritus, Fatigue, Headache, Sensation of Foreign Body
4212570 4441308 56 Years M 4/16/2004 4/16/2004 7/28/2004 103 PER Strattera Asthenia, Depression, Dizziness, Dysuria, Fear, Hyperhidrosis, Mental Impairment, Tremor
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4212572 4441310     M 4/15/2004 7/28/2004 104 MD PER Strattera Enuresis
4212575 4441313 14 Years F 4/18/2004 4/19/2004 7/28/2004 100 PER Strattera Abnormal Behaviour, Agitation
4212577 4441317 8 Years M 3/15/2004 4/19/2004 7/28/2004 100 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Drug Ineffective, Nausea, Pyrexia, Somnolence
4212578 4441321 11 Years M 4/19/2004 7/28/2004 100 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Drug Ineffective, Growth Retardation
4212579 4448957 9 Years F 8/1/2004 8/25/2004 9/9/2004 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Blindness, Vision Blurred Other
4212582 4441323 7 Years M 4/18/2004 4/19/2004 7/28/2004 100 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Feeling Abnormal, Nausea, Somnolence, Stomach Discomfort
4212583 4441326 7 Years M 3/1/2004 4/19/2004 7/28/2004 100 PER Strattera Decreased Appetite, Feeling Abnormal, Tremor, Weight Decreased
4212584 4441296 36 Years M 3/1/2004 3/26/2004 7/28/2004 124 PER Strattera Blood Bilirubin Increased, Headache, Hyperhidrosis
4212586 4441298 13 Years F 3/29/2004 4/16/2004 7/28/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Headache, Nasal Congestion, Nausea, Pallor, Pyrexia, Rhinorrhoea, Somnolence
4212588 4441300 52 Years F 3/26/2004 3/29/2004 7/28/2004 121 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Yawning
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4212589 4441303 13 Years M 3/29/2004 7/28/2004 121 PER Strattera Decreased Appetite, Disturbance in Attention
4212593 4441306 33 Years M 3/26/2004 3/29/2004 7/28/2004 121 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Crying, Drug Ineffective, Mood Swings, Weight Decreased
4212595 4441309 9 Years M 3/27/2004 3/29/2004 7/28/2004 121 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
4212598 4441311 42 Years M 3/28/2004 3/29/2004 7/28/2004 121 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Dry Mouth, Dysuria, Fatigue, Feeling Abnormal, Feeling Hot, Formication, Insomnia, Mydriasis, Nausea, Panic Reaction, Scotoma
4212602 4441314 12 Years M 3/28/2004 4/19/2004 7/28/2004 100 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anorexia, Disturbance in Attention, Early Morning Awakening, Headache, Somnolence
4212604 4441318     M 3/29/2004 7/28/2004 121 MD PER Strattera Amnesia
4212606 4441322 38 Years F 3/24/2004 3/29/2004 7/28/2004 121 PER Strattera Blood Pressure Decreased, Headache, Libido Decreased
4212607 4441129 12 Years F 5/17/2004 5/18/2004 7/28/2004 71 PER Strattera Attention Deficit/Hyperactivity Disorder Nasal Congestion, Nasopharyngitis, Pharyngolaryngeal Pain, Psychomotor Hyperactivity, Weight Increased
4212610 4441131     M 5/17/2004 7/28/2004 72 MD PER Strattera Attention Deficit/Hyperactivity Disorder Otitis Media, Prostatitis
4212611 4441133 41 Years F 5/1/2004 5/18/2004 7/28/2004 71 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Dry Mouth, Somnolence, Thirst
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4212612 4441135 41 Years M 5/1/2004 5/18/2004 7/28/2004 71 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Dysuria, Fatigue, Memory Impairment, Somnolence
4212613 4441137 12 Years 5/18/2004 7/28/2004 71 PER Strattera Agitation
4212614 4441138 11 Years F 5/18/2004 7/28/2004 71 MD PER Strattera Bradyphrenia, Dysarthria
4212616 4441141     F 5/1/2004 5/18/2004 7/28/2004 71 PER Strattera Dyspepsia
4212617 4441143 10 Years M 1/1/2004 5/18/2004 7/28/2004 71 PER Strattera Fatigue, Increased Appetite, Somnolence
4212620 4441144 46 Years F 5/18/2004 7/28/2004 71 PER Strattera Attention Deficit/Hyperactivity Disorder Memory Impairment
4212621 4441145 11 Years M 5/18/2004 7/28/2004 71 PER Strattera Attention Deficit/Hyperactivity Disorder Hunger, Weight Increased
4212623 4441146     M 5/1/2004 5/17/2004 7/28/2004 72 PER Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder, Hot Flush, Piloerection, Urinary Hesitation
4212624 4441147 23 Years M 5/17/2004 7/28/2004 72 PER Strattera Disturbance in Attention Migraine
4212626 4441148     M 5/10/2004 5/17/2004 7/28/2004 72 PER Strattera Attention Deficit/Hyperactivity Disorder Depression
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4212627 4441149 37 Years M 5/17/2004 7/28/2004 72 PER Strattera Attention Deficit/Hyperactivity Disorder Chromaturia, Dehydration, Dry Mouth
4212629 4441150 6 Years M 5/1/2004 5/17/2004 7/28/2004 72 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Asthenia, Mood Swings
4212629 4495974 6 Years M 5/1/2004 7/29/2004 9/27/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Asthenia, Irritability, Mood Swings
4212629 4580293 6 Years M 5/1/2004 8/31/2004 1/27/2005 149 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Asthenia, Irritability, Mood Swings
4212631 4441151 39 Years M 1/1/2003 5/17/2004 7/28/2004 72 PER Strattera Attention Deficit/Hyperactivity Disorder Sexual Dysfunction, Testicular Pain
4212631 4495975 39 Years M 1/1/2003 5/17/2004 9/27/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Sexual Dysfunction, Testicular Pain
4212632 4441152 12 Years M 4/1/2004 5/17/2004 7/28/2004 72 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Educational Problem, Mood Swings
4212634 4441153 12 Years F 5/1/2004 5/25/2004 7/28/2004 64 PER Strattera Micturition Urgency, Urinary Retention
4212636 4441154 17 Years M 5/17/2004 7/28/2004 72 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Hyperhidrosis, Impatience, Insomnia, Irritability, Mononucleosis Syndrome, Muscle Fatigue, Palpitations, Psychomotor Hyperactivity
4212637 4441155     M 5/18/2004 7/28/2004 71 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Formication, Mood Swings, Nervousness, Pruritus
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4212641 4441324 5 Years M 3/1/2004 5/5/2004 7/28/2004 84 PER Strattera Psychomotor Hyperactivity Agitation, Anorexia, Muscle Twitching, Nausea, Tremor
4212643 4441325 32 Years F 3/1/2004 3/26/2004 7/28/2004 124 PER Strattera Anxiety, Erythema, Weight Decreased
4212645 4441327     F 3/26/2004 7/28/2004 124 CN PER Strattera Oral Discomfort
4212656 4441328 53 Years M 3/25/2004 3/26/2004 7/28/2004 124 PER Strattera Attention Deficit/Hyperactivity Disorder, Depression Cold Sweat, Disturbance in Attention, Dry Mouth, Fatigue, Hearing Impaired, Heart Rate Increased, Mydriasis
4212656 4501710 53 Years M 3/25/2004 3/26/2004 9/27/2004 185 PER Strattera Attention Deficit/Hyperactivity Disorder, Depression Cold Sweat, Disturbance in Attention, Dry Mouth, Fatigue, Hearing Impaired, Heart Rate Increased, Mydriasis
4212659 4441330     F 3/26/2004 7/28/2004 124 PER Strattera Anxiety, Headache, Insomnia, Mydriasis, Nausea
4212662 4441332 12 Years F 3/26/2004 7/28/2004 124 MD PER Strattera Attention Deficit/Hyperactivity Disorder Enuresis
4212663 4441334     M 9/1/2003 3/26/2004 7/28/2004 124 PER Strattera Dyspepsia, Hypersomnia, Insomnia, Sensation of Foreign Body, Somnolence
4212664 4441335 14 Years M 1/1/2003 3/26/2004 7/28/2004 124 PER Strattera Nausea, Pain in Extremity, Somnolence, Vision Blurred
4212666 4441338 45 Years M 3/26/2004 7/28/2004 124 MD PER Strattera Depression
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4212667 4441340 14 Years M 3/25/2004 3/26/2004 7/28/2004 124 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation
4212668 4441342 7 Years M 3/11/2004 3/25/2004 7/28/2004 125 PER Strattera Decreased Appetite, Sleep Disorder, Tremor
4212669 4441773 6 Years M 5/5/2004 5/7/2004 7/28/2004 82 PER Strattera Agitation, Fatigue, Irritability, Somnolence
4212670 4441344 16 Years M 3/1/2004 3/25/2004 7/28/2004 125 OT PER Strattera Urinary Retention
4212671 4441774 45 Years F 5/7/2004 7/28/2004 82 MD PER Strattera Asthenia, Muscle Fatigue, Systemic Lupus Erythematosus
4212673 4441347 8 Years M 3/25/2004 7/28/2004 125 MD PER Strattera Sleep Disorder, Therapeutic Response Decreased
4212675 4441781 7 Years M 5/7/2004 7/28/2004 82 PH PER Strattera Attention Deficit/Hyperactivity Disorder Retching
4212676 4441785 14 Years M 5/10/2004 7/28/2004 79 OT PER Strattera Chest Pain
4212677 4441350 8 Years F 3/24/2004 3/25/2004 7/28/2004 125 PER Strattera Disturbance in Attention, Dyslexia Headache, Hypoaesthesia, Nausea, Pruritus Generalised
4212679 4441796 13 Years M 5/8/2004 5/11/2004 7/28/2004 78 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Fatigue, Feeling Abnormal, Increased Appetite, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4212680 4441352 40 Years 3/25/2004 7/28/2004 125 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Orgasm Abnormal, Pain, Swelling, Urinary Tract Disorder
4212681 4441797     M 5/1/2004 5/10/2004 7/28/2004 79 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Middle Insomnia, Thinking Abnormal, Urinary Hesitation
4212683 4441355 46 Years M 3/24/2004 3/25/2004 7/28/2004 125 PER Strattera Micturition Urgency, Nausea
4212684 4441800 52 Years F 5/7/2004 5/10/2004 7/28/2004 79 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Dysgeusia, Feeling Abnormal, Hyperhidrosis, Nausea
4212685 4441842 8 Years M 4/1/2004 5/10/2004 7/28/2004 79 MD PER Strattera Attention Deficit/Hyperactivity Disorder Appetite Disorder, Constipation, Initial Insomnia, Somnolence, Stomach Discomfort, Urinary Retention, Vomiting
4212686 4441356 10 Years M 3/25/2004 3/25/2004 7/28/2004 125 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Fatigue, Headache, Heart Rate Increased, Somnolence
4212688 4441847 8 Years F 5/7/2004 5/10/2004 7/28/2004 79 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased
4212689 4441850 10 Years M 5/10/2004 7/28/2004 79 PER Strattera Attention-Seeking Behaviour, Weight Increased
4212690 4441359 39 Years M 11/1/2003 3/25/2004 7/28/2004 125 PER Strattera Flushing
4212692 4441514 12 Years M 5/11/2004 7/28/2004 78 PER Strattera Insomnia, Tonsillitis
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4212693 4441517 44 Years F 5/11/2004 5/11/2004 7/28/2004 78 PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Insomnia, Nausea
4212694 4441360     F 3/1/2004 3/25/2004 7/28/2004 125 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Depression, Emotional Distress
4212695 4441519     M 5/11/2004 7/28/2004 78 MD PER Strattera Attention Deficit/Hyperactivity Disorder
4212697 4441520 45 Years F 5/6/2004 6/15/2004 7/28/2004 43 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Feeling Abnormal, Vision Blurred
4212697 4495963 45 Years F 5/6/2004 6/15/2004 9/27/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Feeling Abnormal, Vision Blurred
4212698 4441362 12 Years M 3/25/2004 3/26/2004 7/28/2004 124 PER Strattera Vision Blurred Chest Discomfort, Cough, Nasopharyngitis, Stomach Discomfort
4212699 4441521 9 Years M 5/11/2004 7/28/2004 78 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Anger, Drug Ineffective, Irritability
4212702 4441524 15 Years M 5/11/2004 7/28/2004 78 MD PER Strattera Tic
4212703 4441526 13 Years M 5/12/2004 7/28/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Decreased Appetite, Weight Decreased
4212705 4441529 38 Years F 12/1/2003 5/11/2004 7/28/2004 78 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dizziness, Dry Mouth, Mydriasis, Nocturia, Thirst
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4212706 4441531 12 Years 5/11/2004 7/28/2004 78 OT PER Strattera Psychomotor Hyperactivity
4212707 4441539 39 Years M 5/1/2004 5/11/2004 7/28/2004 78 PER Strattera Aggression, Headache, Nausea, Sexual Dysfunction, Urinary Hesitation, Vomiting
4212731 4441186 16 Years 3/15/2004 7/28/2004 135 MD PER Strattera Night Sweats
4212732 4441187 11 Years M 3/17/2004 7/28/2004 133 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4212733 4441188 12 Years 3/16/2004 7/28/2004 134 MD PER Strattera Electrocardiogram Abnormal
4212734 4441189 1 Day M 2/4/2004 4/7/2004 7/28/2004 112 OT PER Strattera Breech Presentation
4212735 4441190 16 Years F 4/6/2004 7/28/2004 113 MD PER Strattera Feeling Abnormal
4212737 4441191 9 Years M 4/8/2004 7/28/2004 111 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
4212738 4441192 15 Years F 5/10/2004 6/10/2004 7/28/2004 48 PER Strattera Attention Deficit/Hyperactivity Disorder Back Pain, Dizziness, Flushing, Headache, Myalgia, Palpitations, Peripheral Coldness, Somnolence, Throat Tightness
4212738 4501234 15 Years F 5/10/2004 6/10/2004 9/27/2004 109 CN PER Strattera Attention Deficit/Hyperactivity Disorder Back Pain, Dizziness, Flushing, Headache, Myalgia, Palpitations, Peripheral Coldness, Somnolence, Throat Irritation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4212740 4441197 8 Years M 4/19/2004 7/28/2004 100 MD PER Strattera Abnormal Behaviour
4212741 4441198 12 Years 4/16/2004 7/28/2004 103 MD PER Strattera Anger
4212742 4441200 46 Years F 4/20/2004 7/28/2004 99 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Libido Increased, Peripheral Coldness, Somnolence
4213079 4441202 51 Years M 3/31/2004 7/28/2004 119 PER Strattera Anxiety, Disturbance in Attention
4213082 4441204 10 Years F 3/31/2004 7/28/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Initial Insomnia, Psychomotor Hyperactivity
4213084 4441206 3 Years F 1/1/2004 3/31/2004 7/28/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Choking, Hypersomnia, Sinusitis, Vomiting
4213087 4441208 35 Years M 2/1/2004 3/31/2004 7/28/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Chills, Dysuria, Excitability, Insomnia
4213088 4441211 47 Years M 3/30/2004 3/31/2004 7/28/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Tremor
4213088 4501717 47 Years M 3/30/2004 8/4/2004 9/27/2004 54 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Tremor
4213088 4580303 47 Years M 3/30/2004 12/1/2004 1/27/2005 57 CN PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Headache, Tremor
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4213088 4637486 47 Years M 3/30/2004 12/1/2004 3/28/2005 117 PER Strattera Blood Pressure Increased, Headache, Tremor
4213089 4441214 9 Years M 3/30/2004 3/31/2004 7/28/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Feeling Abnormal, Headache, Hypersomnia, Lethargy
4213091 4441219 28 Years M 3/31/2004 4/7/2004 7/28/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Urinary Hesitation
4213095 4441222 6 Years F 2/1/2004 3/31/2004 7/28/2004 119 PER Strattera
4213096 4441225 12 Years M 3/31/2004 7/28/2004 119 PER Strattera Abnormal Behaviour
4213097 4441229 13 Years M 3/30/2004 3/31/2004 7/28/2004 119 PER Strattera Attention Deficit/Hyperactivity Disorder, Depression Abdominal Pain Upper, Appetite Disorder, Insomnia
4213391 4441240 7 Years M 4/19/2004 4/26/2004 7/28/2004 93 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Stomach Discomfort
4213506 4447854 63 Years M 5/1/2004 6/8/2004 8/12/2004 65 CN PER Strattera Anorexia, Epistaxis, Headache, Insomnia, Nasal Congestion, Nocturia, Urinary Hesitation, Urine Flow Decreased
4213506 4497203 63 Years M 5/1/2004 6/8/2004 9/27/2004 111 PER Strattera Anorexia, Epistaxis, Headache, Insomnia, Nasal Congestion, Nocturia, Urinary Hesitation, Urine Flow Decreased
4216637 4453044 9 Years M 8/9/2004 9/16/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Aggression, Homicidal Ideation Required Intervention to Prevent Permanent Impairment/Damage
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4217244 4454457 8 Years M 1/25/2004 9/17/2004 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Dysarthria, Middle Insomnia, Mood Swings, Speech Disorder Other
4217410 4455558 14 Years M 1/1/2003 9/1/2004 9/17/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Anger, Disturbance in Attention, Gastric Disorder, Mood Swings Hospitalization - Initial or Prolonged
4217410 4464678 14 Years M 1/1/2003 9/10/2004 9/29/2004 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Condition Aggravated, Disturbance in Attention, Drug Ineffective, Gastric Disorder Hospitalization - Initial or Prolonged
4217425 4455561 43 Years M 8/1/2004 8/26/2004 9/17/2004 22 MD EXP Strattera Cerebrovascular Accident Other
4217449 4455565 9 Years M 8/12/2004 8/30/2004 9/17/2004 18 MD EXP Strattera Abnormal Behaviour, Suicidal Ideation Hospitalization - Initial or Prolonged
4217449 4457410 9 Years M 8/12/2004 9/7/2004 9/22/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Depression, Growth Retardation, Oppositional Defiant Disorder, Suicidal Ideation Hospitalization - Initial or Prolonged
4217450 4455567 25 Years M 1/1/2004 8/27/2004 9/17/2004 21 MD EXP Strattera Suicidal Ideation, Suicide Attempt Other
4219048 4457390 64 Years M 7/9/2004 9/2/2004 9/22/2004 20 MD EXP Strattera Major Depression Atrial Flutter, Dizziness, Palpitations Hospitalization - Initial or Prolonged, Life-Threatening, Required Intervention to Prevent Permanent Impairment/Damage
4219048 4474524 64 Years M 7/9/2004 9/17/2004 10/8/2004 21 MD EXP Strattera Major Depression Atrial Flutter, Dizziness Exertional, Palpitations Hospitalization - Initial or Prolonged, Life-Threatening
4219048 4493306 64 Years M 7/9/2004 10/20/2004 11/2/2004 13 MD EXP Strattera Major Depression Atrial Fibrillation, Atrial Flutter, Dizziness, Palpitations Hospitalization - Initial or Prolonged, Life-Threatening
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4219522 4448075 57 Years M 6/16/2004 8/12/2004 57 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Weight Decreased
4219770 4457298     9/8/2004 9/22/2004 14 MD EXP Strattera Tachycardia, Thyroiditis Hospitalization - Initial or Prolonged, Other
4219770 4501721 13 Years F 8/20/2004 9/27/2004 38 MD PER Strattera Tachycardia Hospitalization - Initial or Prolonged
4219770 4618719 13 Years F 3/14/2005 3/23/2005 9 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Thyroiditis Other
4219778 4457300     F 8/1/2004 9/3/2004 9/22/2004 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Anaphylactic Shock, Erythema, Generalised Oedema, Hypersensitivity, Palpitations Hospitalization - Initial or Prolonged, Other
4219780 4457326 17 Years M 9/3/2004 9/22/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Hypoglycaemia Other
4219782 4457303 12 Years 9/8/2004 9/22/2004 14 MD EXP Strattera Anaphylactic Shock Life-Threatening, Other
4219782 4464677 12 Years 9/8/2004 9/29/2004 21 MD EXP Strattera Anaphylactic Shock Life-Threatening, Other
4219782 4493307 14 Years F 8/31/2004 10/15/2004 11/2/2004 18 MD EXP Strattera Anaphylactic Shock, Choking Life-Threatening, Other
4219786 4457305     F 8/1/2004 9/1/2004 9/22/2004 21 EXP Strattera Attention Deficit/Hyperactivity Disorder Glaucoma, Optic Nerve Cupping, Pruritus Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4219792 4457329 33 Years M 9/2/2004 9/22/2004 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Dysgeusia, Feeling Jittery, Nephrolithiasis Other
4219807 4457331 2 Years M 9/4/2004 9/22/2004 18 EXP Strattera Drooling, Somnolence
4219853 4455693 19 Years M 1/1/2004 8/27/2004 9/17/2004 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Delusion, Drug Ineffective, Irritability, Paranoia, Personality Change, Scratch, Self-Injurious Ideation Hospitalization - Initial or Prolonged
4223299 4465061 5 Years F 8/1/2004 9/28/2004 OT DIR Strattera Attention Deficit/Hyperactivity Disorder Affect Lability, Aggression, Anger, Impulse-Control Disorder Other
4224833 4463922 11 Years F 1/1/2004 9/11/2004 9/29/2004 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion Other
4224833 4487892 10 Years F 1/1/2004 10/12/2004 10/26/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Increased, Convulsion, Depressed Level of Consciousness, Dystonia, Electroencephalogram Abnormal, Mucous Membrane Disorder, Somnolence, Speech Disorder Other
4224833 4572168 10 Years F 1/1/2004 1/19/2005 2/2/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Contusion, Convulsion, Depressed Level of Consciousness, Head Injury, Somnolence, Tremor Other
4224878 4463923 14 Years M 8/1/2004 9/15/2004 9/29/2004 14 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Henoch-Schonlein Purpura, Pharyngitis Other
4224878 4474135 14 Years M 8/1/2004 9/15/2004 10/8/2004 23 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Henoch-Schonlein Purpura, Pharyngitis Other
4224880 4463924 12 Years M 10/1/2003 9/10/2004 9/29/2004 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Haemoglobin Decreased, Neutrophil Count Increased Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
4224880 4483360 12 Years M 10/4/2004 10/20/2004 16 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Haemoglobin Decreased, Neutropenia Other
5650148 4473907 50 Years F 9/22/2004 10/8/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Loss of Consciousness, Rash, Skin Disorder Other
5650204 4473946 13 Years F 9/16/2004 10/8/2004 22 MD EXP Strattera Liver Function Test Abnormal
5650204 4518203 13 Years F 11/12/2004 11/30/2004 18 MD EXP Strattera Aspartate Aminotransferase Increased, Blood Iron Increased, Blood Lactate Dehydrogenase Increased
5650204 4565487 13 Years F 1/10/2005 1/26/2005 16 MD EXP Strattera Aspartate Aminotransferase Increased, Blood Iron Increased, Blood Lactate Dehydrogenase Increased
5650207 4473947 10 Years M 9/1/2004 9/21/2004 10/8/2004 17 OT EXP Strattera Myocardial Infarction Hospitalization - Initial or Prolonged, Other
5650219 4476618 38 Years M 9/22/2004 9/24/2004 10/13/2004 19 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Blindness Transient, Colour Blindness, Vision Blurred, Visual Disturbance Other
5650219 4482209 38 Years M 9/22/2004 10/6/2004 10/20/2004 14 EXP Strattera Attention Deficit/Hyperactivity Disorder Blindness Transient, Colour Blindness, Vision Blurred Other
5650219 4546106 38 Years M 9/22/2004 12/13/2004 1/3/2005 21 EXP Strattera Attention Deficit/Hyperactivity Disorder Blindness Transient, Colour Blindness Acquired, Condition Aggravated, Migraine, Vision Blurred Other
5650226 4476619 12 Years 9/23/2004 10/13/2004 20 OT EXP Strattera Cardiomyopathy, Congenital Anomaly Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5650226 4522458 13 Years 3/29/2004 11/23/2004 12/7/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Body Temperature Decreased, Cardiac Failure Congestive, Cardiac Murmur, Cardiomegaly, Cardiomyopathy, Dyspnoea, Mitral Valve Incompetence, Pleural Effusion, Sinus Tachycardia, Tricuspid Valve Incompetence, Viral Infection, Vomiting Hospitalization - Initial or Prolonged, Other
5650455 4474245 10 Years M 9/20/2004 10/8/2004 18 MD EXP Strattera Blood Bilirubin Increased, Blood Bilirubin Unconjugated Increased, Viral Infection
5650616 4474619 48 Years M 7/14/2004 9/20/2004 10/8/2004 18 EXP Strattera Attention Deficit/Hyperactivity Disorder Anuria, Haematotoxicity, Jaundice, Nausea, Nephrolithiasis, Pain, Pyrexia, Renal Vessel Disorder, Urinary Retention Hospitalization - Initial or Prolonged
5650640 4474620 13 Years M 9/17/2004 10/8/2004 21 MD EXP Strattera Chest Pain, Electrocardiogram T Wave Inversion, Flushing, Headache, Hypertension, Tachycardia, Troponin Increased Hospitalization - Initial or Prolonged
5650663 4474621 47 Years F 8/1/2004 9/17/2004 10/8/2004 21 EXP Strattera Attention Deficit/Hyperactivity Disorder Affective Disorder, Agitation, Contusion, Drug Ineffective, Fall, Impulsive Behaviour, Loss of Consciousness, Mood Swings, Syncope, Thinking Abnormal Other
5650663 4482218 47 Years F 8/1/2004 10/6/2004 10/20/2004 14 EXP Strattera Attention Deficit/Hyperactivity Disorder Agitation, Contusion, Drug Ineffective, Fall, Impulsive Behaviour, Loss of Consciousness, Mood Swings, Pain, Syncope, Thinking Abnormal Other
5650737 4474007 17 Years F 8/30/2004 10/8/2004 39 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion Other
5650737 4773298 17 Years F 8/25/2005 9/16/2005 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Dizziness, Epilepsy, Loss of Consciousness Other
5650881 4475272 10 Years F 6/5/2004 10/13/2004 PH DIR Atomoxetine Attention Deficit/Hyperactivity Disorder Circulatory Collapse, Hypertension, Rash Maculo-Papular, Rash Pruritic, Skin Laceration, Syncope, Tachycardia Hospitalization - Initial or Prolonged
5650971 4475433 11 Years M 8/10/2004 10/14/2004 OT DIR Strattera Attention Deficit/Hyperactivity Disorder Convulsion
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5650984 4473935 40 Years M 9/19/2004 9/21/2004 10/8/2004 17 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Pancreatitis Hospitalization - Initial or Prolonged
5651016 4476640 16 Years M 9/11/2004 9/24/2004 10/13/2004 19 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Appendicitis Hospitalization - Initial or Prolonged
5651020 4476642 9 Years F 9/28/2004 9/28/2004 10/13/2004 15 OT EXP Strattera Blood Glucose Increased, Dizziness
5651048 4476643 39 Years F 8/22/2004 9/27/2004 10/13/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Bronchitis, Chest Pain, Hypomania, Post-Traumatic Stress Disorder, Psychotic Disorder Hospitalization - Initial or Prolonged
5651144 4476584 32 Years F 1/1/2004 1/1/2004 9/27/2004 10/13/2004 16 MD EXP Strattera Overdose, Vomiting Death
5651148 4476585     M 9/27/2004 10/13/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion Other
5651644 4473878     2/1/2003 10/8/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder, Depression Hypoacusis, Oedema Mouth, Swollen Tongue Other
5651828 4476577 11 Years M 1/1/2003 9/27/2004 10/13/2004 16 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Enzyme Abnormality, Grand Mal Convulsion Other
5652202 4476921 13 Years M 9/5/2004 9/27/2004 10/13/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Antisocial Behaviour, Mania Other
5653305 4478195 14 Years M 2/20/2004 10/8/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5653538 4478315 13 Years M 8/4/2004 9/29/2004 10/13/2004 14 EXP Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Dyspnoea Other
5653896 4478406 15 Years M 10/18/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased Other
5653898 4478407 12 Years M 10/18/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased Other
5655145 4465833 9 Years M 4/1/2004 9/13/2004 9/29/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Gait Disturbance, Hypoaesthesia, Myalgia, Paraesthesia, Tic, Viral Infection Hospitalization - Initial or Prolonged
5655145 4482213 9 Years M 4/1/2004 10/5/2004 10/20/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Myalgia Hospitalization - Initial or Prolonged
5655285 4482125 8 Years F 10/4/2004 10/20/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Hallucination (Visual) Other
5655285 4642560 8 Years F 9/5/2004 4/1/2005 4/20/2005 19 OT EXP Strattera Hallucination (Visual) Other
5655285 4662753 8 Years F 9/5/2004 4/21/2005 5/12/2005 21 MD EXP Strattera Emotional Disorder, Hallucination (Visual), Nightmare, Thinking Abnormal Other
5655285 4710645 8 Years F 9/5/2004 6/17/2005 7/7/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Emotional Disorder, Hallucination (Visual), Nightmare, Thinking Abnormal Other
5655411 4483546 13 Years M 7/19/2004 10/21/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Priapism Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5655541 4483440 14 Years M 10/1/2004 10/5/2004 10/20/2004 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Head Injury, Subdural Haematoma Hospitalization - Initial or Prolonged
5655552 4483441 7 Years F 1/1/2004 10/4/2004 10/20/2004 16 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Hallucination (Auditory), Psychotic Disorder, Self Injurious Behaviour
5655758 4483450 12 Years M 9/30/2004 9/30/2004 10/20/2004 20 OT EXP Strattera Blood Pressure Decreased, Heart Rate Decreased, Loss of Consciousness Other
5655758 4509519 12 Years M 9/30/2004 11/2/2004 11/19/2004 17 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Decreased, Hypotension, Loss of Consciousness Other
5655760 4483451 16 Years M 9/30/2004 10/20/2004 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Intentional Self-Injury Other
5655760 4501061 15 Years M 6/29/2004 10/27/2004 11/9/2004 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Agitation, Anxiety, Intentional Self-Injury Other
5655760 4522456 15 Years M 6/29/2004 11/23/2004 12/7/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Agitation, Anxiety, Laceration, Self Mutilation Other
5655897 4483431 47 Years F 8/27/2004 8/28/2004 10/1/2004 10/20/2004 19 MD EXP Strattera Abnormal Behaviour, Contusion, Excoriation, Overdose Death
5655897 4512529 47 Years F 8/27/2004 8/28/2004 11/10/2004 11/24/2004 14 OT EXP Strattera Abnormal Behaviour, Contusion, Drug Screen Positive, Overdose, Scratch Death
5655897 4538791 47 Years F 8/28/2004 8/28/2004 12/1/2004 12/22/2004 21 MD EXP Strattera Abnormal Behaviour, Drug Toxicity, Excoriation Death
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5655899 4483432 18 Years M 10/5/2004 10/20/2004 15 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Mydriasis, Palpitations, Retinal Disorder, Retinal Tear, Scotoma Other
5655899 4572063 18 Years M 4/1/2004 1/13/2005 2/2/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Eye Burns, Insomnia, Mydriasis, Palpitations, Retinal Disorder, Visual Disturbance, Visual Field Defect Other
5655901 4483433 15 Years M 10/4/2004 10/6/2004 10/20/2004 14 CN EXP Strattera Convulsion, Dyspnoea, Somnolence Other
5658262 4488221 42 Years M 10/3/2004 10/7/2004 10/26/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Age Indeterminate Myocardial Infarction, Arteriosclerosis, Cardio-Respiratory Arrest, Cerebral Haematoma, Chest Pain, Circulatory Collapse, Coronary Artery Disease, Coronary Artery Occlusion, Excoriation Death
5658266 4488223 9 Years M 8/9/2004 10/7/2004 10/26/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Homicidal Ideation Other
5658266 4501083 9 Years M 8/9/2004 10/27/2004 11/9/2004 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anger, Belligerence, Physical Assault, Weight Decreased Other
5658275 4488228 19 Years M 10/12/2004 10/26/2004 14 MD EXP Strattera Bradycardia, Dizziness, Headache, Loss of Consciousness, Nausea, Skin Discolouration, Testicular Disorder Other
5658282 4488225 14 Years M 2/1/2004 10/11/2004 10/26/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Autoimmune Hepatitis, B-Lymphocyte Count Decreased, Biopsy Liver Abnormal, Bone Marrow Depression, CD8 Lymphocytes Increased, Cholangitis, Cholestasis, Cough, Decreased Appetite, Hepatic Cyst, Hepatic Fibrosis, Hepatic Necrosis, Hepatic Steatosis, Hepatitis, Hepatitis Infectious, Hypersomnia, Irritable Bowel Syndrome, Peptic Ulcer, Pharyngolaryngeal Pain, Pyrexia, Rhinorrhoea Hospitalization - Initial or Prolonged, Other
5658282 4517983 14 Years M 2/1/2004 11/15/2004 11/30/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Bone Marrow Depression, Cholestasis, Cough, Decreased Appetite, Hepatic Cyst, Hepatic Fibrosis, Hepatic Necrosis, Hepatic Steatosis, Hepatitis, Hypersomnia, Irritable Bowel Syndrome, Pharyngolaryngeal Pain, Rhinorrhoea, Stress Symptoms Hospitalization - Initial or Prolonged, Other
5658282 4642040 14 Years M 2/1/2004 4/5/2005 4/21/2005 16 MD EXP Strattera Blood Immunoglobulin G Increased, Bone Marrow Depression, Ceruloplasmin Increased, Cholangitis Acute, Cholestasis, Cough, Cytomegalovirus Antibody Positive, Diarrhoea, Hepatic Cyst, Hepatic Fibrosis, Hepatic Necrosis, Hepatic Steatosis, Hepatitis, Hypersomnia, Inflammation, Irritable Bowel Syndrome, Peptic Ulcer, Pharyngolaryngeal Pain, Pyrexia, Rhinorrhoea, Vomiting Hospitalization - Initial or Prolonged, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5658282 4658135 14 Years M 2/1/2004 4/20/2005 5/9/2005 19 MD EXP Strattera Bone Marrow Depression, Ceruloplasmin Increased, Cholangitis, Cholestasis, Cough, Decreased Appetite, Diarrhoea, Hepatic Cyst, Hepatic Necrosis, Hepatic Steatosis, Hepatitis, Hypersomnia, Pharyngolaryngeal Pain, Pyrexia, Rhinorrhoea, Vomiting Hospitalization - Initial or Prolonged, Other
5658285 4488232 16 Years M 9/1/2004 10/7/2004 10/26/2004 19 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Loss of Consciousness, Tachycardia Other
5658285 4522453 17 Years M 9/1/2004 12/1/2004 12/7/2004 6 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Loss of Consciousness, Tachycardia Other
5658291 4488234 8 Years M 10/12/2004 10/26/2004 14 MD EXP Strattera Homicidal Ideation Other
5658294 4488236 8 Years M 6/17/2004 10/7/2004 10/26/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Chest Pain, Heart Rate Increased Hospitalization - Initial or Prolonged
5658294 4546083 8 Years M 6/17/2004 12/15/2004 1/3/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Chest Pain, Heart Rate Increased, Pyrexia Hospitalization - Initial or Prolonged
5658341 4488268 17 Years M 10/12/2004 10/26/2004 14 EXP Strattera Cardiac Arrest Life-Threatening
5658343 4488270 17 Years F 10/8/2004 10/26/2004 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Suicidal Ideation Hospitalization - Initial or Prolonged
5658343 4531944 17 Years F 9/30/2004 11/30/2004 12/16/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Affective Disorder, Anxiety, Intentional Self-Injury, Psychiatric Symptom, Suicidal Ideation Hospitalization - Initial or Prolonged
5658345 4488272 14 Years 10/13/2004 10/26/2004 13 EXP Strattera Attention Deficit/Hyperactivity Disorder Lymphadenopathy Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5658348 4488274 13 Years M 10/5/2004 10/8/2004 10/26/2004 18 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased
5658348 4549441 13 Years M 1/1/2004 12/20/2004 1/6/2005 17 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased, Glossodynia, Growth Accelerated, Influenza Like Illness, Insomnia, Laboratory Test Abnormal, Mucosal Erosion, Rash Macular, Strawberry Tongue, Tongue Blistering, Tongue Discolouration, Viral Infection, Weight Increased
5658840 4491001 13 Years M 8/10/2004 9/27/2004 48 MD PER Strattera Attention Deficit/Hyperactivity Disorder Growth Retardation
5658840 4580335 13 Years M 11/8/2004 1/27/2005 80 MD PER Strattera Attention Deficit/Hyperactivity Disorder Growth Retardation
5658842 4491003 10 Years M 8/9/2004 9/27/2004 49 OT PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5658843 4491007 9 Years M 8/10/2004 9/27/2004 48 PER Strattera Attention Deficit/Hyperactivity Disorder Body Height Below Normal, Cough
5658843 4580387 9 Years M 10/18/2004 1/27/2005 101 PER Strattera Attention Deficit/Hyperactivity Disorder Body Height Below Normal, Cough
5658845 4491009 16 Years F 1/1/2004 8/10/2004 9/27/2004 48 MD PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Tract Infection
5658846 4491011     M 8/10/2004 9/27/2004 48 MD PER Strattera Dysuria
5658847 4491013 77 Years M 8/6/2004 8/10/2004 9/27/2004 48 PER Strattera Somnolence Feeling Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5658849 4491015 53 Years F 8/9/2004 9/27/2004 49 PER Strattera Asthenia, Chills, Dry Mouth, Pyrexia
5658851 4491017 49 Years F 8/9/2004 8/9/2004 9/27/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Muscle Contracture
5658871 4491018 13 Years M 8/10/2004 8/10/2004 9/27/2004 48 PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Hesitation, Urinary Retention
5658872 4491021 6 Years M 8/10/2004 9/27/2004 48 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Drug Ineffective
5658929 4491180 7 Years M 7/28/2004 8/2/2004 9/27/2004 56 CN PER Strattera Aggression, Retching, Tremor
5658932 4491181 22 Years F 7/1/2004 8/2/2004 9/27/2004 56 CN PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Irritability
5658934 4491182 40 Years M 8/2/2004 9/27/2004 56 MD PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Fatigue
5658936 4491183 35 Years M 7/1/2004 8/2/2004 9/27/2004 56 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Urinary Hesitation
5658937 4491184 8 Years M 8/2/2004 9/27/2004 56 MD PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
5658939 4491185     8/2/2004 9/27/2004 56 OT PER Strattera Platelet Count Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5658944 4491186 6 Years M 7/26/2004 9/27/2004 63 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anger, Depressed Mood, Tic
5658946 4491187 30 Years M 1/1/2004 8/2/2004 9/27/2004 56 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Weight Decreased, Weight Increased
5658947 4491188 17 Years F 7/29/2004 8/3/2004 9/27/2004 55 CN PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Nausea, Vomiting
5658948 4491189     F 8/1/2004 8/2/2004 9/27/2004 56 CN PER Strattera Muscle Cramp, Pain in Extremity
5659219 4488595 47 Years M 3/1/2003 9/28/2004 10/26/2004 28 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased
5659219 4560960 45 Years M 3/1/2003 1/5/2005 1/21/2005 16 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Anxiety, Chest Pain, Diarrhoea, Hyperhidrosis, Presbyopia, Tremor
5659526 4487916     M 10/7/2004 10/26/2004 19 MD EXP Strattera Loss of Consciousness Other
5659592 4487918 14 Years M 10/7/2004 10/26/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Intestinal Obstruction Hospitalization - Initial or Prolonged
5659601 4491170 39 Years M 8/1/2004 8/2/2004 9/27/2004 56 PER Strattera Attention Deficit/Hyperactivity Disorder Accident, Apathy, Coordination Abnormal, Disturbance in Attention, Limb Injury
5659606 4487919 14 Years M 10/1/2004 10/8/2004 10/26/2004 18 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Loss of Consciousness Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5659606 4501092 14 Years M 10/1/2004 10/26/2004 11/9/2004 14 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Blood Pressure Decreased, Dizziness, Loss of Consciousness, Sinus Pain Other
5659613 4491171 50 Years F 7/28/2004 8/2/2004 9/27/2004 56 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Insomnia
5659615 4491172 13 Years F 7/1/2004 8/3/2004 9/27/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Mydriasis, Photophobia, Stomach Discomfort
5659620 4491173 62 Years M 8/1/2004 8/2/2004 9/27/2004 56 PER Strattera Pruritus
5659633 4491174 8 Years F 8/3/2004 9/27/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Retching
5659641 4491175 48 Years M 7/1/2004 8/2/2004 9/27/2004 56 PER Strattera Ejaculation Delayed, Pollakiuria, Urine Flow Decreased
5659647 4491064 16 Years M 7/1/2004 8/5/2004 9/27/2004 53 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Agitation
5659649 4491066 45 Years F 7/27/2004 9/27/2004 62 CN PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dry Mouth, Hyperhidrosis, Nausea, Somnolence, Vomiting
5659650 4491068 26 Years F 7/27/2004 7/27/2004 9/27/2004 62 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Muscle Cramp, Nausea, Stomach Discomfort
5659655 4491073 9 Years M 7/27/2004 9/27/2004 62 MD PER Strattera Epistaxis
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5659658 4491102 6 Years M 7/27/2004 9/27/2004 62 CN PER Strattera Contusion
5659675 4491105 8 Years F 7/27/2004 9/27/2004 62 CN PER Strattera Contusion
5659680 4491112 26 Years M 8/5/2004 9/27/2004 53 MD PER Strattera Attention Deficit/Hyperactivity Disorder Cyst, Genital Pain
5659689 4491113 47 Years F 7/1/2004 7/27/2004 9/27/2004 62 CN PER Strattera Attention Deficit/Hyperactivity Disorder Hypoaesthesia, Irritability
5659691 4491114 66 Years F 7/28/2004 9/27/2004 61 CN PER Strattera Anger, Feeling Abnormal, Nervousness, Stress Symptoms, Tension, Weight Decreased
5659696 4491118 19 Years F 7/28/2004 9/27/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Nausea
5659698 4491117     F 7/23/2004 7/28/2004 9/27/2004 61 CN PER Strattera Attention Deficit/Hyperactivity Disorder Sinus Disorder, Stomach Discomfort, Visual Acuity Reduced
5659701 4491119 56 Years M 7/21/2004 7/28/2004 9/27/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Discomfort, Depressed Level of Consciousness, Dry Mouth, Dyspnoea, Dysuria, Feeling Abnormal, Urinary Hesitation, Urinary Retention
5659703 4491120 8 Years M 7/25/2004 7/28/2004 9/27/2004 61 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Impulsive Behaviour, Lethargy, Masked Facies
5659705 4491121 12 Years M 7/28/2004 9/27/2004 61 MD PER Strattera Migraine
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5659707 4491122     M 7/28/2004 9/27/2004 61 PER Strattera Disturbance in Attention Excitability, Hunger
5659708 4491123 48 Years M 7/28/2004 9/27/2004 61 MD PER Strattera
5659710 4491125 6 Years M 1/1/2004 8/17/2004 9/27/2004 41 PER Strattera Pervasive Developmental Disorder Anorexia, Contusion, Emotional Distress, Hypersomnia, Insomnia, Psychomotor Hyperactivity, Weight Decreased
5659710 4580519 6 Years M 1/23/2004 9/21/2004 1/27/2005 128 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Contusion, Emotional Distress, Feeling Abnormal, Headache, Insomnia, Psychomotor Hyperactivity, Sedation, Weight Decreased
5659713 4491126     F 7/1/2004 7/28/2004 9/27/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fatigue, Psychomotor Hyperactivity, Sluggishness
5659715 4491127 14 Years M 7/28/2004 9/27/2004 61 MD PER Strattera Attention Deficit/Hyperactivity Disorder Epistaxis
5659716 4491128 29 Years M 6/1/2004 7/28/2004 9/27/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Heart Rate Increased, Thirst
5659719 4491024 6 Years M 8/7/2004 8/9/2004 9/27/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence, Weight Increased
5659722 4491026 9 Years F 7/1/2004 8/6/2004 9/27/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia, Hypotrichosis, Weight Decreased
5659722 4580543 9 Years F 7/1/2004 9/1/2004 1/27/2005 148 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Alopecia, Decreased Appetite, Hypotrichosis, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5659724 4491035 12 Years 8/3/2004 9/27/2004 55 OT PER Strattera Chest Pain
5659726 4491039 5 Years M 8/9/2004 9/27/2004 49 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Rash
5659730 4491040 14 Years M 8/9/2004 9/27/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Suicidal Ideation
5659735 4491042 9 Years M 8/9/2004 9/27/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Weight Abnormal
5659737 4491045 10 Years F 8/9/2004 9/27/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dizziness, Feeling Abnormal, Feeling Hot, Nausea, Somnolence, Vomiting
5659740 4491048 51 Years M 8/6/2004 8/10/2004 9/27/2004 48 PER Strattera Drug Ineffective, Erectile Dysfunction, Feeling Abnormal, Insomnia
5659743 4491051 4 Years F 8/10/2004 9/27/2004 48 PER Strattera Attention Deficit/Hyperactivity Disorder Rash
5659743 4580309 4 Years F 9/3/2004 1/27/2005 146 PER Strattera Attention Deficit/Hyperactivity Disorder Rash
5659746 4491058 16 Years F 8/9/2004 9/27/2004 49 MD PER Strattera Excitability, Thinking Abnormal
5659803 4488653 8 Years M 9/24/2004 10/12/2004 10/26/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Hallucination (Auditory) Hospitalization - Initial or Prolonged, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5659804 4491129 14 Years M 7/27/2004 7/28/2004 9/27/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Anxiety, Decreased Appetite, Nausea, Vomiting
5659805 4491130 12 Years M 4/1/2004 7/28/2004 9/27/2004 61 OT PER Strattera Attention Deficit/Hyperactivity Disorder Cough, Rhinorrhoea
5659806 4491131 16 Years F 7/29/2004 9/27/2004 60 MD PER Strattera Arthralgia, Pain in Extremity
5659807 4491132     F 7/29/2004 9/27/2004 60 MD PER Strattera Vision Blurred
5659808 4491133 52 Years M 7/23/2004 7/29/2004 9/27/2004 60 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blood Creatinine Increased, Blood Urea Increased
5659809 4491176 50 Years F 8/2/2004 8/3/2004 9/27/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Pruritus, Urticaria
5659810 4491177 6 Years M 8/3/2004 9/27/2004 55 PER Strattera Psychomotor Hyperactivity Anorexia, Drug Ineffective, Dyskinesia, Insomnia, Weight Decreased
5659811 4491178 8 Years M 8/3/2004 9/27/2004 55 PH PER Strattera Attention Deficit/Hyperactivity Disorder Muscle Twitching
5659812 4491179 53 Years M 8/2/2004 8/3/2004 9/27/2004 55 PH PER Strattera Throat Irritation
5659815 4491135 9 Years M 5/28/2004 7/29/2004 9/27/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5659819 4491136 9 Years M 1/1/2004 7/29/2004 9/27/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Emotional Distress, Growth Retardation
5659823 4491137 35 Years M 7/30/2004 9/27/2004 59 MD PER Strattera Genital Disorder Male, Peripheral Coldness
5659828 4491138 52 Years F 7/29/2004 7/29/2004 9/27/2004 60 PER Strattera Multiple Sclerosis
5659841 4491140 39 Years F 7/29/2004 7/30/2004 9/27/2004 59 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fatigue, Feeling Jittery, Nervousness, Tremor
5659844 4491141 11 Years M 7/1/2004 7/30/2004 9/27/2004 59 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Somnolence
5659846 4491142 50 Years F 7/1/2004 7/30/2004 9/27/2004 59 PER Strattera Headache, Nausea, Stomach Discomfort
5659848 4491143 5 Years M 6/1/2004 8/2/2004 9/27/2004 56 PER Strattera Pervasive Developmental Disorder Vomiting
5659850 4491144 11 Years M 8/2/2004 9/27/2004 56 PER Strattera Weight Increased
5659857 4491145 43 Years M 8/3/2004 9/27/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder
5659858 4491146 5 Years M 7/1/2004 8/2/2004 9/27/2004 56 PER Strattera Glossodynia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5659858 4726704 5 Years M 7/1/2004 4/11/2005 7/25/2005 105 PER Strattera Disturbance in Attention, Drug Ineffective, Glossodynia
5659869 4491147 37 Years M 8/2/2004 9/27/2004 56 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Urinary Hesitation
5659872 4491148 12 Years 8/3/2004 9/27/2004 55 OT PER Strattera Chest Pain
5659876 4491149 16 Years F 7/1/2004 8/2/2004 9/27/2004 56 OT PER Strattera Blood Cholesterol Increased, Blood Triglycerides Increased, Low Density Lipoprotein Increased
5659879 4491220 22 Years M 7/1/2004 8/4/2004 9/27/2004 54 MD PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Somnolence
5659881 4491221 14 Years F 8/4/2004 9/27/2004 54 PER Strattera Abdominal Pain Upper, Drug Ineffective
5659883 4491222 8 Years M 8/4/2004 8/4/2004 9/27/2004 54 MD PER Strattera Somnolence
5659886 4491223 45 Years M 8/4/2004 9/27/2004 54 MD PER Strattera Disturbance in Attention Skin Odour Abnormal
5659889 4491224 6 Years M 7/1/2004 8/4/2004 9/27/2004 54 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Impulse-Control Disorder, Impulsive Behaviour, Psychomotor Hyperactivity
5659892 4491225 13 Years M 8/5/2004 9/27/2004 53 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5659894 4491226 11 Years M 1/1/2004 8/5/2004 9/27/2004 53 MD PER Strattera Increased Tendency to Bruise
5659894 4580541 12 Years M 7/28/2004 8/30/2004 1/27/2005 150 MD PER Strattera Attention Deficit/Hyperactivity Disorder Increased Tendency to Bruise
5659896 4491227 5 Years M 8/5/2004 9/27/2004 53 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Drug Ineffective, Psychomotor Hyperactivity, Weight Gain Poor
5659897 4491228 20 Years F 8/6/2004 9/27/2004 52 MD PER Strattera Abdominal Discomfort, Vertigo
5659898 4491229     M 8/2/2004 8/5/2004 9/27/2004 53 PER Strattera Dysuria
5659915 4490958 13 Years M 8/9/2004 9/27/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Gastrointestinal Disorder
5659917 4490959     F 8/6/2004 9/27/2004 52 PER Strattera Abnormal Dreams, Somnolence
5659920 4490962     M 8/6/2004 9/27/2004 52 PER Strattera Stomach Discomfort, Tachycardia
5659924 4490964 33 Years F 7/30/2004 8/6/2004 9/27/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Chills, Crying, Dizziness, Emotional Disorder, Fatigue, Feeling Abnormal, Headache, Irritability, Nausea
5659926 4490966 42 Years F 8/6/2004 9/27/2004 52 MD PER Strattera Drug Interaction, Hypomania
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5659926 4580542 42 Years F 9/14/2004 1/27/2005 135 MD PER Strattera Drug Interaction, Hypomania
5659931 4490969 45 Years M 7/1/2004 8/6/2004 9/27/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Lethargy, Somnolence
5659934 4490971 42 Years M 8/1/2004 8/9/2004 9/27/2004 49 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fall, Stomach Discomfort, Suture Insertion, Upper Limb Fracture
5659937 4490973 6 Years M 8/6/2004 9/27/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Choking, Constipation, Emotional Disorder, Insomnia, Oral Discomfort, Restlessness
5659938 4490974 11 Years F 8/9/2004 9/27/2004 49 PER Strattera Hypersomnia
5659940 4490975 13 Years 8/9/2004 9/27/2004 49 PH PER Strattera Hallucination
5659987 4491160 45 Years F 7/29/2004 9/27/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Nasal Discomfort
5659988 4491161 10 Years F 7/29/2004 9/27/2004 60 MD PER Strattera Abdominal Pain Upper, Emotional Disorder, Mood Swings
5659989 4491162 9 Years M 7/1/2004 7/29/2004 9/27/2004 60 PER Strattera Autism Psychomotor Hyperactivity, Stomach Discomfort
5659990 4491163 8 Years M 7/30/2004 9/27/2004 59 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Sedation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5659991 4491164 57 Years M 7/28/2004 7/29/2004 9/27/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Restlessness, Urine Flow Decreased
5659992 4491165 11 Years M 7/29/2004 7/29/2004 9/27/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Eating Disorder, Hunger, Nausea, Somnolence, Stomach Discomfort, Weight Increased
5659993 4491166 55 Years F 7/30/2004 7/30/2004 9/27/2004 59 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Nausea, Vomiting
5659994 4491167 22 Years F 7/1/2004 7/30/2004 9/27/2004 59 PER Strattera Attention Deficit/Hyperactivity Disorder Emotional Distress, Vision Blurred
5659995 4491168 17 Years M 7/30/2004 9/27/2004 59 PER Strattera Drug Ineffective
5659996 4491169 13 Years M 7/30/2004 7/30/2004 9/27/2004 59 PER Strattera Somnolence
5659997 4491150 47 Years F 7/1/2004 7/30/2004 9/27/2004 59 PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Muscle Cramp
5659998 4491151 14 Years M 7/30/2004 7/30/2004 9/27/2004 59 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fatigue, Feeling Abnormal
5659999 4491152 12 Years M 7/29/2004 7/30/2004 9/27/2004 59 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Epistaxis, Somnolence
5660000 4491153 15 Years M 7/30/2004 9/27/2004 59 MD PER Strattera Urinary Hesitation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5660001 4491154 7 Years M 7/1/2004 7/30/2004 9/27/2004 59 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
5660002 4491155     F 7/30/2004 9/27/2004 59 PER Strattera Feeling Abnormal
5660004 4491156 45 Years M 7/30/2004 9/27/2004 59 MD PER Strattera Penis Disorder
5660005 4491157 17 Years M 12/26/2003 7/30/2004 9/27/2004 59 PER Strattera Attention Deficit/Hyperactivity Disorder Dissociation, Disturbance in Attention, Judgement Impaired, Memory Impairment, Tremor
5660006 4491158 45 Years M 7/30/2004 9/27/2004 59 MD PER Strattera Penis Disorder
5660008 4491159 16 Years F 1/1/2004 7/30/2004 9/27/2004 59 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
5660009 4491190 19 Years F 8/3/2004 9/27/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Drug Ineffective, Hypoventilation, Insomnia, Psychomotor Hyperactivity
5660011 4491191 16 Years M 11/1/2003 8/3/2004 9/27/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Platelet Count Decreased
5660012 4491192 34 Years M 8/4/2004 9/27/2004 54 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Disturbance in Attention, Emotional Distress, Lethargy, Nervousness, Rapid Eye Movements Sleep Abnormal, Road Traffic Accident, Skin Hyperpigmentation
5660013 4491193 17 Years M 7/1/2004 8/3/2004 9/27/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Cough, Erythema, Feeling Cold
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5660014 4491194 38 Years M 7/28/2004 8/11/2004 9/27/2004 47 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Chills, Depression, Dizziness, Dyspnoea, Feeling Abnormal, Mood Altered, Somnolence
5660015 4491195 6 Years M 7/1/2004 8/4/2004 9/27/2004 54 PER Strattera Attention Deficit/Hyperactivity Disorder Increased Appetite, Somnolence
5660017 4491196 46 Years F 6/19/2004 8/3/2004 9/27/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Glaucoma, Oedema Peripheral, Vision Blurred
5660018 4491197 18 Years F 7/1/2004 8/3/2004 9/27/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Hyperventilation
5660020 4491198     F 8/2/2004 8/3/2004 9/27/2004 55 PER Strattera Chills, Feeling Cold, Insomnia, Nervousness, Tension
5660021 4491199 17 Years M 7/1/2004 8/3/2004 9/27/2004 55 PER Strattera Attention Deficit/Hyperactivity Disorder Stomach Discomfort, Vomiting
5660022 4491200     M 8/4/2004 9/27/2004 54 MD PER Strattera Attention Deficit/Hyperactivity Disorder Sexual Dysfunction
5660023 4491201     F 8/4/2004 9/27/2004 54 MD PER Strattera Body Temperature Decreased, Cyanosis, Peripheral Coldness, Peripheral Vascular Disorder
5660023 4580540     F 11/2/2004 1/27/2005 86 MD PER Strattera Body Temperature Decreased, Cyanosis, Peripheral Coldness, Peripheral Vascular Disorder
5660025 4491202 6 Years F 8/3/2004 8/4/2004 9/27/2004 54 PER Strattera Attention Deficit/Hyperactivity Disorder Enuresis, Psychomotor Hyperactivity, Sleep Disorder, Stomach Discomfort
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5660028 4491203     F 8/4/2004 9/27/2004 54 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Drug Ineffective, Headache, Hyperhidrosis
5660029 4491204 8 Years M 8/4/2004 9/27/2004 54 PER Strattera Attention Deficit/Hyperactivity Disorder Gastrointestinal Disorder
5660030 4491205 6 Years M 6/1/2004 8/4/2004 9/27/2004 54 PER Strattera Night Cramps
5660031 4491206 12 Years M 8/4/2004 9/27/2004 54 PER Strattera Psychomotor Hyperactivity Drug Ineffective
5660033 4491207 9 Years F 8/3/2004 8/4/2004 9/27/2004 54 PER Strattera Disturbance in Attention Decreased Appetite, Dizziness, Fatigue, Nausea, Stomach Discomfort
5660034 4491208 30 Years F 7/25/2004 8/5/2004 9/27/2004 53 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Fungal Infection, Hypoaesthesia Oral, Peripheral Coldness, Poor Peripheral Circulation
5660036 4491209 9 Years M 8/5/2004 9/27/2004 53 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Increased Appetite, Irritability, Mood Altered, Psychomotor Hyperactivity
5660040 4491210 27 Years M 8/3/2004 8/5/2004 9/27/2004 53 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Euphoric Mood, Mood Swings, Psychomotor Hyperactivity, Somnolence
5660041 4491211 53 Years F 8/6/2004 9/27/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Asthenia, Fatigue, Insomnia
5660042 4491212 35 Years M 8/6/2004 9/27/2004 52 MD PER Strattera Bladder Pain, Ear Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5660043 4491213 11 Years M 8/6/2004 9/27/2004 52 PER Strattera Pain, Skin Nodule
5660044 4491214 7 Years M 8/6/2004 8/6/2004 9/27/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5660045 4491215 6 Years F 8/6/2004 9/27/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Decreased Appetite, Drug Ineffective, Somnolence
5660049 4491216 15 Years M 7/24/2004 8/6/2004 9/27/2004 52 PER Strattera Fatigue
5660050 4491217     F 8/5/2004 8/6/2004 9/27/2004 52 PER Strattera Feeling Abnormal, Feeling Jittery, Nervousness, Paraesthesia
5660051 4491218 51 Years F 5/1/2004 8/6/2004 9/27/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Feeling Abnormal, Malaise
5660052 4491219     M 8/6/2004 9/27/2004 52 PER Strattera
5663496 4497122 11 Years F 5/10/2004 5/26/2004 9/27/2004 124 CN PER Strattera Decreased Appetite, Drug Ineffective, Stomach Discomfort, Vomiting, Weight Decreased
5663499 4497123 7 Years M 5/1/2004 5/26/2004 9/27/2004 124 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Decreased Appetite, Depression, Mood Swings, Screaming
5663509 4497124 24 Years M 6/9/2004 9/27/2004 110 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Back Injury, Crying, Insomnia, Suicidal Ideation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5663511 4497125 11 Years M 10/1/2003 5/26/2004 9/27/2004 124 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Chest Pain, Somnolence
5663514 4497126 9 Years F 3/1/2004 5/26/2004 9/27/2004 124 OT PER Strattera Attention Deficit/Hyperactivity Disorder Chest Discomfort, Drug Ineffective, Fatigue, Insomnia, Palpitations, Tachycardia
5663552 4497127 11 Years M 6/11/2004 9/27/2004 108 OT PER Strattera Abdominal Pain Lower, Change of Bowel Habit, Chills, Diarrhoea, Drug Ineffective, Nausea, Urinary Retention, Weight Decreased
5663562 4497128 29 Years M 5/10/2004 5/26/2004 9/27/2004 124 CN PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Hyperhidrosis
5663563 4497130 37 Years M 3/1/2004 6/23/2004 9/27/2004 96 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Anxiety, Drug Ineffective, Insomnia, Thinking Abnormal
5663569 4497132 42 Years M 5/26/2004 9/27/2004 124 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Fatigue, Feeling Jittery, Tachycardia
5663578 4497133 9 Years M 7/7/2004 9/27/2004 82 OT PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain
5663630 4497314     F 7/21/2004 7/22/2004 9/27/2004 67 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Decreased Appetite, Flushing, Heart Rate Increased, Irritability
5663664 4497315 10 Years M 3/1/2004 7/23/2004 9/27/2004 66 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Chills, Dizziness, Feeling Cold, Nausea, Pallor
5663669 4497317 12 Years 7/16/2004 9/27/2004 73 PH PER Strattera Protein Urine Present
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5663686 4497318 47 Years F 1/1/2004 7/23/2004 9/27/2004 66 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Headache, Psychomotor Hyperactivity
5663686 4580409 47 Years F 1/1/2004 8/30/2004 1/27/2005 150 OT PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Palpitations, Psychomotor Hyperactivity
5663688 4497319 8 Years M 7/1/2004 7/23/2004 9/27/2004 66 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Constipation, Drug Ineffective, Emotional Disorder, Headache
5663701 4497321 7 Years M 7/15/2004 7/23/2004 9/27/2004 66 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anger, Fatigue, Lethargy, Nausea, Psychomotor Hyperactivity, Somnolence
5663701 4580441 7 Years M 7/15/2004 9/22/2004 1/27/2005 127 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Anger, Fatigue, Feeling Abnormal, Glossodynia, Lethargy, Nausea, Psychomotor Hyperactivity, Somnolence, Vomiting
5663708 4497322 15 Years F 7/22/2004 7/23/2004 9/27/2004 66 PER Strattera Fatigue, Insomnia
5663709 4497323 20 Years F 7/23/2004 7/23/2004 9/27/2004 66 PER Strattera Dizziness, Feeling Abnormal, Nausea
5663710 4497324     F 7/23/2004 9/27/2004 66 PER Strattera Normetanephrine Urine Increased
5663710 4580503     F 8/24/2004 1/27/2005 156 PER Strattera Blood Pressure Increased, Hyperhidrosis, Metanephrine Urine Increased, Migraine, Normetanephrine Urine Increased
5663711 4497325 8 Years M 7/20/2004 7/23/2004 9/27/2004 66 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Dysuria
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5663818 4494335 24 Years M 8/26/2004 10/27/2004 11/2/2004 6 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder, Emotional Distress, Genitourinary Tract Infection, Loss of Libido, Mental Disorder, Sexual Dysfunction Other
5663818 4501320 24 Years M 8/26/2004 10/25/2004 11/9/2004 15 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder, Loss of Libido, Sexual Dysfunction Other
5663904 4493931 60 Years F 10/1/2004 10/14/2004 11/2/2004 19 OT EXP Strattera Thinking Abnormal Blood Pressure Increased, Bundle Branch Block Right, Feeling Abnormal Other
5663906 4493932 7 Years M 1/1/2004 10/14/2004 11/2/2004 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Dermatitis Exfoliative, Drug Ineffective, Drug Interaction, Fungal Infection, Psoriasis, Rash Erythematous, Urticaria Other
5663908 4493933     M 10/1/2004 10/13/2004 11/2/2004 20 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Increased
5663909 4493935 14 Years M 10/14/2004 11/2/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Loss of Consciousness, Syncope Other
5663909 4595461 14 Years M 2/7/2005 2/24/2005 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Amnesia, Head Injury, Loss of Consciousness, Syncope Other
5663910 4493936 15 Years F 10/20/2004 10/2/2004 -18 MD EXP Strattera Amnesia, Homicidal Ideation, Scratch, Self Mutilation, Thermal Burn Other
5663910 4509513 15 Years F 10/28/2004 11/19/2004 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Amnesia, Homicidal Ideation, Self Mutilation Other
5663934 4472185     F 9/14/2004 10/8/2004 24 MD EXP Strattera Hepatic Enzyme Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5663934 4493303 20 Years F 9/8/2004 10/15/2004 11/2/2004 18 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Dizziness, Fatigue, Nausea
5664193 4438474 4 Years F 3/23/2004 7/28/2004 127 PER Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder
5664204 4440526 9 Years M 6/11/2003 3/4/2004 7/28/2004 146 CN PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Disturbance in Attention, Somnolence
5664208 4440664 50 Years M 2/19/2004 4/30/2004 7/28/2004 89 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Gastric Disorder
5664728 4465606 14 Years 9/1/2004 9/14/2004 9/29/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Amnesia, Hallucination, Psychotic Disorder Hospitalization - Initial or Prolonged
5664728 4538793 14 Years M 9/11/2004 12/3/2004 12/22/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Amnesia, Asthenia, Diarrhoea, Disorientation, Feeling Abnormal, Hallucination, Mental Status Changes, Psychotic Disorder, Rash Hospitalization - Initial or Prolonged
5664728 4607098 14 Years M 9/11/2004 2/17/2005 3/9/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Amnesia, Asthenia, Diarrhoea, Disorientation, Hallucination, Mental Status Changes, Psychotic Disorder, Rash, Sensory Disturbance Hospitalization - Initial or Prolonged
5664729 4465607 6 Years M 9/15/2004 9/29/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Condition Aggravated, Convulsion Other
5664730 4465609     F 9/15/2004 9/29/2004 14 MD EXP Strattera Suicidal Ideation Hospitalization - Initial or Prolonged
5664731 4465610 15 Years M 9/10/2004 9/13/2004 9/29/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Amnesia, Anger, Scratch Hospitalization - Initial or Prolonged, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5664732 4465611 6 Years M 9/15/2004 9/29/2004 14 OT EXP Strattera Homicidal Ideation Other
5664757 4465835 6 Years 9/10/2004 9/29/2004 19 EXP Strattera Convulsion Other
5664757 4709687 11 Years M 5/3/2004 6/16/2005 7/7/2005 21 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Computerised Tomogram Abnormal, Convulsion, Coordination Abnormal, Enzyme Abnormality, Hypotonia, Insomnia, Memory Impairment, Mental Disorder, Muscular Weakness, Nervous System Disorder, Sleep Walking Other
5664757 4867389 11 Years M 5/3/2004 12/5/2005 12/22/2005 17 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Convulsion, Coordination Abnormal, Decreased Appetite, Distractibility, Grand Mal Convulsion, Hypoaesthesia, Hypotonia, Impulsive Behaviour, Insomnia, Memory Impairment, Mental Disorder, Metabolic Disorder, Muscular Weakness, Restlessness, Self Esteem Decreased, Sleep Walking Other
5664757 4898249 11 Years M 5/3/2004 1/13/2006 1/27/2006 14 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Convulsion, Coordination Abnormal, Decreased Appetite, Distractibility, Hypoaesthesia, Hypotonia, Impulsive Behaviour, Insomnia, Memory Impairment, Metabolic Disorder, Muscular Weakness, Nervousness, Oppositional Defiant Disorder, Self Esteem Decreased, Sleep Walking Other
5664757 4907080 11 Years M 8/22/2003 1/20/2006 2/7/2006 18 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Body Temperature Increased, Convulsion, Coordination Abnormal, Decreased Appetite, Distractibility, Head Injury, Hypoaesthesia, Hypotonia, Impulsive Behaviour, Insomnia, Memory Impairment, Mental Impairment, Metabolic Disorder, Muscular Weakness, Nervousness, Neurological Symptom, Oppositional Defiant Disorder, Oral Mucosal Petechiae, Pharyngeal Erythema, Self Esteem Decreased, Sleep Walking, Vomiting Other
5664757 4932052 11 Years M 8/22/2003 2/3/2006 2/28/2006 25 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Body Temperature Increased, Coordination Abnormal, Decreased Appetite, Distractibility, Erythema, Grand Mal Convulsion, Head Injury, Hypoaesthesia, Hypotonia, Impulsive Behaviour, Insomnia, Memory Impairment, Muscular Weakness, Myoclonus, Nervousness, Petechiae, Self Esteem Decreased, Sleep Walking, Vomiting Other
5664757 4955121 11 Years M 8/22/2003 3/1/2006 3/22/2006 21 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Body Temperature Increased, Computerised Tomogram Abnormal, Confusional State, Convulsion, Coordination Abnormal, Decreased Appetite, Distractibility, Disturbance in Attention, Dysarthria, Fatigue, Grand Mal Convulsion, Head Injury, Hypoaesthesia, Hypotonia, Impulsive Behaviour, Insomnia, Memory Impairment, Mental Impairment, Metabolic Disorder, Muscular Weakness, Myoclonus, Nervousness, Neurological Symptom, Petechiae, Self Esteem Decreased, Sleep Walking, Vomiting Other
5664757 5074683 11 Years M 8/22/2003 7/17/2006 8/3/2006 17 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Body Temperature Increased, Convulsion, Coordination Abnormal, Decreased Appetite, Distractibility, Dysgraphia, Fatigue, Grand Mal Convulsion, Head Injury, Hypoaesthesia, Hypotonia, Impulsive Behaviour, Insomnia, Memory Impairment, Metabolic Disorder, Muscular Weakness, Myoclonus, Nervousness, Oral Mucosal Petechiae, Pharyngeal Erythema, Self Esteem Decreased, Sleep Walking, Vomiting Other
5664757 5089408 11 Years M 8/22/2003 7/31/2006 8/22/2006 22 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Body Temperature Increased, Coordination Abnormal, Decreased Appetite, Delirium, Distractibility, Dysarthria, Dysgraphia, Fatigue, Grand Mal Convulsion, Head Injury, Hypoaesthesia, Hypotonia, Impulsive Behaviour, Insomnia, Memory Impairment, Metabolic Disorder, Muscular Weakness, Myoclonus, Nervousness, Oppositional Defiant Disorder, Petechiae, Self Esteem Decreased, Sleep Walking, Somnolence, Viral Pharyngitis, Vomiting Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5664762 4465896 9 Years M 6/24/2004 7/15/2004 9/30/2004 77 EXP Strattera Attention Deficit/Hyperactivity Disorder Diabetes Mellitus Insulin-Dependent, Enuresis, Fluid Retention
5664762 4498990 9 Years M 6/24/2004 7/15/2004 9/27/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Diabetes Mellitus Insulin-Dependent, Dry Mouth, Enuresis, Fluid Retention, Thirst
5664765 4465907 16 Years M 9/3/2004 9/8/2004 9/29/2004 21 CN EXP Strattera Amnesia, Blood Electrolytes Abnormal, Decreased Appetite, Dehydration, Disturbance in Attention, Feeling Abnormal, Irritability, Loss of Consciousness, Nausea, Vomiting, Weight Decreased Other
5664766 4465910     M 9/10/2004 9/29/2004 19 MD EXP Strattera Convulsion Other
5668355 4472768 7 Years M 8/7/2004 9/16/2004 10/8/2004 22 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Appendicitis Hospitalization - Initial or Prolonged
5668355 4522535 7 Years M 8/7/2004 11/19/2004 12/7/2004 18 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Appendicitis Hospitalization - Initial or Prolonged
5668356 4472773 17 Years M 9/2/2004 9/21/2004 10/8/2004 17 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Irritability, Nausea, Physical Assault, Vomiting Disability
5669320 4474313 12 Years M 9/18/2004 9/20/2004 10/8/2004 18 MD EXP Strattera Anaphylactic Reaction Other
5669320 4577813 12 Years M 9/20/2004 1/25/2005 2/9/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Anaphylactic Reaction, Chest Discomfort, Feeling Abnormal, Foaming at Mouth Other
5669320 4595440 12 Years M 9/20/2004 2/3/2005 2/24/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Anaphylactic Reaction, Chest Discomfort, Feeling Abnormal, Foaming at Mouth Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5669321 4474314 7 Years M 9/21/2004 9/22/2004 10/8/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion Other
5671703 4493571 16 Years M 9/1/2004 10/20/2004 11/2/2004 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Completed Suicide, Injury Asphyxiation Death
5671703 4501050 15 Years M 10/14/2004 10/14/2004 10/27/2004 11/9/2004 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Completed Suicide, Injury Asphyxiation, Self Injurious Behaviour Death
5671703 4538814 15 Years M 10/14/2004 10/14/2004 12/7/2004 12/22/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Completed Suicide Death
5671710 4493574 7 Years F 1/1/2004 10/19/2004 11/2/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Sinus Arrhythmia Other
5671718 4497106 12 Years F 5/24/2004 5/25/2004 9/27/2004 125 CN PER Strattera
5671720 4493577 15 Years M 10/1/2004 10/18/2004 11/2/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Headache, Visual Disturbance Other
5671728 4497107 7 Years F 5/25/2004 9/27/2004 125 CN PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5671730 4497108 11 Years M 5/19/2004 5/25/2004 9/27/2004 125 CN PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Somnolence
5671730 4637496 11 Years M 5/19/2004 2/2/2005 3/28/2005 54 PER Strattera Feeling Abnormal, Somnolence, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5671733 4497109 41 Years F 5/21/2004 5/25/2004 9/27/2004 125 CN PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
5671733 4637390 41 Years F 5/21/2004 2/2/2005 3/28/2005 54 PER Strattera Drug Ineffective, Somnolence, Stomach Discomfort
5671736 4497112 43 Years F 5/1/2004 5/25/2004 9/27/2004 125 CN PER Strattera Attention Deficit/Hyperactivity Disorder Micturition Urgency, Pharyngolaryngeal Pain, Rash, Rash Pruritic, Urine Odour Abnormal
5671739 4497115 10 Years M 2/3/2004 5/21/2004 9/27/2004 129 MD PER Strattera Attention Deficit/Hyperactivity Disorder Haematuria
5671740 4497116 58 Years M 5/21/2004 5/25/2004 9/27/2004 125 CN PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Nausea
5671742 4497117 66 Years M 5/1/2004 5/25/2004 9/27/2004 125 CN PER Strattera Abnormal Behaviour, Feeling Abnormal, Feeling Drunk, Thought Blocking
5671743 4493584 7 Years M 10/16/2004 10/19/2004 11/3/2004 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Ear Infection Viral, Febrile Convulsion Other
5671743 4501089 7 Years M 10/16/2004 10/27/2004 11/9/2004 13 EXP Strattera Attention Deficit/Hyperactivity Disorder Ear Infection, Febrile Convulsion, Feeling Abnormal, Headache, Tremor, Viral Infection Other
5671745 4497118 34 Years F 5/24/2004 5/25/2004 9/27/2004 125 CN PER Strattera Disturbance in Attention Decreased Appetite, Middle Insomnia, Muscle Cramp, Psychomotor Hyperactivity
5671746 4497119 19 Years M 5/25/2004 8/18/2004 9/27/2004 40 CN PER Strattera Attention Deficit/Hyperactivity Disorder Penile Size Reduced
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5671746 4580298 19 Years M 5/25/2004 11/8/2004 1/27/2005 80 PER Strattera Attention Deficit/Hyperactivity Disorder Penile Size Reduced
5671746 4637391 19 Years M 5/25/2004 12/20/2004 3/28/2005 98 PER Strattera Dry Mouth, Penile Size Reduced, Thirst
5671746 4726702 19 Years M 5/25/2004 5/10/2005 7/25/2005 76 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Penile Size Reduced, Thirst
5671746 4782217 19 Years M 1/1/2004 8/19/2005 9/27/2005 39 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dry Mouth, Penile Size Reduced, Thirst
5671844 4497227 9 Years M 6/1/2004 6/24/2004 9/27/2004 95 PER Strattera Disturbance in Attention, Fatigue
5671845 4497228 26 Years F 5/1/2004 6/23/2004 9/27/2004 96 PER Strattera Feeling Abnormal
5671846 4497229 14 Years M 6/24/2004 9/27/2004 95 MD PER Strattera Attention Deficit/Hyperactivity Disorder Psychotic Disorder
5671849 4497232 5 Years M 6/24/2004 9/27/2004 95 OT PER Strattera Autism Hypersensitivity, Psychomotor Hyperactivity
5671851 4497233 9 Years M 6/18/2004 6/24/2004 9/27/2004 95 PER Strattera Fatigue, Somnolence
5671852 4497235 7 Years M 6/1/2004 6/24/2004 9/27/2004 95 PER Strattera Attention Deficit/Hyperactivity Disorder Pyrexia, Rhinorrhoea, Viral Infection
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5671856 4497236 37 Years M 7/12/2004 9/27/2004 77 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Chest Pain
5671857 4497238     F 6/25/2004 6/25/2004 9/27/2004 94 PER Strattera Apathy, Decreased Appetite, Dry Mouth, Fatigue
5671858 4497239 8 Years 6/1/2004 6/25/2004 9/27/2004 94 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Feeling Abnormal, Irritability, Mood Swings
5671863 4497241 13 Years M 6/24/2004 6/25/2004 9/27/2004 94 PER Strattera Insomnia Dizziness, Visual Disturbance
5671875 4497257 12 Years F 6/1/2004 6/25/2004 9/27/2004 94 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Nausea, Sluggishness
5671876 4497258     M 6/25/2004 9/27/2004 94 MD PER Strattera Gynaecomastia, Weight Increased
5671882 4497242     F 7/20/2004 7/20/2004 9/27/2004 69 PER Strattera Stomach Discomfort
5671883 4497260 33 Years F 6/25/2004 9/27/2004 94 PER Strattera Depression Diarrhoea, Drug Ineffective, Hormone Level Abnormal, Menstrual Disorder, Menstruation Irregular
5671884 4497243 6 Years F 7/16/2004 7/20/2004 9/27/2004 69 PER Strattera Dysphagia
5671886 4497262 57 Years M 6/25/2004 6/25/2004 9/27/2004 94 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Excitability, Libido Increased, Muscle Tightness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5671887 4497247     M 7/20/2004 7/21/2004 9/27/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Initial Insomnia, Nausea, Somnolence
5671888 4497263 45 Years M 6/25/2004 6/25/2004 9/27/2004 94 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Feeling Abnormal
5671889 4497265     M 6/25/2004 9/27/2004 94 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dysphagia, Dyspnoea, Throat Tightness
5671889 4580311     M 6/24/2004 8/31/2004 1/27/2005 149 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dysphagia, Dyspnoea, Throat Tightness
5671890 4497249 12 Years M 1/1/2004 7/21/2004 9/27/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Headache, Nausea, Somnolence
5671893 4497267     F 6/25/2004 9/27/2004 94 PER Strattera Attention Deficit/Hyperactivity Disorder Adjustment Disorder, Judgement Impaired, Road Traffic Accident, Thinking Abnormal
5671894 4497250 7 Years F 6/23/2004 7/21/2004 9/27/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Impulsive Behaviour, Psychomotor Hyperactivity
5671897 4497251     F 7/1/2004 7/21/2004 9/27/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder
5671899 4497269 38 Years M 6/25/2004 6/25/2004 9/27/2004 94 PER Strattera Attention Deficit/Hyperactivity Disorder Nervousness
5671902 4497252 9 Years M 5/1/2004 7/21/2004 9/27/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Fatigue
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5671903 4497270     F 6/28/2004 9/27/2004 91 MD PER Strattera Attention Deficit/Hyperactivity Disorder Raynaud's Phenomenon
5671904 4497272 13 Years M 6/23/2004 6/28/2004 9/27/2004 91 PER Strattera Attention Deficit/Hyperactivity Disorder Tic
5671906 4497253 10 Years M 5/1/2004 7/21/2004 9/27/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Anorexia, Feeling Abnormal
5671907 4497254 55 Years F 7/19/2004 7/21/2004 9/27/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Pain, Sleep Disorder, Vomiting
5671909 4497255     F 7/18/2004 7/21/2004 9/27/2004 68 PER Strattera Eye Irritation, Fatigue, Keratoconjunctivitis Sicca, Pollakiuria
5671921 4497064 12 Years M 5/1/2004 5/24/2004 9/27/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Fatigue, Hypersomnia, Psychomotor Hyperactivity
5671923 4497065 12 Years 5/24/2004 9/27/2004 126 PER Strattera Tongue Ulceration
5671924 4497066 7 Years F 5/24/2004 9/27/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Depressed Mood, Drug Ineffective
5671925 4497096 21 Years M 5/24/2004 9/27/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder, Depression, Drug Ineffective
5671928 4497097 46 Years M 5/24/2004 9/27/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Asthma, Fatigue, Feeling Abnormal, Hyperhidrosis
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5671932 4497098 7 Years M 5/24/2004 9/27/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation
5671943 4497286 23 Years M 1/1/2004 7/21/2004 9/27/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Hesitation, Urinary Retention, Urinary Tract Pain
5671944 4497102 37 Years M 5/24/2004 9/27/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Jittery, Irritability
5671947 4497287 41 Years M 7/1/2004 7/21/2004 9/27/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
5671951 4497288 15 Years F 1/1/2003 7/21/2004 9/27/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Restlessness, Somnolence
5671952 4497103 11 Years M 1/1/2004 8/13/2004 9/27/2004 45 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dysgeusia, Nausea, Stomach Discomfort
5671954 4497289 13 Years M 6/1/2004 7/21/2004 9/27/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Crying, Dizziness, Dizziness Postural, Fall, Hyperventilation, Mood Swings, Nervousness
5671957 4497292 5 Years M 4/1/2004 7/21/2004 9/27/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Emotional Disorder, Muscle Twitching, Tic
5671959 4497104 40 Years F 5/24/2004 5/25/2004 9/27/2004 125 PER Strattera Feeling Abnormal, Paraesthesia, Piloerection, Somnolence
5671964 4497293 6 Years M 7/19/2004 7/21/2004 9/27/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Abnormal, Rash
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5671969 4497294 35 Years M 7/21/2004 9/27/2004 68 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Psychomotor Hyperactivity
5671973 4497105     M 5/25/2004 9/27/2004 125 MD PER Strattera Attention Deficit/Hyperactivity Disorder Erectile Dysfunction
5671975 4497296 12 Years 4/1/2004 7/15/2004 9/27/2004 74 MD PER Strattera Hyperhidrosis, Palpitations
5671976 4497215 51 Years M 5/13/2004 7/12/2004 9/27/2004 77 MD PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Pain, Urinary Hesitation
5671978 4497297 52 Years F 7/22/2004 9/27/2004 67 PER Strattera Learning Disorder Depression
5671984 4497216 9 Years F 5/27/2004 9/27/2004 123 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Somnolence
5671991 4497217 40 Years M 5/1/2004 6/21/2004 9/27/2004 98 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Increased
5671995 4497219 42 Years M 5/24/2004 5/27/2004 9/27/2004 123 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Dizziness, Dyspnoea, Fatigue, Headache
5671999 4497220 10 Years M 5/1/2004 6/3/2004 9/27/2004 116 PER Strattera Memory Impairment, Negativism, Personality Change
5672009 4497221 52 Years F 5/27/2004 9/27/2004 123 PER Strattera Abnormal Behaviour Aggression, Agitation, Constipation, Disturbance in Attention, Loss of Libido, Sleep Disorder, Tension, Vulvovaginal Dryness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5672014 4497222 32 Years M 5/22/2004 5/27/2004 9/27/2004 123 PER Strattera Attention Deficit/Hyperactivity Disorder Micturition Urgency, Urinary Hesitation, Urinary Retention
5672019 4497223 8 Years M 5/27/2004 9/27/2004 123 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
5672027 4497224 41 Years F 5/24/2004 5/27/2004 9/27/2004 123 PER Strattera Attention Deficit/Hyperactivity Disorder Migraine, Nausea, Neck Pain, Vomiting
5672028 4497226 11 Years M 5/27/2004 5/27/2004 9/27/2004 123 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Chills
5672030 4497299 32 Years M 7/1/2004 7/22/2004 9/27/2004 67 PER Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder, Somnolence
5672038 4497301 12 Years 7/15/2004 9/27/2004 74 MD PER Strattera Mania
5672041 4497304 30 Years F 7/21/2004 7/22/2004 9/27/2004 67 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Fatigue, Somnolence
5672043 4497305 57 Years F 7/18/2004 7/22/2004 9/27/2004 67 PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Fatigue, Listless
5672046 4497306 25 Years F 7/22/2004 9/27/2004 67 MD PER Strattera Anger, Depression, Irritability, Mood Swings, Suicidal Ideation
5672048 4497307     M 7/22/2004 7/22/2004 9/27/2004 67 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Dizziness Postural, Feeling Hot, Hyperhidrosis
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5672050 4497309     M 7/22/2004 9/27/2004 67 PER Strattera Attention Deficit/Hyperactivity Disorder
5672054 4497310 32 Years F 7/1/2004 7/22/2004 9/27/2004 67 OT PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Feeling Jittery, Gastrooesophageal Reflux Disease, Hot Flush, Hyperhidrosis
5672056 4497311 46 Years M 7/22/2004 9/27/2004 67 PER Strattera Anxiety Agitation, Anger
5672058 4497313 20 Years F 7/20/2004 7/22/2004 9/27/2004 67 PER Strattera Attention Deficit/Hyperactivity Disorder Piloerection
5672059 4497196 64 Years M 5/24/2004 5/28/2004 9/27/2004 122 MD PER Strattera Dysphoria, Insomnia, Urinary Hesitation
5672060 4497197 8 Years M 5/1/2004 5/28/2004 9/27/2004 122 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5672061 4497198 35 Years M 5/1/2004 5/28/2004 9/27/2004 122 PER Strattera Agitation, Fatigue, Somnolence
5672062 4497207 47 Years M 5/7/2004 5/28/2004 9/27/2004 122 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Hyperhidrosis, Myalgia, Nerve Compression, Testicular Pain, Urinary Hesitation
5672063 4497210 44 Years F 5/1/2004 5/28/2004 9/27/2004 122 PER Strattera Attention Deficit/Hyperactivity Disorder Blepharospasm, Dysgeusia, Dyspepsia
5672064 4497211     F 5/1/2004 5/28/2004 9/27/2004 122 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Nausea, Restlessness, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5672065 4497212 8 Years M 5/21/2004 5/28/2004 9/27/2004 122 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Heart Rate Increased, Myalgia
5672066 4497213 15 Years M 5/27/2004 5/28/2004 9/27/2004 122 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fatigue, Nausea, Nightmare
5672067 4497214 12 Years M 5/1/2004 5/28/2004 9/27/2004 122 PER Strattera Attention Deficit/Hyperactivity Disorder Injury
5672433 4494349 12 Years M 9/23/2004 10/14/2004 11/2/2004 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Compulsions, Obsessive Rumination, Obsessive Thoughts, Paranoia, Regressive Behaviour Other
5673310 4497056 7 Years F 2/20/2004 5/21/2004 9/27/2004 129 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Drug Withdrawal Syndrome, Headache, Irritability
5674655 4501189 21 Years M 8/11/2004 8/12/2004 9/27/2004 46 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Cold, Hot Flush, Pyrexia, Vomiting
5674657 4501190 17 Years F 8/11/2004 8/13/2004 9/27/2004 45 PH PER Strattera Attention Deficit/Hyperactivity Disorder Vision Blurred
5674661 4501191 9 Years M 8/13/2004 9/27/2004 45 PER Strattera Tic
5674662 4501193 43 Years F 8/11/2004 8/13/2004 9/27/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Acne
5674667 4501194 60 Years M 2/1/2003 8/13/2004 9/27/2004 45 PER Strattera Disturbance in Attention Early Morning Awakening, Erectile Dysfunction, Feeling Abnormal, Hyperhidrosis, Nausea, Urinary Hesitation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5674667 4580473 60 Years M 2/1/2003 11/10/2004 1/27/2005 78 MD PER Strattera Disturbance in Attention Early Morning Awakening, Erectile Dysfunction, Feeling Abnormal, Hyperhidrosis, Nausea, Urinary Hesitation
5674669 4501196     M 8/12/2004 9/27/2004 46 MD PER Strattera Hyperhidrosis
5674675 4501200 33 Years M 8/1/2004 8/13/2004 9/27/2004 45 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Premature Ejaculation
5674680 4501201     F 1/1/2004 8/13/2004 9/27/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Change of Bowel Habit, Decreased Appetite, Drug Ineffective, Faeces Hard, Headache, Insomnia, Memory Impairment, Somnolence
5674689 4501202 9 Years F 1/1/2004 8/13/2004 9/27/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Feeling Abnormal, Retching, Somnolence
5674692 4501203 8 Years F 8/4/2004 8/16/2004 9/27/2004 42 PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity
5674692 4637425 8 Years F 8/4/2004 2/24/2005 3/28/2005 32 PER Strattera Agitation, Psychomotor Hyperactivity
5674698 4500286 15 Years F 6/29/2004 8/10/2004 9/27/2004 48 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dry Mouth, Epistaxis, Fatigue
5674699 4500287 15 Years M 1/1/2003 7/15/2004 9/27/2004 74 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Depression, Drug Ineffective, Insomnia
5674700 4500289 16 Years F 7/15/2004 9/27/2004 74 MD PER Strattera Raynaud's Phenomenon
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5674703 4500291 16 Years F 7/15/2004 9/27/2004 74 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Respiratory Distress
5674704 4500293 45 Years F 7/16/2004 9/27/2004 73 OT PER Strattera Chills, Cold Sweat
5674711 4500294     M 7/1/2004 7/16/2004 9/27/2004 73 PER Strattera Dry Mouth, Ejaculation Disorder, Pollakiuria, Urinary Retention
5674713 4500296 5 Years M 7/16/2004 9/27/2004 73 PER Strattera Attention Deficit/Hyperactivity Disorder Contusion, Decreased Appetite, Dysgeusia
5674713 4580367 4 Years M 1/1/2004 10/29/2004 1/27/2005 90 OT PER Strattera Attention Deficit/Hyperactivity Disorder Contusion, Dysgeusia
5674723 4500298 15 Years F 7/16/2004 9/27/2004 73 PH PER Strattera Epistaxis
5674724 4498040 11 Years M 11/2/2004 11/9/2004 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anxiety, Depression, Educational Problem, Hallucinations (Mixed), Nightmare, Social Avoidant Behaviour, Stress Symptoms Other
5674726 4500299 10 Years F 7/10/2004 7/16/2004 9/27/2004 73 PER Strattera Attention Deficit/Hyperactivity Disorder Dysphagia
5674728 4500302 4 Years 7/16/2004 9/27/2004 73 MD PER Strattera Asthenia
5674733 4500248 6 Years M 7/2/2004 7/16/2004 9/27/2004 73 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Fatigue, Mood Swings, Stomach Discomfort
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5674735 4500251 10 Years F 7/6/2004 7/16/2004 9/27/2004 73 PH PER Strattera Attention Deficit/Hyperactivity Disorder Urine Protein (Quantitative)
5674737 4500252 46 Years M 7/15/2004 7/19/2004 9/27/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Dysuria, Fatigue, Feeling Abnormal, Insomnia
5674740 4500254 46 Years F 7/16/2004 7/19/2004 9/27/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Crying, Dry Mouth, Insomnia, Nervousness
5674742 4500256 11 Years F 7/1/2004 7/19/2004 9/27/2004 70 MD PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Retention
5674745 4500258 13 Years M 7/19/2004 9/27/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Educational Problem, Eye Redness, Insomnia, Irritability, Skin Discolouration, Somnolence, Thinking Abnormal, Weight Increased
5674749 4500259 6 Years M 7/29/2004 9/27/2004 60 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Attention Deficit Hyperactivity Disorder, Crying, Drug Ineffective, Fatigue, Obsessive-Compulsive Disorder
5674752 4500261 44 Years M 7/1/2004 8/10/2004 9/27/2004 48 PER Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder, Retrograde Ejaculation
5674753 4500264 42 Years M 7/19/2004 9/27/2004 70 OT PER Strattera Attention Deficit/Hyperactivity Disorder Amnesia, Drug Withdrawal Syndrome, Flat Affect
5674753 4580368 42 Years M 10/26/2004 1/27/2005 93 OT PER Strattera Attention Deficit/Hyperactivity Disorder Amnesia, Delirium, Drug Withdrawal Syndrome, Flat Affect
5674757 4500265 38 Years M 7/19/2004 9/27/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Hallucination (Auditory), Libido Increased, Neurosis, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5674761 4500200     M 7/14/2004 9/27/2004 75 PER Strattera Drug Screen Positive
5674763 4500203 5 Years M 7/11/2004 7/14/2004 9/27/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Fatigue, Somnolence
5674769 4500205 9 Years M 7/1/2004 7/14/2004 9/27/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Drug Ineffective, Fatigue, Psychomotor Hyperactivity
5674772 4500207 25 Years M 7/14/2004 9/27/2004 75 PH PER Strattera Gastrointestinal Disorder, Nausea, Weight Decreased
5674774 4500209 16 Years M 1/1/2004 7/14/2004 9/27/2004 75 MD PER Strattera Apathy
5674777 4500211 56 Years M 1/1/2004 7/14/2004 9/27/2004 75 PER Strattera Drug Ineffective, Headache, Somnolence
5674777 4580334 56 Years M 1/1/2004 10/22/2004 1/27/2005 97 CN PER Strattera Drug Ineffective, Fatigue, Headache, Somnolence, Stomach Discomfort
5674780 4500212     F 7/14/2004 9/27/2004 75 PER Strattera Somnolence
5674785 4500214 6 Years M 6/18/2004 7/14/2004 9/27/2004 75 PER Strattera Disturbance in Attention Cough, Disturbance in Attention, Feeling Abnormal, Nausea, Somnolence, Vomiting
5674785 4580336 6 Years M 6/18/2004 9/15/2004 1/27/2005 134 CN PER Strattera Attention Deficit/Hyperactivity Disorder Cough, Disturbance in Attention, Feeling Abnormal, Nausea, Sinusitis, Somnolence, Vomiting, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5674787 4500216 49 Years F 6/1/2004 7/14/2004 9/27/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder Contusion, Fatigue, Platelet Count Decreased
5674787 4580349 49 Years F 6/1/2004 9/20/2004 1/27/2005 129 PER Strattera Attention Deficit/Hyperactivity Disorder Contusion, Fatigue, Neurological Symptom, Platelet Count Decreased
5674789 4500217 10 Years M 5/1/2004 7/14/2004 9/27/2004 75 PER Strattera Attention Deficit/Hyperactivity Disorder
5676159 4499055 8 Years F 10/9/2003 11/10/2004 PH DIR Strattera Attention Deficit/Hyperactivity Disorder Dystonia
5676452 4501231 11 Years M 7/1/2004 8/19/2004 9/27/2004 39 PER Strattera Attention Deficit/Hyperactivity Disorder Cardiac Monitoring, Tachycardia Other
5676452 4580824 11 Years M 7/1/2004 10/26/2004 1/27/2005 93 PER Strattera Attention Deficit/Hyperactivity Disorder Cardiac Monitoring, Tachycardia Other
5676454 4501232 11 Years M 8/23/2004 9/27/2004 35 CN PER Strattera Attention Deficit/Hyperactivity Disorder Enuresis, Flat Affect, Personality Change
5676458 4501233 4 Years F 8/24/2004 9/27/2004 34 CN PER Strattera Dysgeusia, Weight Decreased
5676468 4501235 16 Years 5/24/2004 9/27/2004 126 OT PER Strattera Depressive Symptom, Mania
5676470 4501236 11 Years M 5/1/2004 5/28/2004 9/27/2004 122 CN PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Sleep Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5676472 4501237     M 6/7/2004 9/27/2004 112 MD PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia
5676476 4501238 13 Years F 6/11/2004 9/27/2004 108 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Emotional Disorder
5676485 4501239 39 Years M 1/1/2004 6/18/2004 9/27/2004 101 MD PER Strattera Attention Deficit/Hyperactivity Disorder Erectile Dysfunction, Scrotal Pain
5676519 4501240 8 Years M 6/18/2004 9/27/2004 101 MD PER Strattera Agitation, Dysphoria, Emotional Disorder of Childhood, Irritability
5676892 4501241 70 Years F 7/1/2004 8/17/2004 9/27/2004 41 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Constipation, Dysuria, Seasonal Allergy, Somnolence, Weight Fluctuation
5676900 4501242 10 Years M 8/17/2004 9/27/2004 41 PH PER Strattera Dysgeusia
5676902 4501243     M 8/10/2004 9/27/2004 48 MD PER Strattera Dysuria
5676944 4501244     M 8/10/2004 9/27/2004 48 MD PER Strattera Dysuria
5676948 4501245 9 Years M 8/16/2004 8/17/2004 9/27/2004 41 CN PER Strattera Attention Deficit/Hyperactivity Disorder Emotional Disorder, Feeling Abnormal
5676965 4501246 15 Years F 8/1/2004 8/18/2004 9/27/2004 40 CN PER Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Increased, Mydriasis
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5676965 4580808 15 Years F 8/1/2004 10/1/2004 1/27/2005 118 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Heart Rate Increased, Hyperhidrosis, Mydriasis, Palpitations
5676976 4501247 16 Years 8/1/2004 8/17/2004 9/27/2004 41 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Anxiety, Feeling Jittery, Mydriasis
5676979 4501248     M 8/17/2004 9/27/2004 41 MD PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Somnolence
5676983 4501249 7 Years M 8/18/2004 9/27/2004 40 CN PER Strattera Disturbance in Attention
5676988 4501250     F 8/1/2004 8/18/2004 9/27/2004 40 CN PER Strattera Abdominal Pain, Abdominal Pain Upper, Fatigue, Nausea
5677332 4501037 12 Years F 1/1/2004 10/21/2004 11/9/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Diastolic Decreased, Electrocardiogram QT Corrected Interval Prolonged, Heart Rate Increased Other
5677946 4504033 36 Years M 6/24/2004 6/28/2004 9/27/2004 91 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fear
5677948 4504034 43 Years F 6/1/2004 6/28/2004 9/27/2004 91 CN PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Delusional Disorder (Persecutory Type)
5677951 4504035 57 Years F 6/28/2004 6/28/2004 9/27/2004 91 CN PER Strattera Dizziness, Malaise, Nausea, Vomiting
5677953 4504036 50 Years M 6/27/2004 6/28/2004 9/27/2004 91 CN PER Strattera Drug Screen Positive
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5677957 4504037 12 Years M 6/1/2004 6/28/2004 9/27/2004 91 CN PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Fatigue
5677962 4504038 60 Years F 6/28/2004 9/27/2004 91 PH PER Strattera Attention Deficit/Hyperactivity Disorder Epistaxis
5677965 4504040 21 Years M 6/26/2004 7/6/2004 9/27/2004 83 CN PER Strattera Attention Deficit/Hyperactivity Disorder Difficulty in Walking, Dizziness, Rash
5677975 4504042 11 Years M 1/1/2003 6/28/2004 9/27/2004 91 OT PER Strattera Attention Deficit/Hyperactivity Disorder Tic
5677977 4504043 6 Years M 6/27/2004 6/28/2004 9/27/2004 91 CN PER Strattera Bruxism, Heart Rate Increased, Restlessness
5677977 4580312 6 Years M 6/27/2004 11/17/2004 1/27/2005 71 PER Strattera Bruxism, Dizziness, Feeling Abnormal, Heart Rate Increased, Restlessness
5677980 4504044 36 Years F 6/1/2004 6/28/2004 9/27/2004 91 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Decreased Appetite, Headache, Insomnia, Mood Swings, Tension
5677993 4504003 5 Years M 6/30/2004 9/27/2004 89 CN PER Strattera Autism Decreased Appetite, Dysphagia, Somnolence
5677997 4504005 14 Years M 6/30/2004 9/27/2004 89 OT PER Strattera Testicular Disorder
5678005 4504007 35 Years M 6/30/2004 9/27/2004 89 MD PER Strattera Confusional State, Hallucination, Psychotic Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678005 4580313 35 Years M 6/30/2004 1/27/2005 211 MD PER Strattera Confusional State, Hallucination, Psychotic Disorder
5678018 4504008 34 Years M 5/1/2004 7/6/2004 9/27/2004 83 OT PER Strattera Epistaxis
5678024 4504009     F 7/6/2004 9/27/2004 83 CN PER Strattera Abdominal Pain Upper, Dysphagia
5678030 4504010 13 Years F 5/1/2004 7/6/2004 9/27/2004 83 OT PER Strattera Weight Increased
5678055 4504012 9 Years M 5/18/2004 7/7/2004 9/27/2004 82 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Fear, Mood Swings
5678059 4504013 16 Years F 3/1/2004 7/7/2004 9/27/2004 82 OT PER Strattera Crying, Emotional Disorder, Fatigue, Somnolence
5678063 4504014 10 Years M 7/6/2004 9/27/2004 83 MD PER Strattera Attention Deficit/Hyperactivity Disorder Flushing
5678065 4504015     F 7/7/2004 9/27/2004 82 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Nervousness, Tension
5678072 4504017 26 Years M 1/1/2004 6/28/2004 9/27/2004 91 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Tremor
5678074 4504019 59 Years M 6/1/2004 6/28/2004 9/27/2004 91 CN PER Strattera Attention Deficit/Hyperactivity Disorder Adjustment Disorder, Dry Mouth, Feeling Abnormal, Nausea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678076 4504021 36 Years F 6/25/2004 7/14/2004 9/27/2004 75 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Faeces, Anorexia, Constipation, Dizziness, Feeling Cold, Feeling Hot, Hyperhidrosis, Hypertension, Ill-Defined Disorder, Skin Odour Abnormal
5678078 4504023 13 Years M 6/28/2004 6/28/2004 9/27/2004 91 CN PER Strattera Attention Deficit/Hyperactivity Disorder Pharyngolaryngeal Pain, Retching, Throat Irritation
5678080 4504025 53 Years F 6/18/2004 6/29/2004 9/27/2004 90 CN PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Headache, Movement Disorder, Myalgia, Pyrexia
5678082 4504027 14 Years M 6/1/2004 6/28/2004 9/27/2004 91 CN PER Strattera Attention Deficit/Hyperactivity Disorder Foreign Body Trauma, Pharyngolaryngeal Pain
5678095 4504028 24 Years M 6/29/2004 9/27/2004 90 MD PER Strattera Blood Iron Decreased
5678099 4504029 7 Years M 6/1/2004 7/26/2004 9/27/2004 63 CN PER Strattera Attention Deficit/Hyperactivity Disorder Boredom, Decreased Appetite, Drug Ineffective, Fatigue, Irritability, Mood Swings, Mydriasis, Nervousness, Restlessness, Somnolence
5678112 4504030 5 Years F 6/29/2004 6/29/2004 9/27/2004 90 CN PER Strattera Abdominal Pain Upper, Decreased Appetite, Dysgeusia
5678115 4504031 7 Years M 1/1/2004 6/29/2004 9/27/2004 90 CN PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
5678146 4501111     F 10/21/2004 10/27/2004 11/9/2004 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Suicidal Ideation Hospitalization - Initial or Prolonged
5678147 4503992 50 Years F 6/29/2004 9/27/2004 90 CN PER Strattera Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678150 4503994 34 Years M 6/26/2004 6/29/2004 9/27/2004 90 CN PER Strattera Fatigue, Mood Swings
5678151 4503995 8 Years M 5/31/2004 6/29/2004 9/27/2004 90 CN PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Cognitive Disorder, Decreased Appetite, Headache, Nausea, Pyrexia
5678152 4501113 12 Years M 1/1/2004 10/27/2004 11/9/2004 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Diastolic Decreased, Chest Pain, Dizziness Postural, Electrocardiogram QT Corrected Interval Prolonged Other
5678152 4579412 12 Years M 1/1/2004 1/26/2005 2/9/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Dizziness Postural, Electrocardiogram QT Corrected Interval Prolonged Other
5678154 4501114 15 Years F 11/3/2004 11/9/2004 6 MD EXP Strattera Fall, Loss of Consciousness, Syncope Other
5678158 4503996 6 Years M 6/29/2004 6/29/2004 9/27/2004 90 CN PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5678159 4501116 13 Years M 9/22/2004 11/3/2004 11/9/2004 6 CN EXP Strattera Impulsive Behaviour Convulsion, Educational Problem, Tremor Other
5678160 4503944 37 Years M 7/20/2004 9/27/2004 69 MD PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Incontinence
5678161 4503997 28 Years M 6/29/2004 9/27/2004 90 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dysphonia, Feeling Abnormal, Speech Disorder
5678162 4503945 5 Years M 7/1/2004 7/20/2004 9/27/2004 69 CN PER Strattera Psychomotor Hyperactivity Coordination Abnormal, Eye Movement Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678163 4503998 12 Years 6/29/2004 9/27/2004 90 CN PER Strattera Abnormal Behaviour, Drug Withdrawal Syndrome
5678164 4503946 54 Years M 7/17/2004 7/20/2004 9/27/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Glossodynia, Hyperhidrosis, Insomnia
5678165 4503999 6 Years M 6/28/2004 6/29/2004 9/27/2004 90 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Irritability
5678166 4501204 8 Years M 8/3/2004 8/17/2004 9/27/2004 41 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Apathy, Depression, Drug Ineffective, Emotional Distress, Fatigue, Feeling Abnormal, Insomnia, Sleep Disorder, Somnolence
5678167 4503947 48 Years F 7/19/2004 7/20/2004 9/27/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Dental Treatment, Depression
5678170 4503948 13 Years F 7/20/2004 9/27/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Decreased Appetite, Disturbance in Attention, Irritability, Mood Swings, Somnolence, Suicidal Ideation
5678171 4501206 55 Years F 8/12/2004 8/13/2004 9/27/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Hot Flush, Hyperhidrosis
5678173 4503949 16 Years M 7/1/2004 7/20/2004 9/27/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Somnolence
5678175 4504001 11 Years M 6/30/2004 9/27/2004 89 MD PER Strattera Attention Deficit/Hyperactivity Disorder Growth Retardation
5678175 4782218 10 Years M 2/1/2002 6/22/2005 9/27/2005 97 MD PER Strattera Attention Deficit/Hyperactivity Disorder Growth Retardation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678176 4503951 9 Years M 2/1/2004 7/20/2004 9/27/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Attention Deficit Hyperactivity Disorder, Drug Ineffective, Weight Increased
5678177 4501207 6 Years F 8/16/2004 9/27/2004 42 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Attention Deficit Hyperactivity Disorder, Somnolence
5678178 4504002 24 Years M 6/30/2004 9/27/2004 89 CN PER Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Increased, Hyperthyroidism
5678179 4501208 45 Years F 8/2/2004 8/16/2004 9/27/2004 42 PER Strattera Attention Deficit/Hyperactivity Disorder Emotional Distress, Fatigue, Middle Insomnia
5678180 4503952 10 Years M 7/20/2004 9/27/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Snoring, Somnolence
5678180 4782219 10 Years M 8/1/2003 7/13/2005 9/27/2005 76 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Snoring, Somnolence
5678182 4503953 6 Years F 7/17/2004 7/20/2004 9/27/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Nausea, Stomach Discomfort, Throat Irritation
5678183 4501117 14 Years F 1/1/2004 11/3/2004 11/9/2004 6 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Electrocardiogram QT Corrected Interval Prolonged, Electrocardiogram QT Shortened Other
5678183 4579387 14 Years F 4/1/2004 1/26/2005 2/9/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Chest Discomfort, Chest Pain, Dyspnoea, Electrocardiogram QT Corrected Interval Prolonged Other
5678184 4503955 11 Years M 7/1/2004 7/20/2004 9/27/2004 69 CN PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Drug Ineffective, Headache, Initial Insomnia, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678185 4501281 27 Years F 6/14/2004 9/27/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Bronchitis, Disturbance in Attention, Drug Ineffective, Memory Impairment
5678189 4501209 12 Years 8/13/2004 9/27/2004 45 MD PER Strattera Emotional Distress
5678190 4503971 7 Years M 8/16/2004 8/16/2004 9/27/2004 42 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Chest Pain, Crying, Decreased Appetite, Fatigue, Feeling Abnormal, Feeling Hot, Heart Rate Increased, Nausea, Pharyngolaryngeal Pain
5678190 4580509 7 Years M 8/16/2004 10/5/2004 1/27/2005 114 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Chest Pain, Crying, Decreased Appetite, Fatigue, Feeling Abnormal, Feeling Hot, Heart Rate Increased, Nausea, Pain, Pharyngolaryngeal Pain
5678192 4501210 6 Years M 8/14/2004 8/16/2004 9/27/2004 42 PER Strattera Obsessive-Compulsive Disorder Abnormal Behaviour, Chills, Fatigue, Feeling Abnormal, Flushing, Lethargy
5678193 4503972 18 Years F 1/1/2003 8/16/2004 9/27/2004 42 CN PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Somnolence
5678194 4501211     M 8/13/2004 9/27/2004 45 MD PER Strattera Psychomotor Hyperactivity
5678195 4503974 41 Years F 8/10/2004 8/16/2004 9/27/2004 42 CN PER Strattera Cold Sweat, Irritability, Somnolence
5678196 4501315 10 Years M 11/1/2003 8/11/2004 9/27/2004 47 OT PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Headache, Middle Insomnia, Nausea, Sleep Disorder, Vomiting, Weight Decreased
5678196 4782215 10 Years M 11/1/2003 7/12/2005 9/27/2005 77 OT PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Headache, Insomnia, Middle Insomnia, Nausea, Sleep Disorder, Vomiting, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678197 4503975 20 Years M 7/1/2004 8/16/2004 9/27/2004 42 CN PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Daydreaming, Decreased Appetite, Drug Ineffective, Feeling Abnormal, Impulsive Behaviour, Musculoskeletal Stiffness
5678197 4580743 20 Years M 7/1/2004 11/16/2004 1/27/2005 72 CN PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Daydreaming, Decreased Appetite, Drug Ineffective, Feeling Abnormal, Impulsive Behaviour, Musculoskeletal Stiffness
5678202 4503976 41 Years M 1/1/2004 8/17/2004 9/27/2004 41 CN PER Strattera Attention Deficit/Hyperactivity Disorder Prostatic Pain, Urinary Hesitation, Urinary Retention
5678204 4501212 7 Years M 8/16/2004 9/27/2004 42 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Psychomotor Hyperactivity
5678205 4501213 16 Years M 8/1/2004 8/16/2004 9/27/2004 42 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Depressed Mood, Irritability, Somnolence
5678206 4503977 39 Years F 8/1/2004 8/17/2004 9/27/2004 41 CN PER Strattera Attention Deficit/Hyperactivity Disorder Haematochezia
5678208 4503978 43 Years M 8/10/2004 8/16/2004 9/27/2004 42 CN PER Strattera Feeling Jittery, Heart Rate Increased, Insomnia, Irritability
5678209 4503987 8 Years F 8/13/2004 8/16/2004 9/27/2004 42 CN PER Strattera Disturbance in Attention Nausea, Somnolence, Tic
5678210 4501171 10 Years M 8/12/2004 9/27/2004 46 PER Strattera Disturbance in Attention Agitation, Crying, Irritability, Logorrhoea, Psychomotor Hyperactivity
5678211 4501173 12 Years M 1/1/2004 8/12/2004 9/27/2004 46 PH PER Strattera Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678212 4503989 7 Years M 8/1/2004 8/17/2004 9/27/2004 41 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Weight Increased
5678213 4503990 21 Years M 8/13/2004 9/27/2004 45 MD PER Strattera Semen Abnormal, Testicular Disorder
5678214 4501176     F 8/12/2004 9/27/2004 46 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Nervousness
5678214 4580825 6 Years F 8/18/2004 1/27/2005 162 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Throat Irritation
5678216 4501177 14 Years M 8/11/2004 9/27/2004 47 MD PER Strattera Paraesthesia, Rash
5678219 4501178 14 Years F 8/9/2004 8/12/2004 9/27/2004 46 PER Strattera Feeling Hot and Cold, Mood Swings
5678221 4501179 8 Years M 8/13/2004 9/27/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Increased Appetite, Mood Swings, Restlessness
5678223 4503957     F 8/16/2004 9/27/2004 42 MD PER Strattera Feeling Abnormal
5678224 4501181 26 Years M 8/11/2004 8/13/2004 9/27/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
5678226 4503959 56 Years F 1/1/2004 8/16/2004 9/27/2004 42 PH PER Strattera Attention Deficit/Hyperactivity Disorder Endometrial Hypertrophy, Thrombosis, Uterine Haemorrhage
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678229 4501182 9 Years F 8/12/2004 9/27/2004 46 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Lethargy, Somnolence, Weight Decreased
5678231 4501184 37 Years M 8/12/2004 8/13/2004 9/27/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Pruritus, Rash Generalised, Skin Warm, Somnolence
5678233 4503960 15 Years M 7/27/2004 8/17/2004 9/27/2004 41 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Dyspepsia, Eructation
5678235 4501188 61 Years F 8/12/2004 8/13/2004 9/27/2004 45 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Dry Mouth, Dysgeusia
5678236 4503961 7 Years F 8/16/2004 9/27/2004 42 MD PER Strattera Agitation
5678238 4501218 12 Years 6/21/2004 9/27/2004 98 MD PER Strattera Weight Increased
5678239 4503963     M 8/13/2004 9/27/2004 45 MD PER Strattera Semen Abnormal, Testicular Disorder
5678240 4501220 12 Years 6/22/2004 9/27/2004 97 MD PER Strattera Tachyphylaxis
5678241 4503964 14 Years F 8/15/2004 8/16/2004 9/27/2004 42 MD PER Strattera Attention Deficit/Hyperactivity Disorder Growth Retardation, Pruritus, Rash, Sedation, Weight Gain Poor
5678241 4637429 14 Years F 8/15/2004 12/21/2004 3/28/2005 97 MD PER Strattera Growth Retardation, Pruritus, Rash, Sedation, Weight Gain Poor
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678242 4501221     M 7/1/2004 9/27/2004 88 MD PER Strattera Dysuria, Ejaculation Disorder
5678243 4501223 15 Years F 7/6/2004 9/27/2004 83 OT PER Strattera Palpitations
5678244 4501224 20 Years M 7/7/2004 9/27/2004 82 PER Strattera Somnolence
5678246 4501225 10 Years M 6/8/2004 9/27/2004 111 MD PER Strattera Norepinephrine Increased, Psychomotor Hyperactivity
5678248 4503966 18 Years F 8/16/2004 8/17/2004 9/27/2004 41 CN PER Strattera Depressed Mood, Depression, Fatigue, Pharyngolaryngeal Pain, Vision Blurred, Weight Increased
5678249 4501226 12 Years 7/12/2004 9/27/2004 77 MD PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain
5678251 4501228 12 Years 7/14/2004 9/27/2004 75 MD PER Strattera Blood Galactose Increased, Constipation
5678253 4503967 7 Years M 8/3/2004 8/17/2004 9/27/2004 41 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Crying, Depression
5678254 4501229 12 Years 7/14/2004 9/27/2004 75 MD PER Strattera
5678255 4501230 12 Years 7/20/2004 9/27/2004 69 MD PER Strattera Aggression, Anger
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678257 4503969 54 Years F 8/17/2004 9/27/2004 41 CN PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Hyperhidrosis, Muscle Cramp, Nausea, Nervousness, Retching, Stomach Discomfort
5678258 4501058 7 Years M 4/28/2004 8/12/2004 9/27/2004 46 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Pharyngitis Streptococcal, Psychomotor Hyperactivity, Tachycardia
5678260 4501069     M 8/11/2004 9/27/2004 47 MD PER Strattera Genital Pain
5678260 4580459     M 10/29/2004 1/27/2005 90 MD PER Strattera Genital Pain
5678262 4501073 56 Years F 7/21/2004 8/12/2004 9/27/2004 46 CN PER Strattera Attention Deficit/Hyperactivity Disorder Arthralgia
5678264 4501075 44 Years M 1/1/2003 8/12/2004 9/27/2004 46 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Hypertonia, Libido Decreased
5678267 4501078 16 Years M 8/1/2003 8/12/2004 9/27/2004 46 CN PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
5678269 4501112     M 8/11/2004 9/27/2004 47 CN PER Strattera Personality Change
5678270 4501115     M 8/1/2004 8/11/2004 9/27/2004 47 CN PER Strattera Attention Deficit/Hyperactivity Disorder Erectile Dysfunction, Perseveration
5678281 4501118 10 Years F 8/12/2004 9/27/2004 46 MD PER Strattera Obsessive-Compulsive Disorder Anxiety
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678282 4501122 55 Years M 8/11/2004 8/12/2004 9/27/2004 46 PER Strattera Disturbance in Attention Urinary Incontinence, Urinary Retention
5678295 4501124 52 Years M 8/12/2004 9/27/2004 46 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Decreased Appetite, Drug Ineffective, Infrequent Bowel Movements, Initial Insomnia
5678298 4501627 11 Years F 8/16/2004 9/27/2004 42 MD PER Strattera Agitation, Insomnia, Tachycardia
5678298 4577497 11 Years F 7/17/2004 9/7/2004 1/27/2005 142 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Insomnia, Tachycardia
5678299 4501628 12 Years 7/28/2004 9/27/2004 61 MD PER Strattera Agitation
5678301 4501629 12 Years 7/29/2004 9/27/2004 60 MD PER Strattera Hyperhidrosis
5678302 4501630     F 8/2/2004 9/27/2004 56 PER Strattera Psychomotor Hyperactivity
5678311 4501631 16 Years M 8/18/2003 8/4/2004 9/27/2004 54 OT PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Nausea, Palpitations
5678312 4501632 12 Years 8/3/2004 9/27/2004 55 MD PER Strattera Hostility
5678313 4501633 5 Years 8/3/2004 9/27/2004 55 MD PER Strattera Psychotic Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678313 4577494 5 Years M 10/7/2004 1/27/2005 112 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Psychotic Disorder
5678314 4501634 55 Years F 8/5/2004 9/27/2004 53 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Withdrawal Syndrome, Psychomotor Hyperactivity
5678315 4501635     F 8/6/2004 9/27/2004 52 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Retching
5678316 4501636     M 8/6/2004 9/27/2004 52 MD PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
5678317 4501637 12 Years 8/11/2004 9/27/2004 47 MD PER Strattera Contusion
5678318 4498124 43 Years F 6/1/2004 6/3/2004 9/27/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Nausea, Sleep Disorder, Tremor
5678320 4498125 12 Years 5/28/2004 9/27/2004 122 MD PER Strattera
5678321 4498127 6 Years F 4/29/2004 6/3/2004 9/27/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5678322 4498131 8 Years F 4/29/2004 6/3/2004 9/27/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5678323 4498134 25 Years M 1/1/2003 6/4/2004 9/27/2004 115 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Drug Ineffective, Mania
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678324 4498136 7 Years M 6/2/2004 9/27/2004 117 MD PER Strattera Stomatitis
5678325 4498140 19 Years M 6/4/2004 9/27/2004 115 OT PER Strattera Attention Deficit/Hyperactivity Disorder Educational Problem, Hypersomnia, Somnolence
5678326 4498141 8 Years M 6/2/2004 9/27/2004 117 MD PER Strattera Stomatitis
5678327 4498142 50 Years M 1/1/2004 6/4/2004 9/27/2004 115 PER Strattera Attention Deficit/Hyperactivity Disorder White Blood Cell Count Decreased
5678328 4498143 61 Years F 5/1/2004 6/8/2004 9/27/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Hyperhidrosis, Psychomotor Hyperactivity, Stomach Discomfort, Vision Blurred, Vomiting
5678340 4498231 58 Years F 6/3/2004 6/7/2004 9/27/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Difficulty in Walking, Oedema Peripheral
5678341 4498232     M 6/7/2004 9/27/2004 112 OT PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity
5678342 4498233 42 Years F 6/6/2004 7/1/2004 9/27/2004 88 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Back Pain, Emotional Disorder, Feeling Abnormal, Heart Rate Increased, Insomnia, Memory Impairment, Mood Swings, Tremor
5678343 4498234 26 Years M 6/7/2004 6/7/2004 9/27/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Insomnia, Psychomotor Hyperactivity
5678344 4498235 9 Years F 12/1/2003 6/7/2004 9/27/2004 112 MD PER Strattera Subcutaneous Abscess
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678346 4498236 14 Years M 4/1/2004 6/25/2004 9/27/2004 94 MD PER Strattera Breast Discharge, Gynaecomastia
5678348 4498237     F 6/7/2004 6/8/2004 9/27/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Cold Sweat, Euphoric Mood, Formication, Insomnia, Nervousness
5678349 4498238 17 Years F 6/8/2004 9/27/2004 111 PH PER Strattera Attention Deficit/Hyperactivity Disorder Blood Cholesterol Increased
5678350 4498239 16 Years M 1/1/2004 6/8/2004 9/27/2004 111 PER Strattera Agitation Agitation, Blood Pressure Diastolic Increased, Fatigue, Heart Rate Increased, Thinking Abnormal
5678350 4580301 16 Years M 1/1/2004 9/28/2004 1/27/2005 121 MD PER Strattera Agitation Agitation, Fatigue, Heart Rate Increased, Systolic Hypertension, Thinking Abnormal, Thyroid Neoplasm
5678351 4498240     M 6/8/2004 9/27/2004 111 MD PER Strattera Drug Ineffective, Dyspnoea, Flushing
5678367 4498032 8 Years M 6/3/2004 9/27/2004 116 PH PER Strattera Attention Deficit/Hyperactivity Disorder Tic
5678368 4498035     F 6/3/2004 6/3/2004 9/27/2004 116 CN PER Strattera Psychomotor Hyperactivity
5678369 4498037 15 Years F 2/1/2004 9/27/2004 239 MD PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Emotional Distress
5678370 4498039 16 Years M 2/1/2004 9/27/2004 239 MD PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Emotional Distress
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678371 4498041     M 6/3/2004 9/27/2004 116 CN PER Strattera Nervousness
5678373 4498043     F 6/1/2004 6/3/2004 9/27/2004 116 CN PER Strattera Attention Deficit/Hyperactivity Disorder Blood Caffeine Increased, Drug Ineffective, Food Craving, Stress Symptoms
5678374 4498045 12 Years 6/1/2004 9/27/2004 118 MD PER Strattera Mania
5678375 4498046 12 Years 6/1/2004 9/27/2004 118 MD PER Strattera Mania
5678376 4498064 11 Years F 6/2/2004 9/27/2004 117 OT PER Strattera Abdominal Discomfort, Nausea
5678377 4498065     F 5/1/2004 6/3/2004 9/27/2004 116 MD PER Strattera Palpitations
5678382 4498251 36 Years M 5/1/2004 6/9/2004 9/27/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Pollakiuria, Sexual Dysfunction, Urinary Retention, Urine Abnormality
5678384 4498252 36 Years F 6/9/2004 9/27/2004 110 MD PER Strattera Mania
5678385 4498253 13 Years F 1/1/2004 6/9/2004 9/27/2004 110 PH PER Strattera Disturbance in Attention Retching, Stomach Discomfort
5678387 4498254 12 Years M 6/7/2004 9/27/2004 112 PER Strattera Psychomotor Hyperactivity Anorexia, Stomach Discomfort, Weight Gain Poor
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678388 4498255 6 Years M 6/2/2004 6/9/2004 9/27/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5678390 4498256 40 Years F 1/1/2004 6/9/2004 9/27/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Visual Acuity Reduced
5678392 4498257 8 Years M 6/9/2004 9/27/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Psychomotor Hyperactivity
5678394 4498258     M 6/9/2004 9/27/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Genitalia External Painful
5678397 4498259 57 Years F 6/10/2004 6/10/2004 9/27/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anxiety, Confusional State, Fear, Feeling Abnormal, Mental Impairment, Mydriasis, Nervousness
5678399 4498260 5 Years M 6/9/2004 6/10/2004 9/27/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anorexia, Feeling Abnormal, Sleep Disorder
5678401 4499013 8 Years M 5/22/2004 6/1/2004 9/27/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Drug Ineffective, Fatigue, Somnolence, Stomach Discomfort
5678404 4499018 6 Years M 5/1/2004 5/28/2004 9/27/2004 122 PER Strattera Attention Deficit/Hyperactivity Disorder Emotional Disorder, Psychomotor Hyperactivity
5678405 4499023 8 Years M 5/25/2004 6/1/2004 9/27/2004 118 PER Strattera Diarrhoea, Fatigue, Initial Insomnia, Proctalgia, Somnolence
5678408 4499027 7 Years M 5/29/2004 6/1/2004 9/27/2004 118 PER Strattera Chest Discomfort, Heart Rate Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678410 4499030 18 Years M 6/1/2004 9/27/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Hyperphagia, Weight Increased
5678412 4499033 8 Years M 6/1/2004 9/27/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Drug Ineffective, Growth Retardation
5678420 4499044 7 Years M 6/1/2004 9/27/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity
5678422 4499045 53 Years M 6/1/2004 6/1/2004 9/27/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Dysgeusia, Nausea
5678422 4580300 53 Years M 6/1/2004 8/30/2004 1/27/2005 150 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Dysgeusia, Dysuria, Nausea
5678423 4499053     F 1/1/2004 6/1/2004 9/27/2004 118 MD PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Pain in Extremity
5678426 4499063 60 Years M 5/30/2004 6/1/2004 9/27/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Disturbance in Attention, Dry Mouth, Hearing Impaired, Tension
5678429 4499064 43 Years F 6/1/2004 9/27/2004 118 CN PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Jittery, Irritability, Nausea
5678431 4499069 8 Years M 7/27/2004 9/27/2004 62 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Drug Ineffective, Feeling Abnormal, Pharyngolaryngeal Pain, Somnolence, Stomatitis, Upper Limb Fracture
5678434 4499075 14 Years M 6/2/2004 9/27/2004 117 MD PER Strattera Attention Deficit/Hyperactivity Disorder Galactorrhoea, Hypertrophy Breast
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678435 4499077     F 6/1/2004 9/27/2004 118 PER Strattera Dysgeusia
5678438 4499078 5 Years F 1/1/2004 6/2/2004 9/27/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5678440 4499086 38 Years M 5/1/2004 6/2/2004 9/27/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Impatience, Mood Swings, Tremor
5678450 4498880 42 Years M 6/1/2004 6/21/2004 9/27/2004 98 MD PER Strattera Drug Ineffective, Feeling Abnormal
5678452 4498882 15 Years M 6/22/2004 9/27/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder
5678454 4498886     M 6/22/2004 9/27/2004 97 PH PER Strattera Abnormal Behaviour
5678457 4498887     F 6/22/2004 9/27/2004 97 PER Strattera Dizziness, Hyperhidrosis, Nausea
5678458 4498889     F 1/1/2004 6/22/2004 9/27/2004 97 PH PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia
5678460 4498890 6 Years M 1/1/2004 6/22/2004 9/27/2004 97 MD PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Dyspnoea
5678462 4498892     M 6/22/2004 6/22/2004 9/27/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Retching
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678465 4498934 14 Years F 6/22/2004 9/27/2004 97 MD PER Strattera Attention Deficit/Hyperactivity Disorder Epistaxis
5678467 4498935 14 Years M 7/2/2004 9/27/2004 87 MD PER Strattera Attention Deficit/Hyperactivity Disorder White Blood Cell Count Decreased
5678468 4498950 19 Years F 6/29/2004 9/27/2004 90 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hepatitis, Infectious Mononucleosis
5678471 4498193 45 Years F 6/4/2004 6/4/2004 9/27/2004 115 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dizziness, Dry Mouth, Muscle Cramp
5678474 4498197     F 4/1/2004 6/7/2004 9/27/2004 112 PH PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Menstrual Disorder, Stress Symptoms
5678475 4498203 13 Years M 6/7/2004 9/27/2004 112 PH PER Strattera Dysgeusia
5678477 4498204 12 Years M 6/7/2004 9/27/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Stomach Discomfort, Weight Gain Poor
5678479 4498205 6 Years M 6/1/2004 6/7/2004 9/27/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Asthenopia, Fatigue, Hyperacusis
5678481 4498206 68 Years F 6/1/2004 6/7/2004 9/27/2004 112 PER Strattera Memory Impairment Decreased Appetite, Feeling Abnormal
5678483 4498207 12 Years M 6/7/2004 9/27/2004 112 OT PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Hyperhidrosis, Impulsive Behaviour, Nausea, Restlessness, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678487 4498211 16 Years M 5/1/2004 6/7/2004 9/27/2004 112 PER Strattera Disturbance in Attention Drug Ineffective, Fatigue, Tic, Urinary Hesitation
5678489 4498229 49 Years F 6/7/2004 9/27/2004 112 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Dizziness, Dry Mouth, Fatigue, Hyperhidrosis
5678491 4498230 6 Years M 6/4/2004 9/27/2004 115 MD PER Strattera Attention Deficit/Hyperactivity Disorder Myoclonus
5678500 4498166 7 Years M 5/31/2004 6/4/2004 9/27/2004 115 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Hunger
5678502 4498167 50 Years F 6/4/2004 9/27/2004 115 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Increased Appetite
5678504 4498168 6 Years M 6/3/2004 6/4/2004 9/27/2004 115 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
5678506 4498171 43 Years M 5/31/2004 6/4/2004 9/27/2004 115 MD PER Strattera Cluster Headache, Lacrimation Increased, Nasal Congestion
5678507 4498174 53 Years F 1/1/2004 6/4/2004 9/27/2004 115 PER Strattera Attention Deficit/Hyperactivity Disorder Confusional State, Depression, Drug Ineffective, Ear Infection, Feeling Abnormal, Memory Impairment, Sinusitis, Weight Decreased
5678509 4498180 50 Years M 5/29/2004 6/4/2004 9/27/2004 115 PER Strattera Drug Ineffective, Feeling Abnormal
5678510 4498182     M 6/4/2004 9/27/2004 115 MD PER Strattera Intraocular Pressure Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678511 4498183 13 Years F 12/1/2003 6/4/2004 9/27/2004 115 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anger, Back Pain, Depression, Disturbance In Social Behaviour, Hypertonia, Lower Limb Deformity, Mood Swings, Pelvic Deformity, Scoliosis
5678512 4498185 8 Years M 6/11/2004 9/27/2004 108 PER Strattera Drug Ineffective
5678513 4498188 11 Years F 3/1/2004 6/4/2004 9/27/2004 115 PH PER Strattera Halitosis
5678515 4498087 8 Years M 7/27/2004 9/27/2004 62 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Psychomotor Hyperactivity, Screaming
5678516 4498088     M 7/27/2004 9/27/2004 62 PER Strattera
5678517 4498089 4 Years F 7/1/2004 7/27/2004 9/27/2004 62 MD PER Strattera Appetite Disorder, Irritability
5678518 4498090 12 Years M 7/27/2004 9/27/2004 62 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective
5678519 4498091     F 7/27/2004 9/27/2004 62 PER Strattera Amphetamines Positive
5678520 4498092     M 7/27/2004 9/27/2004 62 PER Strattera Attention Deficit/Hyperactivity Disorder Bladder Disorder
5678521 4498093 9 Years M 7/26/2004 7/27/2004 9/27/2004 62 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Retching
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678522 4498094 6 Years F 7/27/2004 9/27/2004 62 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Skin Lesion
5678522 4580508 6 Years F 1/1/2003 10/28/2004 1/27/2005 91 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Neurodermatitis
5678523 4498095 39 Years M 7/22/2004 7/27/2004 9/27/2004 62 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Nausea, Somnolence, Stomach Discomfort, Tremor
5678524 4498096 45 Years F 7/28/2004 9/27/2004 61 MD PER Strattera Dizziness, Nausea, Somnolence
5678525 4498660 39 Years F 6/18/2004 6/18/2004 9/27/2004 101 PER Strattera Fatigue Conversion Disorder, Crying, Ear Haemorrhage, Feeling Abnormal, Haematochezia
5678526 4498665 32 Years F 6/1/2004 6/18/2004 9/27/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Defaecation Urgency, Feeling Hot, Vomiting
5678527 4498669 11 Years M 6/18/2004 9/27/2004 101 MD PER Strattera Anorexia, Depressed Mood, Stomach Discomfort
5678528 4498677     F 6/14/2004 6/21/2004 9/27/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Cardiac Flutter, Dizziness, Feeling Abnormal, Flushing, Headache, Sluggishness, Tinnitus
5678529 4498684 36 Years M 6/1/2004 6/21/2004 9/27/2004 98 PER Strattera Feeling Abnormal, Somnolence
5678531 4498687 46 Years F 6/20/2004 6/21/2004 9/27/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Chills, Fatigue, Formication, Irritability, Nausea, Paraesthesia, Piloerection, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678532 4498688 8 Years M 1/1/2004 6/21/2004 9/27/2004 98 PER Strattera Abdominal Pain Upper, Anger, Drug Ineffective, Fatigue, Headache, Irritability, Somnolence
5678533 4498689 8 Years F 4/1/2004 6/21/2004 9/27/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Choking, Retching
5678534 4498691 8 Years M 5/1/2004 6/21/2004 9/27/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Disturbance in Attention, Fatigue
5678535 4498692 9 Years M 6/21/2004 9/27/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Impulse-Control Disorder
5678536 4498736 7 Years F 5/1/2004 7/26/2004 9/27/2004 63 PER Strattera Head Discomfort, Mydriasis
5678538 4498738     M 6/16/2004 6/17/2004 9/27/2004 102 PER Strattera Hair Growth Abnormal
5678540 4498740 64 Years F 6/17/2004 6/17/2004 9/27/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Flatulence, Tremor
5678541 4498742 11 Years M 6/17/2004 9/27/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Drug Ineffective, Insomnia
5678543 4498743 41 Years F 6/16/2004 6/17/2004 9/27/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Crying, Depressed Mood, Dry Mouth, Feeling Abnormal, Influenza Like Illness, Pain, Pharyngolaryngeal Pain, Rhinorrhoea, Somnolence, Stress Symptoms
5678545 4498745 30 Years M 6/1/2004 8/18/2004 9/27/2004 40 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Erectile Dysfunction, Muscle Cramp
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678546 4498747 22 Years M 6/17/2004 6/17/2004 9/27/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Euphoric Mood, Fatigue
5678548 4498750 9 Years F 6/15/2004 6/17/2004 9/27/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5678549 4498756 46 Years F 6/13/2004 6/17/2004 9/27/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anxiety, Chest Pain, Confusional State, Constipation, Dry Mouth, Feeling Abnormal, Headache, Speech Disorder Developmental
5678551 4498760 8 Years F 6/16/2004 6/17/2004 9/27/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder
5678555 4498695 31 Years M 6/18/2004 9/27/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Interest, Fatigue, Flat Affect
5678558 4498696 7 Years M 6/18/2004 9/27/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Fear, Retching
5678560 4498698 12 Years F 7/12/2004 9/27/2004 77 MD PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain
5678562 4498700     F 6/18/2004 9/27/2004 101 PER Strattera Hallucination (Visual)
5678564 4498702 8 Years M 6/1/2004 6/18/2004 9/27/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
5678565 4498704 6 Years M 6/18/2004 9/27/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Nasal Discomfort, Pharyngolaryngeal Pain, Retching, Sneezing, Somnolence, Throat Irritation, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678567 4498706 50 Years M 6/18/2004 9/27/2004 101 MD PER Strattera Blood Pressure Increased, Flushing
5678569 4498709     F 6/18/2004 9/27/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder
5678571 4498712 46 Years F 1/1/2004 6/18/2004 9/27/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Drug Interaction, Nausea
5678574 4498715 3 Years F 6/16/2004 6/17/2004 9/27/2004 102 PH PER Strattera Retching
5678576 4498716 6 Years M 6/17/2004 9/27/2004 102 OT PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5678578 4498718 10 Years M 6/1/2004 7/28/2004 9/27/2004 61 PER Strattera Tourette's Disorder Abnormal Behaviour, Aggression, Anger, Depressed Mood, Fatigue, Heart Rate Increased, Irritability, Nausea, Psychomotor Hyperactivity
5678580 4498721 42 Years F 5/31/2004 6/17/2004 9/27/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Drug Withdrawal Syndrome, Migraine
5678580 4580306 42 Years F 5/31/2004 9/1/2004 1/27/2005 148 MD PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Drug Withdrawal Syndrome, Migraine, Pruritus, Tic
5678582 4498723 6 Years F 1/1/2003 6/17/2004 9/27/2004 102 PER Strattera Somnolence, Weight Decreased
5678582 4580307 6 Years F 1/1/2003 9/8/2004 1/27/2005 141 PER Strattera Educational Problem Contusion, Somnolence, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678584 4498724 30 Years F 6/8/2004 6/17/2004 9/27/2004 102 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Chest Pain, Decreased Appetite, Dizziness, Heart Rate Increased, Insomnia, Nausea, Palpitations, Paraesthesia
5678585 4498727     M 6/18/2004 9/27/2004 101 PER Strattera Dysuria
5678587 4498731 8 Years M 6/11/2004 6/18/2004 9/27/2004 101 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Drug Ineffective, Mouth Ulceration, Thirst
5678589 4498733 62 Years M 6/17/2004 6/18/2004 9/27/2004 101 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
5678590 4498735     F 6/18/2004 6/18/2004 9/27/2004 101 PER Strattera Feeling Hot and Cold, Frequent Bowel Movements, Headache, Nausea, Piloerection, Somnolence
5678592 4498764 12 Years F 6/15/2004 7/15/2004 9/27/2004 74 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Micturition Urgency, Urinary Retention
5678593 4498774 13 Years M 9/1/2003 6/16/2004 9/27/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Impulsive Behaviour
5678594 4498778     M 6/2/2004 6/16/2004 9/27/2004 103 PER Strattera Chest Discomfort, Headache, Insomnia, Throat Tightness
5678595 4498780 7 Years M 6/14/2004 6/16/2004 9/27/2004 103 MD PER Strattera Attention Deficit/Hyperactivity Disorder Pallor, Paraesthesia
5678596 4498783 9 Years M 6/16/2004 6/16/2004 9/27/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Fatigue, Somnolence, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678597 4498786 7 Years M 6/16/2004 9/27/2004 103 PER Strattera Abdominal Pain Upper, Lethargy, Sleep Disorder, Weight Decreased
5678599 4498788 34 Years M 6/16/2004 6/16/2004 9/27/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Abnormal, Hyporeflexia, Nausea
5678600 4498791 11 Years F 6/15/2004 6/22/2004 9/27/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Middle Insomnia, Somnolence
5678602 4498805 23 Years F 1/1/2004 6/17/2004 9/27/2004 102 MD PER Strattera Attention Deficit/Hyperactivity Disorder
5678604 4498809 23 Years M 2/1/2003 6/17/2004 9/27/2004 102 CN PER Strattera Attention Deficit/Hyperactivity Disorder Premature Ejaculation
5678625 4498637     M 6/14/2004 9/27/2004 105 PER Strattera Depression, Disturbance in Attention, Dizziness, Dry Mouth, Headache, Hypoaesthesia
5678628 4498638 27 Years M 5/1/2004 6/14/2004 9/27/2004 105 PER Strattera Disturbance in Attention Ear Discomfort, Impatience, Irritability, Stress Symptoms
5678629 4498639 5 Years M 1/1/2004 6/15/2004 9/27/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Nausea, Weight Decreased
5678632 4498640 13 Years M 6/15/2004 9/27/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Growth Hormone, Growth Retardation, Weight Decreased
5678633 4498641 19 Years M 6/15/2004 9/27/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Jittery, Irritability, Libido Decreased, Psychomotor Hyperactivity, Sexual Dysfunction, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678635 4498642 31 Years M 6/1/2004 6/15/2004 9/27/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Drug Ineffective, Heart Rate Increased, Hyperhidrosis, Nervousness
5678636 4498649     F 6/15/2004 9/27/2004 104 OT PER Strattera Attention Deficit/Hyperactivity Disorder Acne
5678637 4498651     F 6/15/2004 9/27/2004 104 PER Strattera Disturbance in Attention Alcohol Poisoning, Confusional State, Migraine
5678638 4498656 10 Years M 6/15/2004 9/27/2004 104 MD PER Strattera Anorexia, Crying, Hallucination, Thinking Abnormal
5678640 4498658 14 Years M 6/1/2004 6/15/2004 9/27/2004 104 MD PER Strattera Attention Deficit/Hyperactivity Disorder Increased Tendency to Bruise, Joint Swelling, Pallor, Skin Discolouration
5678673 4498067 38 Years M 7/26/2004 9/27/2004 63 CN PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
5678677 4498068 50 Years F 7/26/2004 9/27/2004 63 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Feeling Abnormal
5678679 4498069 14 Years M 7/26/2004 9/27/2004 63 CN PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Headache, Somnolence
5678683 4498070 53 Years F 7/23/2004 7/26/2004 9/27/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Hot Flush, Pollakiuria, Sleep Disorder
5678685 4498071 8 Years F 4/1/2004 7/26/2004 9/27/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678687 4498072     M 7/21/2004 7/26/2004 9/27/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Eye Swelling, Feeling Abnormal, Insomnia
5678689 4498073 5 Years M 7/23/2004 7/26/2004 9/27/2004 63 PER Strattera Irritability, Mood Swings, Sleep Disorder
5678691 4498074 23 Years M 7/1/2004 8/13/2004 9/27/2004 45 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Dry Throat, Erectile Dysfunction, Insomnia, Libido Increased, Somnolence
5678693 4498075 47 Years F 7/23/2004 7/26/2004 9/27/2004 63 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Fatigue, Somnolence
5678696 4498076 7 Years M 1/1/2004 7/26/2004 9/27/2004 63 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort, Drug Ineffective, Lethargy
5678697 4500318 50 Years F 7/1/2004 7/13/2004 9/27/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Agitation, Anorexia, Blood Pressure Systolic Increased, Depression, Fatigue, Feeling Abnormal, Formication, Headache, Heart Rate Increased, Nausea, Neurosis, Psychotic Disorder, Sleep Disorder, Urinary Hesitation, Vomiting, Weight Decreased
5678699 4500320     F 7/12/2004 7/13/2004 9/27/2004 76 PER Strattera Dysgeusia, Throat Irritation
5678700 4500323     M 7/13/2004 9/27/2004 76 MD PER Strattera Muscle Spasms
5678702 4500328 49 Years M 1/1/2003 7/13/2004 9/27/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Pruritus, Urticaria
5678703 4500333 40 Years F 7/13/2004 9/27/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Feeling Hot, Nausea, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678705 4500336 6 Years M 7/13/2004 9/27/2004 76 PER Strattera Abdominal Pain Upper, Decreased Appetite, Dizziness, Fatigue, Hyperhidrosis
5678707 4500341 10 Years M 6/13/2004 7/13/2004 9/27/2004 76 PER Strattera Communication Disorder Fatigue, Nausea
5678709 4500346 15 Years M 7/1/2004 7/13/2004 9/27/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Headache, Heart Rate Increased, Irritability
5678710 4500350 13 Years M 7/1/2004 7/13/2004 9/27/2004 76 CN PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Mood Swings, Social Avoidant Behaviour
5678711 4500355 14 Years F 7/13/2004 9/27/2004 76 CN PER Strattera Attention Deficit/Hyperactivity Disorder Educational Problem
5678712 4499087 43 Years M 5/25/2004 6/2/2004 9/27/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Somnolence
5678713 4499109 28 Years F 5/14/2004 6/21/2004 9/27/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Homicidal Ideation, Suicidal Ideation
5678714 4499122 8 Years M 5/1/2004 6/2/2004 9/27/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Body Height Increased, Enuresis, Psychomotor Hyperactivity, Weight Increased
5678715 4499131 12 Years M 6/7/2004 6/21/2004 9/27/2004 98 MD PER Strattera Attention Deficit/Hyperactivity Disorder Cyanosis, Heart Rate Increased, Neck Pain
5678716 4499132     M 11/11/2003 9/27/2004 321 PER Strattera Hypersensitivity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5678719 4499133 52 Years F 5/1/2004 6/2/2004 9/27/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Crying, Decreased Appetite, Fatigue, Feeling Abnormal, Headache, Insomnia, Irritability, Migraine, Mood Swings, Nausea, Night Sweats, Somnolence, Weight Increased
5678721 4499140 7 Years M 12/1/2004 6/2/2004 9/27/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Hyperhidrosis, Migraine, Somnolence, Tremor, Vomiting, Weight Gain Poor
5678725 4499146 10 Years M 6/2/2004 9/27/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
5678726 4499148 7 Years M 3/1/2004 6/2/2004 9/27/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Excitability
5678728 4499149 5 Years F 6/1/2004 7/12/2004 9/27/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Cerumen Impaction
5678772 4501720 43 Years F 8/1/2004 8/11/2004 9/27/2004 47 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hypersensitivity Other
5678778 4501725     F 6/14/2004 9/27/2004 105 OT PER Strattera Abdominal Pain, Blood Pressure Increased, Chest Pain, Tachycardia Hospitalization - Initial or Prolonged
5678780 4501727 41 Years F 6/5/2004 6/8/2004 9/27/2004 111 MD PER Strattera Attention Deficit/Hyperactivity Disorder Amenorrhoea, Menorrhagia Hospitalization - Initial or Prolonged
5678781 4501728 14 Years M 5/20/2004 6/8/2004 9/27/2004 111 MD PER Strattera Attention Deficit/Hyperactivity Disorder Bronchitis, Drug Hypersensitivity, Mood Swings Hospitalization - Initial or Prolonged
5678783 4501729 6 Years M 1/1/2004 8/19/2004 9/27/2004 39 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Crying, Decreased Appetite, Eructation, Heart Rate Increased, Mood Swings Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5679679 4504804 7 Years M 7/7/2004 9/27/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Ecchymosis
5679681 4504807     F 6/1/2004 7/7/2004 9/27/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Dry Throat
5679682 4504808 35 Years F 7/7/2004 9/27/2004 82 OT PER Strattera Leukocytosis
5679685 4504809 64 Years M 7/7/2004 9/27/2004 82 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Decreased, Heart Rate Decreased, Rash, Urine Output Decreased
5679686 4504810 26 Years F 7/7/2004 9/27/2004 82 PER Strattera Delusion
5679689 4504811 6 Years M 7/7/2004 9/27/2004 82 MD PER Strattera Chest Pain, Palpitations, Psychomotor Hyperactivity
5679693 4504813 12 Years 6/29/2004 9/27/2004 90 CN PER Strattera Abnormal Behaviour, Drug Withdrawal Syndrome
5679695 4504814     M 7/8/2004 9/27/2004 81 PER Strattera Alopecia
5679696 4504815 45 Years F 6/1/2004 7/8/2004 9/27/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Fall, Irritability, Limb Injury, Mood Swings, Paranoia, Screaming, Suicidal Ideation
5679700 4504816 17 Years M 7/8/2004 9/27/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Agitation, Irritability, Mood Swings
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5679810 4504817 15 Years M 7/8/2004 9/27/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Agitation, Irritability, Mood Swings
5679813 4504818 13 Years M 7/8/2004 9/27/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Agitation, Irritability, Mood Swings
5679832 4504819 59 Years M 7/8/2004 9/27/2004 81 PER Strattera Excitability Erectile Dysfunction, Nasopharyngitis
5679834 4504820 7 Years F 7/8/2004 9/27/2004 81 MD PER Strattera Attention Deficit/Hyperactivity Disorder Weight Decreased
5679836 4504821     F 6/1/2004 7/8/2004 9/27/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Sleep Disorder, Somnolence
5679839 4504822 50 Years M 6/25/2004 7/8/2004 9/27/2004 81 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Bladder Pain, Blood Pressure Increased, Chills, Dizziness, Feeling Cold, Urinary Hesitation
5679839 4580317 50 Years M 6/25/2004 11/17/2004 1/27/2005 71 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Bladder Pain, Blood Pressure Decreased, Chills, Dizziness, Dysuria, Fear, Feeling Cold, Urinary Hesitation
5679841 4504823 73 Years M 7/8/2004 9/27/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Pollakiuria, Urine Flow Decreased
5679843 4504824 50 Years F 7/8/2004 9/27/2004 81 OT PER Strattera Attention Deficit/Hyperactivity Disorder Urine Odour Abnormal
5679845 4504825 30 Years F 7/8/2004 9/27/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Fatigue, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5679849 4504826 5 Years M 6/28/2004 7/8/2004 9/27/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Anger
5679855 4504681 40 Years M 7/19/2004 9/27/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Obsessive Thoughts, Thinking Abnormal
5679857 4504682 7 Years M 7/1/2004 7/19/2004 9/27/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anxiety, Attention Deficit Hyperactivity Disorder, Fatigue
5679860 4504683 34 Years M 7/16/2004 7/19/2004 9/27/2004 70 PER Strattera Hyperhidrosis, Pyrexia, Sinusitis
5679864 4504684 6 Years F 7/1/2004 7/19/2004 9/27/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
5679867 4504685 16 Years M 7/1/2004 7/19/2004 9/27/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anger, Mood Swings
5679867 4637395 16 Years M 7/1/2004 12/10/2004 3/28/2005 108 PER Strattera Abnormal Behaviour, Aggression, Anger, Drug Ineffective, Lethargy, Mood Swings, Paranasal Sinus Hypersecretion, Pharyngolaryngeal Pain, Somnolence
5679878 4504686     M 6/29/2004 9/27/2004 90 MD PER Strattera Testicular Pain
5679883 4504687 43 Years M 5/1/2004 7/19/2004 9/27/2004 70 PH PER Strattera Attention Deficit/Hyperactivity Disorder Muscle Cramp, Myalgia
5679886 4504688 48 Years M 6/1/2002 7/20/2004 9/27/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Stomach Discomfort
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5679892 4504689 22 Years M 8/11/2004 9/27/2004 47 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Abnormal Dreams, Colonic Haemorrhage, Constipation, Decreased Appetite, Dizziness, Dry Mouth, Erectile Dysfunction, Headache, Hyperhidrosis, Irritability, Middle Insomnia, Mood Swings, Nausea, Palpitations, Restlessness, Urinary Retention, Weight Decreased, Weight Increased
5679896 4504690 40 Years F 7/1/2004 7/20/2004 9/27/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Vision Blurred
5679901 4504671 9 Years M 6/11/2004 7/9/2004 9/27/2004 80 PER Strattera Anger, Anxiety, Depressed Mood, Fear, Inappropriate Affect, Morbid Thoughts
5679904 4504672 18 Years M 7/9/2004 9/27/2004 80 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
5679907 4504673 26 Years M 5/1/2004 7/9/2004 9/27/2004 80 PER Strattera Feeling Hot, Hyperhidrosis, Nausea
5679912 4504674 7 Years M 7/9/2004 9/27/2004 80 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Feeling Abnormal
5679916 4504675     F 7/9/2004 9/27/2004 80 PER Strattera Attention Deficit/Hyperactivity Disorder Bladder Spasm, Nausea, Urinary Retention
5679921 4504676     M 7/9/2004 9/27/2004 80 MD PER Strattera Testicular Pain, Urinary Retention
5679926 4504677 27 Years F 1/1/2004 7/9/2004 9/27/2004 80 PER Strattera Attention Deficit/Hyperactivity Disorder
5679928 4504678 6 Years M 6/27/2004 7/9/2004 9/27/2004 80 PER Strattera Attention Deficit/Hyperactivity Disorder Coxsackie Viral Infection, Pollakiuria, Stomatitis, Urinary Retention
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5679932 4504679 12 Years M 7/9/2004 9/27/2004 80 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Eye Rolling, Stereotypy, Tic
5679984 4504680 12 Years M 7/9/2004 9/27/2004 80 MD PER Strattera Skin Injury, Tic
5679996 4504691 1 Year M 7/12/2004 9/27/2004 77 PER Strattera
5680012 4502210 13 Years M 8/1/2004 10/25/2004 11/9/2004 15 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fall, Respiratory Rate Decreased, Syncope Life-Threatening
5680012 4509970 13 Years M 8/1/2004 11/2/2004 11/19/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Creatine Phosphokinase Increased, Fall, Syncope Life-Threatening
5680012 4588105 13 Years M 8/1/2004 1/27/2005 2/16/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Creatine Phosphokinase Increased, Fall, Respiratory Rate Decreased, Syncope, Weight Decreased Life-Threatening
5680012 4665143 13 Years M 8/1/2004 5/3/2005 5/17/2005 14 MD EXP Strattera Blood Alkaline Phosphatase Increased, Blood Creatine Phosphokinase Increased, Fall, Fatigue, Heart Rate Increased, Hypotension, Irritability, Loss of Consciousness, Respiratory Rate Decreased, Restlessness, Sleep Disorder, Syncope, Weight Decreased Life-Threatening
5680013 4504692     F 7/12/2004 9/27/2004 77 PER Strattera Alopecia
5680016 4502211 14 Years F 10/24/2004 10/25/2004 11/9/2004 15 PH EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Abortion Induced, Convulsion, Drug Exposure During Pregnancy Other
5680016 4522533 14 Years F 10/22/2004 11/19/2004 12/7/2004 18 PH EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Abortion Induced, Drug Exposure During Pregnancy, Epilepsy Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5680016 4540370 14 Years F 10/22/2004 12/6/2004 12/22/2004 16 PH EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Abortion Induced, Drug Exposure During Pregnancy, Epilepsy Hospitalization - Initial or Prolonged
5680017 4504694 12 Years M 7/12/2004 9/27/2004 77 PER Strattera Abnormal Behaviour
5680021 4504698     F 7/12/2004 9/27/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Headache, Nausea
5680023 4504701 10 Years M 7/1/2004 7/12/2004 9/27/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Eye Rolling, Stomach Discomfort, Vomiting
5680028 4504702 44 Years F 7/12/2004 7/13/2004 9/27/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Hypersensitivity
5680030 4504703     M 7/13/2004 9/27/2004 76 PER Strattera Disturbance in Attention
5680034 4504704 15 Years M 7/13/2004 9/27/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Fatigue
5680043 4504707 41 Years M 7/13/2004 7/13/2004 9/27/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Abnormal, Nausea, Stress Symptoms
5680044 4504828 55 Years F 7/7/2004 7/8/2004 9/27/2004 81 OT PER Strattera Insomnia, Piloerection
5680047 4504712 13 Years M 7/1/2004 7/13/2004 9/27/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Eye Redness, Eye Swelling, Hypersensitivity, Rhinorrhoea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5680048 4504830 7 Years M 7/3/2004 7/20/2004 9/27/2004 69 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Psychomotor Hyperactivity
5680052 4504832 14 Years M 7/8/2004 9/27/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
5680054 4504713 62 Years M 7/27/2004 9/27/2004 62 PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Vision Blurred
5680058 4504833 33 Years M 7/23/2004 9/27/2004 66 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hyperhidrosis, Nightmare, Panic Reaction
5680060 4504718 53 Years F 7/12/2004 9/27/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Irritability, Social Avoidant Behaviour, Weight Decreased
5680062 4504834     F 7/8/2004 9/27/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder
5680068 4504836     F 7/8/2004 9/27/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Disturbance in Attention, Insomnia, Middle Insomnia, Sleep Disorder, Stomach Discomfort
5680069 4504723 25 Years M 7/12/2004 9/27/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Migraine, Nausea, Stomach Discomfort
5680070 4504837 35 Years M 7/28/2004 9/27/2004 61 MD PER Strattera Attention Deficit/Hyperactivity Disorder Scrotal Pain, Urethral Discharge
5680073 4502885     F 6/5/2004 11/16/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Cholestasis, Hepatitis Acute, Hepatotoxicity Disability, Required Intervention to Prevent Permanent Impairment/Damage
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5680074 4504726 34 Years F 7/1/2003 7/12/2004 9/27/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Nausea, Pain, Sensation of Heaviness, Somnolence
5680075 4504838 9 Years M 7/1/2004 7/9/2004 9/27/2004 80 OT PER Strattera Attention Deficit/Hyperactivity Disorder Dyskinesia
5680076 4504839     M 7/9/2004 9/27/2004 80 PER Strattera
5680077 4504727 11 Years M 7/12/2004 9/27/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Insomnia, Mood Swings, Pollakiuria
5680084 4504729 20 Years M 7/20/2004 9/27/2004 69 PER Strattera Attention Deficit/Hyperactivity Disorder Burning Sensation, Decreased Appetite
5680087 4504733 11 Years M 7/12/2004 9/27/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence, Vomiting
5680088 4504737     F 7/12/2004 9/27/2004 77 PER Strattera Stomach Discomfort
5680090 4504738 8 Years M 7/12/2004 9/27/2004 77 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5680641 4500703 12 Years F 10/25/2004 10/25/2004 11/9/2004 15 MD EXP Strattera Cardiac Disorder, Chest Discomfort, Heart Rate Increased Other
5680641 4512530 13 Years F 10/25/2004 11/8/2004 11/24/2004 16 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Chest Discomfort, Dyspnoea, Electrocardiogram QT Prolonged, Heart Rate Increased, Hunger, Nausea, Palpitations, Tremor Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5681221 4500679 11 Years M 10/27/2004 11/9/2004 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Cardiac Murmur, Cardiac Valve Disease Other
5681247 4500661 15 Years F 10/26/2004 11/9/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion Other
5681651 4504784 9 Years M 8/11/2004 9/27/2004 47 CN PER Strattera Dizziness, Feeling Abnormal, Feeling Drunk, Thirst
5681811 4504787     F 8/10/2004 8/10/2004 9/27/2004 48 CN PER Strattera Fatigue, Somnolence
5681822 4504788     F 8/10/2004 9/27/2004 48 CN PER Strattera Feeling Cold
5681839 4504792     F 1/1/2004 8/10/2004 9/27/2004 48 CN PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Dyspnoea, Irritability, Malaise, Somnolence
5681840 4504794     F 8/11/2004 9/27/2004 47 CN PER Strattera Dry Mouth, Speech Disorder
5681843 4504797     M 8/10/2004 9/27/2004 48 CN PER Strattera Chest Discomfort, Dyspnoea
5681850 4504799 10 Years M 8/10/2004 8/10/2004 9/27/2004 48 CN PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Nausea, Stomach Discomfort
5681872 4504800 52 Years F 8/8/2004 8/10/2004 9/27/2004 48 CN PER Strattera Attention Deficit/Hyperactivity Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5682151 4501730 10 Years M 3/27/2004 5/24/2004 9/27/2004 126 OT PER Strattera Attention Deficit/Hyperactivity Disorder Dehydration, Vomiting Hospitalization - Initial or Prolonged
5682161 4501732 8 Years M 1/1/2003 7/8/2004 9/27/2004 81 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort, Abdominal Pain Upper, Blood Bilirubin Increased, Drug Withdrawal Syndrome, Dyskinesia, Flatulence, Hyperchlorhydria, Tic, Vomiting, Weight Decreased Hospitalization - Initial or Prolonged
5682257 4504801 4 Years M 7/1/2004 8/10/2004 9/27/2004 48 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
5682272 4504802 6 Years M 8/11/2004 9/27/2004 47 PH PER Strattera Dysphagia
5682273 4498956 15 Years F 6/16/2004 6/23/2004 9/27/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Myalgia, Nausea
5682276 4498971 10 Years F 6/22/2004 9/27/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Mood Swings, Pruritus, Rash
5682277 4498978 9 Years M 6/23/2004 9/27/2004 96 PH PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5682278 4498983 12 Years F 6/23/2004 9/27/2004 96 OT PER Strattera Attention Deficit/Hyperactivity Disorder Oedema Peripheral, Rash Generalised, Swelling Face
5682281 4498986     F 6/1/2004 6/23/2004 9/27/2004 96 PER Strattera Disturbance in Attention Fatigue, Somnolence
5682284 4498988 40 Years M 6/9/2004 6/23/2004 9/27/2004 96 MD PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Feeling Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5682287 4498992 18 Years M 6/23/2004 9/27/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Fear
5682289 4499006     F 6/23/2004 9/27/2004 96 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Dry Mouth, Heart Rate Increased, Sexual Dysfunction, Thirst
5682290 4499008 10 Years M 6/18/2004 6/23/2004 9/27/2004 96 PER Strattera Fatigue, Feeling Cold, Somnolence
5682293 4498848 8 Years M 6/21/2004 9/27/2004 98 PER Strattera Hair Plucking, Nervousness
5682295 4498851 5 Years F 6/1/2004 7/15/2004 9/27/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Middle Insomnia, Nightmare, Sleep Walking, Staring
5682298 4498855 45 Years F 6/19/2004 6/21/2004 9/27/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Dizziness, Headache, Heart Rate Increased, Hyperhidrosis, Insomnia, Tinnitus
5682300 4498858 7 Years M 6/17/2004 6/21/2004 9/27/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5682301 4498861     F 6/12/2004 9/27/2004 107 MD PER Strattera Somnolence
5682304 4498862 44 Years F 6/10/2004 6/22/2004 9/27/2004 97 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Muscle Cramp
5682306 4498867 4 Years M 5/1/2004 6/21/2004 9/27/2004 98 OT PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5682310 4498868 42 Years M 6/21/2004 9/27/2004 98 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Drug Ineffective, Feeling Abnormal
5682311 4498871     F 5/1/2004 6/21/2004 9/27/2004 98 OT PER Strattera Dysgeusia
5682313 4498873 5 Years M 6/21/2004 6/22/2004 9/27/2004 97 PER Strattera Mood Swings Dreamy State, Hallucination, Tremor
5682315 4498109 15 Years M 6/8/2004 9/27/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Sleep-Related Event, Blood Pressure Increased, Depression, Educational Problem, Fatigue, Heart Rate Increased
5682425 4499152 5 Years M 6/2/2004 6/2/2004 9/27/2004 117 MD PER Strattera Excitability
5682427 4499153 19 Years M 5/1/2004 6/2/2004 9/27/2004 117 PER Strattera Attention Deficit/Hyperactivity Disorder Dependent Personality Disorder, Hypokinesia
5682429 4499157 13 Years M 6/2/2004 9/27/2004 117 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Migraine, Vomiting
5682431 4499174 5 Years M 1/1/2004 6/3/2004 9/27/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Dysphagia, Emotional Distress, Vomiting
5682434 4499178 22 Years M 5/1/2004 6/3/2004 9/27/2004 116 MD PER Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder, Feeling Abnormal
5682436 4499181 6 Years F 6/3/2004 6/3/2004 9/27/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Fatigue, Feeling Abnormal, Pallor
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5682439 4499187 45 Years M 1/1/2004 6/3/2004 9/27/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Depression, Disturbance in Attention, Drug Ineffective, Feeling Abnormal
5682440 4499188 7 Years M 6/3/2004 9/27/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder
5682442 4499190 13 Years M 6/3/2004 9/27/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Fear
5682444 4499191 5 Years M 5/31/2004 6/3/2004 9/27/2004 116 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Crying, Increased Appetite
5682450 4498281 42 Years M 6/11/2004 9/27/2004 108 OT PER Strattera Anxiety Disorder Parotid Gland Enlargement
5682452 4504840 7 Years F 8/10/2004 8/11/2004 9/27/2004 47 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5682453 4498282 65 Years M 6/1/2004 6/11/2004 9/27/2004 108 PER Strattera Apathy, Asthenia, Decreased Appetite, Depression, Disorientation, Dizziness, Insomnia, Lethargy, Nausea
5682454 4504841     F 8/11/2004 9/27/2004 47 MD PER Strattera Pollakiuria
5682455 4498283 27 Years M 6/11/2004 9/27/2004 108 PER Strattera Disturbance in Attention Agitation, Headache
5682457 4504842 16 Years M 7/1/2004 8/11/2004 9/27/2004 47 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Anorexia, Chills, Hyperhidrosis, Initial Insomnia, Middle Insomnia, Nightmare, Postnasal Drip, Somnolence, Stomach Discomfort
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5682459 4504843 13 Years F 8/11/2004 8/11/2004 9/27/2004 47 OT PER Strattera Feeling Jittery
5682460 4498285 44 Years F 6/1/2004 6/11/2004 9/27/2004 108 PER Strattera Attention Deficit/Hyperactivity Disorder Sinusitis, Vision Blurred, Visual Disturbance
5682461 4498286 11 Years F 6/11/2004 9/27/2004 108 OT PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Stomach Discomfort, Vomiting
5682462 4504844 7 Years M 8/11/2004 9/27/2004 47 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Impulsive Behaviour, Psychomotor Hyperactivity, Sedation, Stomach Discomfort
5682463 4498287 6 Years M 6/11/2004 9/27/2004 108 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Nightmare
5682464 4504845 16 Years F 8/11/2004 9/27/2004 47 MD PER Strattera Personality Change
5682465 4504846     M 8/11/2004 9/27/2004 47 MD PER Strattera Flat Affect
5682467 4504847 9 Years M 8/6/2004 8/11/2004 9/27/2004 47 PER Strattera Attention Deficit/Hyperactivity Disorder
5682468 4504848 50 Years F 8/4/2004 8/11/2004 9/27/2004 47 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Vision Blurred
5682469 4504849 50 Years F 8/12/2004 9/27/2004 46 PER Strattera Lethargy, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5682470 4498290 13 Years M 1/1/2004 6/11/2004 9/27/2004 108 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Dry Mouth, Fatigue, Initial Insomnia, Mood Swings, Nausea, Pruritus, Somnolence, Urticaria, Vomiting
5682474 4500174 6 Years M 7/15/2004 9/27/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Enuresis, Learning Disorder, Pollakiuria
5682476 4500175 52 Years F 7/15/2004 9/27/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Lethargy, Somnolence
5682478 4500176 8 Years M 7/15/2004 9/27/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Nausea, Pallor, Tremor
5682480 4500177 13 Years M 4/1/2004 7/15/2004 9/27/2004 74 MD PER Strattera Agitation, Hyperhidrosis, Tachycardia
5682485 4500180     M 7/14/2004 9/27/2004 75 MD PER Strattera Attention Deficit/Hyperactivity Disorder Syncope
5682487 4500181 35 Years M 7/14/2004 7/15/2004 9/27/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Mydriasis
5682492 4500182 7 Years M 7/13/2004 7/15/2004 9/27/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Attention Deficit Hyperactivity Disorder
5682493 4500183 40 Years M 7/15/2004 9/27/2004 74 MD PER Strattera Dysuria, Penis Disorder
5682496 4500184 12 Years 7/15/2004 9/27/2004 74 PER Strattera Epistaxis
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5682520 4498811 24 Years F 6/1/2004 6/15/2004 9/27/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Dry Mouth, Somnolence
5682521 4498815 38 Years F 6/12/2004 6/15/2004 9/27/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Bradyphrenia, Drug Ineffective, Feeling Abnormal, Impatience, Mood Swings, Sinusitis, Somnolence
5682523 4498818 6 Years F 6/1/2004 6/15/2004 9/27/2004 104 PER Strattera Autistic Disorder Drug Ineffective, Retching, Vomiting, Weight Decreased
5682524 4498822 10 Years M 6/15/2004 9/27/2004 104 MD PER Strattera Tic
5682527 4498825     M 5/1/2004 6/15/2004 9/27/2004 104 MD PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Pallor
5682528 4498827 12 Years F 6/15/2004 9/27/2004 104 MD PER Strattera Cardiac Disorder
5682531 4498830     M 6/1/2004 6/15/2004 9/27/2004 104 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Urine Flow Decreased
5682535 4498839 60 Years M 6/1/2004 6/16/2004 9/27/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Anxiety, Constipation
5682538 4498842 38 Years M 8/12/2004 9/27/2004 46 OT PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Disorder, Testicular Pain
5682540 4498844 12 Years F 6/15/2004 6/16/2004 9/27/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5682544 4500185 25 Years M 8/13/2004 9/27/2004 45 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Blood Pressure Increased, Heart Rate Increased
5682545 4500186 5 Years M 7/13/2004 9/27/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5682548 4500188 11 Years M 7/13/2004 9/27/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Weight Increased
5682550 4500190 45 Years M 7/13/2004 9/27/2004 76 MD PER Strattera Visual Disturbance
5682553 4500191 30 Years M 5/1/2004 7/15/2004 9/27/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Delusional Disorder (Persecutory Type), Paraesthesia, Sleep Disorder, Tremor
5682554 4500193 12 Years M 7/13/2004 9/27/2004 76 PER Strattera
5682556 4498110     F 6/8/2004 9/27/2004 111 PER Strattera Stomach Discomfort
5682557 4500194 37 Years F 6/1/2004 8/25/2004 9/27/2004 33 PER Strattera Attention Deficit/Hyperactivity Disorder Formication, Head Discomfort, Nausea, Piloerection, Temperature Intolerance, Visual Disturbance
5682559 4500196     F 7/13/2004 9/27/2004 76 MD PER Strattera Skin Discolouration
5682561 4500198     F 7/13/2004 9/27/2004 76 MD PER Strattera Attention Deficit/Hyperactivity Disorder Pruritus Generalised, Urticaria
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5682562 4498111 9 Years M 12/1/2002 6/8/2004 9/27/2004 111 PER Strattera Drug Ineffective, Lethargy, Psychomotor Hyperactivity
5682566 4498112 35 Years M 6/8/2004 6/8/2004 9/27/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Feeling Abnormal, Stomach Discomfort
5682567 4498242 83 Years F 6/1/2004 6/8/2004 9/27/2004 111 PER Strattera Depression Dizziness, Fatigue, Feeling Abnormal, Feeling Hot
5682568 4498113 18 Years F 7/26/2004 9/27/2004 63 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea
5682571 4498243 10 Years M 6/8/2004 9/27/2004 111 PER Strattera Drug Ineffective
5682572 4498114 29 Years F 6/7/2004 6/8/2004 9/27/2004 111 PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Pulse Pressure Increased, Sensation of Heaviness, Somnolence
5682575 4498244 34 Years F 6/1/2004 6/8/2004 9/27/2004 111 PER Strattera Memory Impairment Fibromyalgia, Nervousness, Paraesthesia, Psychomotor Hyperactivity, Rhinorrhoea, Throat Irritation
5682577 4498115 33 Years M 6/6/2004 6/8/2004 9/27/2004 111 PER Strattera
5682578 4498245     M 6/9/2004 9/27/2004 110 MD PER Strattera Ejaculation Disorder, Emotional Distress
5682581 4498119 11 Years M 6/7/2004 6/8/2004 9/27/2004 111 PER Strattera Emotional Distress
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5682582 4498246 6 Years M 6/9/2004 9/27/2004 110 PER Strattera Abdominal Pain, Crying, Eating Disorder, Irritability, Vomiting
5682584 4498247 8 Years M 6/9/2004 9/27/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Hot, Initial Insomnia, Mood Swings, Somnolence, Temperature Intolerance
5682587 4498120 6 Years M 6/8/2004 6/8/2004 9/27/2004 111 PER Strattera Abnormal Behaviour, Lethargy, Somnolence, Vomiting
5682588 4498121 7 Years F 6/7/2004 6/8/2004 9/27/2004 111 PER Strattera Chest Pain, Headache, Heart Rate Increased, Respiratory Rate Increased
5682588 4580304 7 Years F 6/7/2004 10/6/2004 1/27/2005 113 MD PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Headache, Heart Rate Increased, Respiratory Rate Increased
5682588 4637393 7 Years F 6/7/2004 1/4/2005 3/28/2005 83 MD PER Strattera Chest Pain, Headache, Heart Rate Increased, Respiratory Rate Increased
5682589 4498248 44 Years F 6/9/2004 6/9/2004 9/27/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Dysgeusia, Fatigue, Insomnia, Parosmia, Sinus Headache
5682592 4498249 11 Years M 4/1/2004 6/9/2004 9/27/2004 110 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Birth Mark, Crying, Disturbance in Attention, Irritability, Mood Altered, Vein Discolouration
5682599 4498250 46 Years M 6/8/2004 6/9/2004 9/27/2004 110 PER Strattera Cold Sweat, Nausea, Retching, Somnolence
5682607 4498271 11 Years M 6/11/2004 9/27/2004 108 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Drug Ineffective, Fear, Initial Insomnia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5682608 4495916 7 Years F 7/9/2004 9/27/2004 80 PER Strattera Attention Deficit/Hyperactivity Disorder Musculoskeletal Stiffness, Pain in Extremity, Somnolence
5682608 4580296 7 Years F 8/20/2004 1/27/2005 160 MD PER Strattera Attention Deficit/Hyperactivity Disorder Musculoskeletal Stiffness, Pain in Extremity, Somnolence
5682609 4498272 9 Years M 6/1/2004 6/11/2004 9/27/2004 108 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Dysgeusia
5682610 4498273     F 6/11/2004 6/11/2004 9/27/2004 108 PER Strattera Feeling Jittery
5682611 4495918 44 Years F 5/20/2004 5/21/2004 9/27/2004 129 PER Strattera Excitability, Fatigue, Feeling Abnormal, Insomnia
5682612 4498274 12 Years M 6/1/2004 6/14/2004 9/27/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Mood Swings, Verbal Abuse
5682613 4495920     F 5/21/2004 9/27/2004 129 PER Strattera Anorexia, Dry Mouth, Headache, Irritability
5682614 4498275 40 Years F 3/1/2004 6/11/2004 9/27/2004 108 OT PER Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Fluctuation, Chills, Dizziness
5682614 4580305 40 Years F 3/1/2004 9/28/2004 1/27/2005 121 OT PER Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Fluctuation, Chills, Dizziness
5682615 4495921 14 Years M 5/21/2004 7/6/2004 9/27/2004 83 OT PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Dyspnoea, Heart Rate Increased, Paraesthesia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5682616 4498276 8 Years M 6/14/2004 9/27/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anger, Headache, Hyperacusis, Mood Swings
5682617 4495923     M 6/15/2004 9/27/2004 104 MD PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Psychotic Disorder
5682618 4498277 42 Years M 6/12/2004 6/14/2004 9/27/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Micturition Urgency, Urinary Tract Disorder
5682622 4498278 24 Years F 5/1/2004 6/14/2004 9/27/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Mood Swings, Sedation
5682624 4495925 11 Years M 5/1/2004 5/21/2004 9/27/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Initial Insomnia, Nausea, Somnolence
5682629 4495926 7 Years M 5/23/2004 5/24/2004 9/27/2004 126 PER Strattera Disturbance in Attention Abnormal Behaviour, Euphoric Mood, Fatigue, Psychomotor Hyperactivity
5682631 4498280 10 Years M 3/1/2003 6/14/2004 9/27/2004 105 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anger, Somnolence
5682634 4495927 17 Years M 5/24/2004 5/24/2004 9/27/2004 126 PER Strattera Drug Screen Positive
5682635 4495928 13 Years M 5/1/2004 5/24/2004 9/27/2004 126 PER Strattera Attention Deficit/Hyperactivity Disorder Pharyngitis, Stomach Discomfort, Vomiting
5682636 4498261 50 Years M 5/1/2004 6/10/2004 9/27/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Hyperhidrosis, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5682637 4495929 8 Years M 5/17/2004 9/27/2004 133 MD PER Strattera Photophobia, Photopsia
5682638 4498262 46 Years F 6/9/2004 6/10/2004 9/27/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Muscle Twitching, Weight Decreased
5682639 4495933     M 7/6/2004 9/27/2004 83 OT PER Strattera Attention Deficit/Hyperactivity Disorder Protein Urine
5682640 4498263 7 Years M 6/10/2004 9/27/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Crying, Learning Disorder, Mood Swings
5682641 4498264 35 Years M 6/1/2004 6/10/2004 9/27/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Hypokinesia, Somnolence
5682642 4495934 12 Years M 5/21/2004 9/27/2004 129 MD PER Strattera Anxiety, Mood Altered
5682643 4495939 15 Years M 5/21/2004 9/27/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder Epistaxis
5682644 4498265 34 Years M 8/10/2004 9/27/2004 48 MD PER Strattera Attention Deficit/Hyperactivity Disorder Scrotal Pain, Testicular Swelling
5682646 4498266 37 Years F 6/10/2004 9/27/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
5682647 4495940 8 Years M 5/7/2004 5/21/2004 9/27/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Psychomotor Hyperactivity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5682649 4498267 16 Years F 6/1/2004 6/10/2004 9/27/2004 109 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Drug Ineffective, Road Traffic Accident
5682650 4495942     M 5/21/2004 9/27/2004 129 CN PER Strattera Psychomotor Hyperactivity
5682651 4498268     F 6/9/2004 6/10/2004 9/27/2004 109 PER Strattera Chills, Feeling Abnormal, Vomiting
5682652 4495943 42 Years M 5/21/2004 9/27/2004 129 OT PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Paranoia
5682654 4495944 32 Years M 5/21/2004 9/27/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anger, Depression, Drug Withdrawal Syndrome, Flat Affect, Headache, Impulse-Control Disorder, Irritability, Malaise
5682655 4498269 57 Years F 5/31/2004 7/27/2004 9/27/2004 62 MD PER Strattera Disturbance in Attention Alopecia, Arrhythmia, Blood Pressure Increased, Blood Thyroid Stimulating Hormone Abnormal, Chest Discomfort, Constipation, Fatigue, Haemorrhoids, Headache, Hyperhidrosis, Nervousness, Stomach Discomfort
5682656 4495948 8 Years M 1/1/2004 5/21/2004 9/27/2004 129 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anorexia, Emotional Distress, Headache, Somnolence
5682657 4498270 34 Years M 6/11/2004 6/11/2004 9/27/2004 108 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness
5682693 4498077 45 Years F 7/27/2004 9/27/2004 62 PER Strattera Attention Deficit/Hyperactivity Disorder Emotional Disorder, Somnolence
5682695 4498078 58 Years F 7/1/2004 7/26/2004 9/27/2004 63 CN PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Tinnitus
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5682698 4498079 51 Years M 6/28/2004 7/26/2004 9/27/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Erectile Dysfunction, Erythema, Genital Infection Fungal, Hypersensitivity, Libido Decreased, Nausea, Penile Blister, Penile Swelling
5682698 4580507 51 Years M 1/1/1989 11/22/2004 1/27/2005 66 MD PER Strattera Attention Deficit/Hyperactivity Disorder Erectile Dysfunction, Erythema, Genital Infection Fungal, Herpes Simplex, Hypersensitivity, Libido Decreased, Nausea, Penile Blister, Penile Swelling
5682698 4637423 51 Years M 1/1/1989 11/22/2004 3/28/2005 126 MD PER Strattera Erectile Dysfunction, Erythema, Genital Infection, Genital Infection Fungal, Herpes Simplex, Hypersensitivity, Libido Decreased, Nausea, Penile Blister, Penile Swelling
5682707 4498097 7 Years F 7/1/2004 7/23/2004 9/27/2004 66 PER Strattera Disturbance in Attention Nausea, Pallor
5682708 4498080 19 Years M 7/26/2004 9/27/2004 63 PER Strattera Drug Screen Positive
5682709 4498098 42 Years M 7/1/2004 7/26/2004 9/27/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Disturbance in Attention, Dry Mouth, Ejaculation Disorder
5682710 4498081 47 Years F 7/27/2004 7/27/2004 9/27/2004 62 PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity
5682711 4498099 1 Year F 7/26/2004 7/26/2004 9/27/2004 63 PER Strattera
5682712 4498082     F 7/27/2004 9/27/2004 62 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hostility
5682713 4498100 34 Years M 7/26/2004 9/27/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Mania
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5682714 4498101 6 Years F 1/1/2003 7/26/2004 9/27/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Insomnia, Middle Insomnia
5682715 4498083 11 Years M 1/1/2004 7/27/2004 9/27/2004 62 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Depression, Dizziness, Fatigue, Insomnia, Mood Swings, Panic Attack, Vision Blurred, Weight Decreased
5682716 4498084 7 Years M 7/28/2004 9/27/2004 61 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Eating Disorder, Suicidal Ideation
5682717 4498102 6 Years F 7/1/2004 7/26/2004 9/27/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Eating Disorder, Feeling Abnormal
5682718 4498085 8 Years M 7/27/2004 7/27/2004 9/27/2004 62 PER Strattera Attention Deficit/Hyperactivity Disorder
5682719 4498103 12 Years M 7/12/2004 7/26/2004 9/27/2004 63 PER Strattera Headache, Stomach Discomfort
5682720 4498104     F 7/26/2004 9/27/2004 63 MD PER Strattera Dysgeusia
5682721 4498086 14 Years F 7/25/2004 7/27/2004 9/27/2004 62 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Nasopharyngitis, Pyrexia, Somnolence
5682722 4498105 13 Years F 7/26/2004 9/27/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Depression, Flat Affect, Personality Change
5682723 4498106 13 Years M 7/26/2004 7/26/2004 9/27/2004 63 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Testicular Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5682723 4580504 13 Years M 7/26/2004 8/24/2004 1/27/2005 156 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Testicular Pain
5682814 4501261 7 Years M 4/24/2003 6/1/2004 9/27/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Fatigue, Feeling Abnormal, Initial Insomnia, Nausea, Stomach Discomfort, Vomiting, Weight Increased
5682815 4501267 7 Years M 6/16/2004 9/27/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Depression, Drug Ineffective, Mood Swings, Photosensitivity Reaction
5682816 4501270 50 Years F 6/1/2003 8/11/2004 9/27/2004 47 PER Strattera Attention Deficit/Hyperactivity Disorder Arrhythmia, Diarrhoea, Feeling Abnormal, Joint Dislocation, Nausea, Vomiting
5682817 4501272 53 Years F 6/16/2004 9/27/2004 103 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Dissociative Disorder, Disturbance in Attention, Heart Rate Increased, Hyperhidrosis, Irritability, Mood Swings
5682819 4501274 34 Years M 3/1/2003 8/29/2003 9/27/2004 395 PER Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder, Fatigue, Hypertension, Muscular Weakness, Prostatic Disorder
5682823 4495972 9 Years M 5/5/2004 5/17/2004 9/27/2004 133 PER Strattera Attention Deficit/Hyperactivity Disorder Choking, Retching
5682825 4495977 6 Years F 5/1/2004 5/19/2004 9/27/2004 131 PER Strattera Attention Deficit/Hyperactivity Disorder Adjustment Disorder, Drug Ineffective
5682825 4580295 6 Years F 5/1/2004 10/22/2004 1/27/2005 97 PER Strattera Attention Deficit/Hyperactivity Disorder Adjustment Disorder, Drug Ineffective
5683092 4499036 13 Years F 12/1/2003 6/1/2004 9/27/2004 118 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Choking, Fatigue, Pharyngolaryngeal Pain, Stomach Discomfort, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5683093 4499038 12 Years 6/1/2004 9/27/2004 118 MD PER Strattera Mania
5683094 4499039 12 Years M 6/1/2004 9/27/2004 118 MD PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Urinary Retention, Weight Decreased
5683103 4499042 17 Years M 5/29/2004 6/1/2004 9/27/2004 118 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Irritability, Somnolence
5684277 4508980 9 Years F 11/16/2004 11/22/2004 PH DIR Strattera Attention Deficit/Hyperactivity Disorder Angioneurotic Oedema, Cyanosis, Hypersensitivity Other, Required Intervention to Prevent Permanent Impairment/Damage
5687479 4510363 25 Years F 10/31/2004 11/1/2004 11/19/2004 18 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Jaundice, Mental Disorder
5687479 4546493 25 Years F 10/31/2004 12/14/2004 1/3/2005 20 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Jaundice, Mental Disorder, Viral Infection
5688015 4509894 20 Years M 11/1/2004 11/19/2004 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Jaw Fracture, Multiple Fractures, Pain, Victim of Crime Hospitalization - Initial or Prolonged, Other
5688016 4509516 10 Years F 10/1/2004 10/28/2004 11/19/2004 22 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Aphagia, Blood Glucose Decreased, Nausea, Vomiting Other
5688018 4509897 14 Years F 10/30/2004 11/1/2004 11/19/2004 18 EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Multiple Drug Overdose Intentional, Speech Disorder Other
5688019 4509898 8 Years M 9/16/2004 11/1/2004 11/19/2004 18 EXP Strattera Attention Deficit/Hyperactivity Disorder Affective Disorder, Apathy, Convulsion, Emotional Disorder, Fatigue, Headache, Hyperhidrosis, Personality Change, Sinus Disorder, Sleep Disorder Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5688019 4790305 8 Years M 9/16/2004 9/20/2005 10/5/2005 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Apathy, Disturbance in Attention, Drug Ineffective, Dyskinesia, Emotional Disorder, Eye Movement Disorder, Fatigue, Headache, Hyperhidrosis, Insomnia, Irritability, Mood Altered, Personality Change Other
5688062 4509915     F 10/28/2004 11/19/2004 22 EXP Strattera Attention Deficit/Hyperactivity Disorder Condition Aggravated, Convulsion, Feeling Abnormal Other
5688062 4612413     F 3/3/2005 3/16/2005 13 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Feeling Abnormal, Hypervigilance
5688099 4509530 17 Years F 11/1/2004 11/19/2004 18 PH EXP Strattera Blood Pressure Fluctuation, Cyanosis, Grand Mal Convulsion, Stress Symptoms Other
5688574 4515141 17 Years M 11/30/2004 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Depression, Educational Problem, Personality Change, Screaming Other
5688987 4512618     M 11/10/2004 11/24/2004 14 MD EXP Strattera Convulsion Other
5688987 4572042 20 Years M 1/18/2005 2/2/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Confusional State, Grand Mal Convulsion, Headache, Hypokalaemia, Loss of Consciousness, Postictal State Other
5688987 4595433 20 Years M 12/1/2004 2/7/2005 2/24/2005 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Confusional State, Grand Mal Convulsion, Hypokalaemia, Postictal Headache, Postictal State Other
5689671 4512668     F 5/27/2004 11/4/2004 11/24/2004 20 OT EXP Strattera Irritability, Nephrolithiasis Other
5689671 4522451     F 5/27/2004 11/22/2004 12/7/2004 15 OT EXP Strattera Chromaturia, Irritability, Nephrolithiasis Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5689671 4538815     F 5/27/2004 12/1/2004 12/22/2004 21 OT EXP Strattera Nephrolithiasis Hospitalization - Initial or Prolonged, Other
5690110 4512937 8 Years M 11/5/2004 11/8/2004 11/24/2004 16 CN EXP Strattera Abdominal Pain Lower, Appendicitis, Diarrhoea, Lymphadenopathy, Lymphocyte Count Decreased
5690970 4513968 9 Years F 10/22/2004 11/5/2004 11/24/2004 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Obsessive Thoughts Disability
5691528 4517233 8 Years M 10/28/2004 11/12/2004 11/30/2004 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Condition Aggravated, Dizziness, Heart Rate Increased, Night Sweats, Orthostatic Hypotension, Posture Abnormal, Tic Other
5691528 4530767 8 Years M 10/28/2004 12/8/2004 12/16/2004 8 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Condition Aggravated, Dizziness, Heart Rate Increased, Night Sweats, Orthostatic Hypotension, Syncope, Tourette's Disorder Other
5691535 4517236 11 Years M 10/9/2004 11/12/2004 11/30/2004 18 EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Disorder, Contusion Other
5691708 4517977 31 Years F 11/1/2004 11/16/2004 11/30/2004 14 EXP Strattera Attention Deficit/Hyperactivity Disorder Bacterial Infection, Confusional State, Dyspnoea, Electrocardiogram Abnormal, Hepatitis, Nausea, Pruritus, Urticaria, Vomiting Hospitalization - Initial or Prolonged
5691708 4522460 31 Years F 11/1/2004 11/23/2004 12/7/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Back Pain, Bacterial Infection, Cerebral Infarction, Confusional State, Dyspnoea, Dysuria, Electrocardiogram Abnormal, Feeling Abnormal, Hepatitis, Hepatitis B Antibody Positive, Nausea, Neurodermatitis, Neurofibromatosis, Pruritus, Urticaria, Vomiting Hospitalization - Initial or Prolonged
5692326 4519891 30 Years M 6/6/2004 12/2/2004 CN DIR Strattera Dysuria, Prostatic Disorder Required Intervention to Prevent Permanent Impairment/Damage
5692612 4518224 19 Years F 11/15/2004 11/30/2004 15 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Dilatation Atrial, Tachycardia Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5692613 4518225 22 Years F 1/1/2004 11/12/2004 11/30/2004 18 EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Faeces, Eating Disorder, Haematochezia, Nausea, Speech Disorder, Ulcer, Weight Decreased Other
5692613 4597882 22 Years F 11/12/2004 2/7/2005 3/1/2005 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aphasia, Eating Disorder, Haematochezia, Haemorrhoids, Nausea, Speech Disorder, Weight Decreased
5692616 4518227 18 Years M 11/9/2004 11/16/2004 11/30/2004 14 EXP Strattera Abdominal Pain Upper, Depressed Level of Consciousness, Diarrhoea, Disorientation, Dry Skin, Homicidal Ideation, Rash, Sinusitis, Urticaria, Vomiting Hospitalization - Initial or Prolonged
5693478 4523765     M 12/7/2004 12/10/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion Hospitalization - Initial or Prolonged
5693587 4520864 15 Years M 4/1/2004 12/6/2004 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Depressed Mood, Vomiting Other
5694955 4522506 51 Years F 11/20/2004 11/23/2004 12/7/2004 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Coma, Encephalitis Viral, Grand Mal Convulsion, Myalgia Hospitalization - Initial or Prolonged, Other
5694955 4577814 51 Years F 11/20/2004 1/26/2005 2/9/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aura, Body Temperature Increased, Confabulation, Confusional State, Coordination Abnormal, Decerebration, Dyskinesia, Encephalitis Viral, Fear, Grand Mal Convulsion, Korsakoff's Psychosis Non-Alcoholic, Loss of Consciousness, Myalgia, Nausea, Protein Total Increased, Viral Infection, Vomiting Hospitalization - Initial or Prolonged, Other
5694959 4522508 9 Years M 1/1/2004 11/19/2004 12/7/2004 18 EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Urine Present Other
5694959 4545593 9 Years M 8/31/2004 12/14/2004 1/3/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Haematuria, Laboratory Test Abnormal, Protein Urine Present Other
5694959 4546023 9 Years M 8/31/2004 12/14/2004 1/3/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Haematuria, Protein Urine, Urine Analysis Abnormal Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5694959 4599517     M 8/31/2004 2/10/2005 3/3/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Post Streptococcal Glomerulonephritis Other
5694964 4522511     M 5/1/2004 11/17/2004 12/7/2004 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Gastric Cancer, Hernia, Post Gastric Surgery Syndrome, Weight Decreased Other
5694966 4522512 12 Years F 11/2/2004 11/17/2004 12/7/2004 20 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion Other
5694966 4539011 12 Years F 11/2/2004 12/2/2004 12/22/2004 20 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Gastritis, Nervous System Disorder, Oesophagitis, Pain Other
5694966 4565489 12 Years F 11/1/2004 1/6/2005 1/26/2005 20 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Convulsion, Electroencephalogram Abnormal, Feeling Abnormal, Gastritis, Hyperventilation, Nuclear Magnetic Resonance Imaging Brain Abnormal, Oesophagitis, Post Procedural Complication, Sinus Arrhythmia Other
5694966 4572067 12 Years F 11/1/2004 1/18/2005 2/2/2005 15 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Central Nervous System Lesion, Convulsion, Feeling Abnormal, Gastritis, Oesophagitis, Post Procedural Complication Other
5694967 4522513 8 Years F 11/16/2004 11/19/2004 12/7/2004 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Cyanosis, Skin Discolouration, Toxicologic Test Abnormal Other
5694967 4565488 8 Years F 11/16/2004 1/11/2005 1/26/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Listless, Skin Discolouration Other
5694967 4579413 8 Years F 11/16/2004 1/21/2005 2/9/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Listless, Skin Discolouration, Swelling Face
5694967 4581628 8 Years F 11/16/2004 11/19/2004 1/27/2005 69 MD PER Strattera Attention Deficit/Hyperactivity Disorder Skin Discolouration Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5695831 4522501 40 Years F 10/17/2004 11/18/2004 12/7/2004 19 MD EXP Strattera Electrocardiogram QT Corrected Interval Prolonged, Mitral Valve Incompetence, Tachycardia Other
5695831 4538789 40 Years F 10/1/2004 12/8/2004 12/22/2004 14 MD EXP Strattera Electrocardiogram QT Corrected Interval Prolonged, Mitral Valve Incompetence, Tachycardia Other
5695831 4618718 40 Years F 10/1/2004 3/10/2005 3/23/2005 13 MD EXP Strattera Electrocardiogram QT Corrected Interval Prolonged, Tachycardia Other
5695860 4522209 8 Years M 11/11/2004 11/18/2004 12/7/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Jaundice, Loss of Consciousness, Vomiting Hospitalization - Initial or Prolonged, Other
5695860 4530616 8 Years M 11/11/2004 11/29/2004 12/16/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Jaundice, Loss of Consciousness, Vomiting Hospitalization - Initial or Prolonged, Other
5695860 4540384 8 Years M 11/11/2004 12/6/2004 12/22/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Jaundice, Loss of Consciousness, Vomiting Hospitalization - Initial or Prolonged, Other
5695965 4521707     M 11/1/2004 12/8/2004 MD DIR Atomoxetine Attention Deficit/Hyperactivity Disorder Muscle Twitching, Tic Required Intervention to Prevent Permanent Impairment/Damage
5701375 4530573 17 Years M 12/17/2004 DIR Strattera Arthralgia, Liver Function Test Abnormal
5703879 4530823 13 Years M 11/1/2004 11/30/2004 12/16/2004 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Suicidal Ideation Other
5703879 4546498 13 Years M 10/1/2004 12/10/2004 1/3/2005 24 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Suicidal Ideation Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5704124 4531633 44 Years M 11/1/2004 12/17/2004 CN DIR Strattera Anxiety, Compulsions, Depression, Emotional Disorder, Suicidal Ideation Life-Threatening
5704163 4531663 32 Years M 3/20/2003 11/29/2004 12/16/2004 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Blood Cholesterol Increased, Blood Triglycerides Increased, Ejaculation Disorder, Sexual Dysfunction
5704168 4531664 7 Years F 11/2/2004 11/30/2004 12/16/2004 16 EXP Strattera Coma, Malaise, Mydriasis, Overdose, Somnolence, Vomiting Other
5704647 4533961 25 Years M 12/15/2005 12/21/2004 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anorexia, Arthritis, Arthropathy, Back Pain, Chills, Chromaturia, Dysuria, Erectile Dysfunction, Headache, Hyperhidrosis, Insomnia, Lethargy, Orgasm Abnormal, Pruritus, Yawning
5705559 4538173 38 Years M 12/20/2004 12/23/2004 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Dizziness, Dyspnoea, Dysstasia, Heart Rate Increased, Visual Disturbance Hospitalization - Initial or Prolonged
5706175 4538825 30 Years F 6/1/2004 12/2/2004 12/22/2004 20 MD EXP Strattera Adverse Drug Reaction, Alpha 2 Globulin Increased, Antimitochondrial Antibody Positive, Autoimmune Hepatitis, Blood Albumin Decreased, Blood Iron Increased, Hepatitis A Antibody Positive, Hepatitis Acute, Hepatitis Cholestatic, Hepatotoxicity, Iron Binding Capacity Unsaturated Decreased, Mean Platelet Volume Increased, Protein Total Decreased, Red Blood Cell Count Decreased, Red Cell Distribution Width Increased, Serum Ferritin Increased, Viral Infection Other
5706175 4595506 30 Years F 6/1/2004 2/9/2005 2/24/2005 15 MD EXP Strattera Alpha 2 Globulin Increased, Antimitochondrial Antibody Positive, Autoimmune Hepatitis, Blood Iron Increased, Cholestasis, Hepatitis A Antibody Positive, Hepatitis Acute, Hepatotoxicity, Iron Binding Capacity Unsaturated Decreased, Jaundice, Liver Disorder, Mean Platelet Volume Increased, Nausea, Red Blood Cell Count Decreased, Red Cell Distribution Width Increased, Serum Ferritin Increased Other
5706175 4648759 30 Years F 6/1/2004 4/7/2005 4/27/2005 20 MD EXP Strattera Alpha 2 Globulin Increased, Cholestasis, Hepatic Cirrhosis, Hepatitis A Antibody Positive, Hepatitis Acute, Liver Disorder, Viral Infection Other
5706186 4533787 30 Years F 10/15/2004 12/6/2004 52 MD PER Strattera Alopecia, Fatigue
5706192 4539173 15 Years F 12/9/2004 12/27/2004 MD DIR Strattera Abdominal Pain, Asthenia, Hepatic Enzyme Increased, Vomiting Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5707278 4538790 19 Years F 10/1/2004 12/8/2004 12/22/2004 14 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Dilatation Atrial, Heart Rate Abnormal, Tachycardia Other
5707278 4572064 19 Years F 10/1/2004 1/19/2005 2/2/2005 14 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Body Temperature Decreased, Dilatation Atrial, Palpitations, Tachycardia
5707561 4538796 6 Years M 12/15/2004 12/22/2004 7 OT EXP Strattera Abdominal Distension, Abdominal Pain, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Bilirubin Urine, Blood Alkaline Phosphatase Increased
5707561 4552285 6 Years M 12/28/2004 1/12/2005 15 OT EXP Strattera Abdominal Distension, Abdominal Pain, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Bilirubin Urine, Blood Alkaline Phosphatase Increased
5707561 4612416 6 Years M 10/29/2004 3/1/2005 3/16/2005 15 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Abdominal Pain, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Pollakiuria, Urine Bilirubin Increased
5707721 4536726 6 Years M 12/19/2004 12/22/2004 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Aggression Other
5708072 4538735 40 Years M 1/1/2004 12/7/2004 12/22/2004 15 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Eosinophil Count Increased, Fatigue, Malaise, Pneumonia, White Blood Cell Count Increased Hospitalization - Initial or Prolonged
5708075 4538737 15 Years F 12/5/2004 12/6/2004 12/22/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Bronchospasm, Chest Pain, Drug Ineffective, Dyspnoea Hospitalization - Initial or Prolonged
5708078 4538739 9 Years F 12/9/2004 12/22/2004 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Eye Disorder, Nerve Injury Other
5708083 4538742 58 Years F 8/31/2004 12/13/2004 12/22/2004 9 EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Decreased, Constipation, Diarrhoea, Dyspnoea, Genital Pruritus Female, Hyperhidrosis, Incoherent, Pruritus Generalised, Urticaria, Vaginal Haemorrhage Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5708083 4562362 58 Years F 10/12/2004 12/29/2004 1/21/2005 23 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Blood Amylase Increased, Blood Bilirubin Increased, Blood Pressure Decreased, Confusional State, Constipation, Diarrhoea, Drug Ineffective, Dyspnoea, Hyperhidrosis, Incoherent, Lipase Increased, Loss of Consciousness, Pallor, Pruritus Generalised, Urticaria, Vaginal Haemorrhage Hospitalization - Initial or Prolonged
5708083 4562468 58 Years F 10/12/2004 12/29/2004 1/21/2005 23 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Blood Amylase Increased, Blood Bilirubin Increased, Blood Pressure Decreased, Confusional State, Constipation, Diarrhoea, Dyspnoea, Gastrointestinal Haemorrhage, Genital Pruritus Female, Hyperhidrosis, Incoherent, Lipase Increased, Loss of Consciousness, Nausea, Pallor, Pruritus Generalised, Urticaria, Vaginal Haemorrhage, Vomiting Hospitalization - Initial or Prolonged
5708083 4600894 58 Years F 8/31/2004 12/13/2004 1/27/2005 45 CN PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Decreased, Diarrhoea, Dyspnoea, Hyperhidrosis, Pruritus, Urticaria, Vaginal Haemorrhage Hospitalization - Initial or Prolonged
5708698 4540140     M 12/6/2004 12/22/2004 16 MD EXP Strattera Liver Disorder, Liver Function Test Abnormal Other
5708698 4546589 13 Years M 12/13/2004 1/3/2005 21 MD EXP Strattera Aggression, Attention Deficit/Hyperactivity Disorder Liver Disorder, Liver Function Test Abnormal Other
5708698 4553454 13 Years M 12/22/2004 1/12/2005 21 MD EXP Strattera Aggression, Attention Deficit/Hyperactivity Disorder Hepatitis Viral Other
5708723 4539842 25 Years M 11/11/2004 12/2/2004 12/22/2004 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Hyperhidrosis, Loss of Consciousness, Malaise, Vomiting Other
5708723 4572169 25 Years M 11/11/2004 1/19/2005 2/2/2005 14 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Abnormal, Hyperhidrosis, Loss of Consciousness, Vomiting Other
5708723 4601044 25 Years M 11/11/2004 12/2/2004 1/27/2005 56 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Abnormal, Hyperhidrosis, Loss of Consciousness, Vomiting Other
5708733 4539843 25 Years F 11/1/2004 12/1/2004 12/22/2004 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Mania, Psychotic Disorder Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5708733 4546029 25 Years F 11/1/2004 12/15/2004 1/3/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Loss of Employment, Mania, Psychotic Disorder Other
5708757 4539844 43 Years F 11/24/2004 12/3/2004 12/22/2004 19 EXP Strattera Abnormal Behaviour, Aggression, Alcohol Poisoning, Anger, Anxiety, Asthma, Condition Aggravated, Fatigue, Fear, Insomnia, Markedly Reduced Dietary Intake, Multiple Drug Overdose, Pain, Panic Attack, Screaming, Self Mutilation, Skin Laceration, Somnolence, Suicidal Ideation, Thinking Abnormal, Tremor Hospitalization - Initial or Prolonged
5708869 4539893 11 Years M 12/6/2004 12/7/2004 12/23/2004 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Tenderness, Appendicitis, Headache, Nausea, Vomiting Other
5708869 4546030 11 Years M 12/6/2004 12/15/2004 1/3/2005 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Viral Infection
5709199 4539802 6 Years M 12/8/2004 12/23/2004 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder, Autism Aggression, Crying, Emotional Disorder, Excessive Masturbation, Markedly Reduced Dietary Intake, Psychomotor Hyperactivity, Weight Decreased Other
5709610 4540612 7 Years F 12/3/2004 12/22/2004 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Physical Assault, Screaming, Suicidal Ideation Other
5709905 4541014 12 Years M 11/30/2004 12/7/2004 12/28/2004 21 OT EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Hepatitis, Influenza Like Illness, Viral Infection Other
5709905 4546839 12 Years M 11/30/2004 12/16/2004 1/5/2005 20 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Blood Calcium Increased, Blood Cholesterol Increased, Blood Uric Acid Increased, Gastroenteritis Norwalk Virus, Headache, Hepatitis, Influenza Like Illness Other
5709905 4579514 12 Years M 11/30/2004 1/26/2005 2/9/2005 14 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Blood Calcium Increased, Blood Cholesterol Increased, Blood Uric Acid Increased, Gastroenteritis Norwalk Virus, Headache, Hepatitis, Influenza Like Illness, Nausea Other
5710197 4544673 53 Years M 12/23/2004 1/3/2005 OT DIR Strattera Attention Deficit/Hyperactivity Disorder Aggression, Crying, Dysuria, Emotional Disorder, Impaired Work Ability, Suicidal Ideation Life-Threatening
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5711997 4545472     M 12/8/2004 1/3/2005 26 CN EXP Strattera Aortic Stenosis, Blood Glucose Decreased, Constipation, Dizziness, Ejaculation Disorder, Heart Rate Increased, Hyperhidrosis, Micturition Disorder, Nausea, Orthostatic Hypotension, Pain, Prostatic Pain, Sensation of Pressure Other
5711997 4572043 36 Years M 1/24/2005 2/2/2005 9 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Decreased, Constipation, Dizziness, Ejaculation Disorder, Heart Rate Increased, Hyperhidrosis, Micturition Disorder, Nausea, Orthostatic Hypotension, Prostatic Pain
5711998 4545477     M 12/14/2004 1/3/2005 20 MD EXP Strattera Haemorrhage Urinary Tract Other
5712000 4548219 18 Years M 6/1/2003 1/5/2005 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Chills, Chromaturia, Fatigue, Feeling Abnormal, Headache, Hyperhidrosis, Influenza Like Illness, Liver Disorder, Nausea, Nervous System Disorder, Pyrexia, Visual Acuity Reduced, Vomiting Disability, Hospitalization - Initial or Prolonged
5712011 4545486 6 Years 12/15/2004 1/3/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion Other
5712011 4595436 5 Years M 2/3/2005 2/24/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Crying, Insomnia Other
5712015 4545489 10 Years M 12/13/2004 1/3/2005 21 MD EXP Strattera Electrocardiogram Abnormal, Extrasystoles Other
5712021 4545492 9 Years M 12/7/2004 12/17/2004 1/3/2005 17 MD EXP Strattera Haemorrhage Urinary Tract Other
5712024 4545495 24 Years M 12/13/2004 1/3/2005 21 MD EXP Strattera Convulsion Other
5712024 4599506 24 Years M 2/11/2005 3/3/2005 20 MD EXP Strattera Convulsion Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5712024 4612417 24 Years M 2/23/2005 3/16/2005 21 MD EXP Strattera Convulsion Other
5712028 4545503     F 12/15/2004 1/3/2005 19 MD EXP Strattera Suicide Attempt Hospitalization - Initial or Prolonged
5712030 4545504 12 Years F 12/1/2004 12/14/2004 1/3/2005 20 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Drug Toxicity, Overdose Other
5712030 4577799 12 Years F 12/1/2004 1/26/2005 2/9/2005 14 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Hyperventilation, Panic Attack Other
5712032 4545506 54 Years M 2/20/2004 12/16/2004 1/3/2005 18 EXP Strattera Depression Anuria, Anxiety, Blood Pressure Increased, Constipation, Dehydration, Dizziness, Dysuria, Homicidal Ideation, Hypotension, Loss of Consciousness, Nightmare, Suicidal Ideation, Syncope, Urinary Retention Hospitalization - Initial or Prolonged
5712032 4572065 54 Years M 1/1/2004 1/13/2005 2/2/2005 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Constipation, Dehydration, Dizziness, Drug Interaction, Dysuria, Homicidal Ideation, Hypertension, Hypotension, Loss of Consciousness, Suicidal Ideation, Syncope, Tachycardia, Urinary Retention Hospitalization - Initial or Prolonged
5712128 4545858 20 Years M 1/4/2005 OT DIR Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Gastrointestinal Haemorrhage, Haematemesis, Hepatic Enzyme Increased, Hepatocellular Damage Disability, Hospitalization - Initial or Prolonged, Life-Threatening
5712194 4545824 6 Years M 12/24/2004 1/5/2005 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Decreased Appetite Other
5712196 4545514 15 Years M 11/25/2004 12/14/2004 1/3/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion Other
5712280 4545547 15 Years M 10/1/2004 12/14/2004 1/3/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blindness, Dizziness, Headache, Pharmaceutical Product Complaint Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5712280 4612415 15 Years M 10/1/2004 3/1/2005 3/16/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blindness Transient, Dizziness, Headache, Syncope Other
5712280 4631278 15 Years M 10/1/2004 3/23/2005 4/6/2005 14 MD EXP Strattera Blindness, Dizziness, Headache Other
5712402 4548055 36 Years F 10/21/2004 1/4/2005 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Dizziness, Fatigue, Heart Rate Increased, Nausea Hospitalization - Initial or Prolonged
5713686 4546647 8 Years M 12/8/2004 1/3/2005 26 MD EXP Atomoxetine Anxiety, Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Condition Aggravated, Drug Ineffective Other
5713686 4564606 8 Years M 1/12/2005 1/26/2005 14 MD EXP Atomoxetine Anxiety, Attention Deficit/Hyperactivity Disorder Aggression, Agitation, Condition Aggravated, Drug Ineffective Other
5713686 4579511 8 Years M 1/26/2005 2/9/2005 14 MD EXP Atomoxetine Anxiety, Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Agitation, Anxiety, Drug Ineffective Other
5713693 4546648 12 Years M 10/1/2004 12/10/2004 1/3/2005 24 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Headache Other
5713736 4498241 49 Years F 6/3/2004 6/8/2004 9/27/2004 111 PER Strattera Emotional Distress, Palpitations
5713738 4498284 7 Years M 6/9/2004 6/11/2004 9/27/2004 108 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Crying
5713739 4498288 50 Years M 6/25/2004 9/27/2004 94 PER Strattera Constipation, Decreased Appetite, Depression, Dizziness, Dry Mouth, Dysuria, Erectile Dysfunction, Fatigue, Libido Decreased, Mood Swings, Prostatic Specific Antigen Increased, Urinary Retention
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5713740 4500178 17 Years F 7/15/2004 9/27/2004 74 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Anorexia, Decreased Appetite, Emotional Distress, Impulsive Behaviour, Irritability, Tearfulness, Weight Decreased
5713744 4500187 26 Years M 7/13/2004 7/13/2004 9/27/2004 76 PER Strattera Attention Deficit/Hyperactivity Disorder Euphoric Mood
5713749 4501205 12 Years M 8/16/2004 9/27/2004 42 PH PER Strattera Retching
5713760 4504722 30 Years M 7/8/2004 7/19/2004 9/27/2004 70 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Insomnia, Irritability, Migraine
5713951 4546848     M 12/17/2004 1/5/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Leukopenia, Thrombocytopenia, Weight Decreased Other
5713951 4564637     M 12/14/2004 1/10/2005 1/26/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Leukopenia, Thrombocytopenia, Weight Decreased Other
5713975 4546852 17 Years M 10/25/2004 12/9/2004 1/5/2005 27 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Bundle Branch Block Right, Excitability, Impulsive Behaviour, Tachycardia Hospitalization - Initial or Prolonged, Other
5713975 4553457 17 Years M 10/25/2004 12/29/2004 1/12/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder, Autism Bundle Branch Block Right, Tachycardia Hospitalization - Initial or Prolonged, Other
5715272 4547164 14 Years M 11/12/2003 12/15/2004 1/5/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Feeling Cold, Haematemesis, Haemoptysis, Nipple Pain, Nipple Swelling, Rhinitis Allergic, Somnolence, Weight Increased Other
5716302 4548333     M 12/20/2004 1/6/2005 17 EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort, Anosmia, Halitosis, Hepatitis A Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5716302 4595434     M 9/1/2003 2/8/2005 2/24/2005 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort, Hepatitis A, Loss of Employment, Skin Odour Abnormal, Stomach Discomfort Other
5716302 4606826     M 9/1/2003 2/28/2005 3/9/2005 9 EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort, Anosmia, Bile Output Abnormal, Malaise, Skin Odour Abnormal
5716306 4548359 17 Years M 1/1/2004 1/4/2005 1/6/2005 2 EXP Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Hepatic Enzyme Increased, Weight Increased Other
5716306 4599161 16 Years M 1/1/2004 2/15/2005 3/3/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Body Height Increased, Fatigue, Hepatic Steatosis, Viral Infection, Weight Increased
5716866 4548411 16 Years M 12/20/2004 1/6/2005 17 EXP Strattera Abdominal Pain Upper Other
5716870 4548414     F 8/24/2004 12/20/2004 1/6/2005 17 EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5716876 4548417 7 Years M 12/21/2004 1/6/2005 16 EXP Strattera Abdominal Pain, Blood Urine Present, Influenza Like Illness, Vomiting Other
5716876 4595435 7 Years M 12/23/2004 2/8/2005 2/24/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Blood Cholesterol Increased, Blood Immunoglobulin A Increased, Blood Triglycerides Increased, Blood Urine Present, Chromaturia, Influenza Like Illness, Vomiting Other
5716895 4548718 9 Years F 1/1/2004 12/20/2004 1/6/2005 17 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Coma, Dizziness, Encephalitis Viral, Eye Rolling, Fatigue, Feeling Abnormal, General Physical Health Deterioration, Insomnia, Mood Swings, Rash Papular, Speech Disorder, Stomach Discomfort Hospitalization - Initial or Prolonged, Other
5717083 4547307 52 Years M 10/1/2004 12/17/2004 1/5/2005 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Cerebral Cyst, Hypoaesthesia, Paraesthesia Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5717084 4547309     M 12/17/2004 1/5/2005 19 EXP Strattera Decreased Appetite, Pallor, Pruritus, Weight Decreased
5717084 4572040     M 1/14/2005 2/2/2005 19 EXP Strattera Decreased Appetite, Eye Disorder, Pruritus, Skin Discolouration, Weight Decreased
5717087 4547310 53 Years M 12/1/2004 12/17/2004 1/5/2005 19 OT EXP Strattera Back Pain, Chromaturia, Pruritus
5717087 4560907 53 Years M 12/1/2004 1/3/2005 1/21/2005 18 OT EXP Strattera Back Pain, Chromaturia, Pruritus
5717231 4535532 55 Years M 9/13/2004 12/14/2004 92 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Lethargy, Middle Insomnia, Urinary Hesitation
5717231 4581948 55 Years M 9/13/2004 1/27/2005 136 OT PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Lethargy, Middle Insomnia, Urinary Hesitation
5717429 4551655 12 Years M 12/21/2004 1/12/2005 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5717429 4588769 10 Years M 12/17/2004 1/26/2005 2/16/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5717429 4626577 13 Years M 3/1/2005 3/10/2005 3/30/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatic Steatosis Other
5717429 4658591 13 Years M 5/1/2005 4/19/2005 5/9/2005 20 MD EXP Strattera Hepatic Steatosis Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5717430 4551658 16 Years M 12/20/2004 1/12/2005 23 EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Albumin Increased
5717430 4612412 16 Years M 9/22/2004 3/1/2005 3/16/2005 15 CN EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Malaise
5717430 4648779 16 Years M 9/22/2004 4/11/2005 4/27/2005 16 EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Albumin Increased, Blood Lactate Dehydrogenase Increased, Ceruloplasmin Decreased
5717430 4674535 16 Years M 9/22/2004 4/11/2005 5/24/2005 43 EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Albumin Increased, Blood Lactate Dehydrogenase Increased, Ceruloplasmin Decreased, Liver Function Test Abnormal, Malaise
5717430 4687181 16 Years M 9/22/2004 5/24/2005 6/7/2005 14 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Ceruloplasmin Decreased, Sinusitis
5717430 4746264 16 Years M 9/22/2004 7/27/2005 8/16/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Glucose Decreased, Blood Lactate Dehydrogenase Increased, Ceruloplasmin Decreased, Hypoglycaemia, Malaise, Sinusitis
5717649 4552048 6 Years M 12/29/2004 1/12/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blindness Unilateral, Eye Disorder Other
5717659 4552050 8 Years F 1/1/2004 12/27/2004 1/12/2005 16 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Electrocardiogram Low Voltage, Ventricular Hypertrophy Other
5717659 4572045 7 Years F 1/1/2004 1/12/2005 2/2/2005 21 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Decreased, Respiratory Rate Increased, Therapy Non-Responder
5717763 4552098     M 11/1/2004 12/22/2004 1/12/2005 21 EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5717763 4612414 50 Years M 11/1/2004 2/25/2005 3/16/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased
5717763 4703914 50 Years M 11/1/2004 6/9/2005 6/28/2005 19 MD EXP Strattera Alanine Aminotransferase Increased
5717772 4552100 35 Years F 12/22/2004 1/12/2005 21 EXP Strattera Abdominal Pain Upper, Hepatic Haemorrhage, Hepatic Mass, Hepatocellular Damage
5717777 4552101 12 Years F 12/18/2004 12/22/2004 1/12/2005 21 EXP Strattera Angina Pectoris, Crying, Dizziness, Fall, Fatigue, Fear Other
5717793 4552105     F 12/22/2004 1/12/2005 21 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Hypertension, Protein Urine Present Other
5717793 4579384     F 1/25/2005 2/9/2005 15 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Agitation, Creatinine Renal Clearance Decreased, Electrocardiogram Abnormal, Hypertension, Proteinuria Other
5717793 4631298     F 3/21/2005 4/6/2005 16 OT EXP Strattera Aggression, Agitation, Condition Aggravated, Creatinine Renal Clearance Decreased, Electrocardiogram Abnormal, Hypertension, Oedema Peripheral, Proteinuria, Speech Disorder Other
5717803 4552108 52 Years M 12/1/2004 12/29/2004 1/12/2005 14 EXP Strattera Disturbance in Attention Benign Prostatic Hyperplasia, Blood Urine Present, Formication Other
5717803 4561095 52 Years M 10/1/2004 1/7/2005 1/21/2005 14 EXP Strattera Disturbance in Attention Discomfort, Formication
5717829 4552110 7 Years M 11/18/2004 12/29/2004 1/12/2005 14 EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Hepatic Cirrhosis, Intussusception, Liver Disorder Hospitalization - Initial or Prolonged, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5717829 4566632 7 Years M 11/18/2004 1/10/2005 1/26/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Alanine Aminotransferase Increased, Blood Glucose Increased, Intussusception, Ultrasound Liver Abnormal, Vomiting Hospitalization - Initial or Prolonged, Other
5717829 4588770 7 Years M 11/18/2004 2/2/2005 2/16/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Increased, Hepatic Cirrhosis, Intussusception Hospitalization - Initial or Prolonged, Other
5717894 4552114 17 Years M 11/13/2004 12/22/2004 1/12/2005 21 MD EXP Strattera Disturbance in Attention Confusional State, Hallucination Hospitalization - Initial or Prolonged
5717894 4567105 17 Years M 11/13/2004 1/4/2005 1/26/2005 22 MD EXP Strattera Distractibility Hallucination, Mental Disorder Hospitalization - Initial or Prolonged
5717894 4577800 17 Years M 11/13/2004 1/25/2005 2/9/2005 15 MD EXP Strattera Distractibility Aggression, Distractibility, Hallucination, Insomnia Hospitalization - Initial or Prolonged
5717974 4552130     F 12/23/2004 1/12/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Infection, Psychotic Disorder Hospitalization - Initial or Prolonged
5717974 4599402     F 10/12/2004 1/27/2005 107 MD PER Strattera Drug Interaction, Infection, Psychotic Disorder
5717985 4552132 53 Years M 12/1/2004 12/22/2004 1/12/2005 21 OT EXP Strattera Back Pain, Blood Albumin Increased, Chromaturia, Dizziness, Pruritus
5717985 4566631 53 Years M 12/1/2004 1/10/2005 1/26/2005 16 OT EXP Strattera Back Pain, Blood Albumin Increased, Chromaturia, Dizziness, Protein Total Increased, Pruritus
5717985 4603014 53 Years M 12/1/2004 1/10/2005 2/14/2005 35 OT PER Strattera Back Pain, Chromaturia, Dizziness, Pruritus
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5719497 4531279 54 Years F 10/5/2004 12/6/2004 62 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Hot Flush, Insomnia
5719497 4576631 54 Years F 10/5/2004 1/27/2005 114 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Hot Flush, Insomnia
5720923 4553479     M 12/9/2004 12/23/2004 1/12/2005 20 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Lymphopenia, Neutropenia, Thrombocytopenia, Weight Decreased Other
5720923 4625646     M 12/9/2004 3/14/2005 3/30/2005 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Lymphopenia, Neutropenia, Thrombocytopenia, Weight Decreased Other
5723629 4497298 14 Years M 1/1/2004 7/22/2004 9/27/2004 67 PER Strattera Attention Deficit/Hyperactivity Disorder Contusion, Fatigue, Heart Rate Increased, Weight Decreased
5724361 4559192 9 Years F 1/5/2005 1/21/2005 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Blood Disorder, Coagulation Time Prolonged, Contusion Required Intervention to Prevent Permanent Impairment/Damage
5724539 4559000 15 Years F 3/1/2004 1/21/2005 DIR Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anxiety, Feeling Abnormal, Obsessive Thoughts, Thinking Abnormal Hospitalization - Initial or Prolonged, Other
5725544 4561538 40 Years M 12/21/2004 1/21/2005 31 OT EXP Strattera Syncope Other
5725544 4572046 40 Years M 1/17/2005 2/2/2005 16 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Diastolic Decreased, Blood Pressure Diastolic Increased, Blood Pressure Systolic Increased, Convulsion, Syncope Other
5726606 4504000 63 Years M 4/1/2004 6/29/2004 9/27/2004 90 CN PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dizziness, Insomnia, Micturition Urgency, Pollakiuria, Prostatic Specific Antigen Increased, Sexual Dysfunction, Urine Output Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5726606 4726703 63 Years M 4/1/2004 4/12/2005 7/25/2005 104 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dizziness, Insomnia, Micturition Urgency, Pollakiuria, Prostatic Specific Antigen Increased, Sexual Dysfunction, Urine Output Decreased
5726743 4561550 9 Years M 1/1/2004 1/3/2005 1/21/2005 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Liver Function Test Abnormal
5727033 4561462 12 Years 1/5/2005 1/21/2005 16 MD EXP Strattera Mitral Valve Incompetence Other
5727033 4572066 12 Years 1/18/2005 2/2/2005 15 MD EXP Strattera Mitral Valve Incompetence Other
5727042 4561463 38 Years F 1/5/2005 1/21/2005 16 EXP Strattera Cardiac Murmur, Chest Pain, Mitral Valve Incompetence, Tricuspid Valve Incompetence Other
5727300 4562442 11 Years M 11/1/2004 1/4/2005 1/21/2005 17 MD EXP Strattera Pain, Pancreatitis, Viral Infection Other
5727303 4562464 9 Years M 12/1/2004 12/29/2004 1/21/2005 23 EXP Strattera Attention Deficit/Hyperactivity Disorder Jaundice, Pharyngolaryngeal Pain
5727307 4562465 37 Years F 1/1/2004 12/30/2004 1/21/2005 22 EXP Strattera Attention Deficit/Hyperactivity Disorder Cardiomyopathy, Chest Pain, Condition Aggravated, Dyspnoea Other
5727308 4562466 9 Years F 12/29/2004 1/21/2005 23 EXP Strattera Coagulation Time Prolonged, Contusion Other
5728342 4562296 12 Years 1/5/2005 1/21/2005 16 MD EXP Strattera Mitral Valve Incompetence Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5728350 4562298 9 Years F 1/1/2004 1/4/2005 1/21/2005 17 EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion Other
5728351 4562299 14 Years M 1/4/2005 1/21/2005 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatitis, Mononucleosis Syndrome Other
5728351 4566630 14 Years M 1/10/2005 1/26/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatitis, Infectious Mononucleosis Other
5728351 4588773 14 Years M 1/2/2004 2/1/2005 2/16/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatitis, Infectious Mononucleosis, Platelet Count Decreased Other
5729130 4564004 9 Years M 12/1/2004 1/11/2005 1/26/2005 15 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Dehydration, Hallucination, Nausea, Oral Intake Reduced, Thinking Abnormal, Vomiting, Weight Decreased Other
5729135 4564006 14 Years M 12/14/2004 1/6/2005 1/26/2005 20 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Bilirubin Increased, Condition Aggravated, Epilepsy, Leukopenia, Lymphopenia, Neutropenia, Thrombocytopenia, Weight Decreased Other
5729135 4625647 14 Years M 12/14/2004 3/14/2005 3/30/2005 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Bilirubin Increased, Condition Aggravated, Epilepsy, Leukopenia, Lymphopenia, Neutropenia, Thrombocytopenia, Weight Decreased Other
5729653 4565545 31 Years M 1/1/2005 1/10/2005 1/26/2005 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Anxiety, Bone Disorder, Chromaturia, Cough, Formication, Influenza Like Illness, Restlessness, Speech Disorder
5729653 4606823 31 Years M 1/3/2005 2/21/2005 3/9/2005 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anxiety, Bone Disorder, Chromaturia, Condition Aggravated, Cough, Formication, Influenza Like Illness, Oedema Peripheral, Pain, Panic Attack, Restlessness, Speech Disorder
5729657 4565547 70 Years F 1/11/2005 1/26/2005 15 MD EXP Strattera Disturbance in Attention Malignant Hypertension Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5729692 4565553 15 Years M 12/3/2004 1/6/2005 1/26/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Decreased Appetite, Disturbance in Attention, Fatigue, Feeling Abnormal, Nausea, Vomiting, Weight Decreased
5729692 4576928 15 Years M 12/3/2004 1/17/2005 2/8/2005 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Decreased Appetite, Disturbance in Attention, Fatigue, Feeling Abnormal, Irritability, Monocytosis, Nausea, Viral Infection, Vomiting, Weight Decreased
5729692 4595409 15 Years M 12/3/2004 2/8/2005 2/24/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Aspartate Aminotransferase Increased, Decreased Appetite, Fatigue, Feeling Abnormal, Irritability, Monocytosis, Nausea, Viral Infection, Vomiting, Weight Decreased
5729740 4565554 5 Years M 1/7/2005 1/26/2005 19 MD EXP Strattera Electrocardiogram Abnormal Other
5729743 4565555 14 Years M 1/5/2005 1/26/2005 21 MD EXP Strattera Syncope Other
5729745 4565557     F 1/10/2005 1/26/2005 16 MD EXP Strattera Liver Disorder, Tachycardia
5729745 4579385 16 Years F 9/21/2004 1/19/2005 2/9/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Tachycardia
5729754 4565558 50 Years F 1/10/2005 1/26/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased
5729764 4565560     M 1/6/2005 1/26/2005 20 MD EXP Strattera Abdominal Pain Upper, Blood Alkaline Phosphatase Increased, Distractibility, Nausea
5729764 4613143 6 Years M 4/15/2004 2/23/2005 3/16/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Aspartate Aminotransferase Increased, Blood Albumin Abnormal, Blood Alkaline Phosphatase Increased, Distractibility, Nausea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5729789 4565561 9 Years M 1/8/2005 1/10/2005 1/26/2005 16 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anger, Irritability Hospitalization - Initial or Prolonged
5729789 4607091 9 Years M 1/8/2005 3/2/2005 3/9/2005 7 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anger, Asthma, Autism Spectrum Disorder, Bipolar Disorder, Family Stress, Hallucination (Auditory), Irritability, Laboratory Test Abnormal, Oppositional Defiant Disorder, Psychotic Disorder, Schizophrenia, Sleep Disorder, Therapeutic Response Decreased Hospitalization - Initial or Prolonged
5729789 4612422 9 Years M 1/8/2005 3/2/2005 3/16/2005 14 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anger, Autism Spectrum Disorder, Bipolar Disorder, Condition Aggravated, Crying, Hallucination (Auditory), Insomnia, Irritability, Oppositional Defiant Disorder, Psychotic Disorder, Schizophrenia, Stress Hospitalization - Initial or Prolonged, Other
5729789 4687165 9 Years M 1/8/2005 5/24/2005 6/7/2005 14 MD EXP Atomoxetine Aggression, Hallucination (Auditory), Insomnia, Irritability, Oppositional Defiant Disorder, Physical Assault Hospitalization - Initial or Prolonged, Other
5729894 4565685 11 Years M 1/4/2005 1/26/2005 22 MD EXP Strattera Hepatic Enzyme Increased
5730342 4566330 12 Years M 1/26/2005 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Anger, Irritability, Mood Altered Other
5730562 4565328 7 Years F 1/10/2005 1/26/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Depressed Mood, Screaming, Suicidal Ideation Other
5730562 4569551 7 Years F 1/10/2005 2/1/2005 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Condition Aggravated, Depressed Mood, Screaming, Self Esteem Decreased, Suicidal Ideation, Therapy Non-Responder Other
5730714 4565604     M 1/10/2005 1/26/2005 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased
5730717 4565605     F 1/5/2005 1/26/2005 21 MD EXP Strattera Liver Function Test Abnormal, Viral Infection
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5730724 4565606 9 Years M 1/6/2005 1/26/2005 20 OT EXP Strattera Hepatic Enzyme Increased Hospitalization - Initial or Prolonged
5730724 4579382 9 Years M 12/15/2004 1/20/2005 2/9/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort, Alanine Aminotransferase Increased, Anorexia, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Encephalopathy, Lethargy, Pyrexia, Retching, Vomiting Hospitalization - Initial or Prolonged
5731386 4567102 26 Years M 11/18/2004 11/18/2004 1/14/2005 1/26/2005 12 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Drug Toxicity, Hepatic Failure, International Normalised Ratio Increased, Malaise, Overdose, Prothrombin Time Prolonged, Renal Failure, Vomiting Death
5731386 4576930 26 Years M 11/18/2004 11/18/2004 1/27/2005 2/8/2005 12 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Drug Toxicity, Hepatic Failure, Malaise, Renal Failure, Vomiting Death
5731387 4567103 21 Years M 12/23/2004 1/4/2005 1/26/2005 22 EXP Strattera Aspartate Aminotransferase Increased
5731390 4567104 15 Years M 12/23/2004 1/4/2005 1/26/2005 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5733555 4570240 47 Years M 1/24/2005 1/27/2005 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Orgasm Abnormal, Testicular Pain Other
5733724 4569489 12 Years M 1/10/2005 2/1/2005 22 MD EXP Strattera Hepatic Enzyme Increased
5733728 4569491 12 Years 1/10/2005 2/1/2005 22 MD EXP Strattera Hepatic Enzyme Increased
5733728 4579386 15 Years F 10/1/2004 1/24/2005 2/9/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Arthralgia, Aspartate Aminotransferase Increased, Asthma Exercise Induced, Fall, Infectious Mononucleosis, Joint Sprain, Onychomycosis, Sleep Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5733999 4570515 7 Years F 12/1/2004 2/3/2005 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Local Swelling, Thrombosis Hospitalization - Initial or Prolonged
5735831 4571989 15 Years F 12/3/2004 2/3/2005 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anxiety, Crying, Disturbance in Attention, Impaired Work Ability, Insomnia, Mood Altered, School Refusal, Social Avoidant Behaviour Other
5736077 4571921 51 Years F 11/20/2004 2/3/2005 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Arthralgia, Coma, Confusional State, Coordination Abnormal, Grand Mal Convulsion, Nausea, Pyrexia, Vomiting Life-Threatening
5736118 4571153 8 Years 11/1/2004 1/14/2005 2/2/2005 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Headache, Tic Hospitalization - Initial or Prolonged
5736123 4571154 15 Years M 1/18/2005 2/2/2005 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Depressed Mood, Suicidal Ideation Disability, Life-Threatening
5736123 4577924 15 Years M 1/18/2005 2/9/2005 22 EXP Strattera Attention Deficit/Hyperactivity Disorder Depressed Mood, Suicidal Ideation Disability, Life-Threatening
5736128 4571155 52 Years M 11/1/2004 1/19/2005 2/2/2005 14 PH EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Benign Prostatic Hyperplasia Other
5736143 4571158 7 Years M 11/24/2004 1/14/2005 2/2/2005 19 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Anger, Anxiety, Diet Refusal, Mental Disorder, Mood Swings, Social Avoidant Behaviour Other
5736193 4576657 37 Years M 10/7/2004 1/27/2005 112 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Jittery, Insomnia, Nervousness, Restlessness
5736194 4576658 57 Years F 10/6/2004 1/27/2005 113 PH PER Strattera Attention Deficit/Hyperactivity Disorder Hyperhidrosis, Nail Discolouration
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5736196 4576659 42 Years F 10/7/2004 1/27/2005 112 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Constipation, Dizziness, Nausea, Vomiting, Weight Decreased
5736196 4726709 42 Years F 3/2/2005 7/25/2005 145 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Anorexia, Constipation, Cystitis, Dizziness, Drug Ineffective, Erythema, Fatigue, Malaise, Nausea, Pain, Stomach Discomfort, Vomiting, Weight Decreased
5736197 4576660 7 Years M 10/6/2004 1/27/2005 113 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Psychomotor Hyperactivity, Somnolence
5736198 4575685 6 Years F 9/29/2004 1/27/2005 120 CN PER Strattera Trichorrhexis
5736199 4576661 28 Years M 10/4/2004 10/7/2004 1/27/2005 112 PER Strattera Chest Pain, Constipation, Erectile Dysfunction, Feeling Jittery, Heart Rate Increased, Insomnia, Premature Ejaculation, Sexual Dysfunction
5736200 4576662 14 Years F 6/1/2004 10/7/2004 1/27/2005 112 PER Strattera Attention Deficit/Hyperactivity Disorder Schamberg's Disease
5736201 4576663 30 Years F 10/7/2004 1/27/2005 112 PER Strattera Attention Deficit/Hyperactivity Disorder
5736202 4575686 65 Years F 9/28/2004 1/27/2005 121 CN PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Decreased Appetite, Dizziness, Dry Mouth, Dysuria, Fatigue, Nausea, Somnolence
5736203 4576664 8 Years M 10/7/2004 1/27/2005 112 MD PER Strattera Attention Deficit/Hyperactivity Disorder Rash Macular
5736204 4576665     F 10/7/2004 1/27/2005 112 PER Strattera Drug Screen Positive
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5736205 4575687 37 Years M 9/1/2004 9/28/2004 1/27/2005 121 CN PER Strattera Attention Deficit/Hyperactivity Disorder Erythema, Rash, Rash Papular
5736206 4576666 22 Years M 10/7/2004 1/27/2005 112 PER Strattera Drug Ineffective, Feeling Abnormal
5736207 4575690 14 Years M 9/29/2004 1/27/2005 120 CN PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Fatigue, Somnolence, Weight Increased
5736209 4575692 41 Years F 10/25/2004 1/27/2005 94 CN PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dizziness, Sleep Disorder, Somnolence, Thirst
5736210 4575699 7 Years F 9/28/2004 9/29/2004 1/27/2005 120 CN PER Strattera Disturbance in Attention Stomach Discomfort
5736211 4575700     M 9/29/2004 1/27/2005 120 OT PER Strattera Asthenia
5736212 4575702 40 Years 9/29/2004 1/27/2005 120 OT PER Strattera Asthenia
5736213 4575704 8 Years F 9/29/2004 1/27/2005 120 MD PER Strattera Attention Deficit/Hyperactivity Disorder Confusional State, Fatigue
5736217 4575706     F 9/28/2004 1/27/2005 121 MD PER Strattera Weight Increased
5736219 4576647 35 Years F 11/19/2004 1/27/2005 69 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Feeling Abnormal, Menstrual Disorder, Menstruation Irregular, Nausea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5736221 4576648 6 Years M 1/1/2003 11/19/2004 1/27/2005 69 CN PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Attention Deficit Hyperactivity Disorder, Drug Ineffective, Mood Swings, Self Injurious Behaviour
5736222 4576649 17 Years M 11/17/2004 11/19/2004 1/27/2005 69 CN PER Strattera Attention Deficit/Hyperactivity Disorder Jaw Fracture, Road Traffic Accident
5736223 4576650 40 Years F 11/19/2004 11/19/2004 1/27/2005 69 CN PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Stomach Discomfort, Vomiting
5736224 4576651     M 11/19/2004 1/27/2005 69 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger
5736225 4576652 7 Years M 11/19/2004 1/27/2005 69 CN PER Strattera Attention Deficit/Hyperactivity Disorder Blepharospasm, Tic
5736227 4576653 9 Years M 5/1/2004 11/19/2004 1/27/2005 69 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Lethargy, Somnolence
5736230 4576654 32 Years F 11/19/2004 11/19/2004 1/27/2005 69 CN PER Strattera Attention Deficit/Hyperactivity Disorder Balance Disorder, Dizziness, Feeling Abnormal, Hypoaesthesia Oral
5736231 4637315 56 Years F 9/1/2004 11/19/2004 3/28/2005 129 CN PER Strattera Chromaturia, Diarrhoea, Influenza Like Illness, Malaise, Pruritus, Weight Decreased
5736232 4576656 8 Years F 1/1/2004 11/22/2004 1/27/2005 66 CN PER Strattera Distractibility, Disturbance in Attention, Drug Ineffective, Fatigue, Hearing Impaired, Insomnia
5736249 4576627 44 Years M 10/3/2004 11/11/2004 1/27/2005 77 MD PER Strattera Attention Deficit/Hyperactivity Disorder Haematuria, Urinary Retention
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5736251 4576628 15 Years M 10/5/2004 1/27/2005 114 PER Strattera Attention Deficit/Hyperactivity Disorder Excitability, Initial Insomnia
5736252 4576629 9 Years F 1/1/2004 10/4/2004 1/27/2005 115 OT PER Strattera Attention Deficit/Hyperactivity Disorder Choking, Crying, Fear, Retching
5736255 4576630 12 Years M 10/5/2004 1/27/2005 114 MD PER Strattera Attention Deficit/Hyperactivity Disorder Obsessive-Compulsive Disorder
5736255 4599407 16 Years M 10/12/2004 1/27/2005 107 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
5736261 4576632 7 Years M 10/5/2004 1/27/2005 114 CN PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Cyanosis, Feeling Cold
5736264 4576633     F 10/4/2004 1/27/2005 115 MD PER Strattera Trichotillomania
5736266 4576634 27 Years M 10/5/2004 1/27/2005 114 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Dry Mouth, Nausea, Somnolence
5736269 4576635 20 Years F 10/4/2004 10/5/2004 1/27/2005 114 PER Strattera Attention Deficit/Hyperactivity Disorder
5736271 4576636 8 Years M 10/5/2004 1/27/2005 114 PER Strattera Psychomotor Hyperactivity
5736272 4576637 15 Years M 10/5/2004 10/6/2004 1/27/2005 113 OT PER Strattera Attention Deficit/Hyperactivity Disorder Mydriasis, Pupillary Reflex Impaired
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5736276 4576638 35 Years F 10/5/2004 10/6/2004 1/27/2005 113 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Dry Mouth, Insomnia, Paraesthesia, Stomach Discomfort
5736280 4576639 12 Years M 10/5/2004 1/27/2005 114 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Flushing, Lethargy, Nausea, Stomach Discomfort
5736282 4576640 8 Years M 1/1/2004 12/1/2004 1/27/2005 57 OT PER Strattera Attention Deficit/Hyperactivity Disorder Choreoathetosis, Pharyngitis Streptococcal
5736282 4637354 8 Years M 1/1/2004 12/1/2004 3/28/2005 117 OT PER Strattera Choreoathetosis, Pharyngitis Streptococcal
5736284 4576641 9 Years M 9/1/2004 10/5/2004 1/27/2005 114 CN PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Decreased Appetite, Disturbance in Attention, Emotional Distress, Headache, Insomnia, Mood Swings, Stomach Discomfort, Weight Decreased
5736286 4576642 14 Years F 10/6/2004 1/27/2005 113 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anger
5736289 4576643 6 Years M 10/6/2004 1/27/2005 113 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Feeling Abnormal, Pallor, Somnolence
5736291 4576644 17 Years F 10/6/2004 1/27/2005 113 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anger
5736293 4576645     M 9/1/2004 10/6/2004 1/27/2005 113 MD PER Strattera Irritability, Sleep Disorder
5736294 4576646 16 Years 10/6/2004 1/27/2005 113 MD PER Strattera Drug Screen Positive
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5736300 4575762 13 Years F 9/30/2004 1/27/2005 119 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Paraesthesia
5736301 4575765 7 Years M 6/1/2004 9/30/2004 1/27/2005 119 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
5736302 4575769 24 Years M 9/28/2004 10/26/2004 1/27/2005 93 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Disturbance in Attention, Ejaculation Disorder, Erectile Dysfunction, Sleep Disorder
5736303 4575773 6 Years M 9/29/2004 1/27/2005 120 PER Strattera Insomnia, Nervousness
5736304 4575775 6 Years M 9/29/2004 1/27/2005 120 MD PER Strattera Hallucination (Auditory)
5736305 4575776 39 Years F 9/29/2004 9/30/2004 1/27/2005 119 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Abnormal, Headache, Nausea, Paraesthesia
5736306 4575815 48 Years F 9/28/2004 1/27/2005 121 MD PER Strattera Attention Deficit/Hyperactivity Disorder Restless Legs Syndrome
5736307 4575817     M 9/30/2004 1/27/2005 119 MD PER Strattera Hyperacusis, Palpitations
5736308 4575819 10 Years M 10/4/2004 1/27/2005 115 PER Strattera Attention Deficit/Hyperactivity Disorder Impulsive Behaviour, Psychomotor Hyperactivity, Restlessness, Stomach Discomfort, Weight Increased
5736309 4575820 9 Years M 9/1/2004 9/29/2004 1/27/2005 120 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anger
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5736310 4575711     F 9/29/2004 1/27/2005 120 PH PER Strattera
5736311 4575712 24 Years M 9/29/2004 1/27/2005 120 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Prostatic Pain
5736312 4575723 5 Years M 9/27/2004 9/29/2004 1/27/2005 120 PER Strattera Retching
5736313 4575724 58 Years M 9/1/2004 9/29/2004 1/17/2005 110 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased Other
5736314 4575726 6 Years M 9/29/2004 1/27/2005 120 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Decreased Appetite, Impulse-Control Disorder, Insomnia, Somnolence
5736315 4575727 17 Years M 9/1/2004 9/30/2004 1/27/2005 119 PER Strattera Aggression, Anger, Restlessness
5736316 4575732 11 Years M 9/29/2004 1/27/2005 120 OT PER Strattera Insomnia, Screaming
5736317 4575742 22 Years F 9/30/2004 10/7/2004 1/27/2005 112 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Lower, Chest Discomfort, Feeling Abnormal, Nausea
5736318 4575755 16 Years M 9/30/2004 1/27/2005 119 PER Strattera Attention Deficit/Hyperactivity Disorder Road Traffic Accident
5736319 4575758     M 9/29/2004 1/27/2005 120 PER Strattera Attention Deficit/Hyperactivity Disorder Eye Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5736321 4575824 5 Years M 9/30/2004 1/27/2005 119 PER Strattera Attention Deficit/Hyperactivity Disorder Dysphemia
5736326 4575826     F 9/1/2004 9/30/2004 1/27/2005 119 PER Strattera Balance Disorder, Headache, Middle Insomnia, Nausea
5736328 4575827     F 10/8/2004 1/27/2005 111 PER Strattera Attention Deficit/Hyperactivity Disorder Laziness, Somnolence
5736329 4575844 11 Years M 9/30/2004 1/27/2005 119 OT PER Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder, Gastrointestinal Disorder, Mania
5736331 4575878 30 Years M 10/1/2004 1/27/2005 118 PER Strattera Abnormal Behaviour, Depression, Stress
5736332 4575881 9 Years M 1/1/2004 10/1/2004 1/27/2005 118 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Stomach Discomfort
5736334 4575895     9/30/2004 1/27/2005 119 MD PER Strattera White Blood Cell Count Increased
5736347 4576596 13 Years M 10/4/2004 10/19/2004 1/27/2005 100 PER Strattera Attention Deficit/Hyperactivity Disorder Headache
5736348 4576597 11 Years F 4/1/2003 10/4/2004 1/27/2005 115 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
5736350 4576598 24 Years M 10/5/2004 1/27/2005 114 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Genital Disorder Male, Heart Rate Increased, Heart Rate Irregular, Insomnia, Palpitations, Urinary Hesitation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5736350 4637352 24 Years M 10/5/2004 3/28/2005 174 MD PER Strattera Drug Ineffective, Genital Disorder Male, Heart Rate Increased, Heart Rate Irregular, Insomnia, Palpitations, Urinary Hesitation
5736352 4576599     M 1/1/2004 10/4/2004 1/27/2005 115 MD PER Strattera Groin Pain
5736355 4576600 64 Years F 9/29/2004 10/4/2004 1/27/2005 115 CN PER Strattera Fatigue Asthenia, Fatigue, Feeling Jittery, Heart Rate Increased, Nervousness, Somnolence
5736357 4576601 16 Years 9/16/2004 1/27/2005 133 MD PER Strattera Anger, Irritability, Mood Swings
5736357 4637353 16 Years 9/16/2004 3/28/2005 193 MD PER Strattera Anger, Irritability, Mood Swings
5736360 4576602 5 Years M 10/1/2004 1/27/2005 118 PER Strattera Abnormal Behaviour
5736366 4576603 10 Years M 10/4/2004 1/27/2005 115 CN PER Strattera Dizziness, Headache, Increased Appetite, Personality Change
5736368 4576604     9/16/2004 1/27/2005 133 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia
5736369 4576605 14 Years M 10/1/2004 10/5/2004 1/27/2005 114 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective
5736372 4575608 6 Years M 9/1/2004 9/8/2004 1/27/2005 141 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Disturbance in Attention, Drug Ineffective, Impulsive Behaviour
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5736375 4575610 16 Years F 8/31/2004 9/7/2004 1/27/2005 142 CN PER Strattera Crying, Emotional Distress, Fatigue
5736376 4575659 6 Years M 8/1/2004 10/20/2004 1/27/2005 99 CN PER Strattera Attention Deficit/Hyperactivity Disorder Repetitive Speech
5736379 4575664 5 Years F 10/20/2004 10/20/2004 1/27/2005 99 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Decreased Appetite, Dizziness, Urinary Hesitation
5736387 4575665 61 Years M 10/17/2004 10/21/2004 1/27/2005 98 OT PER Strattera Dizziness, Feeling Abnormal, Hot Flush
5736393 4575667 23 Years F 1/1/2004 10/20/2004 1/27/2005 99 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Fatigue, Nausea
5736395 4575680     F 10/20/2004 1/27/2005 99 MD PER Strattera Deafness, Oedema Mouth, Swollen Tongue
5736398 4575681 5 Years M 6/1/2004 10/21/2004 1/27/2005 98 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Abdominal Pain Upper, Aggression, Drug Ineffective, Eczema, Feeling Abnormal, Hunger, Mydriasis, Pruritus, Rash Papular, Tremor, Weight Decreased
5736404 4575682 8 Years M 10/20/2004 1/27/2005 99 MD PER Strattera Anxiety, Dysphoria, Nausea
5736406 4571178 7 Years F 1/1/2005 1/19/2005 2/2/2005 14 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Agitation, Drug Ineffective, Mood Swings Other
5736406 4588065 7 Years F 1/1/2005 1/31/2005 2/16/2005 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Agitation, Attention-Seeking Behaviour, Drug Ineffective, Mood Swings, Suicide Attempt Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5736407 4575683 13 Years M 10/20/2004 10/21/2004 1/27/2005 98 PER Strattera Attention Deficit/Hyperactivity Disorder Epistaxis, Increased Appetite, Weight Increased
5736414 4575911 40 Years F 9/25/2004 10/1/2004 1/27/2005 118 PER Strattera Decreased Appetite, Dizziness, Hyperhidrosis, Nausea Other
5736417 4575924     M 9/30/2004 1/27/2005 119 PER Strattera Drug Ineffective, Growth Retardation
5736418 4575929     F 9/1/2004 10/1/2004 1/27/2005 118 PER Strattera Blood Glucose Increased, Glycosylated Haemoglobin Increased
5736431 4575952 12 Years F 1/1/2004 10/1/2004 1/27/2005 118 CN PER Strattera Attention Deficit/Hyperactivity Disorder Blepharospasm, Dyskinesia, Dystonia, Pruritus
5736434 4575960 44 Years M 10/2/2004 10/4/2004 1/27/2005 115 CN PER Strattera Aggression, Apathy, Feeling Abnormal, Hypokinesia
5736445 4575964 6 Years M 10/1/2004 10/4/2003 1/27/2005 481 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Decreased Appetite, Feeling Abnormal, Nausea
5736446 4575978 8 Years M 9/1/2004 10/1/2004 1/27/2005 118 CN PER Strattera Disturbance in Attention Stomach Discomfort, Toothache, Vomiting
5736452 4575992 41 Years M 10/4/2004 1/27/2005 115 MD PER Strattera Attention Deficit/Hyperactivity Disorder Priapism
5736454 4575997 8 Years M 10/4/2004 1/27/2005 115 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Distractibility, Nervousness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5736464 4576004 61 Years F 10/1/2004 1/27/2005 118 CN PER Strattera Blood Pressure Increased, Influenza Like Illness, Pharyngolaryngeal Pain, Pyrexia, Rhinorrhoea
5736465 4576011 9 Years F 10/4/2004 1/27/2005 115 CN PER Strattera Attention Deficit/Hyperactivity Disorder Stomach Discomfort
5736466 4576018 14 Years M 10/4/2004 1/27/2005 115 CN PER Strattera Disturbance in Attention Fatigue, Sluggishness
5736469 4576024 12 Years 9/30/2004 1/27/2005 119 MD PER Strattera Rectal Haemorrhage
5736735 4571168 21 Years M 1/1/2004 1/18/2005 2/2/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Cerebral Haematoma, Coma, Delusion, Drug Interaction, Hepatic Trauma, Intentional Self-Injury, Persecutory Delusion, Renal Injury Hospitalization - Initial or Prolonged, Life-Threatening, Other
5736735 4614034 20 Years M 1/1/2004 3/1/2005 3/16/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Cerebral Haematoma, Coma, Delusion, Drug Interaction, Hepatic Trauma, Intentional Self-Injury, Persecutory Delusion, Renal Injury Hospitalization - Initial or Prolonged, Life-Threatening, Other
5736738 4571169 10 Years F 1/4/2005 1/17/2005 2/2/2005 16 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Contusion, Headache, Vomiting Other
5736961 4572191 54 Years F 1/11/2005 2/2/2005 22 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5736961 4588786 54 Years F 1/26/2005 2/16/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Sleep Disorder
5736961 4618713 54 Years F 11/15/2004 3/7/2005 3/24/2005 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, High Density Lipoprotein Increased, Insomnia, Low Density Lipoprotein Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5736961 4631276 54 Years F 11/15/2004 3/23/2005 4/6/2005 14 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Glucose Increased, Hepatitis B Surface Antigen Positive, High Density Lipoprotein Increased, Hypertension, Insomnia, Low Density Lipoprotein Increased
5737002 4572194 6 Years M 1/1/2004 1/11/2005 2/2/2005 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Hepatic Enzyme Increased, Jaundice Hospitalization - Initial or Prolonged
5737002 4588801 6 Years M 1/1/2004 2/1/2005 2/16/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Abdominal Pain, Dehydration, Hepatic Enzyme Increased, Jaundice, Pyrexia, Vomiting Hospitalization - Initial or Prolonged
5738681 4571983 30 Years F 1/19/2005 2/2/2005 14 MD EXP Strattera Suicide Attempt Other
5738681 4588785 24 Years F 9/14/2004 1/28/2005 2/16/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Multiple Drug Overdose, Suicide Attempt Other
5738703 4571985 15 Years F 1/13/2005 2/2/2005 20 MD EXP Strattera Abdominal Pain, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Asthenia, Vomiting Hospitalization - Initial or Prolonged
5738703 4579414 15 Years F 1/24/2005 2/9/2005 16 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Asthenia, Cholelithiasis, Vomiting Hospitalization - Initial or Prolonged, Other
5738707 4575271     M 12/10/2004 1/27/2005 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Contusion Required Intervention to Prevent Permanent Impairment/Damage
5738711 4571986 12 Years 1/14/2005 2/2/2005 19 MD EXP Strattera Delusion, Mental Disorder, Psychotic Disorder Hospitalization - Initial or Prolonged
5738728 4571988 17 Years M 11/11/2004 11/11/2004 1/19/2005 2/2/2005 14 MD EXP Strattera Completed Suicide Death
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5738728 4588762 17 Years M 11/11/2004 11/11/2004 1/31/2005 2/16/2005 16 MD EXP Strattera Completed Suicide, Parent-Child Problem Death
5738728 4613142 17 Years M 11/11/2004 11/11/2004 2/28/2005 3/16/2005 16 MD EXP Strattera Completed Suicide Death
5738728 4709545 17 Years M 11/11/2004 11/11/2004 6/16/2005 7/7/2005 21 MD EXP Strattera Completed Suicide Death
5738728 4847949 17 Years M 11/11/2004 11/11/2004 11/15/2005 12/6/2005 21 MD EXP Strattera Depression Completed Suicide, Drug Interaction, Myocardial Infarction, Overdose Death
5738751 4571992 52 Years F 1/14/2005 2/2/2005 19 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Alcohol Use, Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Blood Cholesterol Increased, High Density Lipoprotein Increased
5738759 4571994 45 Years M 11/1/2004 1/20/2005 2/2/2005 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5738767 4571996 38 Years M 1/17/2005 2/2/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Loss of Consciousness, Overdose, Suicide Attempt Hospitalization - Initial or Prolonged, Other
5738769 4571999 7 Years M 1/14/2005 2/2/2005 19 OT EXP Strattera Hepatic Enzyme Increased, Influenza Like Illness
5738770 4572001 15 Years M 1/27/2005 2/2/2005 6 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5738770 4579383 15 Years M 1/21/2005 2/9/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5738770 4642032 15 Years M 4/1/2005 4/21/2005 20 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5738771 4572003 54 Years F 1/12/2005 2/2/2005 21 EXP Strattera Blood Alkaline Phosphatase Increased, Hepatic Enzyme Increased, Nuclear Magnetic Resonance Imaging Abnormal, Stomach Discomfort Other
5738772 4572004     F 1/12/2005 2/2/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased
5738773 4572007 12 Years 1/12/2005 2/2/2005 21 MD EXP Strattera Liver Function Test Abnormal
5738776 4572008     M 1/13/2005 2/2/2005 20 MD EXP Strattera Hepatic Enzyme Increased
5738778 4572009 12 Years 1/12/2005 2/2/2005 21 MD EXP Strattera Liver Function Test Abnormal
5738851 4572005 16 Years M 1/12/2005 2/2/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased
5738851 4642299 16 Years M 4/1/2005 4/20/2005 19 MD EXP Strattera Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased
5738989 4572012 9 Years M 1/14/2005 2/2/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Cholelithiasis, Nephrolithiasis Other
5738991 4572013 16 Years M 1/14/2005 2/2/2005 19 OT EXP Strattera Hepatic Enzyme Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5739057 4572090 50 Years M 1/17/2005 2/2/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased
5739073 4572146 28 Years M 1/12/2005 1/13/2005 2/2/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Adverse Event, Bilirubin Conjugated Increased, Blood Bilirubin Unconjugated Increased, Decreased Appetite
5739073 4588805 28 Years M 1/12/2005 1/31/2005 2/16/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Bilirubin Conjugated Increased, Blood Bilirubin Increased, Blood Bilirubin Unconjugated Increased, Chromaturia, Decreased Appetite, Dry Mouth, Emotional Disorder, Feeling Cold, Nausea, Relationship Breakdown, Retrograde Ejaculation, Sensory Disturbance, Testicular Retraction, Urinary Hesitation, Urinary Retention
5739075 4572083 12 Years M 1/11/2005 2/2/2005 22 EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Chromaturia, Constipation, Nausea, Urine Odour Abnormal
5739163 4572055 25 Years M 1/21/2005 2/2/2005 12 MD EXP Strattera Alanine Aminotransferase Increased, Laboratory Test Interference, Weight Increased
5739166 4572056     F 1/18/2005 2/2/2005 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Glucose-6-phosphate Dehydrogenase Deficiency, Haemolytic Anaemia Hospitalization - Initial or Prolonged
5739166 4612426     F 2/25/2005 3/16/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Haemolytic Anaemia, Hereditary Spherocytosis Hospitalization - Initial or Prolonged
5739170 4572057 12 Years M 1/18/2005 2/2/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Petit Mal Epilepsy Other
5741484 4582416 21 Years F 9/21/2004 1/27/2005 128 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Disturbance in Attention, Fatigue, Heart Rate Increased, Throat Tightness
5741486 4582420 37 Years F 9/21/2004 9/22/2004 1/27/2005 127 PER Strattera Attention Deficit/Hyperactivity Disorder Nausea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5741488 4582423 15 Years M 9/22/2004 1/27/2005 127 MD PER Strattera Attention Deficit/Hyperactivity Disorder Depressed Mood, Drug Ineffective, Dysphoria, Tearfulness
5741489 4582424 23 Years F 9/21/2004 1/27/2005 128 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Restlessness
5741490 4582425 11 Years M 6/1/2004 9/22/2004 1/27/2005 127 PER Strattera Attention Deficit/Hyperactivity Disorder Tic
5741491 4582427 5 Years M 6/1/2004 9/22/2004 1/27/2005 127 PER Strattera Psychomotor Hyperactivity Abdominal Pain Upper
5741599 4580289 12 Years M 9/1/2004 11/16/2004 1/27/2005 72 PER Strattera Attention Deficit/Hyperactivity Disorder Change In Sustained Attention, Disturbance in Attention, Mononucleosis Syndrome, Nervousness, Somnolence, Throat Irritation
5741599 4637488 12 Years M 9/1/2004 11/16/2004 3/28/2005 132 PER Strattera Disturbance in Attention, Mononucleosis Syndrome, Nervousness, Somnolence, Throat Irritation
5741607 4580294 9 Years F 8/1/2004 8/31/2004 1/27/2005 149 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Decreased Appetite, Discomfort, Flatulence, Insomnia, Mood Swings
5741932 4576724 13 Years M 11/15/2004 1/18/2005 2/7/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Calcium Abnormal, Lymphocyte Percentage Increased, Monocyte Percentage Increased, Neutrophil Percentage Decreased, Protein Total Abnormal
5742241 4581676 10 Years F 9/7/2004 9/9/2004 1/27/2005 140 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Nightmare
5742242 4581690 6 Years F 9/9/2004 1/27/2005 140 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742243 4581714 7 Years M 8/1/2004 9/8/2004 1/27/2005 141 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Nausea, Nervousness, Retching
5742244 4581715 69 Years M 9/9/2004 1/27/2005 140 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Urinary Retention
5742246 4581720 8 Years M 9/9/2004 1/27/2005 140 MD PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Somnolence
5742248 4581725 8 Years M 8/1/2004 9/9/2004 1/27/2005 140 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Irritability
5742249 4581737 6 Years M 9/10/2004 1/27/2005 139 PER Strattera Retching, Vomiting
5742251 4581738 12 Years M 8/19/2004 9/10/2004 1/27/2005 139 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Blepharospasm, Fatigue, Nausea, Vomiting
5742252 4581752 8 Years M 9/9/2004 9/9/2004 1/27/2005 140 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Asthenia, Fatigue, Feeling Abnormal
5742255 4581778 10 Years M 9/10/2004 1/27/2005 139 CN PER Strattera Somnolence, Subcutaneous Nodule
5742256 4581797 24 Years M 9/9/2004 9/10/2004 1/27/2005 139 OT PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Heart Rate Increased, Hyperhidrosis, Mydriasis
5742256 4637376 24 Years M 9/9/2004 12/23/2004 3/28/2005 95 MD PER Strattera Chills, Heart Rate Increased, Hyperhidrosis, Mydriasis, Streptococcal Serology Positive, Viral Infection
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742258 4581838 7 Years M 9/9/2004 1/27/2005 140 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Disturbance in Attention, Drug Ineffective
5742260 4581935 5 Years F 9/8/2004 9/9/2004 1/27/2005 140 OT PER Strattera Abnormal Behaviour, Drug Ineffective
5742263 4581941 54 Years M 9/3/2004 9/10/2004 1/27/2005 139 PER Strattera Tourette's Disorder Blood Iron Decreased, Excitability, Fatigue, Nightmare, Throat Tightness
5742265 4581942 19 Years M 10/12/2004 1/27/2005 107 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Decreased Appetite, Dizziness, Drug Ineffective, Fatigue, Feeling Abnormal, Insomnia, Male Sexual Dysfunction
5742266 4581943     F 9/10/2004 1/27/2005 139 MD PER Strattera Depression
5742269 4581944     M 9/10/2004 1/27/2005 139 MD PER Strattera Anxiety, Chest Discomfort
5742271 4581945 7 Years M 9/10/2004 1/27/2005 139 PER Strattera Disturbance in Attention Mood Swings
5742272 4581946 6 Years M 9/1/2004 9/13/2004 1/27/2005 136 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Mood Swings, Negativism
5742273 4581947 46 Years F 9/11/2004 11/23/2004 1/27/2005 65 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Chest Discomfort, Constipation, Dizziness, Dyspnoea, Fatigue, Palpitations, Tachycardia
5742273 4637378 46 Years F 9/11/2004 11/23/2004 3/28/2005 125 MD PER Strattera Blood Pressure Increased, Chest Discomfort, Constipation, Dizziness, Dyspnoea, Fatigue, Palpitations, Tachycardia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742279 4581540 15 Years M 10/12/2004 1/27/2005 107 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased
5742283 4581543 10 Years M 9/1/2004 10/25/2004 1/27/2005 94 PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Pharyngitis Streptococcal
5742286 4581552     F 10/22/2004 1/27/2005 97 MD PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
5742289 4581553 12 Years 10/21/2004 1/27/2005 98 MD PER Strattera Asthenia
5742290 4581557 16 Years M 1/1/2004 10/26/2004 1/27/2005 93 PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination
5742292 4581560 6 Years F 10/27/2004 1/27/2005 92 OT PER Strattera Mydriasis, Visual Tracking Test Abnormal
5742294 4581561 23 Years M 10/1/2004 10/28/2004 1/27/2005 91 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Disturbance in Attention, Drug Ineffective, Insomnia
5742295 4581575 12 Years 10/28/2004 1/27/2005 91 MD PER Strattera
5742296 4581596     M 10/29/2004 1/27/2005 90 PH PER Strattera Abnormal Behaviour
5742299 4581597 8 Years M 11/4/2004 11/11/2004 1/27/2005 77 PER Strattera Attention Deficit/Hyperactivity Disorder Dysphagia, Emotional Distress
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742309 4580779 60 Years M 9/7/2004 1/27/2005 142 PER Strattera Attention Deficit/Hyperactivity Disorder Activities of Daily Living Impaired, Feeling Abnormal, Hypersomnia, Inappropriate Affect, Pruritus
5742310 4580788 54 Years F 8/3/2004 8/19/2004 1/27/2005 161 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Chills, Dry Mouth, Feeling Jittery, Insomnia
5742312 4580790 7 Years M 8/17/2004 8/19/2004 1/27/2005 161 OT PER Strattera Epistaxis
5742313 4580791 4 Years M 8/19/2004 1/27/2005 161 PER Strattera Autism Stomach Discomfort
5742316 4580793 53 Years F 8/19/2004 1/27/2005 161 PER Strattera Dizziness, Fatigue, Somnolence
5742317 4580795 14 Years M 8/19/2004 8/19/2004 1/27/2005 161 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Dizziness, Fatigue, Feeling Abnormal, Lethargy, Paraesthesia
5742322 4580805 25 Years M 7/1/2004 8/18/2004 1/27/2005 162 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Asthenia, Bradyphrenia, Flat Affect, Somnolence
5742323 4580807 9 Years M 8/19/2004 8/19/2004 1/27/2005 161 PER Strattera Psychomotor Hyperactivity Retching, Vomiting
5742324 4580813 55 Years M 8/18/2004 1/27/2005 162 PER Strattera Attention Deficit/Hyperactivity Disorder Blepharospasm
5742326 4582430 43 Years M 9/18/2004 9/22/2004 1/27/2005 127 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Fatigue, Nausea, Vision Blurred
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742331 4580574 52 Years M 8/1/2004 8/18/2004 1/27/2005 162 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Dysuria, Groin Pain, Muscle Spasms, Myalgia, Pain, Paraesthesia
5742334 4580600 37 Years M 8/17/2004 10/26/2004 1/27/2005 93 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Sensation in Eye, Bruxism, Dry Mouth, Fatigue, Feeling Abnormal, Headache, Nasal Dryness, Vision Blurred, Visual Acuity Reduced
5742337 4580626 55 Years F 8/18/2004 1/27/2005 162 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Drug Ineffective, Memory Impairment, Tinnitus
5742340 4582431 8 Years M 8/1/2004 9/23/2004 1/27/2005 126 PER Strattera Sensory Disturbance Drug Ineffective
5742343 4581030     8/19/2004 1/27/2005 161 MD PER Strattera Somnolence
5742344 4580653 15 Years F 10/19/2004 1/27/2005 100 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blood Thyroid Stimulating Hormone Increased
5742348 4581059 8 Years M 8/1/2004 8/19/2004 1/27/2005 161 PH PER Strattera Attention Deficit/Hyperactivity Disorder Dysphagia, Stomach Discomfort
5742349 4582432 7 Years M 9/21/2004 9/23/2004 1/27/2005 126 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Diarrhoea, Feeling Abnormal
5742350 4580687     M 8/18/2004 1/27/2005 162 MD PER Strattera Aggression, Feeling Abnormal
5742352 4580688 5 Years M 1/1/2003 10/26/2004 1/27/2005 93 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742355 4580689     M 8/13/2004 8/19/2004 1/27/2005 161 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Nausea, Sleep Disorder
5742358 4580692 46 Years M 1/1/2003 8/19/2004 1/27/2005 161 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Nightmare, Paralysis, Weight Decreased
5742359 4580723 14 Years F 8/18/2004 8/19/2004 1/27/2005 161 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Impulsive Behaviour, Insomnia, Irritability
5742361 4580742 46 Years F 8/17/2004 8/19/2004 1/27/2005 161 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Euphoric Mood, Insomnia, Middle Insomnia, Paraesthesia
5742362 4580887 9 Years F 8/1/2004 10/27/2004 1/27/2005 92 MD PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Decreased Appetite, Disturbance in Attention, Dizziness, Fatigue, Feeling Abnormal, Insomnia, Muscle Twitching, Somnolence, Stomach Discomfort, Tachycardia
5742364 4580888 40 Years M 8/18/2004 1/27/2005 162 PH PER Strattera Hypoaesthesia
5742365 4580890     M 8/19/2004 1/27/2005 161 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Feeling Abnormal
5742367 4580892 11 Years M 8/1/2004 8/19/2004 1/27/2005 161 MD PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5742369 4580894 42 Years F 8/19/2004 1/27/2005 161 MD PER Strattera Bipolar I Disorder
5742371 4580896 16 Years M 8/19/2004 1/27/2005 161 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Memory Impairment, Psychomotor Hyperactivity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742372 4580907     F 8/19/2004 1/27/2005 161 PER Strattera Alopecia
5742373 4580945 10 Years M 7/1/2004 8/19/2004 1/27/2005 161 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective
5742375 4580989 6 Years M 8/15/2004 8/19/2004 1/27/2005 161 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Heart Rate Increased
5742376 4581060 20 Years M 8/19/2004 1/27/2005 161 PER Strattera Disturbance in Attention Aggression, Drug Ineffective, Insomnia, Mood Swings, Skin Laceration
5742377 4581023 45 Years M 8/20/2004 1/27/2005 160 PER Strattera Attention Deficit/Hyperactivity Disorder Micturition Urgency, Nervousness, Sedation
5742378 4581063 20 Years F 8/18/2004 8/20/2004 1/27/2005 160 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Feeling Abnormal
5742379 4577619 26 Years M 8/23/2004 8/24/2004 1/27/2005 156 PER Strattera Disturbance in Attention Groin Pain
5742381 4581065     F 8/13/2004 8/20/2004 1/27/2005 160 PER Strattera Abnormal Behaviour, Agitation, Insomnia, Sneezing
5742382 4577621 12 Years M 8/24/2004 1/27/2005 156 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anxiety, Depression, Eye Rolling, Irritability, Mood Swings, Self-Injurious Ideation
5742385 4577623     M 8/24/2004 1/27/2005 156 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anger
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742386 4581085 28 Years M 8/20/2004 1/27/2005 160 OT PER Strattera Scrotal Pain
5742389 4577634     F 8/24/2004 1/27/2005 156 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anger
5742392 4581115     F 8/20/2004 1/27/2005 160 MD PER Strattera Attention Deficit/Hyperactivity Disorder Amphetamines Positive
5742397 4581117 5 Years M 10/6/2004 1/27/2005 113 PER Strattera Impulsive Behaviour Abnormal Behaviour, Drug Ineffective, Ear Infection, Fatigue, Nasopharyngitis, Restlessness
5742400 4581121 49 Years F 7/28/2004 8/20/2004 1/27/2005 160 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dry Mouth, Feeling Abnormal, Halitosis, Impulsive Behaviour, Nausea, Restlessness, Thirst
5742402 4581123 41 Years F 8/16/2004 8/20/2004 1/27/2005 160 PER Strattera Anxiety Disorder Central Nervous System Stimulation, Dry Mouth, Hyperhidrosis, Insomnia
5742406 4577635 7 Years F 8/23/2004 8/25/2004 1/27/2005 155 PER Strattera Attention Deficit/Hyperactivity Disorder Ocular Hyperaemia
5742408 4577637 8 Years F 1/1/2004 8/24/2004 1/27/2005 156 MD PER Strattera Hirsutism, Hypertrichosis, Weight Decreased
5742411 4577639 8 Years M 1/1/2004 8/24/2004 1/27/2005 156 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
5742413 4577643 9 Years F 8/25/2004 8/25/2004 1/27/2005 155 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Mood Swings
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742414 4577645 10 Years F 8/23/2004 8/24/2004 1/27/2005 156 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety
5742417 4577647 10 Years F 6/1/2004 8/24/2004 1/27/2005 156 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Psychomotor Hyperactivity
5742420 4577584 8 Years M 9/1/2004 10/6/2004 1/27/2005 113 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Insomnia, Restlessness
5742423 4577588 13 Years M 10/6/2004 1/27/2005 113 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anger, Impulse-Control Disorder
5742424 4577592     F 9/1/2004 10/4/2004 1/27/2005 115 PER Strattera Attention Deficit/Hyperactivity Disorder Dystonia, Pruritus
5742426 4577594     M 10/7/2004 1/27/2005 112 MD PER Strattera Attention Deficit/Hyperactivity Disorder Suicidal Ideation
5742428 4577596 56 Years M 10/7/2004 1/27/2005 112 PER Strattera Amnesia Testicular Pain, Urinary Hesitation
5742429 4577599     M 10/8/2004 1/27/2005 111 PER Strattera Insomnia, Muscle Spasms
5742430 4577602 10 Years M 10/8/2004 10/8/2004 1/27/2005 111 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Chest Pain, Cough, Heart Rate Increased, Pain
5742431 4577604     M 10/12/2004 1/27/2005 107 MD PER Strattera Blood Pressure Increased, Heart Rate Irregular
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742433 4577615 38 Years F 8/1/2004 11/3/2004 1/27/2005 85 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Fatigue, Irritability
5742433 4638825 38 Years F 8/1/2004 1/21/2005 3/28/2005 66 PER Strattera Decreased Appetite, Disturbance in Attention, Fatigue, Irritability, Pharyngolaryngeal Pain, Weight Decreased
5742433 4727773 38 Years F 8/1/2004 4/19/2005 7/25/2005 97 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Discomfort, Decreased Appetite, Disturbance in Attention, Fatigue, Heart Rate Increased, Irritability, Pharyngolaryngeal Pain, Weight Decreased
5742434 4577616 5 Years M 10/1/2004 10/15/2004 1/27/2005 104 MD PER Strattera Abdominal Discomfort, Tremor
5742435 4581160     M 8/17/2004 8/20/2004 1/27/2005 160 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal
5742438 4581184 47 Years F 8/1/2004 8/20/2004 1/27/2005 160 PER Strattera Disturbance in Attention Abdominal Distension, Anorexia, Insomnia, Libido Decreased, Nausea, Somnolence
5742441 4581218 9 Years M 8/1/2004 8/20/2004 1/27/2005 160 PER Strattera Drug Ineffective, Psychomotor Hyperactivity
5742444 4581223 5 Years M 8/20/2004 1/27/2005 160 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Fatigue, Headache, Mood Swings, Weight Decreased
5742445 4581225     M 8/20/2004 1/27/2005 160 MD PER Strattera Testicular Pain
5742448 4581234 12 Years 8/20/2004 1/27/2005 160 PH PER Strattera Choking, Dizziness, Feeling Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742452 4581236 23 Years M 8/17/2004 8/20/2004 1/27/2005 160 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Confusional State, Decreased Appetite, Dizziness, Drug Ineffective, Hot Flush, Hyperhidrosis, Nausea, Nervousness
5742455 4581266 9 Years M 8/1/2004 8/20/2004 1/27/2005 160 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Dyspnoea, Insomnia, Multiple Allergies, Paranoia, Somnolence
5742458 4581273 5 Years F 8/1/2004 8/20/2004 1/27/2005 160 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Attention Deficit Hyperactivity Disorder, Disturbance in Attention
5742460 4581598 8 Years M 11/12/2004 1/27/2005 76 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Drug Ineffective, Stomach Discomfort
5742461 4581616 8 Years M 11/9/2004 1/27/2005 79 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Restlessness
5742462 4581275 38 Years M 8/20/2004 1/27/2005 160 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
5742463 4581475     M 8/1/2004 8/23/2004 1/27/2005 157 PER Strattera Attention Deficit/Hyperactivity Disorder
5742464 4581477 14 Years M 8/15/2004 8/23/2004 1/27/2005 157 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
5742465 4581479 8 Years M 8/23/2004 1/27/2005 157 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Fear, Nausea, Somnolence, Vomiting
5742466 4581497 12 Years M 8/24/2004 1/27/2005 156 MD PER Strattera Epistaxis
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742467 4581500 54 Years F 8/24/2004 1/27/2005 156 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Feeling Abnormal, Hyperacusis, Nausea, Paraesthesia, Photophobia, Piloerection, Postnasal Drip, Urinary Tract Infection
5742468 4581502 7 Years M 8/24/2004 1/27/2005 156 OT PER Strattera Oral Discomfort, Stomatitis
5742469 4581503 11 Years F 8/1/2004 8/24/2004 1/27/2005 156 OT PER Strattera Attention Deficit/Hyperactivity Disorder Eye Rolling, Muscle Twitching, Sleep Walking, Somnolence
5742470 4581504 9 Years F 11/9/2004 1/27/2005 79 PER Strattera Attention Deficit/Hyperactivity Disorder Impulse-Control Disorder, Irritability, Nausea, Stomach Discomfort
5742471 4581949 9 Years F 9/11/2004 9/13/2004 1/27/2005 136 PER Strattera Disturbance in Attention Insomnia, Pollakiuria, Sleep Talking
5742472 4581950 13 Years F 9/9/2004 1/27/2005 140 MD PER Strattera Attention Deficit/Hyperactivity Disorder Sinus Tachycardia Other
5742473 4581951 37 Years M 8/31/2004 9/13/2004 1/27/2005 136 PER Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder, Pelvic Pain, Prostatic Disorder
5742474 4581952 7 Years M 9/13/2004 1/27/2005 136 PER Strattera Anxiety, Depressed Mood, Fear, Nervousness
5742475 4581953 9 Years M 9/13/2004 1/27/2005 136 PER Strattera Attention Deficit/Hyperactivity Disorder Appetite Disorder, Nausea, Personality Change, Retching, Somnolence, Stomach Discomfort, Vomiting
5742476 4581954 3 Years M 9/1/2004 9/13/2004 1/27/2005 136 PER Strattera Psychomotor Hyperactivity Abnormal Behaviour, Anger, Drug Ineffective
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742477 4581505 33 Years F 8/23/2004 1/27/2005 157 MD PER Strattera Personality Change
5742478 4581506 33 Years F 8/23/2004 1/27/2005 157 MD PER Strattera Feeling Abnormal
5742479 4581955 6 Years M 9/13/2004 1/27/2005 136 OT PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Agitation, Anger, Somnolence
5742480 4581956 20 Years M 9/13/2004 1/27/2005 136 MD PER Strattera Asthenia, Ejaculation Disorder
5742481 4581957 8 Years F 9/1/2004 9/13/2004 1/27/2005 136 PER Strattera Abdominal Pain Upper, Dysphagia
5742542 4580333 16 Years M 7/3/2004 9/23/2004 1/27/2005 126 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Chest Pain, Lethargy, Somnolence, Vomiting
5742551 4577653 27 Years M 8/1/2004 10/16/2004 1/27/2005 103 PER Strattera Attention Deficit/Hyperactivity Disorder Erection Increased, Insomnia, Nausea, Painful Erection, Testicular Pain
5742552 4577657 8 Years M 4/1/2003 8/25/2004 1/27/2005 155 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Drug Ineffective, Fatigue, Initial Insomnia, Somnolence, Speech Disorder, Weight Decreased
5742554 4577662 8 Years F 1/1/2004 8/25/2004 1/27/2005 155 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hirsutism
5742555 4577666 10 Years F 9/21/2004 1/27/2005 128 MD PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742556 4577672 6 Years M 7/9/2004 8/25/2004 1/27/2005 155 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Delusional Disorder (Persecutory Type), Feeling Abnormal, Headache, Insomnia, Logorrhoea
5742558 4577677     M 8/25/2004 1/27/2005 155 PER Strattera Delusional Disorder (Persecutory Type), Delusional Disorder (Unspecified Type), Hallucination
5742560 4577682 8 Years M 1/1/2004 8/25/2004 1/27/2005 155 PER Strattera Weight Increased
5742561 4580310 10 Years M 6/1/2003 10/8/2004 1/27/2005 111 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anorexia, Crying, Feeling Abnormal, Mood Swings, Weight Decreased
5742562 4577686 8 Years F 8/24/2004 1/27/2005 156 PER Strattera Dizziness, Erythema, Excoriation, Pruritus, Somnolence, Stomach Discomfort, Urticaria, Vomiting
5742563 4577690 38 Years M 8/25/2004 1/27/2005 155 PER Strattera Attention Deficit/Hyperactivity Disorder Stress, Weight Decreased
5742565 4577691 46 Years F 8/25/2004 1/27/2005 155 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Drug Ineffective, Early Morning Awakening, Fatigue
5742567 4580316 52 Years M 6/1/2004 9/7/2004 1/27/2005 142 MD PER Strattera Cataplexy Diplopia, Photophobia, Vision Blurred
5742588 4580369 49 Years F 7/20/2004 8/30/2004 1/27/2005 150 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Fatigue, Somnolence, Weight Increased
5742591 4580386 10 Years M 1/1/2004 10/11/2004 1/27/2005 108 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Muscle Twitching, Nausea, Sneezing
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742596 4577835 10 Years F 8/25/2004 8/27/2004 1/27/2005 153 PER Strattera Attention Deficit/Hyperactivity Disorder Gastrointestinal Disorder
5742599 4577838 12 Years M 8/27/2004 1/27/2005 153 PER Strattera Educational Problem
5742601 4577840 6 Years M 8/24/2004 8/27/2004 1/27/2005 153 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anorexia, Depression, Lethargy, Mood Swings, Social Avoidant Behaviour, Somnolence
5742603 4577842 17 Years M 8/27/2004 1/27/2005 153 PER Strattera Attention Deficit/Hyperactivity Disorder Gingival Hyperplasia
5742604 4577846 14 Years M 7/30/2004 12/3/2004 1/27/2005 55 MD PER Strattera Attention Deficit/Hyperactivity Disorder Cough, Drug Ineffective, Drug Interaction, Dyspnoea, Fatigue, Rash Maculo-Papular, Respiratory Tract Infection, Somnolence, Upper Respiratory Tract Congestion, Wheezing
5742604 4637369 14 Years M 7/30/2004 12/3/2004 3/28/2005 115 MD PER Strattera Cough, Drug Ineffective, Drug Interaction, Dyspnoea, Fatigue, Rash Maculo-Papular, Respiratory Tract Infection, Somnolence, Upper Respiratory Tract Congestion, Wheezing
5742605 4577849 15 Years M 8/30/2004 1/27/2005 150 PER Strattera Impulsive Behaviour, Logorrhoea, Nervousness
5742606 4577852 8 Years M 8/25/2004 8/27/2004 1/27/2005 153 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Psychomotor Hyperactivity
5742608 4577855     F 8/27/2004 1/27/2005 153 PER Strattera
5742609 4577858 6 Years M 8/28/2004 8/30/2004 1/27/2005 150 PER Strattera Attention Deficit/Hyperactivity Disorder Affect Lability, Feeling Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742610 4577867 17 Years F 8/1/2004 8/30/2004 1/27/2005 150 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hypoaesthesia
5742611 4582501     M 9/23/2004 1/27/2005 126 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination
5742612 4582502 8 Years F 9/22/2004 1/27/2005 127 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
5742613 4582503 24 Years F 6/1/2004 9/23/2004 1/27/2005 126 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hypotension
5742614 4582504     F 9/1/2004 9/23/2004 1/27/2005 126 PER Strattera Attention Deficit/Hyperactivity Disorder Middle Insomnia, Psychomotor Hyperactivity
5742615 4582506 48 Years F 9/21/2004 9/27/2004 1/27/2005 122 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Abnormal, Somnolence, Stomach Discomfort
5742616 4582507     F 9/19/2004 9/23/2004 1/27/2005 126 CN PER Strattera Blood Pressure Increased, Excitability, Headache, Heart Rate Increased, Hypertonia, Stress
5742617 4582508     F 9/23/2004 1/27/2005 126 PER Strattera Dry Mouth, Psychomotor Hyperactivity
5742618 4582512 7 Years M 9/23/2004 1/27/2005 126 PER Strattera Psychomotor Hyperactivity Adjustment Disorder, Initial Insomnia, Somnolence
5742619 4582513 16 Years M 9/23/2004 1/27/2005 126 PER Strattera Myalgia, Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742620 4582514 16 Years M 9/23/2004 9/23/2004 1/27/2005 126 PER Strattera Attention Deficit/Hyperactivity Disorder Nervousness, Urinary Retention
5742622 4577872 7 Years M 8/1/2004 9/13/2004 1/27/2005 136 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Anxiety, Fear, Insomnia, Nightmare
5742623 4577875     F 8/30/2004 1/27/2005 150 OT PER Strattera Paraesthesia
5742624 4577880 15 Years M 8/27/2004 1/27/2005 153 MD PER Strattera Psychotic Disorder
5742625 4577885 14 Years M 8/1/2004 8/30/2004 1/27/2005 150 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Drug Ineffective
5742626 4577888 8 Years F 1/1/2004 8/30/2004 1/27/2005 150 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
5742630 4577893     M 8/29/2004 8/30/2004 1/27/2005 150 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Groin Pain, Testicular Disorder, Urine Analysis Abnormal
5742631 4577901 6 Years M 8/30/2004 1/27/2005 150 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Impulse-Control Disorder, Psychomotor Hyperactivity
5742632 4577904 17 Years F 8/30/2004 1/27/2005 150 PER Strattera Oligomenorrhoea, Weight Increased
5742634 4577907 16 Years M 8/1/2004 8/31/2004 1/27/2005 149 OT PER Strattera Attention Deficit/Hyperactivity Disorder Apathy, Personality Change
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742635 4577913 8 Years M 8/31/2004 8/31/2004 1/27/2005 149 PER Strattera
5742639 4578016 57 Years F 8/27/2004 8/30/2004 1/27/2005 150 PER Strattera Cold Sweat, Dizziness, Feeling Abnormal, Formication, Hyperhidrosis, Nausea
5742643 4578019 7 Years M 8/1/2004 8/30/2004 1/27/2005 150 PER Strattera Attention Deficit/Hyperactivity Disorder Contusion
5742645 4578027 8 Years M 8/31/2004 1/27/2005 149 PER Strattera Erectile Dysfunction
5742646 4578029 21 Years M 8/31/2004 1/27/2005 149 MD PER Strattera Attention Deficit/Hyperactivity Disorder Headache
5742648 4578032 55 Years F 8/21/2004 8/31/2004 1/27/2005 149 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Nervousness
5742649 4578038 12 Years M 8/1/2004 9/22/2004 1/27/2005 127 MD PER Strattera Attention Deficit/Hyperactivity Disorder Contusion, Prothrombin Time Prolonged
5742653 4578040 14 Years M 8/30/2004 9/1/2004 1/27/2005 148 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Lethargy, Stomach Discomfort
5742654 4578042 13 Years M 8/17/2004 9/1/2004 1/27/2005 148 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Disturbance in Attention, Dry Mouth, Feeling Abnormal, Heart Rate Increased, Pyrexia, Stomach Discomfort
5742656 4577917 15 Years M 1/1/2004 8/31/2004 1/27/2005 149 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Decreased Appetite, Drug Ineffective, Fatigue, Insomnia, Mood Swings, Somnolence, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742658 4577931 18 Years M 7/1/2004 8/31/2004 1/27/2005 149 PER Strattera Attention Deficit/Hyperactivity Disorder Adjustment Disorder, Memory Impairment
5742659 4577937 14 Years M 10/1/2003 8/30/2004 1/27/2005 150 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Somnolence
5742660 4577945 5 Years M 9/17/2004 1/27/2005 132 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
5742662 4577948 7 Years M 8/30/2004 1/27/2005 150 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Drug Ineffective, Dysphonia, Psychomotor Hyperactivity, Somnolence
5742664 4577949 54 Years M 8/31/2004 1/27/2005 149 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Pollakiuria, Rhinorrhoea
5742665 4577950 9 Years M 6/1/2004 8/31/2004 1/27/2005 149 PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Vomiting
5742666 4577951 10 Years M 8/1/2004 8/31/2004 1/27/2005 149 PER Strattera Attention Deficit/Hyperactivity Disorder Bradyphrenia, Crying, Drug Ineffective, Educational Problem
5742668 4577981 8 Years M 9/1/2004 9/21/2004 1/27/2005 128 PER Strattera Attention Deficit/Hyperactivity Disorder Dermatitis Contact, Erythema, Eye Swelling, Pruritus, Swelling, Urticaria
5742672 4578008 50 Years F 8/30/2004 1/27/2005 150 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
5742674 4581296 13 Years M 8/20/2004 1/27/2005 160 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742677 4581308 62 Years F 8/1/2004 8/20/2004 1/27/2005 160 PER Strattera Depression
5742680 4581310 43 Years F 8/20/2004 8/23/2004 1/27/2005 157 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Insomnia, Psychomotor Hyperactivity
5742681 4581314 56 Years F 7/1/2004 8/23/2004 1/27/2005 157 PER Strattera Attention Deficit/Hyperactivity Disorder Activities of Daily Living Impaired, Dizziness, Somnolence
5742684 4581356 52 Years F 8/23/2004 1/27/2005 157 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Dizziness, Headache, Nausea
5742686 4581402 16 Years M 2/25/2004 9/16/2004 1/27/2005 133 MD PER Strattera Attention Deficit/Hyperactivity Disorder Growth Retardation, Tremor
5742688 4581433 8 Years F 8/20/2004 8/23/2004 1/27/2005 157 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Fatigue, Hypersensitivity, Psychomotor Hyperactivity
5742690 4581435 6 Years M 8/21/2004 11/5/2004 1/27/2005 83 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Heart Rate Increased
5742692 4581449 12 Years M 4/1/2004 8/23/2004 1/27/2005 157 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Back Pain, Crying, Fatigue, Muscle Spasms, Somnolence
5742695 4582258 9 Years M 9/22/2004 9/24/2004 1/27/2005 125 PER Strattera Eating Disorder, Fatigue, Headache, Speech Disorder, Stomach Discomfort
5742697 4582259     M 9/24/2004 1/27/2005 125 CN PER Strattera Tic
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742700 4582260 12 Years F 9/22/2004 9/23/2004 1/27/2005 126 MD PER Strattera Hot Flush
5742701 4582261 6 Years M 10/1/2004 10/18/2004 1/27/2005 101 PER Strattera Abnormal Behaviour, Crying, Headache, Irritability, Mood Altered, Vomiting
5742702 4582262 25 Years F 9/23/2004 1/27/2005 126 MD PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
5742703 4582263 21 Years M 9/1/2004 9/24/2004 1/27/2005 125 OT PER Strattera Impulse-Control Disorder, Psychomotor Hyperactivity Aggression, Drug Ineffective
5742705 4582264 8 Years M 1/1/2004 9/24/2004 1/27/2005 125 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Drug Ineffective, Dyskinesia, Tremor, Weight Decreased
5742707 4582265 7 Years M 1/1/2004 9/24/2004 1/27/2005 125 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue
5742708 4582266 7 Years M 9/24/2004 1/27/2005 125 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Agitation, Disturbance in Attention, Drug Ineffective
5742710 4582267 10 Years M 9/14/2004 9/24/2004 1/27/2005 125 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anxiety, Crying, Mood Altered, Stomach Discomfort
5742711 4582268 9 Years F 1/1/2004 9/24/2004 1/27/2005 125 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia
5742715 4582269     M 9/22/2004 9/27/2004 1/27/2005 122 PER Strattera Dysuria, Erectile Dysfunction, Urinary Hesitation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742719 4582271 10 Years M 1/1/2004 9/27/2004 1/27/2005 122 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Feeling Abnormal, Impulsive Behaviour, Insomnia, Mood Swings, Psychomotor Hyperactivity, Restless Legs Syndrome
5742720 4582273 8 Years F 9/27/2004 1/27/2005 122 PER Strattera Abdominal Pain Upper, Fatigue, Headache, Nausea
5742721 4582274     M 9/24/2004 9/24/2004 1/27/2005 125 PER Strattera Attention Deficit/Hyperactivity Disorder Excitability, Irritability
5742722 4582275 7 Years M 11/23/2004 1/27/2005 65 OT PER Strattera Abnormal Behaviour, Hypoaesthesia, Oral Pain
5742723 4582276 13 Years F 10/11/2004 1/27/2005 108 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Memory Impairment
5742725 4582277     M 9/27/2004 1/27/2005 122 OT PER Strattera Ear Discomfort, Oral Discomfort
5742726 4582278 48 Years F 9/27/2004 1/27/2005 122 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Stress, Weight Increased
5742727 4579044 9 Years M 9/2/2004 9/3/2004 1/27/2005 146 PER Strattera Attention Deficit/Hyperactivity Disorder Dysphagia, Fatigue, Somnolence
5742729 4579048     M 9/2/2004 1/27/2005 147 MD PER Strattera Hypoaesthesia
5742731 4579054 7 Years M 8/1/2004 9/3/2004 1/27/2005 146 MD PER Strattera Headache, Palpitations
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742734 4579056 7 Years M 7/30/2004 9/3/2004 1/27/2005 146 PER Strattera Autism Dyskinesia, Eye Movement Disorder, Insomnia, Tic
5742735 4582248 28 Years F 9/2/2004 9/7/2004 1/27/2005 142 PER Strattera Dependence Somnolence
5742738 4579066 8 Years M 8/1/2004 9/3/2004 1/27/2005 146 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
5742740 4579072     M 9/1/2004 1/27/2005 148 MD PER Strattera Chills
5742741 4579073 43 Years F 9/2/2004 9/2/2004 1/27/2005 147 PER Strattera Depression Feeling Abnormal, Urinary Tract Disorder
5742742 4580544 35 Years F 7/1/2004 9/12/2004 1/27/2005 137 CN PER Strattera Depression Hypoaesthesia, Oedema Peripheral, Rash Papular
5742743 4579074 12 Years 8/24/2004 1/27/2005 156 PER Strattera Hot Flush
5742744 4579075 5 Years M 8/27/2004 9/3/2004 1/27/2005 146 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Dysgeusia, Psychomotor Hyperactivity
5742745 4579076 14 Years M 9/3/2004 1/27/2005 146 PER Strattera
5742746 4578166     M 9/1/2004 1/27/2005 148 OT PER Strattera Dehydration
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742747 4578178 18 Years F 9/1/2004 1/27/2005 148 MD PER Strattera Attention Deficit/Hyperactivity Disorder Diarrhoea, Insomnia, Nausea, Somnolence
5742748 4578183     F 9/1/2004 9/2/2004 1/27/2005 147 PER Strattera Narcolepsy Asthenia, Dizziness, Nervousness
5742751 4578188 7 Years M 9/2/2004 1/27/2005 147 OT PER Strattera Retching
5742752 4578201 9 Years M 8/30/2004 9/2/2004 1/27/2005 147 PER Strattera Attention Deficit/Hyperactivity Disorder Stomach Discomfort, Vision Blurred, Vomiting
5742754 4578206 9 Years M 8/31/2004 9/2/2004 1/27/2005 147 PER Strattera Abdominal Pain Upper, Feeling Abnormal, Nausea
5742755 4578210     M 9/2/2004 9/2/2004 1/27/2005 147 PER Strattera Multiple Allergies, Vomiting
5742757 4582249 8 Years M 9/7/2004 1/27/2005 142 PER Strattera Affective Disorder Affect Lability, Drug Ineffective
5742758 4578211 10 Years M 9/1/2004 1/27/2005 148 MD PER Strattera Attention Deficit/Hyperactivity Disorder Back Pain, Drug Ineffective, Paraesthesia
5742759 4582250 11 Years M 1/1/2004 9/7/2004 1/27/2005 142 PH PER Strattera Attention Deficit/Hyperactivity Disorder Trichotillomania
5742760 4582251 9 Years M 10/4/2004 1/27/2005 115 PH PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination (Visual)
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742761 4578216 50 Years F 9/2/2004 1/27/2005 147 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Dry Mouth, Initial Insomnia, Paraesthesia, Thirst
5742762 4582252 12 Years 9/3/2004 1/27/2005 146 CN PER Strattera
5742763 4582253 32 Years F 9/7/2004 1/27/2005 142 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Depression, Feeling Abnormal, Lethargy, Mood Swings, Nausea, Paraesthesia Oral, Respiratory Tract Congestion, Sensitivity of Teeth, Sinus Headache, Swelling Face, Thinking Abnormal
5742764 4578242 17 Years M 9/2/2004 1/27/2005 147 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Drug Ineffective, Impulsive Behaviour
5742765 4582254     F 9/3/2004 1/27/2005 146 OT PER Strattera Chest Discomfort
5742770 4578058     M 8/31/2004 1/27/2005 149 MD PER Strattera Urine Analysis Abnormal
5742771 4582256 12 Years M 9/8/2004 1/27/2005 141 PER Strattera Abnormal Behaviour, Disturbance in Attention, Fatigue, Sluggishness
5742773 4582257 13 Years M 9/8/2004 1/27/2005 141 MD PER Strattera Impulse-Control Disorder Gynaecomastia, Weight Increased
5742775 4578062 10 Years M 9/1/2004 1/27/2005 148 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Headache, Pain in Extremity, Weight Decreased
5742778 4578068 44 Years F 8/30/2004 9/1/2004 1/27/2005 148 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Hypersomnia, Lip Dry, Rash, Swelling Face
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742779 4578071 16 Years M 8/1/2004 9/1/2004 1/27/2005 148 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Decreased Appetite, Flat Affect, Mood Swings
5742783 4578106 15 Years M 6/1/2004 8/31/2004 1/27/2005 149 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Influenza Like Illness, Skin Disorder
5742785 4578109     M 8/31/2004 1/27/2005 149 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation
5742790 4578114 15 Years F 9/1/2004 1/27/2005 148 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Dizziness, Hypersomnia, Malaise, Nausea
5742793 4578124     M 1/1/2004 9/1/2004 1/27/2005 148 MD PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Pain, Testicular Retraction
5742797 4578133 43 Years M 1/1/2004 10/21/2004 1/27/2005 98 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Drug Ineffective, Overdose, Sleep Disorder
5742799 4578137 10 Years M 9/1/2004 1/27/2005 148 MD PER Strattera Mania
5742801 4577518 40 Years M 9/9/2004 1/27/2005 140 MD PER Strattera Attention Deficit/Hyperactivity Disorder Depressed Mood
5742803 4577521 4 Years F 9/9/2004 1/27/2005 140 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression
5742805 4577529 15 Years M 8/10/2004 9/8/2004 1/27/2005 141 PER Strattera Attention Deficit/Hyperactivity Disorder Acne
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742837 4577714 30 Years M 8/25/2004 8/26/2004 1/27/2005 154 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Feeling Abnormal, Nausea
5742838 4577715 6 Years M 8/27/2004 1/27/2005 153 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Psychomotor Hyperactivity, Stomach Discomfort, Vomiting
5742840 4577716 47 Years M 8/22/2004 8/26/2004 1/27/2005 154 PER Strattera Anxiety Hypokinesia
5742841 4577717     F 8/26/2004 1/27/2005 154 OT PER Strattera Oedema Peripheral
5742842 4577718 48 Years F 8/17/2004 8/27/2004 1/27/2005 153 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Depressed Mood, Depression, Fatigue
5742844 4577719     8/19/2004 1/27/2005 161 MD PER Strattera Somnolence
5742845 4577720 41 Years F 8/25/2004 8/26/2004 1/27/2005 154 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Fatigue, Irritability, Nervousness
5742846 4577721     F 8/1/2004 8/27/2004 1/27/2005 153 PH PER Strattera Nightmare
5742848 4577722     8/19/2004 1/27/2005 161 MD PER Strattera Somnolence
5742849 4577723     8/19/2004 1/27/2005 161 MD PER Strattera Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742851 4577692 58 Years M 8/1/2004 10/25/2004 1/27/2005 94 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Drug Ineffective, Feeling Abnormal, Lethargy, Nausea, Somnolence, Stomach Discomfort
5742852 4577693 10 Years M 8/22/2004 8/25/2004 1/27/2005 155 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Hyperhidrosis, Pallor, Restlessness, Speech Disorder, Vomiting
5742853 4577695 8 Years M 8/23/2004 8/25/2004 1/27/2005 155 PH PER Strattera Dyspnoea
5742854 4577697 10 Years M 8/24/2004 1/27/2005 156 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Somnolence
5742855 4577698 50 Years F 6/1/2004 8/25/2004 1/27/2005 155 OT PER Strattera Drug Ineffective, Feeling Hot, Hyperhidrosis
5742857 4577699 9 Years M 8/1/2004 8/25/2004 1/27/2005 155 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Educational Problem, Somnolence
5742859 4577700 19 Years F 8/25/2004 1/27/2005 155 PER Strattera Attention Deficit/Hyperactivity Disorder Cognitive Disorder, Crying, Drug Ineffective
5742860 4577701 20 Years M 8/25/2004 1/27/2005 155 PER Strattera Attention Deficit/Hyperactivity Disorder Eye Disorder, Grimacing
5742861 4577702 14 Years M 2/1/2004 8/25/2004 1/27/2005 155 MD PER Strattera Attention Deficit/Hyperactivity Disorder Acne
5742862 4577703     M 8/15/2004 8/31/2004 1/27/2005 149 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Drug Interaction, Erectile Dysfunction, Feeling Jittery, Freezing Phenomenon, Insomnia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742863 4577552     M 3/1/2004 10/13/2004 1/27/2005 106 PER Strattera Attention Deficit/Hyperactivity Disorder Prostate Tenderness
5742864 4577554 48 Years M 9/18/2004 9/21/2004 1/27/2005 128 MD PER Strattera Attention Deficit/Hyperactivity Disorder Heat Exhaustion, Hyperhidrosis
5742866 4577557 8 Years M 9/22/2004 1/27/2005 127 OT PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
5742867 4577559 53 Years F 9/22/2004 1/27/2005 127 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Hot Flush, Mood Swings
5742869 4577561     M 9/23/2004 1/27/2005 126 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Palpitations
5742870 4577563 46 Years F 9/29/2004 1/27/2005 120 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hyperhidrosis, Palpitations
5742872 4577566 35 Years M 7/1/2004 10/20/2004 1/27/2005 99 PER Strattera Attention Deficit/Hyperactivity Disorder Coordination Abnormal, Delusion, Drug Ineffective, Nausea, Paraesthesia
5742873 4577567 12 Years M 1/1/2004 9/30/2004 1/27/2005 119 MD PER Strattera Attention Deficit/Hyperactivity Disorder Negative Thoughts
5742874 4577569 12 Years 9/30/2004 1/27/2005 119 MD PER Strattera Anger
5742877 4577572 55 Years F 9/29/2004 10/4/2004 1/27/2005 115 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742879 4577499     M 8/6/2004 1/27/2005 174 MD PER Strattera Genital Pain
5742881 4577501 16 Years M 8/20/2004 8/27/2004 1/27/2005 153 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Drug Ineffective, Paranasal Sinus Hypersecretion, Pharyngolaryngeal Pain
5742882 4577503 8 Years M 9/3/2004 1/27/2005 146 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
5742884 4577505 13 Years M 9/2/2004 1/27/2005 147 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Drug Ineffective, Excitability, Insomnia, Memory Impairment, Nasopharyngitis, Psychomotor Hyperactivity, Weight Increased
5742885 4577507 22 Years F 9/8/2004 1/27/2005 141 PER Strattera Attention Deficit/Hyperactivity Disorder Mydriasis
5742887 4577510     M 9/2/2004 1/27/2005 147 MD PER Strattera Aggression, Anger
5742889 4577512 11 Years M 9/7/2004 1/27/2005 142 MD PER Strattera Drug Withdrawal Headache
5742890 4577514 9 Years M 9/8/2004 1/27/2005 141 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination (Auditory)
5742891 4577704 10 Years F 8/25/2004 1/27/2005 155 PER Strattera Attention Deficit/Hyperactivity Disorder Enuresis
5742894 4577706 15 Years M 8/25/2004 1/27/2005 155 MD PER Strattera
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742894 4637368 15 Years M 12/14/2004 3/28/2005 104 MD PER Strattera Blood Pressure Increased
5742895 4577707 7 Years M 8/23/2004 8/26/2004 1/27/2005 154 PER Strattera Attention Deficit/Hyperactivity Disorder Dysgeusia, Somnolence
5742897 4577708 7 Years F 8/26/2004 1/27/2005 154 MD PER Strattera Aggression, Psychomotor Hyperactivity
5742898 4577709 52 Years M 8/25/2004 8/26/2004 1/27/2005 154 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Lacrimation Increased, Paraesthesia, Tremor
5742899 4577710 13 Years M 8/25/2004 8/26/2004 1/27/2005 154 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Laziness, Mydriasis, Pupillary Reflex Impaired
5742901 4577711     F 8/26/2004 8/26/2004 1/27/2005 154 PER Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Increased, Insomnia, Somnolence
5742903 4577712     M 8/26/2004 1/27/2005 154 MD PER Strattera
5742904 4577713 7 Years M 1/1/2004 9/9/2004 1/27/2005 140 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression
5742910 4579077 12 Years F 11/13/2004 9/3/2004 1/27/2005 146 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Drug Ineffective, Malaise
5742911 4579078 59 Years M 9/3/2004 1/27/2005 146 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dry Mouth, Fatigue, Penile Pain, Stomach Discomfort
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742912 4579079 36 Years F 9/7/2004 1/27/2005 142 PER Strattera Anorexia, Feeling Abnormal, Tremor
5742913 4579080 4 Years F 9/7/2004 1/27/2005 142 PER Strattera Hypoaesthesia Oral
5742914 4579081 13 Years M 9/3/2004 1/27/2005 146 PER Strattera Headache, Pallor, Somnolence, Weight Decreased
5742916 4579082 14 Years F 9/1/2004 9/3/2004 1/27/2005 146 PER Strattera Attention Deficit/Hyperactivity Disorder Bronchitis
5742918 4579083 7 Years F 9/7/2004 9/7/2004 1/27/2005 142 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Stomach Discomfort, Vomiting
5742923 4579084 16 Years M 8/1/2004 9/3/2004 1/27/2005 146 OT PER Strattera Epistaxis
5742925 4579085 29 Years F 9/2/2004 9/3/2004 1/27/2005 146 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Hyperhidrosis, Infection, Nausea, Urinary Tract Infection Fungal
5742927 4579086 11 Years F 9/7/2004 1/27/2005 142 PER Strattera Attention Deficit/Hyperactivity Disorder Daydreaming
5742931 4578268     M 9/1/2004 1/27/2005 148 MD PER Strattera Hallucination (Auditory)
5742932 4578274 12 Years M 9/2/2004 1/27/2005 147 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Faeces Discoloured
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5742934 4578277 13 Years M 8/29/2004 9/2/2004 1/27/2005 147 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Tachycardia
5742935 4578345     M 9/2/2004 1/27/2005 147 PER Strattera Anger, Mood Swings
5742936 4578349 13 Years M 9/3/2004 1/27/2005 146 PER Strattera Attention Deficit/Hyperactivity Disorder Flatulence, Nausea
5742937 4578352 10 Years M 9/2/2004 1/27/2005 147 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Fight In School
5742939 4578354 8 Years F 9/1/2004 9/2/2004 1/27/2005 147 PER Strattera Attention Deficit/Hyperactivity Disorder
5742942 4578355 12 Years M 1/1/2004 9/2/2004 1/27/2005 147 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Depression, Mood Swings, Speech Disorder
5742944 4578357 8 Years M 9/2/2004 1/27/2005 147 MD PER Strattera Disturbance in Attention, Hypoaesthesia
5743039 4582280 40 Years F 9/27/2004 1/27/2005 122 PER Strattera Feeling Cold, Feeling Hot, Headache, Hyperhidrosis, Paraesthesia, Sinus Disorder
5743041 4582281 49 Years F 9/24/2004 9/24/2004 1/27/2005 125 PER Strattera Attention Deficit/Hyperactivity Disorder
5743042 4582282 40 Years F 9/23/2004 9/27/2004 1/27/2005 122 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Nasal Discomfort, Nausea, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5743044 4582286     F 9/27/2004 1/27/2005 122 OT PER Strattera Nausea, Weight Increased
5743045 4582292 18 Years M 9/27/2004 1/27/2005 122 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Dizziness, Nausea, Somnolence
5743046 4582296 12 Years M 9/27/2004 1/27/2005 122 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Food Craving
5743047 4582302 15 Years M 9/27/2004 1/27/2005 122 MD PER Strattera Suicide Attempt
5743049 4582306 24 Years M 8/1/2004 9/27/2004 1/27/2005 122 OT PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Somnolence
5743050 4582312 9 Years F 9/1/2004 9/27/2004 1/27/2005 122 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Decreased Appetite, Epistaxis, Insomnia, Irritability, Mood Swings, Screaming, Tic
5743051 4582316     M 9/27/2004 1/27/2005 122 CN PER Strattera Drug Screen Positive
5743056 4581663 13 Years F 11/11/2004 1/27/2005 77 MD PER Strattera Attention Deficit/Hyperactivity Disorder Mania
5743057 4581667 16 Years M 11/11/2004 1/27/2005 77 MD PER Strattera Attention Deficit/Hyperactivity Disorder Mania
5743060 4581668     M 11/12/2004 1/27/2005 76 PER Strattera Feeling Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5743062 4581669 12 Years M 11/1/2004 11/15/2004 1/27/2005 73 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
5743064 4581670 53 Years F 11/15/2004 11/15/2004 1/27/2005 73 PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Pain
5743066 4581671 7 Years M 11/1/2004 11/12/2004 1/27/2005 76 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Conversion Disorder
5743070 4581675 44 Years F 11/15/2004 1/27/2005 73 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Constipation, Decreased Appetite, Dry Mouth, Feeling Drunk, Sleep Disorder, Weight Decreased
5743071 4577531 7 Years M 8/1/2004 9/10/2004 1/27/2005 139 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Feeling Abnormal, Psychomotor Hyperactivity, Weight Increased
5743071 4638821 7 Years M 8/1/2004 2/11/2005 3/28/2005 45 PER Strattera Crying, Emotional Distress, Feeling Abnormal, Impulsive Behaviour, Mood Swings, Psychomotor Hyperactivity, Therapeutic Response Decreased, Weight Increased
5743073 4577533 10 Years F 9/10/2004 1/27/2005 139 MD PER Strattera Eye Disorder
5743076 4577536     M 9/16/2004 1/27/2005 133 MD PER Strattera Attention Deficit/Hyperactivity Disorder Memory Impairment
5743079 4577538 18 Years M 9/22/2004 1/27/2005 127 PH PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
5743082 4577541 14 Years M 9/14/2004 9/15/2004 1/27/2005 134 MD PER Strattera Raynaud's Phenomenon
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5743090 4577544 30 Years F 9/22/2004 9/23/2004 1/27/2005 126 PER Strattera Attention Deficit/Hyperactivity Disorder Nocturia
5743132 4577546 54 Years F 9/22/2004 9/24/2004 1/27/2005 125 PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Decreased Appetite, Depression, Dizziness, Insomnia
5743145 4578499     M 1/18/2005 2/9/2005 22 MD EXP Strattera Jaundice
5743265 4578233     F 1/21/2005 2/9/2005 19 OT EXP Strattera Ocular Icterus
5743266 4578239 15 Years M 1/6/2005 1/21/2005 2/9/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased
5743267 4578249 8 Years M 7/1/2004 1/20/2005 2/9/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Photophobia, Somnolence, Urinary Incontinence Other
5743268 4578263 11 Years M 1/12/2005 1/20/2005 2/9/2005 20 OT EXP Strattera Jaundice
5743428 4578350     M 1/20/2005 2/9/2005 20 MD EXP Strattera Hepatic Enzyme Increased
5743428 4595459     M 2/3/2005 2/24/2005 21 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Gamma-Glutamyltransferase Increased
5743469 4578305 5 Years M 1/26/2005 2/9/2005 14 EXP Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dehydration, Gastric Disorder, Gastrooesophageal Reflux Disease, Stomach Discomfort, Vomiting Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5743469 4658134 5 Years M 4/18/2005 5/9/2005 21 MD EXP Strattera Constipation, Dehydration, Gastric Disorder, Stomach Discomfort, Vomiting Hospitalization - Initial or Prolonged
5743478 4578308 17 Years M 10/1/2004 1/21/2005 2/9/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Effusion, Herpes Simplex, Hypoaesthesia, Lung Disorder, Lupus-Like Syndrome, Pain, Pulmonary Embolism Hospitalization - Initial or Prolonged
5743478 4626573 17 Years M 10/1/2004 3/14/2005 3/30/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Deep Vein Thrombosis, Hypoaesthesia, Pain, Pleural Effusion, Pulmonary Embolism, Systemic Lupus Erythematosus Hospitalization - Initial or Prolonged, Other
5743478 4648764 17 Years M 10/1/2004 4/7/2005 4/27/2005 20 MD EXP Strattera Convulsion, Deep Vein Thrombosis, Lupus-Like Syndrome, Pleural Effusion, Pulmonary Embolism Hospitalization - Initial or Prolonged
5743492 4578312 14 Years M 1/26/2005 2/9/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion Hospitalization - Initial or Prolonged, Other
5743492 4606822 14 Years M 2/22/2005 3/9/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Agitation, Grand Mal Convulsion Hospitalization - Initial or Prolonged, Other
5743494 4578314 54 Years F 1/25/2005 2/9/2005 15 MD EXP Strattera Hepatic Enzyme Increased, Liver Disorder Other
5743494 4626571 54 Years F 8/31/2004 3/16/2005 3/30/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Fatigue, Influenza Like Illness
5743495 4582969 19 Years F 9/17/2004 1/27/2005 132 MD PER Strattera Heart Rate Increased
5743497 4582970 56 Years M 9/20/2004 1/27/2005 129 OT PER Strattera Attention Deficit/Hyperactivity Disorder Semen Volume Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5743497 4637380 56 Years M 12/23/2004 3/28/2005 95 MD PER Strattera Semen Volume Decreased
5743498 4582971 9 Years F 1/1/2003 9/20/2004 1/27/2005 129 CN PER Strattera Disturbance in Attention Disturbance in Attention, Insomnia, Nightmare, Sleep Disorder, Stomach Discomfort
5743499 4578320     F 1/20/2005 2/9/2005 20 MD EXP Strattera Aspartate Aminotransferase Increased, Dizziness, Epstein-Barr Virus Antigen Positive, Fatigue, Heart Rate Increased, Infectious Mononucleosis, Lymphadenopathy, Pharyngolaryngeal Pain, Pyrexia
5743502 4578332     F 1/25/2005 2/9/2005 15 MD EXP Strattera Hepatic Enzyme Increased
5743502 4626148 16 Years F 3/9/2005 3/30/2005 21 MD EXP Strattera Abdominal Distension, Depression, Fatigue, Hepatic Enzyme Increased, Nausea
5743502 4631329 16 Years F 3/21/2005 4/6/2005 16 MD EXP Strattera Abdominal Distension, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Depression, Fatigue, Hepatic Enzyme Increased, Nausea
5743504 4582972 58 Years M 7/1/2004 9/20/2004 1/27/2005 129 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dysgeusia, Nausea, Stomach Discomfort, Vomiting
5743507 4578338 25 Years M 1/1/2005 1/20/2005 2/9/2005 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Chromaturia, Hepatic Enzyme Increased, Rhabdomyolysis Hospitalization - Initial or Prolonged, Other
5743507 4631294 25 Years M 1/14/2005 3/23/2005 4/6/2005 14 EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Calcium Decreased, Blood Glucose Increased, Blood Lactate Dehydrogenase Increased, Blood Urine Present, PCO2 Increased, Protein Total Decreased, Protein Urine Present, Rhabdomyolysis Hospitalization - Initial or Prolonged, Other
5743508 4582973 10 Years M 9/20/2004 1/27/2005 129 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blepharospasm
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5743510 4578339 19 Years M 1/21/2005 2/9/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Muscle Spasms, Pain in Extremity
5743510 4618717 19 Years M 3/3/2005 3/23/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Muscle Spasms
5743516 4582975 8 Years M 9/17/2004 9/20/2004 1/27/2005 129 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Dry Mouth, Dyspnoea, Hot Flush, Mood Swings, Stomach Discomfort
5743521 4582977 7 Years F 9/20/2004 1/27/2005 129 MD PER Strattera Attention Deficit/Hyperactivity Disorder Muscle Twitching
5743527 4582978 50 Years M 9/1/2004 10/7/2004 1/27/2005 112 CN PER Strattera Depression Antisocial Behaviour, Anxiety, Arthralgia, Depression, Drug Ineffective, Dry Mouth, Feeling Abnormal, Hyperhidrosis, Insomnia, Nervousness, Psychomotor Hyperactivity, Suicidal Ideation
5743531 4582979 6 Years M 1/1/2004 9/20/2004 1/27/2005 129 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Decreased Appetite, Drug Ineffective, Fatigue, Somnolence
5743534 4582980 12 Years M 9/21/2004 1/27/2005 128 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention
5743538 4582959     M 9/17/2004 1/27/2005 132 CN PER Strattera Attention Deficit/Hyperactivity Disorder Eye Disorder, Heart Rate Increased
5743541 4582960 13 Years F 9/14/2004 9/16/2004 1/27/2005 133 PER Strattera Attention Deficit/Hyperactivity Disorder Depressed Mood, Depression
5743545 4582961     M 9/17/2004 1/27/2005 132 OT PER Strattera Attention Deficit/Hyperactivity Disorder Nervousness, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5743549 4582962 10 Years M 9/17/2004 1/27/2005 132 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
5743550 4582963 12 Years F 9/17/2004 1/27/2005 132 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
5743559 4582964 17 Years M 8/4/2004 9/17/2004 1/27/2005 132 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Drug Ineffective, Mood Swings
5743563 4582965 5 Years F 9/10/2004 9/17/2004 1/27/2005 132 CN PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Psychomotor Hyperactivity
5743565 4582966 11 Years M 9/20/2004 1/27/2005 129 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Mood Swings
5743567 4582967 19 Years F 9/1/2004 9/20/2004 1/27/2005 129 CN PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Decreased Appetite, Depression, Disturbance in Attention, Increased Appetite, Middle Insomnia, Weight Decreased
5743572 4582968 10 Years M 9/10/2004 9/17/2004 1/27/2005 132 PH PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5743574 4582981 15 Years 9/21/2004 1/27/2005 128 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
5743575 4582982 8 Years M 9/21/2004 1/27/2005 128 CN PER Strattera Tic
5743578 4582983 23 Years M 9/21/2004 1/27/2005 128 MD PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Paraesthesia, Piloerection, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5743580 4582984 9 Years M 8/1/2004 9/21/2004 1/27/2005 128 CN PER Strattera Decreased Appetite, Increased Appetite, Psychomotor Hyperactivity, Weight Decreased, Weight Increased
5743583 4582985 14 Years M 10/11/2004 1/27/2005 108 PH PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Impulsive Behaviour, Suicidal Ideation, Suicide Attempt
5743587 4582986 51 Years F 9/21/2004 1/27/2005 128 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Somnolence
5743589 4582987 7 Years M 9/1/2004 9/21/2004 1/27/2005 128 CN PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Disturbance in Attention, Feeling Abnormal, Impulsive Behaviour, Insomnia, Psychomotor Hyperactivity, Weight Decreased
5743600 4582988     M 9/21/2004 1/27/2005 128 MD PER Strattera
5743602 4582989 35 Years F 9/21/2004 9/21/2004 1/27/2005 128 CN PER Strattera Attention Deficit/Hyperactivity Disorder
5743605 4582990 17 Years M 9/22/2004 1/27/2005 127 CN PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Insomnia, Prostatitis, Scrotal Oedema
5743608 4582877 30 Years M 1/1/2004 9/13/2004 1/27/2005 136 CN PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Decreased Appetite, Disturbance in Attention, Drug Ineffective, Feeling of Body Temperature Change, Gastrooesophageal Reflux Disease, Insomnia, Pyrexia, Stomach Discomfort, Weight Decreased
5743612 4582878 42 Years F 9/1/2004 9/13/2004 1/27/2005 136 CN PER Strattera Attention Deficit/Hyperactivity Disorder Body Temperature Increased, Paraesthesia, Pruritus, Urinary Tract Infection
5743613 4582880 9 Years F 9/13/2004 1/27/2005 136 CN PER Strattera Anxiety, Attention Deficit/Hyperactivity Disorder Anxiety
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5743616 4582881 9 Years M 5/14/2004 9/13/2004 1/27/2005 136 OT PER Strattera Psychomotor Hyperactivity Cellulitis, Drug Interaction, Psychomotor Hyperactivity
5743623 4582882 15 Years M 9/13/2004 9/14/2004 1/27/2005 135 CN PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Motion Sickness, Photophobia, Stomach Discomfort, Vomiting
5743626 4582884 7 Years F 1/1/2004 9/14/2004 1/27/2005 135 PH PER Strattera Sleep Disorder, Weight Decreased
5743629 4582885 58 Years F 9/13/2004 9/14/2004 1/27/2005 135 CN PER Strattera Feeling Cold, Hyperhidrosis, Psychomotor Hyperactivity
5743633 4582886 33 Years M 9/14/2004 9/14/2004 1/27/2005 135 CN PER Strattera Attention Deficit/Hyperactivity Disorder
5743642 4582887 8 Years M 9/14/2004 1/27/2005 135 CN PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Disturbance in Attention, Drug Ineffective, Feeling Abnormal, Irritability
5743644 4582888 7 Years F 9/12/2004 9/13/2004 1/27/2005 136 OT PER Strattera Attention Deficit/Hyperactivity Disorder Nightmare
5743645 4582891 9 Years M 9/14/2004 1/27/2005 135 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Emotional Distress
5743647 4582892 52 Years M 1/1/2004 11/16/2004 1/27/2005 72 MD PER Strattera Attention Deficit/Hyperactivity Disorder Retrograde Ejaculation
5743650 4582896 47 Years F 9/13/2004 9/14/2004 1/27/2005 135 CN PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Feeling Abnormal, Feeling Jittery, Insomnia, Mydriasis, Paraesthesia, Visual Acuity Reduced
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5743652 4582897 7 Years M 9/14/2004 1/27/2005 135 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective
5743653 4582898 9 Years M 9/14/2004 1/27/2005 135 CN PER Strattera Mydriasis, Visual Disturbance
5743655 4582899 18 Years M 9/1/2004 9/14/2004 1/27/2005 135 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Anxiety, Confusional State, Disturbance in Attention, Hyperhidrosis, Insomnia, Major Depression, Memory Impairment, Paranoia, Suicidal Ideation, Weight Decreased
5743656 4582900 9 Years M 8/1/2004 9/14/2004 1/27/2005 135 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Educational Problem, Somnolence
5743658 4582901     M 1/1/2004 9/14/2004 1/27/2005 135 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dependence, Drug Screen Positive
5743660 4582902 52 Years F 9/15/2004 1/27/2005 134 CN PER Strattera Somnolence Hyperphagia, Polydipsia, Weight Decreased
5743661 4582903 6 Years M 8/1/2004 9/15/2004 1/27/2005 134 CN PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Fatigue, Mood Swings, Sluggishness
5743915 4582908 16 Years M 9/14/2004 1/27/2005 135 MD PER Strattera Dysgeusia
5743917 4582911 8 Years M 9/1/2004 9/14/2004 1/27/2005 135 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue
5743918 4582913     M 9/1/2004 1/27/2005 148 MD PER Strattera Dehydration
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5743919 4582914 14 Years M 9/1/2004 9/14/2004 1/27/2005 135 PER Strattera Alopecia
5743922 4582915 48 Years F 9/15/2004 1/27/2005 134 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
5743929 4582917 65 Years M 9/1/2004 9/15/2004 1/27/2005 134 PER Strattera Attention Deficit/Hyperactivity Disorder Confusional State, Decreased Appetite, Dizziness, Dysuria, Insomnia
5743930 4582918 12 Years 1/1/2004 9/14/2004 1/27/2005 135 MD PER Strattera Mydriasis, Photophobia
5743931 4582921 6 Years M 9/15/2004 1/27/2005 134 MD PER Strattera Hallucination (Auditory)
5743938 4582923 7 Years M 1/1/2002 9/15/2004 1/27/2005 134 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Agitation, Fatigue, Feeling Abnormal, Flat Affect, Middle Insomnia, Restlessness, Tremor
5743939 4582927 21 Years M 9/1/2004 9/15/2004 1/27/2005 134 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Disturbance in Attention, Drug Ineffective, Feeling Abnormal, Headache, Hypersomnia, Increased Appetite, Somnolence
5743940 4582928 17 Years M 9/15/2004 1/27/2005 134 MD PER Strattera Attention Deficit/Hyperactivity Disorder Prostatitis
5743944 4582929 6 Years F 9/15/2004 9/15/2004 1/27/2005 134 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Oral Discomfort
5743947 4582930 47 Years F 9/16/2004 1/27/2005 133 OT PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Activity, Drug Ineffective, Headache, Nausea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5743948 4582931 11 Years M 9/1/2004 9/15/2004 1/27/2005 134 PER Strattera Attention Deficit/Hyperactivity Disorder Ear Pain, Enuresis, Nasal Congestion, Nasopharyngitis
5743950 4582932     M 9/15/2004 1/27/2005 134 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Bradyphrenia, Fatigue, Feeling Abnormal, Nausea, Overdose, Stomach Discomfort
5743953 4582933 29 Years F 9/1/2004 9/15/2004 1/27/2005 134 MD PER Strattera Attention Deficit/Hyperactivity Disorder Bipolar Disorder, Depression, Disorientation
5743954 4582934     9/2/2004 1/27/2005 147 MD PER Strattera Depression
5743956 4582935 14 Years M 9/13/2004 9/15/2004 1/27/2005 134 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Headache, Insomnia, Stomach Discomfort, Vision Blurred
5743958 4582937 27 Years M 8/1/2004 9/16/2004 1/27/2005 133 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Mood Swings
5744111 4578097     M 1/19/2005 1/27/2005 2/9/2005 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Immune System Disorder, Neutropenia Other
5744111 4595898 15 Years M 1/19/2005 2/3/2005 2/24/2005 21 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Condition Aggravated, Drug Ineffective, Immune System Disorder, Neutropenia Hospitalization - Initial or Prolonged
5744117 4578099 7 Years F 1/25/2005 2/9/2005 15 MD EXP Strattera Irritability, Suicidal Ideation Other
5744440 4579234     F 2/8/2005 PH DIR Strattera Attention Deficit/Hyperactivity Disorder Condition Aggravated, Tic
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5744732 4582939 7 Years M 9/16/2004 1/27/2005 133 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Disturbance in Attention, Drug Ineffective, Dysgraphia, Psychomotor Hyperactivity, Thinking Abnormal
5744733 4582940 14 Years M 9/14/2004 9/15/2004 1/27/2005 134 PER Strattera Attention Deficit/Hyperactivity Disorder Eye Pain, Headache, Stomach Discomfort
5744735 4582941 33 Years M 9/1/2004 10/25/2004 1/27/2005 94 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Ejaculation Disorder
5744737 4582942 9 Years F 1/1/2004 10/26/2004 1/27/2005 93 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Crying, Irritability, Mood Swings
5744739 4582943 14 Years M 9/15/2004 1/27/2005 134 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety
5744747 4582944     M 9/15/2004 1/27/2005 134 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Headache, Middle Insomnia
5744748 4582945 50 Years F 1/1/2004 9/16/2004 1/27/2005 133 OT PER Strattera Hyperhidrosis
5744749 4582946 12 Years M 9/16/2004 1/27/2005 133 PER Strattera Disturbance in Attention
5744751 4582948 13 Years M 1/1/2004 9/16/2004 1/27/2005 133 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Depressed Mood, Self-Injurious Ideation
5744764 4582949 15 Years F 9/1/2004 9/16/2004 1/27/2005 133 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Chills, Constipation, Dehydration, Hyperhidrosis, Splenomegaly
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5744765 4582950     M 9/16/2004 1/27/2005 133 PER Strattera Ejaculation Disorder, Urinary Incontinence
5744766 4582951 35 Years F 9/17/2004 9/17/2004 1/27/2005 132 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Headache, Insomnia, Thinking Abnormal
5744767 4582952 12 Years M 9/17/2004 1/27/2005 132 OT PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Weight Increased
5744768 4582953 14 Years M 1/1/2004 9/17/2004 1/27/2005 132 MD PER Strattera Attention Deficit/Hyperactivity Disorder Epistaxis
5744769 4582954 28 Years M 9/16/2004 9/16/2004 1/27/2005 133 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Hyperhidrosis, Stomach Discomfort
5744770 4582955 8 Years M 9/17/2004 1/27/2005 132 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Dyspnoea, Feeling Abnormal
5744771 4582956 8 Years M 1/1/2003 9/17/2004 1/27/2005 132 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Emotional Disorder
5744772 4582957 28 Years F 8/23/2004 10/28/2004 1/27/2005 91 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Drug Interaction, Dyskinesia, Hypoaesthesia, Muscle Twitching, Paraesthesia
5744773 4582958 12 Years M 1/1/2004 9/17/2004 1/27/2005 132 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Nervousness, Somnolence, Weight Decreased
5744981 4579512     M 1/21/2005 2/9/2005 19 MD EXP Strattera Completed Suicide Death
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5744981 4772991 39 Years M 8/29/2005 9/15/2005 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Completed Suicide Death
5745040 4579425 39 Years M 1/24/2005 1/25/2005 2/9/2005 15 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Anorexia, Appendicitis, Diarrhoea, Gamma-Glutamyltransferase Increased, Vomiting Hospitalization - Initial or Prolonged
5745040 4612418 39 Years M 1/24/2005 2/28/2005 3/16/2005 16 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Appendicitis, Blood Urine Present, Gamma-Glutamyltransferase Increased, Gastroenteritis, Liver Disorder, Protein Urine Present Hospitalization - Initial or Prolonged
5745049 4579426 16 Years M 1/25/2005 2/9/2005 15 OT EXP Strattera
5746466 4580035 6 Years F 9/1/2004 9/28/2004 1/27/2005 121 CN PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Screaming, Somnolence, Vomiting
5746469 4580052 10 Years M 1/1/2004 9/27/2004 1/27/2005 122 MD PER Strattera Autism Tic
5746472 4580063 45 Years M 9/26/2004 9/27/2004 1/27/2005 122 CN PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Insomnia, Paraesthesia, Social Avoidant Behaviour
5746487 4580065 52 Years F 9/28/2004 1/27/2005 121 CN PER Strattera Anxiety, Depression, Disturbance in Attention, Hot Flush
5746491 4580070 52 Years F 9/1/2004 9/27/2004 1/27/2005 122 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Dizziness, Hyperhidrosis, Hypoaesthesia, Influenza Like Illness, Nausea, Pruritus
5746494 4580094 49 Years M 9/1/2004 9/27/2004 1/27/2005 122 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5746513 4580101 36 Years F 9/25/2004 10/1/2004 1/27/2005 118 MD PER Strattera Attention Deficit/Hyperactivity Disorder Migraine
5746518 4580107 11 Years M 9/27/2004 1/27/2005 122 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
5746526 4580111     F 9/27/2004 1/27/2005 122 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Insomnia, Joint Swelling, Migraine, Oedema Peripheral, Vision Blurred, Wheezing
5746527 4580115 29 Years M 9/27/2004 9/27/2004 1/27/2005 122 CN PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
5746530 4581031 15 Years F 8/1/2004 9/8/2004 1/27/2005 141 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Drug Ineffective, Weight Increased
5746535 4581058 17 Years M 11/1/2004 12/6/2004 1/27/2005 52 PH PER Strattera Abnormal Behaviour
5746535 4638826 17 Years M 11/1/2004 12/6/2004 3/28/2005 112 PH PER Strattera Abnormal Behaviour
5746538 4581061 22 Years F 11/16/2004 1/27/2005 72 PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination, Somnolence
5746544 4581064 20 Years F 11/15/2004 1/27/2005 73 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Impulsive Behaviour, Palpitations, Skin Discolouration, Thinking Abnormal, Wheezing
5746547 4581078 9 Years M 1/1/2004 11/16/2004 1/27/2005 72 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5746550 4581114 8 Years M 1/1/2004 11/17/2004 1/27/2005 71 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Vomiting
5746552 4581116 4 Years F 11/17/2004 1/27/2005 71 MD PER Strattera Attention Deficit/Hyperactivity Disorder Skin Odour Abnormal
5746559 4581122 27 Years M 11/17/2004 1/27/2005 71 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Asthenia, Constipation, Headache, Insomnia, Paraesthesia, Restlessness
5746562 4581128 13 Years M 11/17/2004 1/27/2005 71 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Somnolence, Thinking Abnormal
5746563 4581159 13 Years M 7/1/2003 11/17/2004 1/27/2005 71 PER Strattera Attention Deficit/Hyperactivity Disorder Body Height Increased, Lethargy, Weight Increased
5746565 4581343 14 Years M 1/1/2004 9/8/2004 1/27/2005 141 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Blood Pressure Increased, Heart Rate Increased, Nausea, Vomiting
5746565 4726705 14 Years M 1/1/2004 4/12/2005 7/25/2005 104 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Blood Pressure Increased, Heart Rate Increased, Nausea, Vomiting
5746570 4581398 8 Years M 1/1/2004 9/8/2004 1/27/2005 141 CN PER Strattera Attention Deficit/Hyperactivity Disorder Fear, Psychomotor Hyperactivity, Vomiting
5746571 4599597 61 Years F 10/1/2004 10/19/2004 1/27/2005 100 PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Feeling Abnormal, Mood Swings, Thinking Abnormal
5746572 4581434     M 9/9/2004 9/9/2004 1/27/2005 140 CN PER Strattera
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5746575 4581436 9 Years M 9/9/2004 1/27/2005 140 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Psychomotor Hyperactivity
5746577 4581457 16 Years F 9/9/2004 1/27/2005 140 CN PER Strattera Somnolence, Stomach Discomfort
5746579 4581474 6 Years M 8/31/2004 9/9/2004 1/27/2005 140 CN PER Strattera Attention Deficit/Hyperactivity Disorder Tic
5746580 4581476 10 Years F 9/9/2004 1/27/2005 140 CN PER Strattera Somnolence, Stomach Discomfort
5746584 4581478 44 Years M 9/1/2004 11/2/2004 1/27/2005 86 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Anxiety, Confusional State, Depression, Disorientation, Disturbance in Attention, Dizziness, Dysuria, Fatigue, Flushing, Hyperhidrosis, Memory Impairment, Mood Swings, Nausea, Pruritus Generalised, Sleep Disorder, Testicular Pain, Urinary Retention
5746586 4581499 9 Years M 8/1/2004 9/24/2004 1/27/2005 125 OT PER Strattera Attention Deficit/Hyperactivity Disorder Psychiatric Symptom
5746588 4581501 12 Years M 9/8/2004 1/27/2005 141 MD PER Strattera Hyperhidrosis
5747295 4498289 25 Years M 1/1/2004 6/11/2004 9/27/2004 108 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Drug Ineffective, Hyperhidrosis, Insomnia, Memory Impairment
5747377 4580297 11 Years M 2/2/2004 9/9/2004 1/27/2005 140 CN PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Micturition Disorder, Mydriasis
5747380 4580302 10 Years M 10/20/2004 1/27/2005 99 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Drug Ineffective, Logorrhoea, Psychomotor Hyperactivity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5747410 4580889 57 Years F 11/15/2004 11/15/2004 1/27/2005 73 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Excitability, Feeling Abnormal, Mania, Somnolence
5747411 4580891 10 Years M 11/1/2004 11/15/2004 1/27/2005 73 CN PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Feeling Abnormal, Nausea, Vomiting
5747412 4580893 11 Years M 11/15/2004 11/16/2004 1/27/2005 72 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Mydriasis, Psychomotor Hyperactivity, Somnolence
5747418 4580895 14 Years M 11/16/2004 1/27/2005 72 CN PER Strattera Anorexia, Dizziness, Fatigue, Feeling Abnormal, Nausea
5747428 4580918 14 Years F 11/16/2004 1/27/2005 72 CN PER Strattera Attention Deficit/Hyperactivity Disorder Acne, Feeling Abnormal, Fungal Infection, Hormone Level Abnormal
5747429 4580972 11 Years F 10/1/2004 11/16/2004 1/27/2005 72 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
5747433 4581021 36 Years F 11/14/2004 11/16/2004 1/27/2005 72 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Feeling Jittery, Somnolence
5747434 4581027 23 Years M 11/16/2004 1/27/2005 72 MD PER Strattera Exercise Tolerance Decreased
5747436 4581028 39 Years F 11/16/2004 1/27/2005 72 MD PER Strattera Exercise Tolerance Decreased
5747439 4581029 50 Years F 11/16/2004 11/16/2004 1/27/2005 72 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Nervousness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5747444 4580768 13 Years M 8/13/2004 11/22/2004 1/27/2005 66 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Disturbance in Attention, Drug Ineffective, Headache, Nausea, Somnolence, Vomiting
5747444 4637366 13 Years M 8/13/2004 11/22/2004 3/28/2005 126 CN PER Strattera Abdominal Pain Upper, Disturbance in Attention, Drug Ineffective, Headache, Nausea, Somnolence, Vomiting
5747454 4580789 4 Years F 6/1/2004 8/18/2004 1/27/2005 162 PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Mood Swings, Sleep Disorder, Staring
5747455 4580792 51 Years F 8/11/2004 8/18/2004 1/27/2005 162 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Drug Ineffective, Hunger, Nausea, Psychomotor Hyperactivity
5747456 4580794     M 8/17/2004 1/27/2005 163 MD PER Strattera Nightmare
5747458 4580806 13 Years F 8/18/2004 1/27/2005 162 MD PER Strattera Attention Deficit/Hyperactivity Disorder
5747465 4580831 8 Years M 8/18/2004 1/27/2005 162 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anxiety, Crying, Decreased Appetite, Logorrhoea, Psychomotor Hyperactivity, Vomiting, Weight Decreased
5747468 4580886 5 Years M 8/18/2004 1/27/2005 162 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Retching
5749486 4588973     F 2/1/2005 2/16/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased
5749486 4607082 37 Years F 2/22/2005 3/9/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5749488 4588975 16 Years M 1/31/2005 1/31/2005 2/16/2005 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Blindness Transient, Vision Blurred Other
5749488 4599513 16 Years M 1/31/2005 2/11/2005 3/3/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blindness Transient, Hypoglycaemia, Migraine with Aura, Vision Blurred Other
5749488 4631271 16 Years M 1/31/2005 3/22/2005 4/6/2005 15 MD EXP Strattera Blindness Transient, Hypoglycaemia, Ophthalmoplegic Migraine, Vision Blurred Other
5749493 4588977 53 Years F 1/1/2004 1/31/2005 2/16/2005 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Diabetes Mellitus, Weight Increased, Weight Loss Poor
5749601 4588040 14 Years M 1/31/2005 2/16/2005 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Agitation, Anxiety, Emotional Distress, Insomnia, Mood Swings, Psychomotor Hyperactivity, Restlessness Other
5749607 4588041 15 Years M 2/4/2005 2/16/2005 12 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased, Fatigue
5749620 4588951 36 Years M 1/27/2005 2/16/2005 20 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Viral Infection
5749647 4588956     M 1/28/2005 2/16/2005 19 MD EXP Strattera Cardiomegaly, Hypertension Other
5749647 4595460 43 Years M 2/8/2005 2/24/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Diastolic Increased, Cardiac Ventricular Disorder, Cardiomegaly, Hypertension Other
5749735 4588959 10 Years M 1/26/2005 2/16/2005 21 MD EXP Strattera Abdominal Pain, Hepatic Enzyme Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5749735 4612425 9 Years M 1/1/2004 2/25/2005 3/16/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anorexia, Dizziness, Nausea
5749738 4588961 12 Years M 1/26/2005 2/16/2005 21 MD EXP Strattera Hepatic Enzyme Increased
5749740 4588962 35 Years M 11/30/2004 2/4/2005 2/16/2005 12 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5749742 4588963 7 Years M 1/10/2005 1/28/2005 2/16/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Gastrointestinal Haemorrhage, Haematemesis, Haematochezia, Haemoglobin Decreased, Henoch-Schonlein Purpura, Movement Disorder, Proteinuria, Rash, Shock Haemorrhagic, Somnolence Hospitalization - Initial or Prolonged
5749746 4588964     1/31/2005 2/16/2005 16 MD EXP Strattera Hepatic Enzyme Abnormal, Serum Ferritin Increased
5749748 4588966 15 Years F 1/26/2005 2/16/2005 21 MD EXP Strattera Hepatitis
5749748 4612421 15 Years F 10/1/2004 2/25/2005 3/16/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Feeling Abnormal, Hepatic Enzyme Increased, Jaundice, Vomiting
5749754 4588968 15 Years M 1/31/2005 2/16/2005 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Daydreaming, Imprisonment, Libido Increased, Memory Impairment Other
5749756 4588970 35 Years F 1/27/2005 2/16/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Feeling Abnormal, Malaise
5749857 4588653 11 Years F 1/27/2005 2/16/2005 20 MD EXP Strattera Blood Alkaline Phosphatase Increased, Blood Parathyroid Hormone Increased, Bone Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5749892 4589204     F 1/25/2005 2/15/2005 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Headache, Nausea Required Intervention to Prevent Permanent Impairment/Damage
5749989 4581217 39 Years M 9/8/2004 1/27/2005 141 CN PER Strattera Disturbance in Attention Agitation, Asthenia, Catatonia, Disorientation, Dizziness, Fatigue, Feeling Abnormal, Hyperacusis, Irritability, Nausea, Paraesthesia, Photophobia, Somnolence, Vomiting
5749999 4581224 5 Years M 9/4/2004 9/7/2004 1/27/2005 142 PER Strattera Impulsive Behaviour, Psychomotor Hyperactivity Abnormal Behaviour, Somnolence
5750002 4581233 62 Years M 9/8/2004 1/27/2005 141 CN PER Strattera Decreased Appetite, Pruritus
5750004 4581235 10 Years M 9/8/2004 1/27/2005 141 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Psychomotor Hyperactivity, Somnolence
5750005 4581267 16 Years M 1/1/2004 9/8/2004 1/27/2005 141 MD PER Strattera Abdominal Pain Upper, Chromaturia, Dehydration, Fatigue, Insomnia
5750006 4581268 8 Years M 9/1/2004 9/8/2004 1/27/2005 141 CN PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dysphagia, Emotional Disorder, Fear, Insomnia, Vomiting
5750008 4581274     M 9/7/2004 1/27/2005 142 CN PER Strattera Attention Deficit/Hyperactivity Disorder Hyperhidrosis
5750009 4581282 7 Years F 9/8/2004 1/27/2005 141 CN PER Strattera Attention Deficit/Hyperactivity Disorder Choking, Insomnia, Nightmare, Weight Decreased
5750010 4581298     M 9/8/2004 1/27/2005 141 PH PER Strattera
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5750012 4581309 16 Years F 9/8/2004 1/27/2005 141 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Abnormal
5750327 4589213 11 Years M 12/13/2004 2/14/2005 OT DIR Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Diarrhoea, Fatigue, Muscle Spasms, Nausea, Vomiting Other
5750852 4580149 8 Years M 1/1/2004 9/28/2004 1/27/2005 121 CN PER Strattera Attention Deficit/Hyperactivity Disorder Laboratory Test Abnormal
5750857 4580151 7 Years M 9/18/2004 9/28/2004 1/27/2005 121 PER Strattera Decreased Appetite, Feeling Abnormal, Lacrimation Increased, Nausea, Night Sweats, Retching, Somnolence, Stomach Discomfort
5750858 4580153 13 Years M 9/20/2004 9/28/2004 1/27/2005 121 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Mood Swings, Stomach Discomfort, Vomiting
5750859 4580154 12 Years 9/28/2004 1/27/2005 121 MD PER Strattera Agitation, Insomnia, Irritability
5750860 4580157 15 Years M 9/28/2004 1/27/2005 121 MD PER Strattera Cold Sweat, Nausea, Vomiting
5750862 4580163 12 Years 9/28/2004 1/27/2005 121 MD PER Strattera Aggression, Anger
5750863 4580190 14 Years M 1/1/2004 9/29/2004 1/27/2005 120 PH PER Strattera Retching
5750864 4580192 12 Years M 9/24/2004 9/28/2004 1/27/2005 121 PER Strattera Attention Deficit/Hyperactivity Disorder Cough, Fatigue, Feeling Abnormal, Nasal Congestion, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5751078 4580447 14 Years M 1/1/2004 11/1/2004 1/27/2005 87 PER Strattera Attention Deficit/Hyperactivity Disorder Bradyphrenia, Decreased Appetite, Depression, Disturbance in Attention, Dizziness, Drug Ineffective, Flat Affect, Headache, Thinking Abnormal
5751164 4580502 42 Years F 8/14/2004 10/22/2004 1/27/2005 97 PER Strattera Disturbance in Attention Anxiety, Dizziness, Feeling Hot and Cold, Headache, Heart Rate Abnormal, Panic Disorder, Somnolence, Tremor
5751166 4580505 7 Years F 8/1/2004 11/30/2004 1/27/2005 58 OT PER Strattera Impulsive Behaviour Aggression, Anger, Decreased Appetite, Drug Ineffective, Irritability, Somnolence
5751166 4637426 7 Years F 8/1/2004 11/30/2004 3/28/2005 118 OT PER Strattera Aggression, Anger, Decreased Appetite, Drug Ineffective, Irritability, Somnolence
5751171 4580539 8 Years F 12/1/2004 1/27/2005 57 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Crying, Decreased Appetite, Drug Ineffective, Emotional Disorder, Emotional Distress, Fatigue, Memory Impairment, Nightmare, Rash, Rhinorrhoea, Sinusitis, Sleep Talking, Somnolence, Weight Decreased
5751171 4637428 8 Years F 12/1/2004 3/28/2005 117 PER Strattera Aggression, Crying, Decreased Appetite, Drug Ineffective, Emotional Disorder, Emotional Distress, Fatigue, Memory Impairment, Nightmare, Rash, Rhinorrhoea, Sinusitis, Sleep Talking, Somnolence, Weight Decreased
5752013 4637176 68 Years F 9/22/2004 1/19/2005 3/25/2005 65 PER Strattera Fatigue, Glossodynia, Insomnia, Rash Papular, Rash Scaly, Tongue Disorder
5752234 4598349 21 Years F 1/1/2005 3/1/2005 OT DIR Strattera Attention Deficit/Hyperactivity Disorder Rash Other
5752293 4590962     M 2/8/2005 2/22/2005 MD DIR Strattera Tic Other
5752462 4580209 12 Years F 10/1/2004 11/5/2004 1/27/2005 83 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Feeling Abnormal, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5752471 4580210 6 Years M 1/1/2004 11/5/2004 1/27/2005 83 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Nausea, Somnolence, Vomiting
5752476 4580213 38 Years F 1/1/2004 9/7/2004 1/27/2005 142 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abortion Spontaneous
5752581 4580254 22 Years F 12/16/2003 9/24/2004 1/27/2005 125 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abortion Spontaneous
5752721 4591064 25 Years M 2/18/2005 2/22/2005 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Hypertension, Tachycardia Other
5753078 4595878     M 1/1/2005 2/7/2005 2/24/2005 17 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Alanine Aminotransferase Increased, Albumin Urine Present, Anorexia, Blood Creatine Phosphokinase Increased, Blood Sodium Decreased, Dry Mouth, Feeling Abnormal, Fluid Intake Reduced, Gastroenteritis Viral, Insomnia, Nausea, Palpitations, Pruritus, Restlessness, Urinary Tract Infection, Vomiting Hospitalization - Initial or Prolonged, Other
5753078 4625582 9 Years M 1/21/2005 2/24/2005 3/30/2005 34 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Alanine Aminotransferase Increased, Anorexia, Aspartate Aminotransferase Increased, Blood Sodium Decreased, Constipation, Dry Mouth, Feeling Abnormal, Feeling Drunk, Formication, Gastroenteritis Viral, Insomnia, Nausea, Palpitations, Pruritus, Psychomotor Hyperactivity, Vomiting, Weight Increased Hospitalization - Initial or Prolonged, Other
5753078 4765254 9 Years M 1/21/2005 8/10/2005 9/6/2005 27 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Alanine Aminotransferase Increased, Albumin Urine, Anorexia, Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Blood Sodium Decreased, Condition Aggravated, Constipation, Dry Mouth, Eating Disorder, Fluid Intake Reduced, Formication, Gastroenteritis Viral, Insomnia, Nausea, Palpitations, Pruritus, Psychomotor Hyperactivity, Restlessness, Sleep Disorder, Vomiting, Weight Increased Hospitalization - Initial or Prolonged, Other
5753080 4595879 14 Years M 1/24/2005 2/9/2005 2/24/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Agitation, Condition Aggravated Other
5753083 4595881 12 Years M 12/1/2004 2/8/2005 2/24/2005 16 EXP Strattera Tourette's Disorder Dizziness, Palpitations Disability
5753087 4595883 14 Years M 11/30/2004 2/8/2005 2/24/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aspartate Aminotransferase Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5753087 4600136 14 Years M 11/29/2004 2/14/2005 3/3/2005 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aspartate Aminotransferase Increased, Blood Albumin Increased, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Blood Testosterone Decreased, Blood Thyroid Stimulating Hormone Decreased, Delayed Puberty, Insulin-Like Growth Factor Decreased Other
5753087 4618301 14 Years M 11/29/2004 2/14/2005 3/24/2005 38 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aspartate Aminotransferase Increased, Blood Albumin Increased, Blood Bilirubin Increased, Blood Testosterone Decreased, Blood Thyroid Stimulating Hormone Decreased, Insulin-Like Growth Factor Decreased
5753193 4595872 5 Years M 2/4/2005 2/24/2005 20 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Convulsion, Psychomotor Hyperactivity Hospitalization - Initial or Prolonged
5753193 4600188 5 Years M 2/11/2005 3/3/2005 20 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Psychomotor Hyperactivity, Status Epilepticus Hospitalization - Initial or Prolonged
5753303 4595889 12 Years M 9/1/2004 2/7/2005 2/24/2005 17 EXP Strattera Attention Deficit/Hyperactivity Disorder, Psychomotor Hyperactivity Compulsions, Obsessive Thoughts, Paranoia, Suicidal Ideation Other
5753792 4595456 19 Years F 2/4/2005 2/24/2005 20 MD EXP Strattera Hepatic Enzyme Increased Hospitalization - Initial or Prolonged
5754016 4595793 15 Years F 2/7/2005 2/24/2005 17 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Confusional State, Convulsion, Postictal State Other
5754016 4692437 15 Years F 1/5/2005 5/30/2005 6/16/2005 17 MD EXP Atomoxetine Asthenia, Confusional State, Convulsion, Postictal Paralysis, Postictal State Other
5754407 4595535 8 Years M 2/3/2005 2/24/2005 21 EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Disturbance in Attention, Tic Other
5754648 4595199 8 Years F 2/1/2005 2/25/2005 24 MD EXP Strattera Alanine Aminotransferase Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5754648 4638221 8 Years F 12/20/2004 3/23/2005 4/18/2005 26 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5754650 4595536 14 Years M 12/22/2004 2/3/2005 2/24/2005 21 EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased
5754650 4681579 14 Years M 12/22/2004 5/16/2005 6/2/2005 17 EXP Strattera Abdominal Pain, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Diarrhoea, Nausea
5754653 4595538 11 Years M 10/8/2004 10/8/2004 2/7/2005 2/24/2005 17 EXP Strattera Depression Cardio-Respiratory Arrest Death
5754653 4638248 11 Years M 10/8/2004 10/8/2004 3/24/2005 4/15/2005 22 MD EXP Strattera Cardio-Respiratory Arrest, Fatigue, Suicidal Ideation Death
5754690 4595539 15 Years M 12/27/2004 2/4/2005 2/24/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Bilirubin Increased, Nasopharyngitis, Pyrexia
5754710 4595541 11 Years M 2/7/2005 2/14/2005 2/24/2005 10 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased, Nausea
5754772 4595558 61 Years F 12/29/2004 2/7/2005 2/24/2005 17 OT EXP Strattera Alanine Aminotransferase Increased Other
5754794 4595559 11 Years M 2/3/2005 2/8/2005 2/24/2005 16 MD EXP Strattera Abdominal Pain, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Band Neutrophil Percentage Decreased, Eosinophil Percentage Increased
5754798 4595560 20 Years M 2/9/2005 2/24/2005 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Gastrointestinal Haemorrhage, Hepatocellular Damage Hospitalization - Initial or Prolonged, Life-Threatening
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5754798 4599594 22 Years M 2/16/2005 3/3/2005 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Haematemesis, Hepatocellular Damage, Oesophageal Ulcer Hospitalization - Initial or Prolonged, Life-Threatening
5754808 4595561 58 Years F 8/30/2004 2/3/2005 2/24/2005 21 MD EXP Strattera Joint Injury, Myoclonus, Plastic Surgery to the Face, Post Procedural Complication Other
5754883 4595550 14 Years M 2/2/2005 2/24/2005 22 EXP Strattera Attention Deficit/Hyperactivity Disorder Liver Function Test Abnormal, Rash
5754991 4600600 13 Years M 10/8/2004 1/27/2005 111 PH PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
5754992 4600603 10 Years M 11/8/2004 1/27/2005 80 OT PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Drug Ineffective, Hypoglycaemia, Tachycardia
5754995 4600605 47 Years F 9/1/2004 10/11/2004 1/27/2005 108 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Feeling Abnormal, Heart Rate Increased, Hyperaesthesia, Nausea, Pruritus
5754996 4600609 6 Years M 10/11/2004 1/27/2005 108 PER Strattera Attention Deficit/Hyperactivity Disorder Vomiting
5754998 4600614 12 Years 10/11/2004 1/27/2005 108 OT PER Strattera Throat Irritation
5755007 4600618 45 Years F 10/8/2004 1/27/2005 111 PER Strattera Bipolar Disorder Abnormal Sleep-Related Event, Bruxism, Disturbance in Attention, Drug Ineffective, Initial Insomnia, Insomnia, Logorrhoea, Mental Status Changes, Nausea, Personality Change, Psychomotor Hyperactivity
5755011 4600620 6 Years F 10/6/2004 11/23/2004 1/27/2005 65 MD PER Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Increased, Nausea, Vomiting Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5755011 4637358 6 Years F 9/21/2004 3/2/2005 3/28/2005 26 OT PER Strattera Nausea, Tachycardia, Vomiting Other
5755011 4726572 6 Years F 9/21/2004 3/2/2005 7/25/2005 145 OT PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Tachycardia, Vomiting Other
5755013 4600622 47 Years M 10/11/2004 1/27/2005 108 PER Strattera Attention Deficit/Hyperactivity Disorder Excitability, Somnolence
5755016 4600624 7 Years M 1/1/2004 10/11/2004 1/27/2005 108 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Insomnia, Psychomotor Hyperactivity
5755017 4600625 7 Years M 10/11/2004 1/27/2005 108 OT PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Drug Ineffective
5755017 4637359 7 Years M 1/24/2005 3/28/2005 63 OT PER Strattera Chest Pain, Drug Ineffective
5755048 4598338 12 Years M 1/20/2005 3/1/2005 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Decreased, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased Other
5755109 4600568     F 1/1/2004 10/7/2004 1/27/2005 112 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Anxiety, Crying, Depression, Dysuria, Feeling Jittery, Sleep Disorder, Urinary Hesitation
5755110 4600572 15 Years M 1/1/2004 11/18/2004 1/27/2005 70 MD PER Strattera Attention Deficit/Hyperactivity Disorder Swelling Face, Throat Tightness, Urticaria
5755110 4637355 15 Years M 1/1/2004 11/18/2004 3/28/2005 130 MD PER Strattera Swelling Face, Throat Tightness, Urticaria
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5755111 4600576 7 Years F 1/1/2004 10/7/2004 1/27/2005 112 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Muscle Spasms, Vomiting
5755112 4600579 8 Years M 10/9/2004 10/8/2004 1/27/2005 111 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain
5755113 4600581     F 10/8/2004 1/27/2005 111 OT PER Strattera Attention Deficit/Hyperactivity Disorder Overdose
5755114 4600585 18 Years F 10/6/2004 10/8/2004 1/27/2005 111 PER Strattera Attention Deficit/Hyperactivity Disorder Hypoaesthesia, Peripheral Coldness
5755115 4600589 14 Years F 10/8/2004 1/27/2005 111 MD PER Strattera Attention Deficit/Hyperactivity Disorder Suicidal Ideation
5755115 4637356 14 Years F 10/8/2004 3/28/2005 171 MD PER Strattera Suicidal Ideation
5755116 4600591     F 1/1/2004 10/8/2004 1/27/2005 111 PER Strattera Dizziness, Feeling Abnormal, Somnolence
5755117 4600909 10 Years M 9/7/2004 1/27/2005 142 PER Strattera Alopecia
5755118 4600910 4 Years M 9/1/2004 9/22/2004 1/27/2005 127 PH PER Strattera Psychomotor Hyperactivity Blood Ketone Body Increased
5755119 4600911 65 Years F 10/21/2004 1/27/2005 98 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dysgeusia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5755120 4600899 7 Years M 11/1/2004 1/27/2005 87 PER Strattera Crying, Retching, Vomiting
5755121 4600900 6 Years M 11/1/2004 1/27/2005 87 PER Strattera Panic Reaction, Retching
5755122 4600901     M 10/29/2004 1/27/2005 90 MD PER Strattera Attention Deficit/Hyperactivity Disorder Stomach Discomfort
5755123 4600902     M 10/29/2004 1/27/2005 90 MD PER Strattera Attention Deficit/Hyperactivity Disorder Stomach Discomfort
5755124 4600903     M 10/29/2004 1/27/2005 90 MD PER Strattera Attention Deficit/Hyperactivity Disorder Stomach Discomfort
5755125 4600904 50 Years F 8/1/2004 11/1/2004 1/27/2005 87 PER Strattera Attention Deficit/Hyperactivity Disorder Migraine
5755126 4600905 38 Years M 1/1/2004 11/2/2004 1/27/2005 86 PER Strattera Dizziness, Tremor
5755127 4600906 6 Years M 11/2/2004 1/27/2005 86 PER Strattera Attention Deficit/Hyperactivity Disorder Excitability, Insomnia, Obsessive-Compulsive Personality Disorder, Tension
5755128 4600912 53 Years F 10/21/2004 1/27/2005 98 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Herpes Simplex, Rhinorrhoea
5755129 4600913 5 Years M 10/21/2004 1/27/2005 98 PER Strattera Psychomotor Hyperactivity Abnormal Behaviour
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5755130 4600907 17 Years M 10/28/2004 11/2/2004 1/27/2005 86 OT PER Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder, Pain
5755131 4600908 10 Years M 11/2/2004 11/2/2004 1/27/2005 86 PER Strattera Attention Deficit/Hyperactivity Disorder Balance Disorder, Dizziness, Dysstasia, Erythema, Pruritus Generalised
5755132 4600594 18 Years F 9/1/2004 10/11/2004 1/27/2005 108 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Mood Swings
5755133 4600914 8 Years M 10/21/2004 10/21/2004 1/27/2005 98 PER Strattera Disturbance in Attention Affect Lability, Crying, Nausea, Somnolence
5755134 4600597     M 1/1/2004 10/11/2004 1/27/2005 108 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
5755135 4600915 12 Years 10/11/2004 1/27/2005 108 MD PER Strattera Throat Irritation
5755136 4599600 13 Years M 10/18/2004 10/18/2004 1/27/2005 101 PER Strattera Attention Deficit/Hyperactivity Disorder Snoring, Somnolence
5755137 4599602     M 10/19/2004 1/27/2005 100 MD PER Strattera Urinary Retention
5755138 4600916 45 Years M 10/11/2004 1/27/2005 108 OT PER Strattera Attention Deficit/Hyperactivity Disorder Dysgeusia, Hyperhidrosis
5755139 4600917     M 10/22/2004 1/27/2005 97 MD PER Strattera Nightmare
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5755140 4600918 44 Years F 10/22/2004 1/27/2005 97 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Ear Infection, Oedema Peripheral
5755141 4600919 39 Years M 10/1/2004 10/22/2004 1/27/2005 97 PER Strattera Dysuria, Micturition Urgency, Urinary Retention, Urine Analysis Abnormal
5755142 4599603 24 Years M 10/1/2004 10/19/2004 1/27/2005 100 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Feeling Abnormal, Feeling Hot, Hyperhidrosis
5755144 4600920 6 Years M 10/22/2004 1/27/2005 97 PER Strattera Attention Deficit/Hyperactivity Disorder Human Bite, Vomiting
5755145 4599605 6 Years M 1/1/2004 10/22/2004 1/27/2005 97 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Frequent Bowel Movements, Weight Decreased
5755146 4599608 8 Years M 1/1/2004 10/19/2004 1/27/2005 100 PH PER Strattera Attention Deficit/Hyperactivity Disorder Seasonal Allergy
5755147 4600921     M 10/22/2004 1/27/2005 97 PER Strattera Dysuria, Urine Analysis Abnormal
5755148 4599611     M 1/1/2004 10/18/2004 1/27/2005 101 PER Strattera Attention Deficit/Hyperactivity Disorder Pain in Extremity, Paraesthesia
5755149 4600922     F 1/1/2004 10/29/2004 1/27/2005 90 OT PER Strattera Depression Erythema Nodosum
5755150 4599612 55 Years F 9/1/2004 10/19/2004 1/27/2005 100 OT PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Nausea, Sleep Disorder, Vision Blurred
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5755151 4599615     M 1/1/2004 10/4/2004 1/27/2005 115 MD PER Strattera Groin Pain
5755152 4600923 20 Years M 10/1/2004 10/22/2004 1/27/2005 97 PER Strattera Attention Deficit/Hyperactivity Disorder Extrasystoles, Insomnia, Irritability, Palpitations
5755153 4600924     F 10/22/2004 1/27/2005 97 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Headache, Nausea, Thinking Abnormal
5755154 4599619 16 Years 10/7/2004 1/27/2005 112 MD PER Strattera Attention Deficit/Hyperactivity Disorder Suicidal Ideation
5755155 4600925 5 Years F 10/1/2004 10/25/2004 1/27/2005 94 PER Strattera Abnormal Behaviour, Dysgeusia, Dysphagia
5755155 4637365 5 Years F 10/1/2004 10/25/2004 3/28/2005 154 PER Strattera Abnormal Behaviour
5755158 4599621 13 Years M 10/14/2004 10/19/2004 1/27/2005 100 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Attention Deficit Hyperactivity Disorder, Decreased Appetite, Drug Ineffective, Hyperphagia, Mydriasis, Weight Decreased
5755170 4600926 10 Years F 10/22/2004 11/10/2004 1/27/2005 78 PER Strattera Attention Deficit/Hyperactivity Disorder Mydriasis, Nausea, Tremor, Vision Blurred
5755172 4600927 40 Years M 10/22/2004 1/27/2005 97 PER Strattera Anorexia, Asthenia, Dry Mouth, Penile Discharge, Sleep Disorder
5755173 4600928     M 10/25/2004 1/27/2005 94 PER Strattera Acne, Depression, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5755174 4600929 13 Years M 1/1/2004 10/25/2004 1/27/2005 94 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Restlessness, Vomiting
5755175 4600930 8 Years M 9/18/2004 10/25/2004 1/27/2005 94 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Crying, Decreased Interest, Drug Ineffective, Emotional Distress, Increased Appetite, Tremor, Weight Increased
5755190 4600941 46 Years F 10/26/2004 1/27/2005 93 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Nausea, Tremor
5755194 4600942     M 10/24/2004 10/25/2004 1/27/2005 94 PER Strattera Feeling Abnormal
5755198 4600943 14 Years M 9/1/2004 10/25/2004 1/27/2005 94 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Nervousness
5755199 4600944 10 Years M 1/1/2003 10/26/2004 1/27/2005 93 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Decreased Appetite, Weight Decreased
5755201 4600945 32 Years F 7/22/2004 12/10/2004 1/27/2005 48 MD PER Strattera Attention Deficit/Hyperactivity Disorder Rash Other
5755201 4637334 32 Years F 7/22/2004 12/10/2004 3/28/2005 108 MD PER Strattera Rash Other
5755202 4600946 16 Years M 1/1/2004 10/26/2004 1/27/2005 93 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
5755205 4600947     F 10/26/2004 1/27/2005 93 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Emotional Disorder, Feeling Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5755210 4600948 9 Years M 8/1/2004 10/25/2004 1/27/2005 94 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Dysphemia
5755215 4600950 22 Years M 10/26/2004 10/26/2004 1/27/2005 93 PER Strattera Dizziness, Hunger, Somnolence, Strabismus
5755231 4600931 11 Years F 8/1/2004 11/22/2004 1/27/2005 66 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination
5755236 4600932 10 Years F 10/1/2004 10/22/2004 1/27/2005 97 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Nausea, Stomach Discomfort
5755237 4600933 15 Years F 10/25/2004 1/27/2005 94 OT PER Strattera Attention Deficit/Hyperactivity Disorder Educational Problem, Fatigue, Nausea
5755240 4600934 11 Years M 6/1/2004 10/25/2004 1/27/2005 94 OT PER Strattera Fatigue, Insomnia
5755243 4600935     M 10/1/2004 10/25/2004 1/27/2005 94 PER Strattera Fatigue, Pain
5755244 4600936 14 Years M 10/25/2004 1/27/2005 94 PER Strattera Abnormal Behaviour Feeling Abnormal, Somnolence
5755248 4600937 5 Years M 10/18/2004 11/23/2004 1/27/2005 65 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Hallucination (Auditory), Lacrimation Increased, Micturition Urgency, Pollakiuria, Urinary Retention
5755248 4637326 5 Years M 10/18/2004 2/2/2005 3/28/2005 54 MD PER Strattera Drug Ineffective, Hallucination (Auditory), Lacrimation Increased, Micturition Urgency, Pollakiuria, Urinary Retention
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5755250 4600938 44 Years M 10/1/2004 10/25/2004 1/27/2005 94 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Personality Change, Social Avoidant Behaviour
5755252 4600939 33 Years F 10/27/2004 10/27/2004 1/27/2005 92 PER Strattera Panic Disorder Disease Progression, Drug Withdrawal Syndrome, Dry Mouth, Hallucination, Headache, Heart Rate Increased, Insomnia, Night Sweats, Panic Attack
5755256 4600940     F 10/26/2004 1/27/2005 93 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Somnolence
5755293 4599217 77 Years M 10/26/2004 10/27/2004 1/27/2005 92 PER Strattera Attention Deficit/Hyperactivity Disorder
5755294 4599218     F 10/27/2004 1/27/2005 92 PER Strattera Abnormal Behaviour, Drug Ineffective, Impulsive Behaviour, Nausea, Nervousness, Stomach Discomfort
5755296 4599219 9 Years M 10/1/2004 10/27/2004 1/27/2005 92 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Crying, Nervousness
5755298 4599220 12 Years 10/25/2004 1/27/2005 94 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort, Dyspnoea
5755304 4599221 7 Years F 1/1/2003 10/27/2004 1/27/2005 92 PER Strattera Attention Deficit/Hyperactivity Disorder Nervousness, Psychomotor Hyperactivity, Weight Increased
5755310 4599222     F 10/27/2004 12/7/2004 1/27/2005 51 PER Strattera Attention Deficit/Hyperactivity Disorder Appetite Disorder, Blood Pressure Increased, Coordination Abnormal, Hyperhidrosis, Nausea, Night Sweats, Oropharyngeal Swelling, Pruritus, Somnolence
5755310 4637340     F 10/27/2004 12/7/2004 3/28/2005 111 CN PER Strattera Blood Pressure Increased, Coordination Abnormal, Hunger, Hyperhidrosis, Nausea, Night Sweats, Oropharyngeal Swelling, Pruritus, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5755339 4599223 58 Years F 10/1/2004 10/27/2004 1/27/2005 92 MD PER Strattera Fatigue, Pain, Personality Disorder
5755352 4599224 49 Years F 10/1/2004 10/28/2004 1/27/2005 91 PER Strattera Fatigue, Somnolence
5755354 4599225 8 Years M 12/6/2004 1/27/2005 52 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Drug Ineffective, Vomiting, Weight Increased
5755354 4637346 8 Years M 12/6/2004 3/28/2005 112 MD PER Strattera Abdominal Pain, Drug Ineffective, Vomiting, Weight Increased
5755357 4599226 7 Years F 10/27/2004 10/28/2004 1/27/2005 91 PER Strattera Attention Deficit/Hyperactivity Disorder Blepharospasm
5756068 4600317     M 10/29/2004 1/27/2005 90 OT PER Strattera Abnormal Behaviour, Aggression, Agitation
5756069 4600319     M 10/29/2004 1/27/2005 90 OT PER Strattera Abnormal Behaviour, Aggression, Agitation
5756070 4600321     M 10/29/2004 1/27/2005 90 OT PER Strattera Abnormal Behaviour, Aggression, Agitation
5756072 4600325     M 10/29/2004 1/27/2005 90 OT PER Strattera Abnormal Behaviour, Aggression, Agitation
5756073 4600330     M 10/29/2004 1/27/2005 90 OT PER Strattera Abnormal Behaviour, Aggression, Agitation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756074 4600334     M 10/29/2004 1/27/2005 90 OT PER Strattera Abnormal Behaviour, Aggression, Agitation
5756079 4600337 6 Years M 1/1/2004 11/4/2004 1/27/2005 84 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Feeling Abnormal, Heart Rate Increased, Insomnia, Lethargy, Psychomotor Hyperactivity, Screaming
5756080 4600340 13 Years M 11/4/2004 1/27/2005 84 PER Strattera Weight Increased
5756081 4600341 57 Years F 1/1/2004 11/4/2004 1/27/2005 84 PER Strattera Attention Deficit/Hyperactivity Disorder Impaired Driving Ability, Panic Attack, Tremor
5756084 4600344 20 Years M 11/3/2004 12/1/2004 1/27/2005 57 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Mydriasis
5756084 4637350 20 Years M 11/3/2004 12/1/2004 3/28/2005 117 CN PER Strattera Fatigue, Feeling Abnormal, Mydriasis
5756099 4598280     M 1/27/2005 3/1/2005 MD DIR Atomoxetine Attention Deficit/Hyperactivity Disorder Chromaturia, Pruritus Generalised Life-Threatening, Other
5756117 4599207 5 Years M 10/1/2004 10/26/2004 1/27/2005 93 PH PER Strattera Crying, Pain, Tearfulness
5756121 4599208 45 Years M 10/26/2004 1/27/2005 93 MD PER Strattera Irritability, Vision Blurred
5756134 4599209 11 Years M 10/1/2004 10/26/2004 1/27/2005 93 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hair Colour Changes
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756139 4599210 6 Years M 10/27/2004 1/27/2005 92 PER Strattera Attention Deficit/Hyperactivity Disorder Dysphagia
5756149 4599211 10 Years M 10/26/2004 1/27/2005 93 MD PER Strattera Vertigo
5756150 4599212 10 Years F 9/15/2004 10/27/2004 1/27/2005 92 PER Strattera Attention Deficit/Hyperactivity Disorder Blepharospasm, Stress
5756151 4599213 48 Years F 1/1/2004 10/27/2004 1/27/2005 92 MD PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia, Drug Ineffective
5756152 4599214     M 10/27/2004 1/27/2005 92 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tremor
5756153 4599215 12 Years F 10/27/2004 1/27/2005 92 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Apathy, Depression, Disturbance in Attention, Drug Ineffective, Hypersomnia, Mental Impairment, Peripheral Coldness, Self Esteem Decreased, Sleep Disorder, Somnolence
5756154 4599216     F 10/26/2004 1/27/2005 93 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Depression, Fatigue, Hypersomnia, Insomnia, Peripheral Coldness, Sleep Disorder, Somnolence
5756155 4601061 8 Years M 1/1/2004 11/12/2004 1/27/2005 76 PH PER Strattera Attention Deficit/Hyperactivity Disorder Enuresis, Retching
5756157 4601065 13 Years M 1/1/2004 11/12/2004 1/27/2005 76 PH PER Strattera Abnormal Behaviour
5756158 4601073 13 Years M 11/12/2004 1/27/2005 76 PER Strattera Retching
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756159 4601087 13 Years M 11/12/2004 1/27/2005 76 PER Strattera Disturbance in Attention, Insomnia, Psychomotor Hyperactivity Abnormal Behaviour, Headache, Insomnia, Sleep Disorder, Sleep Talking, Thinking Abnormal
5756161 4601088 13 Years F 11/12/2004 1/27/2005 76 MD PER Strattera Attention Deficit/Hyperactivity Disorder Muscle Twitching, Tic
5756164 4601090 9 Years M 2/1/2004 11/18/2004 1/27/2005 70 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anorexia, Disturbance in Attention, Emotional Distress, Feeling Abnormal, Intermittent Explosive Disorder, Psychiatric Symptom, Somnolence
5756165 4601091     M 11/17/2004 1/27/2005 71 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination (Visual)
5756166 4601092 52 Years F 8/1/2004 11/18/2004 1/27/2005 70 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Feeling Abnormal, Personality Disorder
5756459 4599392 18 Years M 2/10/2005 3/2/2005 MD DIR Strattera Attention Deficit/Hyperactivity Disorder, Hepatitis Abdominal Discomfort, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Body Temperature Increased, Nausea, Pharyngolaryngeal Pain, Somnolence, Sputum Discoloured, Upper Respiratory Tract Infection, White Blood Cell Count Decreased Required Intervention to Prevent Permanent Impairment/Damage
5756482 4600412 26 Years M 1/1/2004 11/4/2004 1/27/2005 84 CN PER Strattera Attention Deficit/Hyperactivity Disorder Bradyphrenia, Fatigue, Stomach Discomfort, Yawning
5756483 4600415 11 Years F 11/4/2004 1/27/2005 84 OT PER Strattera Manganese Decreased, Zinc Deficiency
5756487 4600417     1/1/2004 11/4/2004 1/27/2005 84 OT PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Jittery, Hyperhidrosis, Nervousness
5756490 4600419 35 Years M 1/1/2004 11/4/2004 1/27/2005 84 CN PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756492 4600420 10 Years M 11/4/2004 11/4/2004 1/27/2005 84 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Psychomotor Hyperactivity
5756495 4600424 6 Years M 11/4/2004 11/4/2004 1/27/2005 84 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Headache
5756501 4600426     F 11/5/2004 1/27/2005 83 MD PER Strattera Attention Deficit/Hyperactivity Disorder Visual Disturbance
5756503 4600428     M 11/8/2004 1/27/2005 80 MD PER Strattera Attention Deficit/Hyperactivity Disorder Testicular Pain
5756510 4600430     M 11/3/2004 11/5/2004 1/27/2005 83 CN PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Listless, Nausea, Stomach Discomfort, Vomiting
5756511 4600433 31 Years F 11/5/2004 11/5/2004 1/27/2005 83 CN PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal
5756567 4599422     M 10/13/2004 1/27/2005 106 PER Strattera Attention Deficit/Hyperactivity Disorder
5756569 4599423 9 Years F 1/1/2004 10/13/2004 1/27/2005 106 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Drug Ineffective, Somnolence, Yawning
5756571 4599424 35 Years M 10/14/2004 1/27/2005 105 MD PER Strattera Piloerection, Vomiting
5756572 4599425 10 Years M 10/13/2004 1/27/2005 106 PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia, Drug Ineffective
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756575 4599427 8 Years M 10/14/2004 1/27/2005 105 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Hunger, Hypersomnia, Psychomotor Hyperactivity
5756578 4599428     M 10/14/2004 1/27/2005 105 MD PER Strattera Piloerection, Vomiting
5756580 4599429 8 Years M 10/1/2004 10/13/2004 1/27/2005 106 PER Strattera Retching
5756581 4599430 9 Years M 10/14/2004 1/27/2005 105 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Mydriasis
5756583 4599431 14 Years M 6/1/2004 10/14/2004 1/27/2005 105 CN PER Strattera Attention Deficit/Hyperactivity Disorder Ear Infection, Tremor
5756585 4599432     F 10/1/2004 10/14/2004 1/27/2005 105 PER Strattera Abdominal Pain Upper, Abnormal Sensation in Eye, Constipation, Dizziness, Dry Mouth, Feeling Abnormal, Headache, Middle Insomnia, Nausea
5756587 4599433 18 Years M 10/12/2004 10/14/2004 1/27/2005 105 PER Strattera Cold Sweat, Nausea
5756588 4599434 12 Years F 10/14/2004 1/27/2005 105 MD PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Feeling Abnormal, Hyperhidrosis
5756589 4599435 30 Years F 10/10/2004 10/13/2004 1/27/2005 106 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Excitability, Insomnia, Somnolence
5756591 4599436 41 Years F 1/1/2004 10/13/2004 1/27/2005 106 PER Strattera Attention Deficit/Hyperactivity Disorder Tension, Tremor
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756593 4599441 44 Years F 10/1/2004 10/14/2004 1/27/2005 105 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Hypersomnia, Irritability
5756594 4599442     M 10/1/2004 10/14/2004 1/27/2005 105 PER Strattera Erectile Dysfunction, Groin Pain
5756596 4599443 18 Years M 10/1/2004 10/15/2004 1/27/2005 104 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Fatigue, Mood Swings
5756597 4599444 56 Years M 10/12/2004 10/14/2004 1/27/2005 105 PER Strattera Disturbance in Attention Dysuria
5756599 4599445 11 Years M 9/30/2004 10/15/2004 1/27/2005 104 PER Strattera Attention Deficit/Hyperactivity Disorder, Psychomotor Hyperactivity Hypoaesthesia Oral
5756601 4599446 7 Years M 10/14/2004 10/15/2004 1/27/2005 104 PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity
5756602 4599467 7 Years M 10/15/2004 10/15/2004 1/27/2005 104 PER Strattera Human Bite, Insomnia
5756603 4599468 8 Years M 9/1/2004 10/13/2004 1/27/2005 106 MD PER Strattera Tic
5756604 4599470 8 Years M 1/1/2004 10/14/2004 1/27/2005 105 MD PER Strattera Attention Deficit/Hyperactivity Disorder Panic Attack
5756605 4599473 11 Years M 10/14/2004 1/27/2005 105 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Fatigue, Malaise, Mydriasis
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756607 4599474     M 10/15/2004 1/27/2005 104 OT PER Strattera Abnormal Behaviour, Tic
5756608 4599475 8 Years M 10/15/2004 1/27/2005 104 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Dependent Personality Disorder, Disturbance in Attention, Headache, Somnolence, Tearfulness, Weight Increased
5756610 4599479     M 10/15/2004 1/27/2005 104 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Feeling Abnormal, Headache
5756612 4599484 15 Years M 10/15/2004 1/27/2005 104 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Headache, Initial Insomnia, Tic
5756613 4599487 8 Years F 9/1/2004 10/15/2004 1/27/2005 104 PER Strattera Attention Deficit/Hyperactivity Disorder Overdose, Sleep Disorder
5756614 4599509     M 10/15/2004 1/27/2005 104 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Feeling Abnormal, Headache
5756615 4599520 40 Years 9/29/2004 1/27/2005 120 OT PER Strattera Asthenia
5756616 4599531 7 Years M 10/15/2004 10/15/2004 1/27/2005 104 PER Strattera Attention Deficit/Hyperactivity Disorder Body Temperature Increased, Nausea
5756618 4599532 70 Years M 8/1/2004 11/9/2004 1/27/2005 79 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Laboratory Test Abnormal
5756619 4599533 7 Years M 10/18/2004 1/27/2005 101 MD PER Strattera Attention Deficit/Hyperactivity Disorder Migraine
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756621 4599534     10/15/2004 1/27/2005 104 MD PER Strattera Drug Screen Positive
5756622 4599538 50 Years F 10/13/2004 10/28/2004 1/27/2005 91 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dry Mouth, Feeling Abnormal, Hangover, Mood Altered, Nausea, Sleep Disorder
5756624 4599539     F 10/18/2004 1/27/2005 101 OT PER Strattera Attention Deficit/Hyperactivity Disorder Psychotic Disorder
5756626 4599540     M 10/1/2004 10/15/2004 1/27/2005 104 PER Strattera Balance Disorder, Fatigue, Feeling Abnormal, Gait Disturbance
5756628 4599551 8 Years M 1/1/2004 10/15/2004 1/27/2005 104 PER Strattera Attention Deficit/Hyperactivity Disorder Cough, Ear Infection, Nasopharyngitis, Pharyngitis Streptococcal
5756629 4599552 8 Years F 10/1/2004 10/18/2004 1/27/2005 101 PER Strattera Fatigue, Nausea, Sluggishness
5756630 4599566 24 Years F 10/15/2004 10/15/2004 1/27/2005 104 PER Strattera Abdominal Pain Upper, Dizziness
5756631 4599567 19 Years F 10/15/2004 1/27/2005 104 MD PER Strattera Sedation
5756632 4599576 50 Years F 10/1/2004 10/18/2004 1/27/2005 101 PER Strattera Attention Deficit/Hyperactivity Disorder Nervousness
5756634 4599581 35 Years F 10/18/2004 10/18/2004 1/27/2005 101 PER Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Increased, Hyperhidrosis, Panic Reaction
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756635 4599584 10 Years M 10/1/2004 10/18/2004 1/27/2005 101 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hypertension
5756636 4599585 17 Years M 1/1/2004 10/19/2004 1/27/2005 100 PER Strattera Attention Deficit/Hyperactivity Disorder Nausea, Vomiting
5756637 4599588 9 Years F 10/1/2004 10/18/2004 1/27/2005 101 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
5756639 4599591 9 Years F 10/19/2004 1/27/2005 100 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Drug Ineffective, Insomnia, Mood Swings
5756640 4599595 12 Years M 10/19/2004 1/27/2005 100 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Impulsive Behaviour
5756644 4599412 6 Years F 10/13/2004 1/27/2005 106 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Retching, Vomiting
5756651 4599413 7 Years M 1/1/2004 10/13/2004 1/27/2005 106 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Educational Problem
5756653 4599414 12 Years 9/28/2004 1/27/2005 121 MD PER Strattera Aggression, Anger
5756655 4599415 50 Years M 10/11/2004 10/13/2004 1/27/2005 106 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Fatigue, Feeling Abnormal
5756655 4637361 50 Years M 10/11/2004 1/7/2005 3/28/2005 80 PER Strattera Constipation, Decreased Appetite, Dizziness, Dry Mouth, Fatigue, Feeling Abnormal, Stomach Discomfort, Vision Blurred
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756657 4599416 29 Years F 1/1/2004 10/13/2004 1/27/2005 106 PER Strattera Attention Deficit/Hyperactivity Disorder Alcohol Interaction
5756659 4600347     M 11/5/2004 1/27/2005 83 PER Strattera Testicular Pain
5756660 4599417 16 Years M 11/15/2004 1/27/2005 73 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Depression, Personality Change, Suicidal Ideation
5756661 4600349 7 Years M 11/5/2004 11/5/2004 1/27/2005 83 OT PER Strattera Aggression, Fatigue
5756662 4599418 29 Years M 10/13/2004 1/27/2005 106 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Abdominal Pain Upper
5756663 4599419     M 1/1/2004 10/13/2004 1/27/2005 106 MD PER Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder, Migraine
5756664 4599420 15 Years M 10/14/2004 1/27/2005 105 PER Strattera
5756665 4600351 12 Years M 9/1/2004 11/5/2004 1/27/2005 83 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective, Educational Problem, Psychomotor Hyperactivity
5756666 4599421 45 Years F 1/1/2004 10/13/2004 1/27/2005 106 MD PER Strattera Attention Deficit/Hyperactivity Disorder Migraine
5756668 4600354 27 Years M 8/19/2004 11/3/2004 1/27/2005 85 OT PER Strattera Insomnia, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756671 4600358 14 Years M 11/5/2004 1/27/2005 83 MD PER Strattera Aggression, Anger
5756688 4600361 11 Years F 11/5/2004 1/27/2005 83 PER Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder, Educational Problem, Therapeutic Response Decreased
5756699 4600363 5 Years M 11/5/2004 1/27/2005 83 PER Strattera Abnormal Behaviour, Aggression, Drug Ineffective, Psychomotor Hyperactivity
5756700 4600376 8 Years F 9/1/2004 10/11/2004 1/27/2005 108 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Nervousness
5756701 4600380 45 Years F 10/11/2004 1/27/2005 108 MD PER Strattera Attention Deficit/Hyperactivity Disorder Extrapyramidal Disorder
5756702 4600366 30 Years F 11/5/2004 1/27/2005 83 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Abnormal
5756703 4600368 10 Years F 11/4/2004 1/27/2005 84 MD PER Strattera Tic
5756704 4600383     F 10/11/2004 1/27/2005 108 CN PER Strattera Depression Feeling Hot, Hyperhidrosis
5756707 4600384 13 Years F 10/11/2004 1/27/2005 108 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Feeling Abnormal
5756708 4600371 48 Years M 1/1/2004 11/8/2004 1/27/2005 80 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Pain, Priapism, Urinary Retention
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756709 4600387 19 Years M 10/7/2004 10/11/2004 1/27/2005 108 CN PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Movement Disorder
5756711 4601012 37 Years M 11/3/2004 11/10/2004 1/27/2005 78 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dry Mouth, Epigastric Discomfort, Erectile Dysfunction, Heart Rate Increased, Irritability, Orgasmic Sensation Decreased, Somnolence, Urinary Hesitation, Urine Flow Decreased
5756714 4601015 16 Years M 8/1/2004 11/10/2004 1/27/2005 78 PER Strattera Attention Deficit/Hyperactivity Disorder Weight Decreased
5756716 4601016 15 Years M 10/21/2004 11/10/2004 1/27/2005 78 CN PER Strattera Headache, Tic
5756718 4601017 16 Years F 10/12/2004 1/27/2005 107 MD PER Strattera Eye Pain, Intraocular Pressure Increased
5756719 4600390     F 10/11/2004 10/12/2004 1/27/2005 107 CN PER Strattera Fatigue, Feeling Abnormal
5756720 4600392 8 Years F 10/11/2004 10/12/2004 1/27/2005 107 CN PER Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Increased, Sleep Talking, Somnolence, Stomach Discomfort
5756721 4601023 52 Years M 9/1/2004 11/10/2004 1/27/2005 78 PER Strattera Attention Deficit/Hyperactivity Disorder Defaecation Urgency, Dysuria, Ejaculation Disorder, Libido Decreased, Penile Discharge, Pollakiuria, Semen Viscosity Increased, Sexual Inhibition, Urine Flow Decreased
5756723 4600397 31 Years M 10/11/2004 1/27/2005 108 CN PER Strattera Disturbance in Attention Abdominal Pain Upper, Depressed Mood
5756724 4601029 8 Years M 10/1/2004 11/11/2004 1/27/2005 77 PH PER Strattera Attention Deficit/Hyperactivity Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756725 4601031     11/11/2004 1/27/2005 77 PER Strattera Personality Disorder
5756727 4600400 6 Years M 10/12/2004 1/27/2005 107 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Disturbance in Attention, Fatigue, Mood Swings, Stomach Discomfort
5756729 4601032 36 Years F 11/1/2004 11/19/2004 1/27/2005 69 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Depressed Mood, Feeling Abnormal, Feeling Hot, Insomnia, Sedation, Social Avoidant Behaviour
5756729 4637351 36 Years F 11/1/2004 11/19/2004 3/28/2005 129 PER Strattera Crying, Depressed Mood, Feeling Abnormal, Feeling Hot, Insomnia, Sedation, Social Avoidant Behaviour
5756730 4600403 10 Years M 10/11/2004 1/27/2005 108 MD PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Dysgraphia
5756734 4601037 13 Years F 11/11/2004 1/27/2005 77 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Laboratory Test Abnormal
5756735 4600761 8 Years F 11/8/2004 1/27/2005 80 CN PER Strattera Retching, Vomiting
5756740 4600766 38 Years M 11/1/2004 11/15/2004 1/27/2005 73 CN PER Strattera Attention Deficit/Hyperactivity Disorder Balance Disorder, Chest Discomfort, Ejaculation Failure
5756743 4600782 7 Years M 11/9/2004 11/9/2004 1/27/2005 79 CN PER Strattera Attention Deficit/Hyperactivity Disorder Increased Upper Airway Secretion, Vomiting
5756747 4600783 20 Years F 11/9/2004 1/27/2005 79 MD PER Strattera Attention Deficit/Hyperactivity Disorder Urinary Hesitation, Urinary Tract Infection
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756749 4600784 9 Years F 11/9/2004 1/27/2005 79 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Excitability, Increased Appetite, Somnolence, Vomiting
5756758 4600787 8 Years F 8/1/2004 11/9/2004 1/27/2005 79 CN PER Strattera Attention Deficit/Hyperactivity Disorder Distractibility, Disturbance in Attention, Educational Problem
5756767 4600794 6 Years M 1/1/2004 11/9/2004 1/27/2005 79 MD PER Strattera Attention Deficit/Hyperactivity Disorder Impulsive Behaviour
5756769 4600797 41 Years M 11/9/2004 11/9/2004 1/27/2005 79 CN PER Strattera Attention Deficit/Hyperactivity Disorder Paraesthesia, Psychomotor Hyperactivity
5756770 4600820 15 Years M 11/9/2004 1/27/2005 79 MD PER Strattera Attention Deficit/Hyperactivity Disorder
5756771 4600822 9 Years M 11/10/2004 1/27/2005 78 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Aphasia, Crying, Disturbance in Attention, Memory Impairment, Staring, Tic
5756773 4600670 40 Years F 11/3/2004 1/27/2005 85 OT PER Strattera Hyperthyroidism, Insomnia
5756776 4600673 9 Years M 11/4/2004 11/5/2004 1/27/2005 83 CN PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
5756780 4600677 33 Years F 10/10/2004 11/8/2004 1/27/2005 80 PH PER Strattera Depression Antiphospholipid Syndrome, Disturbance in Attention, Dyspnoea, Headache
5756786 4600679     M 11/5/2004 1/27/2005 83 CN PER Strattera Testicular Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756790 4600681 11 Years M 11/8/2004 1/27/2005 80 CN PER Strattera Attention Deficit/Hyperactivity Disorder, Mental Disorder Abnormal Dreams, Anxiety, Educational Problem, Fear, Hallucination (Auditory), Hallucination (Visual), Nightmare, Social Avoidant Behaviour, Stress
5756811 4600683     M 11/8/2004 1/27/2005 80 CN PER Strattera Abnormal Dreams, Anxiety, Depression, Educational Problem, Fear, Hallucination (Auditory), Hallucination (Visual), Nightmare, Social Avoidant Behaviour, Stress
5756814 4600686 10 Years M 11/8/2004 1/27/2005 80 MD PER Strattera Attention Deficit/Hyperactivity Disorder Depression
5756818 4600689 11 Years M 11/1/2004 11/8/2004 1/27/2005 80 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination, Hallucination (Auditory)
5756820 4600691 32 Years F 1/1/2004 11/8/2004 1/27/2005 80 CN PER Strattera Alopecia, Nervousness
5756821 4600695     M 11/9/2004 1/27/2005 79 CN PER Strattera Dysuria
5756825 4600824 14 Years M 10/29/2004 1/27/2005 90 MD PER Strattera Attention Deficit/Hyperactivity Disorder Psychotic Disorder
5756829 4600826     F 10/29/2004 1/27/2005 90 CN PER Strattera Depression
5756832 4600827     M 10/29/2004 1/27/2005 90 MD PER Strattera Attention Deficit/Hyperactivity Disorder Stomach Discomfort
5756836 4600829     10/28/2004 1/27/2005 91 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Erythema
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756842 4600831 54 Years M 10/1/2004 10/29/2004 1/27/2005 90 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Gastrointestinal Pain
5756844 4600833 43 Years F 10/18/2004 10/29/2004 1/27/2005 90 CN PER Strattera Anorexia, Fatigue, Lethargy, Mood Swings
5756847 4600834 50 Years M 10/29/2004 10/28/2004 1/27/2005 91 CN PER Strattera Dysuria, Penis Disorder
5756849 4600836     M 11/1/2004 1/27/2005 87 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic
5756853 4600838 11 Years M 1/1/2004 11/1/2004 1/27/2005 87 CN PER Strattera Disturbance in Attention Blepharospasm, Dyskinesia, Strabismus, Tic
5756856 4600840 8 Years M 9/21/2004 10/29/2004 1/27/2005 90 MD PER Strattera Blepharospasm
5756864 4600842 40 Years F 11/1/2004 1/27/2005 87 CN PER Strattera Dry Mouth, Feeling Jittery
5756867 4600843 61 Years F 11/1/2004 11/1/2004 1/27/2005 87 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Abnormal
5756870 4600844     F 10/31/2004 11/1/2004 1/27/2005 87 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Dizziness, Drug Interaction, Fatigue, Feeling Abnormal, Feeling Jittery, Heart Rate Increased, Hypersensitivity, Nasopharyngitis, Nervousness, Paranoia, Wheezing
5756880 4600846 12 Years M 10/29/2004 10/29/2004 1/27/2005 90 OT PER Strattera Attention Deficit/Hyperactivity Disorder Palpitations, Swelling Face, Urticaria Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756885 4600848 3 Years M 11/1/2004 11/1/2004 1/27/2005 87 CN PER Strattera Attention Deficit/Hyperactivity Disorder Choking, Retching, Vomiting
5756887 4600849     M 11/1/2004 1/27/2005 87 MD PER Strattera Attention Deficit/Hyperactivity Disorder Suicidal Ideation
5756887 4637347 16 Years M 1/11/2005 3/28/2005 76 MD PER Strattera Suicidal Ideation
5756889 4600851 16 Years M 1/1/2004 10/28/2004 1/27/2005 91 OT PER Strattera
5756892 4600853     F 10/28/2004 1/27/2005 91 CN PER Strattera Abdominal Pain Upper
5756893 4600861 30 Years F 10/30/2004 11/1/2004 1/27/2005 87 CN PER Strattera Attention Deficit/Hyperactivity Disorder Lethargy, Pain in Extremity
5756894 4600873 29 Years M 10/29/2004 11/1/2004 1/27/2005 87 CN PER Strattera Thinking Abnormal Amnesia, Confusional State
5756900 4600876 11 Years F 10/19/2004 10/20/2004 1/27/2005 99 MD PER Strattera Diarrhoea, Tachycardia, Urinary Tract Infection, Viral Infection Other
5756903 4600878 61 Years M 10/1/2004 10/19/2004 1/27/2005 100 CN PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Depressed Mood, Somnolence
5756906 4600880 34 Years M 10/20/2004 1/27/2005 99 CN PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Erectile Dysfunction, Feeling Abnormal, Lethargy, Urinary Retention
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756909 4600882     F 10/20/2004 1/27/2005 99 CN PER Strattera Depression
5756910 4600883 6 Years M 10/19/2004 10/19/2004 1/27/2005 100 MD PER Strattera Attention Deficit/Hyperactivity Disorder Suicidal Ideation
5756910 4637363 6 Years M 10/19/2004 10/19/2004 3/28/2005 160 MD PER Strattera Suicidal Ideation
5756913 4600885 47 Years F 10/18/2004 10/20/2004 1/27/2005 99 CN PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Dry Mouth, Fatigue, Feeling Abnormal, Irritability, Mood Swings, Sluggishness
5756915 4600887 16 Years 10/6/2004 1/27/2005 113 MD PER Strattera Drug Screen Positive
5756918 4600889 16 Years 10/6/2004 1/27/2005 113 MD PER Strattera Drug Screen Positive
5756921 4600891 16 Years 10/6/2004 1/27/2005 113 MD PER Strattera Drug Screen Positive
5756926 4600892     M 10/20/2004 1/27/2005 99 CN PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Emotional Disorder, Increased Appetite
5756933 4601046 5 Years M 11/10/2004 1/27/2005 78 PER Strattera Retching
5756935 4601049 10 Years M 9/1/2004 11/11/2004 1/27/2005 77 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756936 4600893 7 Years M 9/1/2003 10/29/2004 1/27/2005 90 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Gastroenteritis Viral, Gastrooesophageal Reflux Disease Hospitalization - Initial or Prolonged
5756936 4981038 7 Years M 9/1/2003 3/31/2006 4/18/2006 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Creatinine Decreased, Blood Potassium Decreased, Blood Pressure Increased, Blood Thyroid Stimulating Hormone Increased, Constipation, Dehydration, Drug Ineffective, Dry Skin, Fatigue, Gastroenteritis Viral, Gastrooesophageal Reflux Disease, Lethargy, Platelet Count Increased, Poor Peripheral Circulation, Somnolence, White Blood Cell Count Increased Hospitalization - Initial or Prolonged
5756938 4601051 54 Years M 1/1/2004 11/11/2004 1/27/2005 77 CN PER Strattera Frequent Bowel Movements, Stomach Discomfort
5756945 4601053 6 Years M 11/11/2004 11/12/2004 1/27/2005 76 CN PER Strattera Attention Deficit/Hyperactivity Disorder Illiteracy, Irritability, Nausea, Psychiatric Symptom, Psychomotor Hyperactivity
5756952 4601054 8 Years F 11/11/2004 1/27/2005 77 CN PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Feeling Abnormal
5756953 4600896 12 Years 9/15/2004 1/27/2005 134 OT PER Strattera Hospitalization - Initial or Prolonged
5756958 4600897 44 Years M 10/1/2004 11/5/2004 1/27/2005 83 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hypotension Hospitalization - Initial or Prolonged
5756961 4601055 8 Years M 9/1/2004 11/11/2004 1/27/2005 77 CN PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5756963 4601057 10 Years M 9/1/2004 11/11/2004 1/27/2005 77 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Tic
5756965 4601059 10 Years M 9/1/2004 11/11/2004 1/27/2005 77 MD PER Strattera Attention Deficit/Hyperactivity Disorder Clumsiness, Fall, Gait Disturbance, Injury
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5756966 4600898 8 Years M 8/1/2004 11/16/2004 1/27/2005 72 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Disturbance in Attention, Drug Ineffective, Impulsive Behaviour, Nervousness Hospitalization - Initial or Prolonged
5756970 4601060     11/12/2004 1/27/2005 76 MD PER Strattera Hallucination
5756976 4600632 6 Years F 11/1/2004 11/18/2004 1/27/2005 70 PER Strattera Attention Deficit/Hyperactivity Disorder Gastroenteritis Viral, Vomiting
5756977 4600634 4 Years M 10/18/2004 1/27/2005 101 OT PER Strattera Attention Deficit/Hyperactivity Disorder Lethargy, Somnolence, Urinary Incontinence
5756980 4600637 54 Years M 11/18/2004 11/18/2004 1/27/2005 70 PER Strattera Hypotonia
5756982 4600640 8 Years M 11/18/2004 1/27/2005 70 CN PER Strattera Fatigue, Irritability, Somnolence
5756987 4600642 17 Month F 11/18/2004 1/27/2005 70 CN PER Strattera
5756990 4600653 11 Years M 11/18/2004 1/27/2005 70 MD PER Strattera Attention Deficit/Hyperactivity Disorder Sickle Cell Anaemia with Crisis
5756993 4600655 5 Years M 9/1/2004 11/18/2004 1/27/2005 70 MD PER Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Increased, Irritability, Vomiting Other
5756998 4600658 46 Years F 11/18/2004 1/27/2005 70 CN PER Strattera Feeling Cold, Feeling Jittery, Paraesthesia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5757003 4600660 44 Years M 11/19/2004 1/27/2005 69 LW PER Strattera Attention Deficit/Hyperactivity Disorder, Disturbance in Attention Anxiety, Chills, Dehydration, Disorientation, Dry Mouth, Feeling Abnormal, Heart Rate Increased
5757006 4600666 29 Years M 10/1/2004 11/19/2004 1/27/2005 69 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Hyperphagia
5757340 4599616 21 Years M 2/14/2005 3/3/2005 17 OT EXP Strattera Hepatic Enzyme Increased
5757707 4599508 65 Years F 12/1/2004 2/15/2005 3/3/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Adrenal Insufficiency, Hypertension, Malignant Hypertension, Renal Artery Stenosis Other
5757707 4612427 65 Years F 12/1/2004 3/1/2005 3/16/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Adrenal Insufficiency, Malignant Hypertension, Renal Artery Stenosis Other
5757707 4638076 65 Years F 12/1/2004 3/31/2005 4/15/2005 15 MD EXP Strattera Adrenal Insufficiency, Dizziness, Fall, Headache, Malignant Hypertension, Renal Disorder Other
5757729 4599518 12 Years 1/18/2005 3/3/2005 44 MD EXP Strattera Mitral Valve Incompetence Other
5757760 4599620 12 Years M 2/9/2005 3/3/2005 22 MD EXP Strattera Laboratory Test Abnormal
5757780 4599623 6 Years M 2/1/2005 2/15/2005 3/3/2005 16 MD EXP Strattera Liver Function Test Abnormal
5757890 4600375 8 Years F 10/19/2004 1/27/2005 100 OT PER Strattera Obsessive-Compulsive Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5757892 4600381 64 Years F 1/1/2004 10/20/2004 1/27/2005 99 PH PER Strattera Crying, Stomach Discomfort
5757894 4600386 11 Years M 10/20/2004 1/27/2005 99 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anorexia, Headache, Nausea, Nervousness, Tremor
5757898 4600393 6 Years F 10/18/2004 10/19/2004 1/27/2005 100 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Feeling Abnormal, Hyperacusis
5757906 4600401 12 Years F 10/20/2004 1/27/2005 99 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Feeling Abnormal, Impulsive Behaviour, Nausea, Psychomotor Hyperactivity, Stomach Discomfort
5757907 4600404 8 Years M 10/19/2004 1/27/2005 100 MD PER Strattera Growth Retardation
5757909 4600405 7 Years M 10/16/2004 10/20/2004 1/27/2005 99 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Vomiting
5757911 4600407 15 Years M 10/20/2004 1/27/2005 99 CN PER Strattera Disturbance in Attention Aggression, Disturbance in Attention, Living In Residential Institution, Psychomotor Hyperactivity
5757912 4600408 7 Years F 1/1/2003 10/20/2004 1/27/2005 99 CN PER Strattera Disturbance in Attention Chapped Lips, Dry Mouth, Lip Dry, Skin Chapped, Subcutaneous Nodule, Thirst
5757913 4600410 8 Years M 1/1/2004 10/20/2004 1/27/2005 99 MD PER Strattera Attention Deficit/Hyperactivity Disorder Urticaria
5757943 4600211     F 10/1/2004 11/2/2004 1/27/2005 86 MD PER Strattera Drug Withdrawal Syndrome, Feeling Abnormal, Hypersomnia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5757944 4600213     M 11/2/2004 1/27/2005 86 PER Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Increased, Stomach Discomfort
5757945 4600216 47 Years F 8/1/2004 12/7/2004 1/27/2005 51 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Asthenia, Night Sweats, Subcutaneous Nodule, Tremor, Weight Decreased
5757945 4637348 47 Years F 8/1/2004 12/7/2004 3/28/2005 111 OT PER Strattera Anorexia, Asthenia, Night Sweats, Subcutaneous Nodule, Tremor, Weight Decreased
5757946 4600234 57 Years M 11/2/2004 1/27/2005 86 PER Strattera Psychomotor Hyperactivity Dry Mouth, Micturition Disorder, Middle Insomnia, Nasal Dryness
5757947 4600242 10 Years F 10/1/2004 11/2/2004 1/27/2005 86 CN PER Strattera Attention Deficit/Hyperactivity Disorder Laziness
5757948 4600253 8 Years M 11/3/2004 1/27/2005 85 PER Strattera Abnormal Behaviour, Increased Appetite, Middle Insomnia
5757949 4600256 17 Years M 10/29/2004 1/27/2005 90 OT PER Strattera Drug Ineffective
5757950 4600265 14 Years M 11/3/2004 1/27/2005 85 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Emotional Distress, Hallucination (Auditory), Irritability, Psychotic Disorder, Thinking Abnormal
5757951 4600282 8 Years M 11/3/2004 11/3/2004 1/27/2005 85 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Fatigue, Vomiting
5757952 4600284     M 10/29/2004 1/27/2005 90 OT PER Strattera Abnormal Behaviour, Aggression, Agitation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5758001 4599622 7 Years M 12/25/2004 2/15/2005 3/3/2005 16 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Pyrexia Hospitalization - Initial or Prolonged, Other
5758005 4599624 14 Years M 2/10/2005 3/3/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Affective Disorder, Anuria, Condition Aggravated, Constipation, Convulsion, Coordination Abnormal, Dysuria, Impulsive Behaviour, Lethargy, Tremor, Urinary Hesitation Hospitalization - Initial or Prolonged, Other
5758005 4607081 14 Years M 1/28/2004 2/23/2005 3/9/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Complex Partial Seizures, Condition Aggravated, Constipation, Coordination Abnormal, Impulsive Behaviour, Lethargy, Panic Reaction, Somnolence, Tremor, Urinary Hesitation, Urinary Retention Hospitalization - Initial or Prolonged, Other
5758163 4599494 48 Years F 11/1/2004 2/10/2005 3/3/2005 21 EXP Strattera Abnormal Dreams, Anxiety, Disease Recurrence, Insomnia, Pharmaceutical Product Complaint, Somnolence, Thinking Abnormal, Weight Increased Other
5758163 4684723 48 Years F 11/1/2004 2/10/2005 5/31/2005 110 PER Strattera Abnormal Dreams, Anxiety, Confusional State, Disturbance in Attention, Drug Ineffective, Insomnia, Somnolence, Weight Increased Other
5758163 4713667 48 Years F 11/1/2004 6/30/2005 7/13/2005 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Abnormal Dreams, Anxiety, Confusional State, Disturbance in Attention, Hyperhidrosis, Insomnia, Pharmaceutical Product Complaint, Somnolence, Thinking Abnormal, Weight Increased
5758166 4599495 45 Years F 2/10/2005 3/3/2005 21 MD EXP Strattera Cerebrovascular Accident Other
5758166 4737831 45 Years F 7/12/2005 8/3/2005 22 MD EXP Strattera Blood Pressure Increased, Carotid Artery Dissection, Cerebrovascular Accident, Cognitive Disorder, Headache, Hypoaesthesia, Paraesthesia, Speech Disorder, Thinking Abnormal Other
5758167 4599496 22 Years F 2/10/2005 3/3/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Weight Increased
5758167 4618716 22 Years M 2/9/2005 3/8/2005 3/23/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5758167 4658133 22 Years M 2/9/2005 4/19/2005 5/9/2005 20 MD EXP Strattera Alanine Aminotransferase Increased, Weight Increased
5758167 4681580 22 Years M 2/9/2005 5/17/2005 6/2/2005 16 MD EXP Strattera Alanine Aminotransferase Increased
5758173 4599500 14 Years M 2/9/2005 3/3/2005 22 MD EXP Strattera Blood Bilirubin Increased
5758176 4599502 20 Years F 12/1/2004 2/10/2005 3/3/2005 21 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased
5758535 4600140 12 Years M 2/1/2005 2/16/2005 3/3/2005 15 MD EXP Strattera Convulsion, Dyskinesia, Petit Mal Epilepsy, Staring Other
5758535 4607540 12 Years M 2/1/2005 2/22/2005 3/9/2005 15 MD EXP Strattera Dyskinesia, Petit Mal Epilepsy, Staring Other
5758535 4614033 13 Years M 1/21/2005 3/1/2005 3/16/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder, Tic Petit Mal Epilepsy, Simple Partial Seizures, Tourette's Disorder Other
5758575 4600288 6 Years M 1/1/2004 10/29/2004 1/27/2005 90 MD PER Strattera Sleep Walking
5758577 4600292 10 Years M 1/1/2004 10/29/2004 1/27/2005 90 MD PER Strattera Sleep Walking
5758580 4600294 4 Years F 1/1/2004 11/3/2004 1/27/2005 85 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Crying, Emotional Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5758581 4600296 6 Years M 10/1/2004 12/2/2004 1/27/2005 56 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anger, Attention Deficit Hyperactivity Disorder, Drug Ineffective, Headache, Personality Disorder
5758581 4637349 6 Years M 10/1/2004 12/2/2004 3/28/2005 116 CN PER Strattera Abnormal Behaviour, Aggression, Anger, Attention Deficit Hyperactivity Disorder, Belligerence, Drug Ineffective, Headache, Personality Disorder
5758581 4726710 6 Years M 10/1/2004 5/3/2005 7/25/2005 83 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Aggression, Anger, Attention Deficit Hyperactivity Disorder, Belligerence, Drug Ineffective, Dysuria, Feeling Abnormal, Headache, Personality Disorder
5758582 4600299 12 Years M 1/1/2004 11/3/2004 1/27/2005 85 CN PER Strattera Attention Deficit/Hyperactivity Disorder Stomach Discomfort
5758586 4600301 14 Years M 11/3/2004 1/27/2005 85 CN PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Decreased Appetite, Dizziness, Dysuria, Hyperhidrosis
5758588 4600305 27 Years F 10/30/2004 1/27/2005 89 CN PER Strattera Fatigue, Hypotonia, Sedation
5758603 4600308     M 10/29/2004 1/27/2005 90 OT PER Strattera Abnormal Behaviour, Aggression, Agitation
5758613 4600309     M 10/29/2004 1/27/2005 90 OT PER Strattera Abnormal Behaviour, Aggression, Agitation
5758623 4600313     M 10/29/2004 1/27/2005 90 OT PER Strattera Abnormal Behaviour, Aggression, Agitation
5758770 4600516     M 10/1/2004 10/27/2004 1/27/2005 92 PER Strattera Feeling Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5758786 4600518     F 10/27/2004 1/27/2005 92 MD PER Strattera Attention Deficit/Hyperactivity Disorder Headache
5758788 4600520 12 Years M 10/28/2004 1/27/2005 91 MD PER Strattera Tachycardia Other
5758791 4600525 40 Years F 10/28/2004 1/27/2005 91 CN PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Drug Ineffective, Feeling Abnormal, Hot Flush, Insomnia, Irritability, Tremor
5758795 4600528 10 Years M 1/1/2004 10/28/2004 1/27/2005 91 PER Strattera Attention Deficit/Hyperactivity Disorder Educational Problem, Memory Impairment
5758797 4600531     M 10/28/2004 1/27/2005 91 PH PER Strattera Drug Screen Positive
5758801 4600533 45 Years F 10/28/2004 1/27/2005 91 MD PER Strattera Somnolence
5758804 4600536 32 Years M 10/28/2004 1/27/2005 91 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Lethargy, Somnolence, Urinary Retention
5758812 4600543 50 Years F 10/25/2004 10/28/2004 1/27/2005 91 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Upper Respiratory Tract Infection
5758851 4599403     M 10/11/2004 1/27/2005 108 PER Strattera Attention Deficit/Hyperactivity Disorder Erectile Dysfunction, Testicular Disorder
5758853 4599404 13 Years F 1/1/2004 10/12/2004 1/27/2005 107 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Decreased Appetite, Feeling Abnormal, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5758856 4599405 8 Years M 10/12/2004 1/27/2005 107 OT PER Strattera Fear
5759566 4603872     F 3/2/2005 3/8/2005 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Pulse Abnormal, Tachycardia Required Intervention to Prevent Permanent Impairment/Damage
5759772 4604050 31 Years M 11/28/2004 3/8/2005 PH DIR Strattera Intentional Misuse Grand Mal Convulsion, Hypertension, Tachycardia, Toxicologic Test Abnormal Life-Threatening
5759843 4599406 10 Years M 10/12/2004 1/27/2005 107 PER Strattera Attention Deficit/Hyperactivity Disorder Pruritus, Swelling Face, Urticaria
5759844 4599408 26 Years F 10/12/2004 10/12/2004 1/27/2005 107 PH PER Strattera
5759850 4599409 6 Years M 10/13/2004 10/13/2004 1/27/2005 106 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5759851 4599410 8 Years M 10/9/2004 1/27/2005 110 MD PER Strattera Abnormal Behaviour, Aggression
5759852 4599411 17 Years M 10/12/2004 1/27/2005 107 MD PER Strattera Attention Deficit/Hyperactivity Disorder Lymphocyte Percentage Increased, Neutrophil Percentage Decreased
5760670 4604088     F 3/6/2005 3/9/2005 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Tachycardia Required Intervention to Prevent Permanent Impairment/Damage
5760674 4604057 35 Years M 3/4/2005 3/8/2005 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Erectile Dysfunction, Suprapubic Pain Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5761495 4606742     M 2/14/2005 2/21/2005 3/9/2005 16 MD EXP Strattera Alanine Aminotransferase Increased
5761544 4609620 6 Years M 4/8/2004 3/14/2005 PH DIR Atomoxetine Drooling, Dysphonia, Movement Disorder, Swelling Face Hospitalization - Initial or Prolonged
5762162 4606774 37 Years M 2/1/2005 2/18/2005 3/9/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Mania Hospitalization - Initial or Prolonged
5762162 4626572 37 Years M 2/1/2005 3/16/2005 3/30/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Mania Hospitalization - Initial or Prolonged
5762165 4606775     M 2/18/2005 3/9/2005 19 MD EXP Strattera Blood Bilirubin Increased
5762165 4618714 8 Years M 2/1/2005 3/9/2005 3/23/2005 14 MD EXP Strattera Blood Bilirubin Increased
5762171 4606777 28 Years F 2/15/2005 2/18/2005 3/9/2005 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Increased, Loss of Consciousness, Muscle Disorder, Muscle Fatigue Other
5762176 4606779 16 Years F 1/1/2004 2/22/2005 3/9/2005 15 MD EXP Strattera Dyspnoea, Palpitations, Tachycardia
5762176 4637914 16 Years F 1/1/2004 2/22/2005 3/28/2005 34 MD PER Strattera Dyspnoea, Palpitations, Tachycardia
5762183 4607048     F 2/22/2005 3/9/2005 15 MD EXP Strattera Liver Function Test Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5762186 4607051     F 2/22/2005 3/9/2005 15 MD EXP Strattera Liver Function Test Abnormal
5762189 4607053     M 1/1/2005 2/22/2005 3/9/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5762201 4606762 35 Years F 1/24/2005 2/22/2005 3/9/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Mononucleosis Heterophile Test Positive, White Blood Cell Count Decreased
5762201 4631275 42 Years F 1/24/2005 3/16/2005 4/6/2005 21 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Band Neutrophil Count Increased, Blood Bilirubin Increased, Blood Potassium Decreased, Blood Urea Decreased, Infectious Mononucleosis, Lymphocyte Count Decreased, Lymphocyte Morphology Abnormal, Neutrophil Count Decreased, Platelet Count Decreased, Red Blood Cell Sedimentation Rate Increased, White Blood Cell Count Decreased
5762201 4648819 42 Years F 1/24/2005 4/11/2005 4/27/2005 16 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Band Neutrophil Count Increased, Blood Bilirubin Increased, Blood Potassium Decreased, Blood Urea Decreased, Haematocrit Decreased, Haemoglobin Decreased, Infectious Mononucleosis, Lymphocyte Count Decreased, Neutrophil Count Decreased, Platelet Count Decreased, Red Blood Cell Count Decreased, White Blood Cell Count Decreased
5762201 4674534 42 Years F 1/24/2005 4/11/2005 5/24/2005 43 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Band Neutrophil Count Increased, Blood Bilirubin Increased, Blood Potassium Decreased, Blood Urea Decreased, Haematocrit Decreased, Haemoglobin Decreased, Infectious Mononucleosis, Lymphocyte Count Decreased, Lymphocyte Morphology Abnormal, Neutrophil Count Decreased, Platelet Count Decreased, Red Blood Cell Count Decreased, Red Blood Cell Sedimentation Rate Increased, White Blood Cell Count Decreased
5762202 4606764     M 2/22/2005 3/9/2005 15 MD EXP Strattera Hepatic Enzyme Increased
5762203 4606766 34 Years M 2/16/2005 3/9/2005 21 MD EXP Strattera Hepatic Enzyme Increased, Vomiting
5762203 4648947 34 Years M 4/8/2005 4/27/2005 19 MD EXP Strattera Alanine Aminotransferase Increased, Vomiting, Weight Decreased
5762203 4674486 34 Years M 4/8/2005 5/24/2005 46 MD EXP Strattera Alanine Aminotransferase Increased, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5762203 4681581 34 Years M 5/17/2005 6/2/2005 16 MD EXP Strattera Alanine Aminotransferase Increased, Vomiting, Weight Decreased
5762206 4606769     M 2/18/2005 3/9/2005 19 MD EXP Strattera Atrioventricular Block First Degree Other
5762206 4618708 12 Years M 3/3/2005 3/24/2005 21 MD EXP Strattera Atrioventricular Block First Degree, Blood Triglycerides Increased, High Density Lipoprotein Decreased Other
5762209 4606771 15 Years M 2/18/2005 3/9/2005 19 MD EXP Strattera Blood Bilirubin Increased
5762209 4618715 15 Years M 1/31/2005 3/9/2005 3/23/2005 14 MD EXP Strattera Blood Bilirubin Increased
5762827 4609655 8 Years M 3/14/2005 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Aggression, Anger, Bipolar Disorder, Crying, Depression, Diarrhoea, Emotional Disorder, Hyperaesthesia, Lethargy, Mood Swings, Negativism, Nightmare, Screaming, Social Problem, Suicidal Ideation, Vomiting, Weight Decreased Required Intervention to Prevent Permanent Impairment/Damage
5762842 4607694 17 Years M 2/25/2005 3/9/2005 12 MD EXP Strattera Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Epistaxis, Headache, Inadequate Analgesia, Malaise, Pyrexia, Viral Infection
5762842 4618200 14 Years M 2/19/2005 3/3/2005 3/23/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Epistaxis, Feeling Abnormal, Gilbert's Syndrome, Headache, Pyrexia, Therapy Non-Responder, Viral Infection Other
5762842 4665144 14 Years M 2/19/2005 4/29/2005 5/17/2005 18 MD EXP Strattera Epistaxis, Gilbert's Syndrome, Headache, Therapy Non-Responder, Viral Infection Other
5762849 4607699 14 Years M 1/24/2005 2/22/2005 3/9/2005 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Condition Aggravated, Impulsive Behaviour Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5764249 4607026     F 2/21/2005 2/21/2005 2/22/2005 3/9/2005 15 MD EXP Strattera Death Death
5764251 4607027     M 1/1/2005 2/22/2005 3/9/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5764265 4607029 10 Years M 2/1/2005 2/23/2005 3/9/2005 14 EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Influenza Like Illness, Vomiting Other
5764265 4658122 10 Years M 2/1/2005 4/14/2005 5/9/2005 25 MD EXP Strattera Abdominal Pain, Alanine Aminotransferase Increased, Anorexia, Aspartate Aminotransferase Increased, Diarrhoea, Fatigue, Headache, Influenza Like Illness, Nausea, Pharyngolaryngeal Pain, Vomiting Other
5764265 4681582 10 Years M 2/1/2005 5/13/2005 6/2/2005 20 MD EXP Strattera Blood Glucose Increased, Blood Potassium Decreased, Blood Pressure Diastolic Decreased, Chromaturia, Colitis Ulcerative, Confusional State, Diarrhoea, Gastric Disorder, Haematemesis, Haematocrit Decreased, Haemoglobin Decreased, Hepatic Steatosis, Influenza Like Illness, Obesity, Pharyngitis Streptococcal, Pruritus, Red Blood Cell Count Decreased, Somnolence, Viral Infection Other
5764275 4607032 14 Years M 2/22/2005 3/9/2005 15 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Gamma-Glutamyltransferase Increased, Heart Rate Increased
5764865 4611109 14 Years F 3/13/2005 3/16/2005 OT DIR Strattera Attention Deficit/Hyperactivity Disorder Hepatitis B, International Normalised Ratio Increased, Prothrombin Time Prolonged Hospitalization - Initial or Prolonged, Life-Threatening, Required Intervention to Prevent Permanent Impairment/Damage
5766214 4612227 44 Years F 1/27/2005 2/24/2005 3/16/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Fatigue, Nausea Other
5766214 4626585 44 Years F 1/27/2005 3/10/2005 3/30/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Fatigue, Nausea Other
5766216 4612229     M 2/28/2005 3/16/2005 16 EXP Strattera Convulsion Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5766224 4612231 9 Years F 3/1/2005 3/16/2005 15 MD EXP Strattera Convulsion, Drug Screen Positive Other
5766224 4638075 9 Years F 3/29/2005 4/15/2005 17 MD EXP Strattera Grand Mal Convulsion Other
5766391 4612249 7 Years M 2/28/2005 3/16/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Anion Gap Abnormal, Hepatic Fibrosis Hospitalization - Initial or Prolonged
5766391 4631301 7 Years M 3/22/2005 4/6/2005 15 MD EXP Strattera Hospitalization - Initial or Prolonged
5766392 4612250     F 2/28/2005 3/16/2005 16 MD EXP Strattera Atrioventricular Block Hospitalization - Initial or Prolonged
5766392 4626570 50 Years F 3/10/2005 3/30/2005 20 MD EXP Strattera Bundle Branch Block, Chest Pain Hospitalization - Initial or Prolonged
5766395 4612252 15 Years F 2/25/2005 3/16/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aura, Grand Mal Convulsion, Loss of Consciousness, Myalgia, Somnolence Other
5766399 4612254 18 Years F 11/15/2004 2/23/2005 3/16/2005 21 EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Hepatic Function Abnormal, Migraine, Platelet Count Decreased, White Blood Cell Count Decreased
5766399 4631273 18 Years F 11/15/2004 3/16/2005 4/6/2005 21 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Migraine, Platelet Count Decreased, White Blood Cell Count Decreased
5766399 5008824 18 Years F 11/15/2004 5/1/2006 5/18/2006 17 EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Depression, Disease Recurrence, Fatigue, Headache, Malaise, Migraine, Mononucleosis Syndrome, Pharyngitis Streptococcal, Platelet Count Decreased, Red Blood Cell Count Increased, Tonsillitis, Weight Decreased, White Blood Cell Count Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5766400 4612256 12 Years M 2/22/2005 2/28/2005 3/16/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abasia, Conversion Disorder, Crying, Dizziness, Facial Palsy, Mental Status Changes, Motor Dysfunction Hospitalization - Initial or Prolonged
5766400 4642289 12 Years M 2/22/2005 4/8/2005 4/20/2005 12 MD EXP Strattera Abasia, Conversion Disorder, Crying, Dizziness, Facial Paresis, Mental Status Changes, Motor Dysfunction Hospitalization - Initial or Prolonged
5766845 4614060 10 Years F 2/25/2005 3/16/2005 19 MD EXP Strattera Aggression, Agitation, Insomnia Other
5766845 4625583 10 Years F 3/10/2005 3/30/2005 20 MD EXP Strattera Aggression, Agitation, Coprolalia, Insomnia, Speech Disorder Other
5766948 4613309 10 Years F 12/30/2004 3/2/2005 3/15/2005 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Body Temperature Increased, Dizziness, Headache, Increased Tendency to Bruise, Pharyngolaryngeal Pain, Vomiting Other
5766948 4724438 10 Years F 12/30/2004 7/1/2005 7/21/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Body Temperature Increased, Dizziness, Feeling Abnormal, Headache, Increased Tendency to Bruise, Pharyngolaryngeal Pain, Vomiting Other
5766948 4737433 10 Years F 12/30/2004 7/12/2005 8/3/2005 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Contusion, Dizziness, Feeling Abnormal, Headache, Pharyngolaryngeal Pain, Pyrexia, Vomiting Other
5767009 4614047 13 Years M 2/1/2005 2/24/2005 3/16/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased
5767014 4614048 12 Years F 2/25/2005 3/16/2005 19 MD EXP Strattera Agitation, Mania Other
5767014 4625645 12 Years F 3/10/2005 3/30/2005 20 MD EXP Strattera Agitation, Coprolalia, Inappropriate Affect, Mania Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5767349 4613565 14 Years F 2/7/2005 3/2/2005 3/16/2005 14 OT EXP Strattera Disturbance in Attention Blood Alkaline Phosphatase Increased Other
5767491 4619697     F 11/10/2004 3/17/2005 PH DIR Strattera Abnormal Behaviour CSF Pressure Decreased, Headache, Nausea, Papilloedema, Paralysis, Physical Examination Abnormal, Vomiting Hospitalization - Initial or Prolonged
5769346 4614835 17 Years M 3/13/2005 3/18/2005 PH DIR Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Nasopharyngitis, Oedema Peripheral, Pain, Rhabdomyolysis Hospitalization - Initial or Prolonged
5769643 4618722 54 Years F 3/2/2005 3/23/2005 21 MD EXP Strattera Hepatic Enzyme Increased
5769645 4618723 14 Years M 3/9/2005 3/23/2005 14 MD EXP Strattera Aspartate Aminotransferase Increased Other
5769645 4658119 14 Years M 4/19/2005 5/9/2005 20 MD EXP Strattera Aspartate Aminotransferase Increased Other
5769650 4618724 6 Years M 1/1/2005 3/7/2005 3/23/2005 16 MD EXP Strattera Grand Mal Convulsion Other
5769650 4658120 6 Years M 4/18/2005 5/9/2005 21 MD EXP Strattera Amnesia, Loss of Consciousness, Petit Mal Epilepsy, Sleep Disorder Other
5769652 4618725 70 Years M 3/3/2005 3/23/2005 20 MD EXP Strattera Myocardial Infarction Death
5769652 4898688 71 Years M 1/4/2005 1/4/2005 1/13/2006 1/27/2006 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Acute Myocardial Infarction, Cardiac Arrest, Loss of Consciousness, Ventricular Fibrillation Death
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5769652 4936578 71 Years M 1/4/2004 1/4/2005 2/14/2006 3/2/2006 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Acute Myocardial Infarction, Cardiac Arrest, Ventricular Fibrillation Death
5769653 4618726 9 Years M 3/3/2005 3/23/2005 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Contusion, Thrombocytopenia Other
5769680 4618727 39 Years F 3/8/2005 3/23/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Dyspnoea, Rash Life-Threatening
5769680 4637937 38 Years F 1/19/2005 3/28/2005 68 MD PER Strattera Chest Pain, Dyspnoea, Rash
5770122 4618836     M 3/8/2005 3/23/2005 15 MD EXP Strattera Hepatic Enzyme Increased
5770125 4618837 18 Years M 12/14/2004 3/8/2005 3/23/2005 15 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased
5770125 4666326 18 Years M 12/14/2004 4/27/2005 5/17/2005 20 OT EXP Strattera Alanine Aminotransferase Increased, Blood Bilirubin Increased
5770127 4618838 7 Years M 3/7/2005 3/23/2005 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Fatigue, Headache, Jaundice
5770129 4618839 11 Years M 3/3/2005 3/23/2005 20 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5770168 4618198 16 Years M 2/1/2005 3/4/2005 3/23/2005 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Liver Function Test Abnormal, Malaise
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5770171 4618204 10 Years F 2/28/2005 3/3/2005 3/23/2005 20 EXP Atomoxetine Attention Deficit/Hyperactivity Disorder, Oppositional Defiant Disorder Abdominal Pain, Condition Aggravated, Crying, Feeling Abnormal, Irritability, Mood Swings, Nausea, Overdose, Suicidal Ideation Other
5771186 4619940 16 Years M 3/21/2005 3/23/2005 OT DIR Strattera Fatigue, Laboratory Test Abnormal, Pruritus, Somnolence Other
5772928 4623670 5 Years M 12/15/2004 3/7/2005 3/29/2005 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Anorexia, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Somnolence, Weight Decreased
5772928 4638508 5 Years M 12/15/2004 3/29/2005 4/18/2005 20 MD EXP Strattera Alanine Aminotransferase Increased, Anorexia, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Depressed Level of Consciousness, Gamma-Glutamyltransferase Increased, Somnolence, Weight Decreased
5773104 4622249     M 3/21/2005 DIR Strattera
5773135 4625581 14 Years M 12/1/2004 3/14/2005 3/30/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Bilirubin Increased, Condition Aggravated, Drug Interaction, Epilepsy, Leukopenia, Liver Disorder, Lymphopenia, Neutropenia, Thrombocytopenia, Weight Decreased Other
5773135 4681869 14 Years M 12/1/2004 5/17/2005 6/2/2005 16 MD EXP Strattera Abnormal Behaviour, Blood Bilirubin Increased, Condition Aggravated, Drug Interaction, Epilepsy, Leukopenia, Liver Disorder, Lymphopenia, Neutropenia, Thrombocytopenia, Weight Decreased Other
5773135 4737437 14 Years M 12/1/2004 7/13/2005 8/3/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Blood Bilirubin Increased, Drug Interaction, Epilepsy, Leukopenia, Liver Disorder, Lymphopenia, Monocyte Count Decreased, Thrombocytopenia, Weight Decreased Other
5773358 4626136 29 Years M 3/11/2005 3/30/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Chromaturia, Headache, Pyrexia
5773358 4639652 29 Years M 12/17/2004 3/28/2005 101 CN PER Strattera Chromaturia, Headache, Pyrexia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5773488 4626540 13 Years M 3/14/2005 3/30/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Heart Rate Increased, Hypotension, Loss of Consciousness, Syncope Other
5773488 4642297 13 Years M 3/31/2005 4/20/2005 20 MD EXP Strattera Blood Pressure Decreased, Dizziness, Heart Rate Increased, Syncope Other
5773491 4626541 11 Years F 1/1/2005 3/9/2005 3/30/2005 21 EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased
5773492 4627238 14 Years F 4/1/2005 4/1/2005 0 MD DIR Strattera Coordination Abnormal Other
5773493 4626542 5 Years M 3/11/2005 3/30/2005 19 MD EXP Strattera Overdose Hospitalization - Initial or Prolonged
5773496 4626543 9 Years M 3/11/2005 3/30/2005 19 MD EXP Strattera Hepatic Failure, Myalgia, Myositis, Pain in Extremity, Pyrexia, Tenderness, White Blood Cell Count Decreased Other
5773498 4626544 16 Years M 3/18/2005 3/30/2005 12 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased, Blood Bilirubin Decreased
5773498 4631279 16 Years M 3/18/2005 4/6/2005 19 OT EXP Strattera Blood Alkaline Phosphatase Increased, Blood Bilirubin Decreased
5773501 4626545 14 Years F 3/8/2005 3/10/2005 3/30/2005 20 OT EXP Strattera Hepatitis B Other
5773501 4666411 14 Years F 3/1/2005 5/2/2005 5/17/2005 15 OT EXP Strattera Hepatitis B, International Normalised Ratio Increased, Prothrombin Time Prolonged Hospitalization - Initial or Prolonged, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5773501 4860676 14 Years F 3/11/2005 12/5/2005 12/16/2005 11 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Aplastic Anaemia, Diarrhoea, Hepatic Failure, International Normalised Ratio Increased, Prothrombin Level Increased, Prothrombin Time Prolonged, Prothrombin Time Shortened Hospitalization - Initial or Prolonged, Other
5773619 4625830 28 Years M 3/15/2005 3/30/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Blood Bilirubin Increased, Dizziness, Jaundice, Nausea, Transaminases Increased, Vomiting
5773619 4664869 31 Years M 4/28/2005 5/17/2005 19 MD EXP Strattera Asthenia, Dizziness, Jaundice, Nausea, Pyrexia, Transaminases Increased, Vomiting, Weight Decreased Hospitalization - Initial or Prolonged
5773619 4686746 31 Years M 5/20/2005 6/6/2005 17 MD EXP Strattera Asthenia, Blood Bilirubin Increased, Dizziness, Jaundice, Nausea, Pyrexia, Transaminases Increased, Vomiting, Weight Decreased Hospitalization - Initial or Prolonged
5773667 4622293 11 Years M 3/24/2005 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Aggression, Educational Problem, Memory Impairment Other
5773863 4626594     M 3/9/2005 3/30/2005 21 MD EXP Strattera Depression, Suicidal Ideation Hospitalization - Initial or Prolonged
5773864 4626595     3/9/2005 3/30/2005 21 MD EXP Strattera Convulsion Other
5773873 4626596 30 Years M 3/9/2005 3/30/2005 21 MD EXP Strattera Liver Function Test Abnormal
5774329 4625704 10 Years M 1/17/2005 3/11/2005 3/30/2005 19 EXP Atomoxetine Attention Deficit/Hyperactivity Disorder, Oppositional Defiant Disorder Appendicitis Hospitalization - Initial or Prolonged
5774329 4639970 10 Years M 1/17/2005 3/23/2005 4/15/2005 23 OT EXP Atomoxetine Appendicitis Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5774878 4625620 16 Years F 3/15/2005 3/31/2005 PH DIR Strattera Attention Deficit/Hyperactivity Disorder, Depression, Obsessive-Compulsive Disorder, Tic Jaundice, Ocular Icterus Required Intervention to Prevent Permanent Impairment/Damage
5775969 4634132 11 Years M 7/19/2004 4/5/2005 MD DIR Strattera Blood Pressure Decreased Other
5776357 4629738 18 Years M 3/9/2005 3/17/2005 4/7/2005 21 MD EXP Atomoxetine Diarrhoea, Food Poisoning, Hepatic Steatosis Other
5776357 4642960 18 Years M 3/9/2005 4/4/2005 4/21/2005 17 MD EXP Atomoxetine Blood Cholesterol Increased, Diarrhoea, Food Poisoning, Hepatic Steatosis, Irritability Other
5776357 4648476 18 Years M 3/9/2005 4/13/2005 4/27/2005 14 OT EXP Atomoxetine Blood Cholesterol Increased, Educational Problem, Hepatic Steatosis, Increased Appetite, Irritability, Liver Disorder, Weight Increased Other
5776357 4831003 18 Years M 3/9/2005 10/31/2005 11/14/2005 14 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Blood Cholesterol Increased, Blood Uric Acid Increased, Diarrhoea, Educational Problem, Food Poisoning, Gamma-Glutamyltransferase Increased, Hepatic Steatosis, Increased Appetite, Irritability, Liver Disorder, Weight Increased Other
5776446 4629746 13 Years M 3/4/2005 3/18/2005 4/7/2005 20 OT EXP Strattera Abnormal Behaviour, Drug Withdrawal Syndrome, Suicidal Ideation Other
5776446 4746314 13 Years M 3/4/2005 8/1/2005 8/15/2005 14 EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Withdrawal Syndrome, Suicidal Ideation Other
5776713 4629691 13 Years M 1/11/2005 3/15/2005 4/7/2005 23 MD EXP Strattera Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased
5777543 4630680 16 Years M 3/3/2005 3/22/2005 4/6/2005 15 OT EXP Strattera Hepatotoxicity, Pruritus Generalised, Somnolence Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5777544 4630687 9 Years M 1/11/2005 3/17/2005 4/6/2005 20 EXP Strattera Band Neutrophil Count Increased, Blood Alkaline Phosphatase Increased, Haemoglobin Decreased, Jaundice, Laboratory Test Abnormal, Mental Disorder, Monocyte Count Abnormal, Neutrophil Count Abnormal, White Blood Cell Count Decreased Hospitalization - Initial or Prolonged
5777545 4630691 55 Years F 1/1/2005 3/16/2005 4/6/2005 21 OT EXP Strattera Blood Glucose Increased, Feeling Abnormal
5777545 4674283 55 Years F 1/1/2005 5/10/2005 5/24/2005 14 OT EXP Strattera Blood Glucose Increased, Blood PH Decreased, Blood Pressure Increased, Feeling Abnormal, Glycosylated Haemoglobin Increased, Nausea, Polyuria
5778107 4630326 84 Years F 3/22/2005 4/6/2005 15 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Abnormal
5778107 4662373 11 Years F 4/25/2005 5/12/2005 17 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5778111 4630327 27 Years M 3/16/2005 4/6/2005 21 EXP Strattera Fatigue, Insomnia, Pain, Pruritus
5778112 4630328 17 Years M 3/13/2005 3/17/2005 4/6/2005 20 PH EXP Strattera Abdominal Pain, Nasopharyngitis, Rhabdomyolysis Hospitalization - Initial or Prolonged
5778112 4662380 17 Years M 3/13/2005 4/25/2005 5/12/2005 17 PH EXP Strattera Abdominal Pain, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Nasopharyngitis, Oedema Peripheral, Pain, Rhabdomyolysis Hospitalization - Initial or Prolonged
5778333 4633067     M 12/23/2004 4/11/2005 PH DIR Strattera Blood Pressure Increased, Palpitations, Premature Ejaculation, Sexual Dysfunction Other
5779288 4637280     F 11/29/2004 3/28/2005 119 PER Strattera Heart Rate Increased, Hyperhidrosis, Mood Altered
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5779290 4637282     M 11/29/2004 3/28/2005 119 OT PER Strattera Rash
5779293 4637283 16 Years M 11/30/2004 3/28/2005 118 OT PER Strattera Drug Screen Positive
5779296 4637284 14 Years F 11/30/2004 12/1/2004 3/28/2005 117 PER Strattera Blood Potassium Decreased, Chest Pain, Drug Screen Positive, Dyspnoea, Electrocardiogram Abnormal
5779297 4637285 13 Years F 11/10/2004 11/30/2004 3/28/2005 118 PER Strattera Abnormal Behaviour, Aggression, Irritability
5779301 4637286 9 Years M 11/30/2004 3/28/2005 118 PER Strattera Apathy, Somnolence
5779315 4637287 17 Years F 11/30/2004 3/28/2005 118 PER Strattera Nonspecific Reaction
5779317 4637288 17 Years M 8/1/2004 11/30/2004 3/28/2005 118 PER Strattera Aggression, Apathy, Depression, Disturbance in Attention, Dysarthria, Emotional Distress, Headache, Nausea, Nervousness, Nonspecific Reaction, Personality Change, Somnolence, Tremor
5779318 4637289 16 Years M 11/27/2004 11/30/2004 3/28/2005 118 PER Strattera Balance Disorder, Drug Ineffective, Middle Insomnia, Nausea, Tremor
5779320 4637294 31 Years F 12/1/2004 3/28/2005 117 PER Strattera Anxiety, Dizziness
5780014 4634731 9 Years M 12/10/2004 4/13/2005 CN DIR Strattera Abdominal Pain Upper, Abnormal Behaviour, Anxiety, Depression, Drug Withdrawal Headache, Fear, Feeding Disorder, Paranoia, Stomach Discomfort Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5780845 4639838 16 Years M 1/11/2005 3/28/2005 76 OT PER Strattera Agitation, Mood Swings
5780846 4639842 13 Years F 2/17/2005 3/28/2005 39 MD PER Strattera Blood Pressure Increased, Growth Retardation
5780847 4639843 16 Years M 1/11/2005 3/28/2005 76 MD PER Strattera Drug Screen Positive
5780849 4639844 20 Years M 1/1/2005 1/11/2005 3/28/2005 76 MD PER Strattera Drug Screen Positive
5780850 4639847 16 Years M 1/10/2005 1/11/2005 3/28/2005 76 PER Strattera Dizziness, Heart Rate Increased, Hypotension Hospitalization - Initial or Prolonged
5780851 4639849     M 1/11/2005 3/28/2005 76 PER Strattera Abnormal Behaviour
5780853 4639851 12 Years M 1/11/2005 3/28/2005 76 PER Strattera Weight Increased
5780854 4639853 15 Years F 1/11/2005 3/28/2005 76 MD PER Strattera Crying, Hyperphagia, Irritability
5780855 4639854 15 Years M 1/1/2005 1/11/2005 3/28/2005 76 PER Strattera Decreased Appetite, Lethargy, Social Avoidant Behaviour
5780856 4639856 67 Years M 1/10/2005 1/11/2005 3/28/2005 76 PER Strattera Abdominal Pain Upper, Burning Sensation, Disorientation, Headache, Migraine, Mydriasis
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5780857 4639790 8 Years M 1/6/2005 3/28/2005 81 MD PER Strattera Hallucination (Auditory)
5780858 4639791 42 Years M 1/6/2004 1/10/2005 3/28/2005 77 PER Strattera Aggression, Dry Mouth, Excitability, Fatigue, Feeling Abnormal, Hyperhidrosis, Irritability, Personality Change
5780859 4639792 8 Years M 10/1/2004 1/6/2005 3/28/2005 81 PER Strattera Conversion Disorder, Micturition Disorder, Urinary Incontinence, Urinary Retention
5780860 4639793 10 Years M 12/1/2004 1/6/2005 3/28/2005 81 PER Strattera Affect Lability, Anger, Disturbance in Attention
5780861 4639794 19 Years M 1/6/2005 3/28/2005 81 PER Strattera Drug Screen Positive
5780862 4639795 10 Years F 12/1/2004 1/6/2005 3/28/2005 81 PH PER Strattera Dizziness, Nausea, Vision Blurred
5780863 4639796 9 Years M 9/1/2004 1/6/2004 3/28/2005 447 PER Strattera Crying, Ear Infection, Mood Swings, Nausea, Nightmare
5780864 4639797 10 Years F 1/7/2005 3/28/2005 80 MD PER Strattera Vitreous Floaters
5780865 4639798 7 Years F 1/1/2004 1/6/2005 3/28/2005 81 PER Strattera Anorexia, Drug Ineffective, Feeling Abnormal, Headache, Hyperacusis, Nausea, Somnolence, Weight Decreased
5780867 4639780 7 Years M 12/1/2004 1/11/2005 3/28/2005 76 PER Strattera Circadian Rhythm Sleep Disorder, Middle Insomnia, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5780868 4639781 44 Years M 1/7/2005 1/12/2005 3/28/2005 75 PER Strattera Feeling Jittery, Insomnia
5780870 4639782 38 Years M 1/8/2005 2/3/2005 3/28/2005 53 PER Strattera Dependence, Sperm Count Decreased, Spermatozoa Progressive Motility Decreased
5780871 4639783 15 Years F 1/12/2005 1/12/2005 3/28/2005 75 OT PER Strattera Abnormal Behaviour, Anorexia, Nausea, Nystagmus
5780872 4639784 13 Years M 1/1/2004 1/12/2005 3/28/2005 75 PER Strattera Hypoaesthesia, Peripheral Coldness, Skin Discolouration
5780873 4639785 14 Years M 1/12/2005 3/28/2005 75 CN PER Strattera Peripheral Coldness
5780874 4639786 8 Years F 1/8/2005 1/12/2005 3/28/2005 75 PER Strattera Fatigue, Personality Change, Somnolence
5780875 4639787 12 Years 1/12/2005 3/28/2005 75 MD PER Strattera Disturbance in Attention, Somnolence
5780876 4639788     M 1/13/2005 3/28/2005 74 MD PER Strattera Drug Screen Positive
5780877 4639789 15 Years M 1/13/2005 3/28/2005 74 PH PER Strattera Chromaturia, Melaena
5780920 4639799 7 Years M 1/31/2005 3/28/2005 56 PER Strattera Abnormal Behaviour, Anorexia, Fatigue, Pharyngolaryngeal Pain, Rash, Respiratory Tract Congestion, Somnolence, Speech Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5780930 4639770 36 Years F 1/13/2005 3/28/2005 74 PER Strattera Asthenia, Dizziness, Fear, Feeling Abnormal, Headache, Insomnia, Palpitations, Paraesthesia, Peripheral Coldness, Social Avoidant Behaviour
5780933 4639771 13 Years M 1/13/2005 1/13/2005 3/28/2005 74 PER Strattera Muscle Tightness, Myalgia
5780935 4639772 58 Years F 1/13/2005 3/28/2005 74 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Depression, Headache, Insomnia
5780936 4639773 14 Years M 1/13/2005 3/28/2005 74 PER Strattera Abnormal Behaviour, Dysphonia
5780937 4639774 27 Years M 1/12/2005 1/13/2005 3/28/2005 74 PER Strattera Attention Deficit/Hyperactivity Disorder Communication Disorder, Dissociation, Euphoric Mood, Feeling Abnormal, Headache, Nausea, Paraesthesia
5780938 4639775 10 Years M 2/16/2005 3/28/2005 40 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Hallucination (Visual), Psychotic Disorder
5780939 4639776 39 Years M 1/11/2005 3/28/2005 76 OT PER Strattera Agitation, Anxiety
5780941 4639646 32 Years M 12/16/2004 3/28/2005 102 PER Strattera Drug Ineffective, Libido Decreased, Pollakiuria, Urine Flow Decreased
5780942 4639647 12 Years 12/13/2004 3/28/2005 105 MD PER Strattera Tic
5780943 4639777 12 Years M 1/13/2005 3/28/2005 74 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Fatigue
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5780944 4639648     M 12/17/2004 3/28/2005 101 PER Strattera Disturbance in Attention, Fatigue
5780945 4639650 12 Years M 1/1/2004 12/17/2004 3/28/2005 101 MD PER Strattera Fatigue, Feeling Abnormal
5780946 4639778 9 Years F 1/13/2005 3/28/2005 74 PER Strattera Headache
5780947 4639653 14 Years M 12/17/2004 12/17/2004 3/28/2005 101 PER Strattera Blepharospasm, Muscle Twitching
5780948 4639654 7 Years M 12/17/2004 3/28/2005 101 PER Strattera Dyspnoea, Influenza Like Illness, Respiratory Tract Infection, Rhinorrhoea, Tic
5780949 4639655     M 12/8/2004 3/28/2005 110 MD PER Strattera Pain, Penile Pain
5780950 4639656 22 Years M 12/17/2004 12/17/2004 3/28/2005 101 PER Strattera Fatigue, Feeling Abnormal, Vomiting
5780951 4639657     F 1/1/2003 12/20/2004 3/28/2005 98 PER Strattera Agitation, Confusional State, Disorientation, Initial Insomnia, Nausea
5780952 4639779     M 1/14/2005 3/28/2005 73 MD PER Strattera Asthenia, Hyperhidrosis
5780954 4639760 25 Years F 1/13/2005 1/14/2005 3/28/2005 73 PER Strattera Attention Deficit/Hyperactivity Disorder Menstruation Irregular, Muscle Spasms
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5780956 4639761 4 Years M 1/14/2005 3/28/2005 73 PER Strattera Agitation, Dysphonia
5780958 4639762     M 1/14/2005 3/28/2005 73 MD PER Strattera Urinary Hesitation
5780960 4639763 14 Years M 1/14/2005 3/28/2005 73 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hypertrophy Breast
5780962 4639764 15 Years M 1/1/2005 1/17/2005 3/28/2005 70 PER Strattera Abnormal Behaviour, Agitation, Cold Sweat, Heart Rate Increased, Hypoaesthesia, Pallor, Screaming, Thinking Abnormal
5780963 4639765 6 Years F 7/1/2003 2/28/2005 3/28/2005 28 OT PER Strattera Attention Deficit/Hyperactivity Disorder Growth Retardation
5780963 4726715 6 Years F 7/1/2003 2/28/2005 7/25/2005 147 OT PER Strattera Attention Deficit/Hyperactivity Disorder Growth Retardation
5780965 4639766 12 Years F 1/1/2004 1/14/2005 3/28/2005 73 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Intentional Self-Injury, Mood Swings
5780970 4639767 16 Years M 1/14/2005 3/28/2005 73 PER Strattera Suicidal Ideation
5780971 4639768 14 Years 1/3/2005 3/28/2005 84 MD PER Strattera Abdominal Discomfort
5780972 4639769     M 1/17/2005 3/28/2005 70 PH PER Strattera Abnormal Behaviour, Drug Ineffective
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5780973 4639658 27 Years M 12/9/2004 12/9/2004 3/28/2005 109 OT PER Strattera Hypoaesthesia, Palpitations, Paraesthesia
5780974 4639660 6 Years M 12/15/2004 3/28/2005 103 PER Strattera Abnormal Behaviour, Decreased Appetite, Fatigue, Feeling Abnormal, Hypersomnia
5780975 4639661     F 12/10/2004 12/15/2004 3/28/2005 103 PER Strattera Abdominal Pain, Asthenia, Dizziness, Feeling Abnormal, Feeling Jittery, Flat Affect, Headache, Nausea
5780976 4639662 12 Years M 12/15/2004 3/28/2005 103 PER Strattera Abdominal Pain Upper, Fatigue, Headache, Malaise
5780977 4639663     12/15/2004 3/28/2005 103 PER Strattera Drug Withdrawal Syndrome
5780978 4639664 42 Years F 12/16/2004 3/28/2005 102 PER Strattera Anxiety, Irritability
5780979 4639666 12 Years M 1/1/2004 12/16/2004 3/28/2005 102 MD PER Strattera Drug Ineffective, Weight Increased
5780980 4639667 12 Years 12/13/2004 3/28/2005 105 MD PER Strattera Tic
5780981 4639668     M 12/16/2004 3/28/2005 102 PH PER Strattera Tongue Exfoliation
5780982 4639670     M 12/13/2004 3/28/2005 105 MD PER Strattera Dry Mouth, Sexual Dysfunction
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5780982 4726713 40 Years M 9/1/2005 3/8/2005 7/25/2005 139 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Sexual Dysfunction
5780993 4639671 9 Years M 11/1/2004 2/3/2005 3/28/2005 53 PER Strattera Abdominal Pain, Abdominal Pain Upper, Pain in Extremity
5780996 4639675 9 Years M 11/1/2004 12/20/2004 3/28/2005 98 PER Strattera Headache, Lethargy, Somnolence
5780997 4639676 10 Years F 12/20/2004 3/28/2005 98 PER Strattera Anorexia, Dyspepsia, Pallor, Retching, Weight Decreased
5780999 4639679 36 Years F 12/13/2004 2/3/2005 3/28/2005 53 MD PER Strattera Anxiety, Palpitations
5781015 4639681 7 Years M 12/20/2004 3/28/2005 98 MD PER Strattera Hypoaesthesia
5781017 4639683 15 Years M 12/20/2004 3/28/2005 98 MD PER Strattera Growth Retardation
5781019 4639685 39 Years M 12/20/2004 3/28/2005 98 PER Strattera Paraesthesia, Tremor
5781020 4639686 67 Years M 12/21/2004 3/28/2005 97 PER Strattera Dysuria
5781021 4639688 7 Years M 12/21/2004 3/28/2005 97 PER Strattera Abnormal Behaviour, Drug Ineffective
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5781024 4639690 61 Years F 12/21/2004 3/28/2005 97 PER Strattera Amnesia, Crying, Depression, Drug Ineffective, Feeling Abnormal, Heart Rate Irregular, Somnolence
5781025 4639916 49 Years M 12/1/2004 1/5/2005 3/28/2005 82 PER Strattera Drug Ineffective, Middle Insomnia, Nervousness
5781034 4639920     F 1/5/2005 3/28/2005 82 PH PER Strattera Opiates Positive
5781039 4639929 7 Years M 11/1/2004 1/5/2005 3/28/2005 82 PER Strattera Abdominal Pain, Decreased Appetite, Listless
5781042 4639932 64 Years F 1/4/2005 1/5/2005 3/28/2005 82 PER Strattera Anxiety, Depression, Fear, Headache, Heart Rate Increased, Thinking Abnormal
5781044 4639956 7 Years M 12/22/2004 1/5/2005 3/28/2005 82 PER Strattera Aggression, Anger, Weight Decreased
5781046 4639959 10 Years M 1/5/2005 3/28/2005 82 PER Strattera Depressed Mood
5781048 4639966 14 Years M 1/6/2005 1/6/2005 3/28/2005 81 OT PER Strattera Asthenia, Fatigue, Lethargy
5781050 4639967 9 Years F 1/6/2005 3/28/2005 81 PER Strattera Aggression, Drug Ineffective, Feeling Abnormal, Vomiting
5781055 4639968 5 Years M 1/5/2005 2/5/2005 3/28/2005 51 PER Strattera Anorexia, Communication Disorder, Constipation, Heart Rate Increased, Indifference, Mydriasis, Social Avoidant Behaviour, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5781063 4639719     M 12/27/2004 3/28/2005 91 PER Strattera Abdominal Pain, Benign Prostatic Hyperplasia, Dysuria
5781066 4639720     F 12/28/2004 3/28/2005 90 PER Strattera Alopecia
5781068 4639721 8 Years M 11/1/2004 12/28/2004 3/28/2005 90 PER Strattera Asthenia, Crying, Eye Disorder, Insomnia, Mood Swings, Nightmare, Weight Increased
5781069 4639722 6 Years F 12/28/2004 3/28/2005 90 PER Strattera Disturbance in Attention, Drug Ineffective, Psychomotor Hyperactivity
5781070 4639723 25 Years F 12/28/2004 3/28/2005 90 PER Strattera Alopecia, Dry Mouth, Keratoconjunctivitis Sicca, Nasal Dryness
5781071 4639724 31 Years M 12/6/2004 12/28/2004 3/28/2005 90 PER Strattera Dysuria, Feeling Cold, Pollakiuria, Testicular Atrophy, Testicular Pain
5781073 4639725 11 Years M 12/28/2004 3/28/2005 90 PER Strattera Sinus Headache, Weight Decreased
5781074 4639726     M 1/1/2004 12/28/2004 3/28/2005 90 PER Strattera Heart Rate Irregular
5781075 4639727 11 Years M 12/27/2004 12/28/2004 3/28/2005 90 PER Strattera Aggression, Hostility
5781076 4639728 10 Years F 1/1/2004 12/28/2004 3/28/2005 90 PER Strattera Decreased Appetite, Drug Ineffective, Pruritus
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5781079 4640035 8 Years M 1/3/2005 3/28/2005 84 PER Strattera Anorexia, Feeling Abnormal, Nausea, Vomiting
5781083 4640046     F 1/3/2005 3/28/2005 84 PH PER Strattera Dysgeusia
5781166 4638835     F 4/11/2005 4/18/2005 MD DIR Strattera Dizziness, Heart Rate Increased, Palpitations, Tachycardia Required Intervention to Prevent Permanent Impairment/Damage
5781796 4638213 16 Years F 3/15/2005 3/23/2005 4/18/2005 26 MD EXP Strattera Bilirubin Conjugated Increased, Blood Bilirubin Increased, Jaundice, Oral Intake Reduced, Pallor
5781796 4666312 16 Years F 3/15/2005 5/11/2005 5/17/2005 6 MD EXP Strattera Anorexia, Blood Bilirubin Increased, Ocular Icterus, Pallor
5781796 4674282 16 Years F 3/15/2005 5/9/2005 5/24/2005 15 MD EXP Strattera Anorexia, Bilirubin Conjugated Increased, Blood Bilirubin Increased, Ocular Icterus, Pallor
5781798 4638214     M 3/23/2005 4/18/2005 26 EXP Strattera Alcohol Use, Hepatic Enzyme Increased
5781798 4747052     M 3/14/2005 8/4/2005 8/15/2005 11 EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5781952 4638407 15 Years M 3/24/2005 4/18/2005 25 OT EXP Strattera Arrhythmia, Palpitations, Syncope, Tachycardia Other
5781955 4638408 43 Years M 3/29/2005 3/30/2005 4/18/2005 19 MD EXP Strattera Haemorrhagic Stroke Hospitalization - Initial or Prolonged, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5781955 4642295 43 Years M 3/26/2005 4/6/2005 4/20/2005 14 MD EXP Strattera Cerebrovascular Disorder, Drug Ineffective, Haemorrhagic Stroke, Headache, Hemiplegia, Speech Disorder Hospitalization - Initial or Prolonged, Other
5781956 4638409 27 Years M 12/1/2004 3/30/2005 4/18/2005 19 MD EXP Strattera Cholecystectomy, Pancreatitis Hospitalization - Initial or Prolonged, Other
5781956 4703976 27 Years M 12/1/2004 6/14/2005 6/28/2005 14 MD EXP Strattera Cholelithiasis, Pancreatitis Hospitalization - Initial or Prolonged, Other
5782424 4640470     F 1/1/2005 1/27/2005 3/28/2005 60 PER Strattera Blood Pressure Increased, Chest Discomfort, Feeling Abnormal, Heart Rate Increased, Nausea, Nervousness
5782425 4640473 41 Years M 1/27/2005 3/28/2005 60 PER Strattera Feeling Abnormal, Feeling Hot and Cold
5782436 4640474     M 1/26/2005 3/28/2005 61 MD PER Strattera Sexual Dysfunction, Testicular Pain
5782438 4640475     M 1/26/2005 3/28/2005 61 MD PER Strattera Sexual Dysfunction, Testicular Pain
5782443 4640478 8 Years M 1/28/2005 3/28/2005 59 MD PER Strattera Pupils Unequal
5782503 4640481     M 1/28/2005 3/28/2005 59 MD PER Strattera Testicular Pain
5782506 4640483 17 Years M 1/1/2004 1/28/2005 3/28/2005 59 PER Strattera
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5782509 4640485     F 1/28/2005 3/28/2005 59 MD PER Strattera Endometriosis
5782538 4640487 10 Years F 8/1/2004 1/28/2005 3/28/2005 59 PER Strattera Attention Deficit/Hyperactivity Disorder Hypotrichosis
5782553 4640490     M 1/28/2005 3/28/2005 59 MD PER Strattera Hyperventilation, Panic Attack
5782575 4639558 5 Years M 2/1/2005 2/10/2005 3/28/2005 46 OT PER Strattera Retching
5782585 4639560     M 2/10/2005 3/28/2005 46 PER Strattera Conjunctivitis
5782586 4639563 18 Years M 2/10/2005 3/28/2005 46 MD PER Strattera Agitation, Anxiety, Tic
5782587 4639565 36 Years M 2/1/2005 2/10/2005 3/28/2005 46 PER Strattera Dry Mouth, Initial Insomnia, Speech Disorder, Thirst
5782587 4784022 36 Years M 2/1/2005 7/26/2005 9/27/2005 63 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Initial Insomnia, Speech Disorder, Sperm Count Decreased, Thirst
5782589 4639566 38 Years F 2/11/2005 3/28/2005 45 PER Strattera Somnolence
5782590 4639568 10 Years M 2/8/2005 2/11/2005 3/28/2005 45 PER Strattera Early Morning Awakening, Social Avoidant Behaviour, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5782591 4639570     F 2/1/2005 2/11/2005 3/28/2005 45 PER Strattera Feeling Jittery, Palpitations, Weight Decreased
5782593 4639572 53 Years F 1/1/2005 2/14/2005 3/28/2005 42 PER Strattera Abdominal Pain, Flushing, Headache, Heart Rate Increased, Insomnia
5782594 4639573 14 Years F 2/15/2005 3/28/2005 41 PER Strattera Dental Plaque, Dry Mouth, Gingival Bleeding, Gingival Swelling
5782600 4639556 50 Years F 2/10/2005 3/28/2005 46 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
5783344 4640697 40 Years F 3/9/2005 4/19/2005 41 MD EXP Strattera Anxiety, Depression, Palpitations, Panic Attack, Suicidal Ideation Other
5783663 4640047 5 Years M 11/1/2004 1/4/2005 3/28/2005 83 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Decreased Appetite, Eye Disorder, Mydriasis
5783666 4640048 9 Years M 1/4/2005 3/28/2005 83 PER Strattera Decreased Appetite
5783668 4640065 7 Years M 1/3/2005 1/4/2005 3/28/2005 83 OT PER Strattera Attention Deficit/Hyperactivity Disorder Eye Swelling, Urticaria
5783674 4640073     F 1/4/2005 3/28/2005 83 PER Strattera Head Discomfort, Nausea
5783677 4640075 14 Years 1/3/2005 3/28/2005 84 MD PER Strattera Abdominal Discomfort
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5783680 4640078 15 Years M 1/1/2005 1/17/2005 3/28/2005 70 PER Strattera Anorexia, Exophthalmos, Hunger, Hyperhidrosis
5783865 4640098 6 Years M 2/2/2005 3/28/2005 54 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Fatigue, Feeling Abnormal
5783869 4640100 48 Years F 2/2/2005 3/28/2005 54 PER Strattera Menorrhagia, Metrorrhagia
5783878 4640103 10 Years M 1/1/2005 2/2/2005 3/28/2005 54 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Tremor
5783881 4640104 8 Years F 1/20/2005 2/3/2005 3/28/2005 53 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Feeling Abnormal
5783888 4640106 6 Years F 2/2/2005 3/28/2005 54 PER Strattera Mydriasis, Retching, Vomiting
5783893 4640110 14 Years M 1/1/2005 2/2/2005 3/28/2005 54 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Psychomotor Hyperactivity, Stomach Discomfort, Vomiting
5783901 4640123 12 Years M 2/3/2005 3/28/2005 53 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Stomach Discomfort
5783911 4640134 10 Years M 2/3/2005 3/28/2005 53 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Fatigue, Mononucleosis Syndrome, Pallor, Weight Decreased
5783918 4640136     M 2/8/2005 2/2/2005 3/28/2005 54 PER Strattera Constipation, Micturition Disorder, Penis Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5783966 4639895 6 Years M 1/7/2005 3/28/2005 80 PER Strattera Tic
5783972 4639900 9 Years F 1/1/2004 1/7/2005 3/28/2005 80 PER Strattera Abdominal Pain Upper, Urinary Tract Infection
5783976 4639904 18 Years F 8/5/2004 1/7/2005 3/28/2005 80 PER Strattera Nausea, Pain
5783981 4639906     M 1/7/2005 3/28/2005 80 PER Strattera Psychomotor Hyperactivity
5783983 4639907 40 Years M 12/22/2004 1/7/2005 3/28/2005 80 PER Strattera Insomnia, Tinnitus, Urine Output Increased
5783986 4639908 6 Years M 1/7/2005 3/28/2005 80 OT PER Strattera Abdominal Pain Upper, Fatigue, Feeling Abnormal
5783988 4639909 17 Years M 1/25/2005 3/28/2005 62 PH PER Strattera Jaw Fracture
5783992 4639910 58 Years M 11/24/2004 2/14/2005 3/28/2005 42 MD PER Strattera Benign Prostatic Hyperplasia
5783994 4639911 11 Years M 1/1/2003 1/10/2005 3/28/2005 77 PER Strattera Decreased Appetite, Epistaxis
5783995 4639912 40 Years F 1/11/2005 3/28/2005 76 PER Strattera Anorexia, Weight Decreased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5784004 4640083 55 Years M 1/28/2005 2/3/2005 3/28/2005 53 PER Strattera Feeling Abnormal, Thinking Abnormal
5784007 4640084 10 Years M 2/28/2005 3/28/2005 28 PH PER Strattera
5784007 4726723 10 Years M 2/28/2005 7/25/2005 147 PH PER Strattera Attention Deficit/Hyperactivity Disorder
5784008 4640085 27 Years M 2/3/2005 2/3/2005 3/28/2005 53 PER Strattera Asthenia, Dizziness, Feeling Abnormal
5784010 4640088 38 Years M 2/3/2005 3/28/2005 53 CN PER Strattera Anxiety, Illusion, Irritability
5784012 4640089 9 Years M 8/1/2004 2/3/2005 3/28/2005 53 MD PER Strattera Abnormal Behaviour, Mood Swings
5784017 4640091 8 Years M 2/4/2005 3/28/2005 52 MD PER Strattera Abnormal Behaviour, Negativism
5784017 4726724 8 Years M 2/4/2005 7/25/2005 171 MD PER Strattera Anxiety Abnormal Behaviour, Negativism
5784019 4640093 6 Years M 1/31/2005 2/3/2005 3/28/2005 53 PER Strattera Abdominal Pain Upper, Appetite Disorder, Drug Ineffective, Headache, Lymphadenopathy, Pain in Extremity, Pharyngolaryngeal Pain, Pyrexia, Sleep Disorder, Weight Decreased
5784021 4640095 6 Years M 1/1/2003 2/4/2005 3/28/2005 52 OT PER Strattera Retching, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5784022 4640096 9 Years M 2/3/2005 3/28/2005 53 MD PER Strattera Disease Progression
5784025 4639709 5 Years M 1/1/2004 12/21/2004 3/28/2005 97 PER Strattera Abnormal Behaviour, Aggression, Bronchitis, Drug Ineffective
5784029 4639710 14 Years M 12/21/2004 3/28/2005 97 PER Strattera Anger, Dry Mouth, Eye Pruritus, Fatigue, Infection, Insomnia, Mood Swings, Somnolence, Stomach Discomfort, Tremor, Yawning
5784032 4639711 15 Years M 12/1/2004 12/21/2004 3/28/2005 97 PER Strattera Dysuria
5784035 4639712 30 Years M 11/1/2004 12/22/2004 3/28/2005 96 MD PER Strattera Affect Lability, Agitation, Blood Pressure Increased, Dyspnoea, Exercise Tolerance Decreased
5784042 4639714 19 Years F 12/21/2004 12/22/2004 3/28/2005 96 PER Strattera Abnormal Dreams, Insomnia, Sleep Talking
5784043 4639715 8 Years M 1/1/2004 12/22/2004 3/28/2005 96 PER Strattera Attention Deficit Hyperactivity Disorder
5784045 4639716 46 Years M 12/1/2004 12/22/2004 3/28/2005 96 PER Strattera Drug Ineffective, Dry Mouth, Ejaculation Disorder, Halitosis, Pain, Urinary Hesitation
5784046 4639717 13 Years M 12/22/2004 3/28/2005 96 MD PER Strattera Decreased Appetite, Weight Decreased, Weight Increased
5784051 4639718 345 Weeks M 11/4/2004 12/27/2004 3/28/2005 91 CN PER Strattera Abdominal Pain, Ear Infection, Fatigue, Retching, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5784254 4639976 11 Years M 3/10/2005 3/23/2005 4/15/2005 23 PH EXP Strattera Depression Suicidal, Suicide Attempt Other
5784254 4642561 11 Years M 3/10/2005 4/4/2005 4/20/2005 16 PH EXP Strattera Depression Suicidal, Suicide Attempt Other
5784254 4658958 11 Years M 3/1/2005 4/4/2005 5/9/2005 35 PH EXP Strattera Suicide Attempt Other
5784354 4639952 9 Years M 3/16/2005 3/17/2005 4/15/2005 29 MD EXP Strattera Blood Alkaline Phosphatase Increased, Serum Ferritin Increased
5784354 4647450 9 Years M 3/16/2005 4/5/2005 4/26/2005 21 MD EXP Strattera Blood Alkaline Phosphatase Increased, Serum Ferritin Increased
5784354 4710641 9 Years M 3/16/2005 6/20/2005 7/7/2005 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased, Serum Ferritin Increased
5784410 4641588 12 Years M 1/27/2005 4/4/2005 4/20/2005 16 OT EXP Strattera Aggression, Depressed Mood, Disturbance in Attention, Disturbance In Social Behaviour, Irritability, Mood Altered Other
5784411 4641589 9 Years F 11/1/2004 3/31/2005 4/20/2005 20 EXP Strattera Abdominal Pain, Dizziness, Headache, Pallor Other
5784712 4641557     M 4/5/2005 4/20/2005 15 MD EXP Strattera Hepatitis Other
5784712 4662375 19 Years M 2/17/2005 4/26/2005 5/12/2005 16 MD EXP Strattera Hepatitis Infectious Mononucleosis, Sleep Disorder, Thrombocytopenia Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5784714 4641558 44 Years M 4/2/2005 4/5/2005 4/20/2005 15 MD EXP Atomoxetine Delusion of Grandeur Hospitalization - Initial or Prolonged
5784726 4637035 14 Years M 11/1/2004 12/9/2004 3/28/2005 109 CN PER Strattera Abdominal Pain Upper, Nausea, Somnolence, Vomiting
5784741 4637049 49 Years M 12/10/2004 12/10/2004 3/28/2005 108 PER Strattera Dysgeusia, Feeling Jittery, Nervousness
5784742 4637051 6 Years M 12/10/2004 3/28/2005 108 MD PER Strattera Oedema Peripheral
5784745 4637055 28 Years F 1/1/2004 1/6/2005 3/28/2005 81 MD PER Strattera Acne, Constipation, Suicidal Ideation, Urinary Retention
5784747 4641954 13 Years M 3/1/2005 3/30/2005 4/20/2005 21 EXP Strattera Blood Bilirubin Increased, Jaundice, Liver Disorder, Pruritus, Viral Infection Other
5784749 4637069 16 Years M 12/9/2004 3/28/2005 109 PER Strattera Fatigue, Feeling Abnormal
5784752 4637077 9 Years M 12/1/2004 12/10/2004 3/28/2005 108 PER Strattera Abnormal Behaviour, Aggression, Drug Ineffective
5784756 4637079 6 Years M 11/19/2004 12/10/2004 3/28/2005 108 PER Strattera Abdominal Pain Upper, Insomnia
5784804 4641987 6 Years F 3/29/2005 4/5/2005 4/20/2005 15 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Liver Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5784804 4703989 6 Years F 3/29/2005 6/10/2005 6/28/2005 18 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5784818 4641988 13 Years M 3/23/2005 3/30/2005 4/20/2005 21 EXP Strattera Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased
5784823 4641990     M 3/1/2005 4/1/2005 4/20/2005 19 MD EXP Strattera Abdominal Pain Upper, Blood Bilirubin Increased
5784823 4658137 16 Years M 3/1/2005 4/19/2005 5/9/2005 20 MD EXP Strattera Abdominal Pain Upper, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Diarrhoea, Lipase Increased, Nausea, Syncope, Vomiting
5784834 4641991 13 Years M 3/31/2005 4/20/2005 20 MD EXP Strattera Dizziness, Heart Rate Increased, Hypotension, Syncope Hospitalization - Initial or Prolonged
5784843 4641993 14 Years F 4/6/2005 4/20/2005 14 MD EXP Strattera Convulsion, Mydriasis Other
5784843 4666315 14 Years F 3/22/2005 5/3/2005 5/17/2005 14 MD EXP Strattera Drug Interaction, Grand Mal Convulsion, Mydriasis Other
5784857 4641994 37 Years M 4/4/2005 4/20/2005 16 MD EXP Strattera Blood Bilirubin Increased, Jaundice
5784857 4658136 37 Years M 4/19/2005 5/9/2005 20 MD EXP Strattera Bilirubin Conjugated Increased, Jaundice
5784876 4640515 17 Years M 1/27/2005 3/28/2005 60 MD PER Strattera Urine Abnormality
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5784880 4640516 23 Years M 9/1/2004 2/1/2005 3/28/2005 55 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Intermittent Explosive Disorder, Irritability, Overdose, Sleep Disorder
5784881 4641995 8 Years M 2/1/2005 4/4/2005 4/20/2005 16 EXP Strattera Aspartate Aminotransferase Increased
5784883 4640519 13 Years M 9/1/2004 2/1/2005 3/28/2005 55 PER Strattera Decreased Appetite, Educational Problem, Fatigue, Weight Gain Poor
5784883 4726720 13 Years M 9/1/2004 2/1/2005 7/25/2005 174 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Educational Problem, Fatigue, Weight Gain Poor
5784892 4640524 12 Years M 1/31/2005 2/1/2005 3/28/2005 55 PER Strattera Abnormal Behaviour, Drug Ineffective
5784894 4640527 7 Years M 12/1/2004 2/1/2005 3/28/2005 55 PER Strattera
5784909 4640541 8 Years M 1/1/2004 2/1/2005 3/28/2005 55 PER Strattera Drug Ineffective
5784918 4640542 42 Years M 2/1/2005 3/28/2005 55 PER Strattera Agitation, Balance Disorder, Chromaturia, Diarrhoea, Dizziness, Faecal Incontinence, Intracranial Pressure Increased, Irritable Bowel Syndrome, Libido Decreased, Urine Flow Decreased, Urine Output Decreased
5784922 4640544 10 Years M 1/29/2005 2/1/2005 3/28/2005 55 PER Strattera Dysphagia, Fatigue, Headache, Influenza Like Illness, Pharyngolaryngeal Pain, Pyrexia, Somnolence
5784922 4726721 10 Years M 1/29/2005 5/27/2005 7/25/2005 59 MD PER Strattera Attention Deficit/Hyperactivity Disorder Pharyngitis Streptococcal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5784922 4784020 10 Years M 1/29/2005 5/27/2005 9/27/2005 123 MD PER Strattera Attention Deficit/Hyperactivity Disorder Pharyngitis Streptococcal
5784933 4640545 36 Years M 1/27/2005 2/1/2005 3/28/2005 55 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Erectile Dysfunction, Insomnia, Visual Disturbance
5784936 4640546 23 Years M 2/1/2005 2/9/2005 3/28/2005 47 PER Strattera Attention Deficit/Hyperactivity Disorder Dysgeusia, Nausea, Testicular Pain
5784936 4726722 23 Years M 2/1/2005 2/9/2005 7/25/2005 166 PER Strattera Attention Deficit/Hyperactivity Disorder Dysgeusia, Nausea, Testicular Pain
5784939 4640018     M 1/3/2005 3/28/2005 84 PER Strattera Nausea, Somnolence
5784949 4640020 29 Years M 1/4/2005 1/4/2005 3/28/2005 83 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Jittery
5784953 4640021 9 Years M 1/1/2004 1/4/2005 3/28/2005 83 OT PER Strattera Constipation, Decreased Appetite, Dysgeusia, Food Aversion, Middle Insomnia, Psychomotor Hyperactivity, Somnolence, Weight Decreased
5785120 4640025 19 Years M 1/3/2005 1/4/2005 3/28/2005 83 PER Strattera Asthenia, Fatigue, Irritability
5785124 4640026 6 Years F 1/4/2005 3/28/2005 83 PER Strattera Retching
5785127 4640027 11 Years M 1/1/2004 1/3/2005 3/28/2005 84 MD PER Strattera Pollakiuria, Thirst
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5785129 4640028 13 Years M 1/1/2004 1/3/2005 3/28/2005 84 MD PER Strattera Pollakiuria, Thirst
5785133 4640032 57 Years M 12/1/2004 1/4/2005 3/28/2005 83 PER Strattera Anorexia, Body Temperature Increased, Chromaturia, Constipation, Dizziness, Dry Mouth, Dysuria, Fatigue, Hot Flush, Hyperhidrosis, Hypersomnia, Urinary Incontinence, Vomiting
5785136 4640034 18 Years M 12/1/2004 1/4/2005 3/28/2005 83 MD PER Strattera Migraine
5785139 4640491 9 Years M 1/28/2005 3/28/2005 59 PER Strattera Disturbance in Attention, Personality Disorder
5785141 4640493     F 1/28/2005 3/28/2005 59 PER Strattera Hirsutism
5785143 4640496 6 Years M 1/31/2005 3/28/2005 56 PER Strattera Abnormal Behaviour, Anger, Decreased Appetite, Oppositional Defiant Disorder
5785143 4726719 6 Years M 4/1/2005 5/16/2005 7/25/2005 70 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anger, Decreased Appetite, Drug Ineffective, Mood Swings, Oppositional Defiant Disorder
5785145 4640498     M 1/31/2005 3/28/2005 56 PER Strattera Drug Screen Positive
5785149 4640500 43 Years M 1/1/2005 1/31/2005 3/28/2005 56 PER Strattera Diarrhoea, Headache, Nausea, Pain, Pyrexia
5785151 4640501     F 1/27/2005 1/31/2005 3/28/2005 56 PER Strattera Constipation, Mood Swings
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5785154 4640504     F 1/25/2005 1/31/2005 3/28/2005 56 PER Strattera Insomnia, Peripheral Coldness, Pollakiuria, Pruritus
5785157 4640506 15 Years F 1/30/2005 1/31/2005 3/28/2005 56 PER Strattera Disturbance in Attention, Dizziness, Fatigue
5785159 4640507 21 Years M 1/31/2005 3/28/2005 56 PER Strattera Eczema, Rash
5785162 4640512 42 Years M 11/1/2004 2/1/2005 3/28/2005 55 MD PER Strattera Drug Ineffective, Fatigue, Feeling Cold, Feeling Hot, Heart Rate Increased
5785460 4637043 15 Years F 12/1/2004 3/28/2005 117 MD PER Strattera Blood Pressure Increased, Heart Rate Abnormal
5785465 4637045 14 Years M 1/1/2004 12/10/2004 3/28/2005 108 OT PER Strattera Inappropriate Affect
5785467 4637078 10 Years F 12/10/2004 3/28/2005 108 PER Strattera Retching
5785574 4642162 9 Years M 4/1/2005 4/20/2005 19 MD EXP Strattera Convulsion Other
5785574 4723857 9 Years M 7/1/2005 7/21/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Convulsion, Crying, Disorientation, Dizziness, Drooling, Dyskinesia, Electrocardiogram QT Prolonged, Hyperhidrosis, Pyrexia, Urinary Incontinence Other
5785589 4642164 14 Years M 3/1/2005 4/7/2005 4/20/2005 13 MD EXP Strattera Abdominal Pain, Anorexia, Aspartate Aminotransferase Increased, Jaundice, Nausea, Somnolence, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5786173 4642872 10 Years M 4/4/2005 4/20/2005 16 OT EXP Strattera Burning Sensation, Pharmaceutical Product Complaint Other
5786177 4642873 8 Years M 1/18/2005 4/5/2005 4/20/2005 15 PH EXP Strattera Chest Pain Other
5786177 4686744 8 Years M 1/18/2005 5/25/2005 6/6/2005 12 PH EXP Strattera Chest Pain, Constipation Other
5786177 4704486 8 Years M 1/18/2005 6/13/2005 6/28/2005 15 MD EXP Strattera Chest Pain, Constipation, Discomfort, Dyspepsia Other
5786184 4642874 11 Years M 3/10/2005 3/31/2005 4/20/2005 20 EXP Strattera Depression Suicidal, Suicide Attempt Life-Threatening
5786184 4658747 11 Years M 3/10/2005 4/4/2005 5/9/2005 35 EXP Strattera Depression Suicidal, Suicide Attempt Life-Threatening
5789485 4648571 14 Years M 4/11/2005 4/27/2005 16 MD EXP Strattera Lethargy, Malaise, Nausea, Weight Increased Other
5789496 4646779 17 Years M 4/1/2005 4/26/2005 OT DIR Strattera Alcohol Use, Hepatic Enzyme Increased, Jaundice, Nausea, Ocular Icterus, Pruritus, Stomach Discomfort, Vomiting Other
5789754 4648344 13 Years M 4/8/2005 4/27/2005 19 EXP Strattera Diabetes Mellitus Insulin-Dependent Hospitalization - Initial or Prolonged
5789754 4681870 13 Years M 5/18/2005 6/2/2005 15 EXP Strattera Diabetes Mellitus Insulin-Dependent Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5789754 4692267 13 Years M 5/25/2005 6/16/2005 22 MD EXP Strattera Diabetes Mellitus Insulin-Dependent Hospitalization - Initial or Prolonged
5789754 4954764 13 Years M 3/2/2006 3/22/2006 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Diabetes Mellitus Insulin-Dependent, Pollakiuria, Thirst Hospitalization - Initial or Prolonged
5789814 4648782 12 Years F 4/11/2005 4/27/2005 16 MD EXP Strattera Alpha-1 Anti-Trypsin Increased, Antinuclear Antibody Positive, Biopsy Liver Abnormal, Hepatic Fibrosis, Hepatic Steatosis, Hepatitis Acute Hospitalization - Initial or Prolonged
5789814 4650617 12 Years F 4/11/2005 4/29/2005 18 EXP Strattera Hepatic Steatosis, Hepatitis Acute Hospitalization - Initial or Prolonged
5789814 4725206 12 Years F 7/5/2005 7/25/2005 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatic Steatosis, Hepatitis Acute, Hepatocellular Damage, Weight Decreased Hospitalization - Initial or Prolonged
5789814 5044989 12 Years F 6/15/2006 7/5/2006 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Alpha-1 Anti-Trypsin Increased, Antinuclear Antibody Increased, Diarrhoea, Hepatic Steatosis, Hepatitis Acute, Hepatocellular Damage, Weight Decreased Hospitalization - Initial or Prolonged
5789818 4648808 13 Years M 1/23/2005 4/18/2005 4/27/2005 9 MD EXP Atomoxetine Abdominal Pain, Appendicitis, Headache, Post Procedural Pain, Specific Gravity Urine Increased, Urine Ketone Body Present Hospitalization - Initial or Prolonged
5789833 4649153 15 Years M 4/6/2005 4/27/2005 21 MD EXP Strattera Aspartate Aminotransferase Increased, Blood Bilirubin Increased
5789836 4649155 20 Years M 4/12/2005 4/27/2005 15 OT EXP Strattera Hepatic Enzyme Increased
5789838 4649156 16 Years M 4/11/2005 4/27/2005 16 MD EXP Strattera Alanine Aminotransferase Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5789838 4686556 16 Years M 5/17/2005 6/7/2005 21 OT EXP Strattera Alanine Aminotransferase Increased
5789843 4649154 57 Years M 8/30/2004 4/7/2005 4/27/2005 20 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5789843 4686951 57 Years M 8/30/2004 5/23/2005 6/8/2005 16 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Albumin Decreased, Liver Function Test Abnormal, Prothrombin Time Shortened
5789843 4690222 57 Years M 8/30/2004 5/23/2005 6/13/2005 21 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Prothrombin Time Shortened
5789850 4649160 11 Years M 4/12/2005 4/27/2005 15 MD EXP Strattera Alanine Aminotransferase Increased Other
5789891 4648949 9 Years M 2/1/2005 4/6/2005 4/27/2005 21 MD EXP Strattera Aspartate Aminotransferase Increased, Bronchitis
5791712 4578034 13 Years M 8/19/2004 8/31/2004 1/27/2005 149 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Somnolence
5791713 4581297 16 Years M 8/20/2004 1/27/2005 160 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Dyspepsia, Fear, Oesophagitis
5791974 4652046     M 2/5/2005 5/2/2005 MD DIR Strattera Cerebrovascular Accident, Dysarthria, Ear Pain, Headache, Hemiparesis, Vasospasm Disability, Hospitalization - Initial or Prolonged
5792531 4650620 11 Years F 4/11/2005 4/29/2005 18 EXP Strattera Arthralgia, Autoimmune Hepatitis, Hepatic Fibrosis, Spleen Palpable, Weight Decreased Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5792531 4725208 11 Years F 7/5/2005 7/25/2005 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Arthralgia, Autoimmune Hepatitis, Hepatic Fibrosis, Weight Decreased Other
5792531 5044984 11 Years F 6/15/2006 7/5/2006 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Arthralgia, Autoimmune Hepatitis, Blood Albumin Decreased, Chronic Hepatitis, Coagulopathy, Fatigue, Hepatic Fibrosis, Hepatitis Acute, Liver Palpable Subcostal, Prothrombin Time Prolonged, Pyrexia, Weight Decreased Other
5792531 5499298 11 Years F 10/1/2007 10/24/2007 23 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Arthralgia, Autoimmune Hepatitis, Blood Immunoglobulin G Increased, Coagulopathy, Condition Aggravated, Hepatic Fibrosis, Liver Injury, Liver Palpable Subcostal, Pyrexia, Spleen Palpable, Weight Decreased Other
5795485 4639739 38 Years M 1/21/2005 3/28/2005 66 OT PER Strattera Libido Decreased, Testicular Pain, Urinary Hesitation
5795490 4639740 26 Years M 1/19/2005 3/28/2005 68 OT PER Strattera Sexual Dysfunction
5795494 4639741 35 Years M 1/18/2005 3/28/2005 69 MD PER Strattera Anger
5795496 4639742 9 Years M 1/25/2005 3/28/2005 62 MD PER Strattera Painful Erection
5795496 4726718 9 Years M 3/8/2005 7/25/2005 139 MD PER Strattera Attention Deficit/Hyperactivity Disorder Painful Erection
5795499 4639743     F 1/20/2005 3/28/2005 67 OT PER Strattera Palpitations, Pharyngitis Streptococcal
5795524 4639744 9 Years F 1/22/2005 3/28/2005 65 PER Strattera Anxiety, Feeling Abnormal, Nervousness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5795529 4639745 13 Years F 5/1/2004 1/25/2005 3/28/2005 62 PER Strattera Choking, Dysphagia
5795532 4639746 10 Years M 1/1/2004 1/22/2005 3/28/2005 65 PER Strattera Change In Sustained Attention, Heart Rate Increased, Hyperhidrosis, Psychomotor Hyperactivity, Somnolence
5795537 4639747 43 Years M 1/25/2005 3/28/2005 62 OT PER Strattera Attention Deficit/Hyperactivity Disorder Peripheral Coldness, Skin Discolouration
5795541 4639748 12 Years M 1/25/2005 3/28/2005 62 OT PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fatigue
5795659 4639729     M 1/27/2005 3/28/2005 60 PER Strattera
5795662 4639730     F 1/27/2005 1/27/2005 3/28/2005 60 PER Strattera Throat Irritation
5795664 4639731 13 Years M 1/27/2005 3/28/2005 60 PER Strattera Disturbance in Attention, Somnolence
5795668 4639732 10 Years M 1/1/2005 1/27/2005 3/28/2005 60 PER Strattera Disturbance in Attention
5795671 4639733 18 Years M 1/27/2005 3/28/2005 60 MD PER Strattera Urinary Tract Infection
5795674 4639734 40 Years F 1/1/2005 1/27/2005 3/28/2005 60 PER Strattera Anger, Anxiety, Dizziness, Excitability, Fatigue, Feeling Abnormal, Irritability, Nausea, Paraesthesia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5795677 4639735 14 Years F 10/1/2004 1/27/2005 3/28/2005 60 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Drug Ineffective
5795680 4639736 41 Years F 1/26/2005 1/27/2005 3/28/2005 60 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Disturbance in Attention, Feeling Abnormal, Lethargy, Nausea, Sedation, Somnolence
5795681 4639737 18 Years M 1/27/2005 3/28/2005 60 PER Strattera Attention Deficit/Hyperactivity Disorder Communication Disorder, Depressed Mood, Depression, Stomach Discomfort
5795683 4639738 29 Years F 1/1/2005 1/27/2005 3/28/2005 60 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Nausea
5795695 4639575 7 Years F 2/5/2005 2/7/2005 3/28/2005 49 CN PER Strattera Abdominal Pain Upper, Chest Pain, Heart Rate Increased, Urticaria
5795695 4726729 7 Years F 2/5/2005 3/24/2005 7/25/2005 123 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anxiety, Chest Pain, Heart Rate Increased, Urticaria
5795697 4639576     M 2/8/2005 3/28/2005 48 MD PER Strattera Mania, Pressure of Speech, Thinking Abnormal
5795699 4639577 39 Years F 2/1/2005 2/7/2005 3/28/2005 49 MD PER Strattera Chills, Feeling Abnormal, Insomnia, Paraesthesia, Rhinorrhoea, Thinking Abnormal
5795700 4639579 8 Years M 2/8/2005 3/28/2005 48 MD PER Strattera Anger
5795701 4639580 10 Years M 2/9/2005 3/28/2005 47 PH PER Strattera Dysgeusia, Dysphagia, Retching, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5795706 4639591     F 2/8/2005 3/28/2005 48 CN PER Strattera Cognitive Disorder, Feeling Abnormal
5795706 4726728 13 Years F 3/8/2005 7/25/2005 139 PER Strattera Attention Deficit/Hyperactivity Disorder Cognitive Disorder, Disturbance in Attention, Feeling Abnormal
5795707 4639592     F 1/31/2005 2/8/2005 3/28/2005 48 CN PER Strattera Memory Impairment, Uterine Dilation and Curettage
5795709 4639593 40 Years F 2/8/2005 3/28/2005 48 CN PER Strattera Change In Sustained Attention, Memory Impairment
5795710 4639595 8 Years M 2/8/2005 3/28/2005 48 CN PER Strattera Drug Ineffective, Psychomotor Hyperactivity, Weight Increased
5795713 4639597     M 2/8/2005 3/28/2005 48 MD PER Strattera Dyskinesia
5795714 4639598 10 Years M 2/9/2005 3/28/2005 47 CN PER Strattera Drug Ineffective, Weight Increased
5795715 4639599 12 Years F 1/1/2004 2/9/2005 3/28/2005 47 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Drug Ineffective, Educational Problem
5795716 4639600 13 Years M 1/31/2005 2/9/2005 3/28/2005 47 CN PER Strattera Attention Deficit/Hyperactivity Disorder Rash
5795718 4639601 6 Years M 9/5/2003 2/7/2005 3/28/2005 49 MD PER Strattera Muscle Spasms, Urinary Retention
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5795719 4639602 8 Years M 2/1/2005 2/8/2005 3/28/2005 48 MD PER Strattera Abdominal Pain, Crying, Muscle Spasms, Urinary Retention
5795822 4639603     M 12/28/2004 3/28/2005 90 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite
5795824 4639605     M 12/28/2004 3/28/2005 90 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite
5795827 4639608 57 Years M 12/28/2004 3/28/2005 90 MD PER Strattera Anxiety, Drug Withdrawal Syndrome, Headache, Hyperhidrosis
5795829 4639609     F 12/29/2004 3/28/2005 89 PER Strattera Retching
5795844 4639610 39 Years F 12/29/2004 12/29/2004 3/28/2005 89 PER Strattera Fatigue, Hypersomnia
5795847 4639613     M 12/27/2004 12/29/2004 3/28/2005 89 PER Strattera Chromaturia, Somnolence
5795849 4639614 8 Years M 10/1/2004 12/30/2004 3/28/2005 88 PER Strattera Abdominal Pain Upper, Decreased Appetite, Dyspepsia, Fatigue, Pallor, Vomiting, Weight Decreased
5795850 4639615 10 Years F 12/30/2004 3/28/2005 88 PER Strattera
5795854 4639616 8 Years M 1/1/2004 12/30/2004 3/28/2005 88 PH PER Strattera Abnormal Behaviour, Anxiety, Drug Ineffective, Irritability
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5795857 4639618 38 Years M 12/30/2004 3/28/2005 88 PH PER Strattera Drug Ineffective, Psychomotor Hyperactivity
5795858 4639749 7 Years M 1/21/2005 3/28/2005 66 PER Strattera Abdominal Pain Upper, Drug Ineffective, Hallucination (Auditory), Headache, Psychomotor Hyperactivity
5795862 4639750 16 Years M 1/21/2005 1/24/2005 3/28/2005 63 PER Strattera Diarrhoea, Drug Screen Positive, Malaise, Vomiting
5795888 4639751 61 Years F 1/24/2005 3/28/2005 63 PER Strattera Anxiety, Decreased Appetite, Dry Mouth, Dysgeusia, Weight Decreased
5795891 4639752     F 1/19/2005 3/28/2005 68 MD PER Strattera Dysuria
5795910 4639753 32 Years F 1/24/2005 3/28/2005 63 PER Strattera Anorexia, Blood Pressure Increased, Headache, Insomnia, Paranoia, Weight Decreased
5795911 4639754 12 Years 1/4/2005 3/28/2005 83 OT PER Strattera Drug Ineffective, Middle Insomnia
5795915 4639755 15 Years M 1/24/2005 3/28/2005 63 PH PER Strattera
5795916 4639756     M 1/21/2005 3/28/2005 66 MD PER Strattera Urinary Retention
5795920 4639757     M 1/21/2005 3/28/2005 66 MD PER Strattera Tachycardia Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5795921 4639758 12 Years 1/21/2005 3/28/2005 66 MD PER Strattera Tachycardia Other
5795938 4639634 12 Years 12/9/2004 3/28/2005 109 PER Strattera Affect Lability
5795944 4639636 11 Years M 12/1/2004 12/20/2004 3/28/2005 98 PER Strattera Decreased Appetite, Drug Ineffective, Increased Appetite, Pallor, Stomach Discomfort, Vomiting
5795947 4639637     M 12/17/2004 3/28/2005 101 PH PER Strattera Decreased Appetite, Discomfort, Thirst, Urinary Hesitation
5795948 4639638 56 Years M 12/1/2004 12/20/2004 3/28/2005 98 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Decreased Appetite, Drug Ineffective, Dry Mouth, Feeling Cold, Mood Swings, Paraesthesia
5795951 4639639 7 Years M 12/20/2004 3/28/2005 98 PER Strattera Attention Deficit/Hyperactivity Disorder Hypersomnia, Muscle Twitching, Somnolence, Stomach Discomfort
5795954 4639640 9 Years M 12/20/2004 3/28/2005 98 PER Strattera Decreased Appetite, Pallor, Skin Discolouration
5795955 4639642 45 Years M 12/18/2004 12/20/2004 3/28/2005 98 PER Strattera Constipation, Insomnia, Paraesthesia, Psychomotor Hyperactivity, Stomach Discomfort
5795957 4639643 14 Years M 12/20/2004 3/28/2005 98 PER Strattera Abdominal Pain Upper, Feeling Abnormal
5795960 4639644 9 Years M 12/20/2004 3/28/2005 98 PER Strattera
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5795961 4639645 13 Years M 12/20/2004 3/28/2005 98 PER Strattera Chills, Fatigue, Stomach Discomfort
5796217 4655387 20 Years F 4/18/2005 5/5/2005 17 OT EXP Strattera Completed Suicide Death
5796217 4713671 24 Years F 4/27/2005 6/23/2005 7/13/2005 20 OT EXP Strattera Intentional Self-Injury, Overdose, Suicide Attempt Hospitalization - Initial or Prolonged, Other
5796221 4655388 8 Years 4/15/2005 5/5/2005 20 MD EXP Strattera Hepatic Function Abnormal
5796221 4687158 12 Years M 5/19/2005 6/7/2005 19 MD EXP Strattera Blood Alkaline Phosphatase Increased, Liver Function Test Abnormal
5796411 4655417 17 Years M 4/1/2005 4/15/2005 5/5/2005 20 MD EXP Strattera Mitral Valve Prolapse Other
5796413 4655418 15 Years M 3/1/2005 4/14/2005 5/5/2005 21 MD EXP Strattera Loss of Consciousness Other
5796422 4655421 5 Years M 4/1/2005 4/20/2005 5/5/2005 15 EXP Strattera Abnormal Behaviour, Self-Injurious Ideation Other
5796424 4655422 13 Years M 12/1/2004 4/14/2005 5/5/2005 21 MD EXP Strattera Jaundice
5796424 4703916 15 Years M 12/1/2004 6/10/2005 6/28/2005 18 MD EXP Strattera Abdominal Discomfort, Bilirubin Conjugated Increased, Blood Bilirubin Increased, Jaundice
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5796425 4655423 10 Years M 4/14/2005 5/5/2005 21 MD EXP Strattera Convulsion, Pyrexia Other
5796425 4674507 10 Years M 5/11/2005 5/24/2005 13 MD EXP Strattera Confusional State, Convulsion, Loss of Consciousness, Postictal State, Pyrexia, Tonic Clonic Movements Other
5796426 4655424     F 4/18/2005 5/5/2005 17 OT EXP Strattera Agitation, Anger, Condition Aggravated, Intentional Self-Injury Other
5796426 4697542     F 3/2/2005 6/8/2005 6/21/2005 13 OT EXP Strattera Agitation, Anger, Intentional Self-Injury, Thermal Burn Hospitalization - Initial or Prolonged, Other
5796456 4655462 15 Years F 1/1/2005 4/15/2005 5/5/2005 20 MD EXP Strattera Blood Bilirubin Increased, Blood Bilirubin Unconjugated Increased
5796485 4655463 9 Years F 4/18/2005 4/19/2005 5/5/2005 16 OT EXP Strattera Coordination Abnormal, Depressed Level of Consciousness, Difficulty in Walking, Dizziness, Lethargy Other
5796485 4674505 9 Years F 4/18/2005 5/9/2005 5/24/2005 15 OT EXP Strattera Cold Sweat, Coordination Abnormal, Difficulty in Walking, Dizziness, Eye Disorder, Feeling Abnormal, Gait Disturbance, Hypertension, Lethargy, Livedo Reticularis, Loss of Consciousness, Tachycardia Other
5796485 4687164 9 Years F 4/18/2005 5/19/2005 6/7/2005 19 OT EXP Strattera Blood Glucose Increased, Cold Sweat, Coordination Abnormal, Difficulty in Walking, Dizziness, Feeling Abnormal, Feeling Cold, Hypertension, Lethargy, Livedo Reticularis, Tachycardia, Unresponsive to Verbal Stimuli Other
5796485 4737827 9 Years F 4/18/2005 7/18/2005 8/3/2005 16 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Increased, Cold Sweat, Coordination Abnormal, Difficulty in Walking, Dizziness, Feeling Abnormal, Feeling Cold, Hypertension, Lethargy, Livedo Reticularis, Loss of Consciousness, Tachycardia Other
5796518 4655587 14 Years M 2/1/2004 4/20/2005 5/5/2005 15 MD EXP Strattera Platelet Count Decreased, White Blood Cell Count Decreased Hospitalization - Initial or Prolonged, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5797309 4655847 11 Years F 1/26/2005 4/18/2005 5/5/2005 17 MD EXP Strattera Abdominal Pain, Dizziness, Headache, Malaise, Urticaria Other
5797314 4655856 10 Years M 4/17/2005 4/18/2005 5/5/2005 17 MD EXP Strattera Appendicitis Hospitalization - Initial or Prolonged
5797314 4681844 10 Years M 4/17/2005 5/13/2005 6/2/2005 20 MD EXP Strattera Appendicitis Hospitalization - Initial or Prolonged
5797320 4655858 15 Years M 4/6/2005 4/20/2005 5/5/2005 15 MD EXP Strattera Blood Glucose Decreased, Fall, Loss of Consciousness Other
5797475 4655881 13 Years M 10/9/2004 4/18/2005 5/5/2005 17 OT EXP Strattera Abnormal Behaviour, Blood Alkaline Phosphatase Increased, Decreased Appetite, Insomnia
5797476 4655883 8 Years M 4/13/2005 5/5/2005 22 OT EXP Strattera Abdominal Pain, Blood Alkaline Phosphatase Increased
5797478 4655884 2 Years M 3/1/2005 4/14/2005 5/5/2005 21 MD EXP Strattera Hepatitis Other
5797478 4665145 2 Years M 3/1/2005 4/29/2005 5/17/2005 18 MD EXP Strattera Acholia, Anorexia, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Lactate Dehydrogenase Increased, Choluria, Chromaturia, Lymphocyte Count Increased, Nausea, Vomiting Other
5797478 4698444 2 Years M 3/1/2005 6/8/2005 6/21/2005 13 MD EXP Strattera Acholia, Anorexia, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Lactate Dehydrogenase Increased, Choluria, Chromaturia, Dehydration, Lymphocyte Percentage Increased, Nausea, Vomiting Other
5797478 4713930 2 Years M 3/1/2005 6/24/2005 7/13/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Acholia, Anorexia, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Lactate Dehydrogenase Increased, Choluria, Chromaturia, Dehydration, Hepatomegaly, Lymphocyte Percentage Abnormal, Nausea, Vomiting Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5797478 4791171 2 Years M 3/1/2005 9/21/2005 10/5/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Acholia, Anorexia, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Lactate Dehydrogenase Increased, Choluria, Chromaturia, Dehydration, Hepatomegaly, Lymphocyte Percentage Increased, Nausea, Poisoning, Vomiting Other
5797478 4806939 2 Years M 3/1/2005 10/4/2005 10/19/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Acholia, Alanine Aminotransferase Increased, Anorexia, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Lactate Dehydrogenase Increased, Choluria, Chromaturia, Culture Stool Positive, Dehydration, Hepatomegaly, Lymphocyte Percentage Increased, Nausea, Platelet Count Increased, Poisoning, Vomiting Other
5797719 4654475     F 5/5/2005 MD DIR Strattera Hypothyroidism Other
5798497 4637837 5 Years M 1/1/2003 2/4/2005 3/28/2005 52 PER Strattera Drug Ineffective, Psychomotor Hyperactivity
5798498 4637838 12 Years M 2/4/2005 3/28/2005 52 OT PER Strattera Abdominal Pain Upper, Depressed Mood, Diarrhoea, Hot Flush, Weight Decreased
5798498 4726725 11 Years M 12/13/2004 3/15/2005 7/25/2005 132 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Depressed Mood, Diarrhoea, Hot Flush, Muscle Spasms, Nausea, Vomiting, Weight Decreased
5798500 4637839 11 Years F 2/4/2005 3/28/2005 52 MD PER Strattera Abnormal Behaviour, Drug Ineffective, Fatigue, Sleep Disorder
5798502 4637840     M 2/22/2005 3/28/2005 34 MD PER Strattera
5798503 4637841     M 2/22/2005 3/28/2005 34 MD PER Strattera
5798505 4637842 11 Years F 2/4/2005 3/28/2005 52 MD PER Strattera Agitation, Psychomotor Hyperactivity, Restlessness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5798508 4637844 16 Years M 2/4/2005 3/28/2005 52 MD PER Strattera
5798510 4637845 12 Years M 2/4/2005 3/28/2005 52 PER Strattera Aggression, Decreased Appetite, Dizziness, Masked Facies, Mood Swings, Nausea, Psychiatric Symptom, Somnolence
5798511 4637846 10 Years M 12/1/2004 2/2/2005 3/28/2005 54 OT PER Strattera Dyskinesia, Pneumonia
5798512 4637847 12 Years 2/2/2005 3/28/2005 54 MD PER Strattera Overdose, Suicidal Ideation
5798579 4636653 55 Years M 12/7/2004 3/28/2005 111 PER Strattera Dysuria, Urinary Hesitation
5798585 4636656 55 Years F 1/1/2004 12/7/2004 3/28/2005 111 PER Strattera Anger, Excitability, Fatigue
5798587 4636658 3 Years F 12/7/2004 12/7/2004 3/28/2005 111 PER Strattera
5798589 4636660     M 12/1/2004 12/7/2004 3/28/2005 111 PER Strattera Feeling Abnormal, Flatulence, Heart Rate Increased, Libido Increased, Respiratory Sighs
5798590 4636662 48 Years F 12/7/2004 3/28/2005 111 PER Strattera
5798592 4636663 7 Years M 1/1/2004 12/7/2004 3/28/2005 111 PER Strattera Abnormal Behaviour, Drug Ineffective, Fatigue, Tic
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5798593 4636665     F 12/7/2004 3/28/2005 111 PER Strattera Anxiety, Sexual Dysfunction
5798594 4636667 8 Years M 12/7/2004 3/28/2005 111 MD PER Strattera Hallucination
5798597 4636669 68 Years F 12/7/2004 3/28/2005 111 PER Strattera Blood Pressure Increased, Disturbance in Attention, Dry Mouth, Dysgeusia, Memory Impairment, Rash, Rash Erythematous, Rash Pruritic, Seasonal Allergy, Throat Irritation
5798600 4636672 5 Years M 12/8/2004 12/8/2004 3/28/2005 110 PER Strattera Malaise, Vomiting
5798604 4637018 11 Years M 12/2/2004 12/2/2004 3/28/2005 116 PER Strattera Retching
5798606 4637027 27 Years M 11/30/2004 12/2/2004 3/28/2005 116 PER Strattera Erectile Dysfunction, Indifference, Irritability, Libido Decreased
5798607 4637028     F 11/29/2004 3/28/2005 119 MD PER Strattera Nausea, Suicidal Ideation
5798608 4637029 62 Years M 10/1/2004 11/30/2004 3/28/2005 118 CN PER Strattera Asthenia, Dizziness, Hyperhidrosis
5798610 4637030 9 Years M 12/2/2004 3/28/2005 116 PER Strattera Night Sweats
5798611 4637031 63 Years F 12/2/2004 3/28/2005 116 PER Strattera Chills, Erythema, Feeling Hot, Flushing
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5798612 4637032 56 Years M 11/1/2004 2/21/2005 3/28/2005 35 PER Strattera Kidney Infection, Urinary Hesitation
5798613 4637033 26 Years M 12/2/2004 3/28/2005 116 MD PER Strattera Testicular Pain
5798614 4637034 43 Years F 11/1/2004 12/3/2004 3/28/2005 115 PER Strattera Depressed Mood, Excitability
5798617 4637037 7 Years M 11/1/2004 12/2/2004 3/28/2005 116 PER Strattera Aggression, Erythema, Fatigue, Insomnia, Psychomotor Hyperactivity
5799769 4637764 7 Years M 12/1/2004 1/17/2005 3/28/2005 70 PER Strattera Abdominal Pain Upper, Aggression, Apathy, Disturbance in Attention, Intermittent Explosive Disorder, Social Avoidant Behaviour
5799770 4637774 44 Years F 1/17/2005 3/28/2005 70 PER Strattera Feeling Abnormal, Headache
5799771 4637775 16 Years M 1/18/2005 3/28/2005 69 MD PER Strattera Priapism
5799773 4637776 7 Years F 1/18/2005 3/28/2005 69 PER Strattera Abnormal Behaviour, Drug Ineffective
5799791 4637777 8 Years M 1/18/2005 3/28/2005 69 PER Strattera Abnormal Behaviour, Mood Swings
5799792 4637778 6 Years F 1/18/2005 3/28/2005 69 PER Strattera Anxiety, Dizziness, Heart Rate Increased Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5799793 4637780 8 Years M 1/18/2005 3/28/2005 69 PER Strattera Abnormal Behaviour
5799794 4637782 45 Years F 1/18/2005 3/28/2005 69 PER Strattera Asthenia, Decreased Appetite, Headache, Nausea
5799796 4637789 27 Years F 1/18/2005 3/28/2005 69 PER Strattera Drug Ineffective, Erythema, Oedema Peripheral, Paranasal Sinus Hypersecretion, Pruritus, Sleep Disorder
5799808 4637790     M 1/1/2005 1/17/2005 3/28/2005 70 PER Strattera Drug Ineffective, Feeling Abnormal
5799808 4726716     M 1/1/2005 1/17/2005 7/25/2005 189 PER Strattera Disturbance in Attention Drug Ineffective, Feeling Abnormal
5799810 4637848 9 Years M 12/30/2004 3/28/2005 88 PER Strattera Protein Urine
5799813 4637849 32 Years M 11/1/2004 12/30/2004 3/28/2005 88 PER Strattera Ejaculation Disorder, Paraesthesia, Testicular Pain, Testicular Swelling
5799814 4637850 15 Years F 12/25/2004 12/30/2004 3/28/2005 88 MD PER Strattera Hypoaesthesia, Hypoaesthesia Oral
5799815 4637854     M 12/30/2004 3/28/2005 88 PER Strattera Testicular Disorder
5799817 4637855 40 Years M 1/1/2004 12/30/2004 3/28/2005 88 MD PER Strattera Dysuria, Penis Disorder, Testicular Atrophy
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5799818 4637856 17 Years M 12/1/2004 1/3/2005 3/28/2005 84 PER Strattera Feeling Abnormal, Vomiting
5799819 4637857     M 1/3/2005 3/28/2005 84 PER Strattera Jaw Fracture
5799821 4637858 17 Years M 1/3/2005 3/28/2005 84 PER Strattera Abdominal Pain, Constipation, Urticaria
5799822 4637859 49 Years M 1/3/2005 3/28/2005 84 PER Strattera Constipation, Dysuria, Insomnia, Sexual Dysfunction, Urinary Retention
5799823 4637860     F 1/1/2004 1/3/2005 3/28/2005 84 PER Strattera Malaise
5799824 4637305 9 Years F 11/23/2004 3/28/2005 125 CN PER Strattera Abdominal Pain Upper, Aggression, Anger, Anxiety, Insomnia, Mood Swings
5799826 4637306 32 Years M 11/22/2004 3/28/2005 126 MD PER Strattera Dependence
5799828 4637307 12 Years M 11/24/2004 12/8/2004 3/28/2005 110 MD PER Strattera Pupils Unequal
5799830 4637308 9 Years M 11/24/2004 3/28/2005 124 PER Strattera Feeling Abnormal, Heart Rate Increased, Nausea, Vomiting
5799831 4637309 50 Years F 11/24/2004 3/28/2005 124 PER Strattera Bladder Disorder, Chills, Disturbance In Sexual Arousal, Dry Mouth, Libido Decreased, Nausea, Weight Decreased, Yawning
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5799833 4637310 49 Years M 11/23/2004 3/28/2005 125 OT PER Strattera Anxiety, Insomnia, Prostatic Pain, Testicular Pain, Urinary Retention
5799836 4637311 57 Years M 11/23/2004 11/24/2004 3/28/2005 124 PER Strattera Feeling Hot, Flushing, Hyperhidrosis
5799838 4637312 33 Years F 11/11/2004 11/24/2004 3/28/2005 124 PER Strattera Tinnitus
5799839 4637313     M 11/24/2004 3/28/2005 124 PER Strattera Chills, Dizziness, Fatigue, Feeling Abnormal
5799841 4637314 41 Years F 11/1/2004 11/24/2004 3/28/2005 124 PER Strattera Blood Glucose Decreased, Dizziness, Drug Ineffective, Fall
5799848 4637329 9 Years M 12/2/2004 3/28/2005 116 MD PER Strattera Tic
5799849 4637330 7 Years M 12/2/2004 3/28/2005 116 PER Strattera Abdominal Pain Upper, Dizziness, Feeling Abnormal
5799913 4637331 12 Years 12/3/2004 3/28/2005 115 PER Strattera Anger, Nausea
5799914 4637332     M 12/3/2004 3/28/2005 115 PER Strattera Ejaculation Disorder, Genital Disorder Male, Penile Discharge, Sexual Dysfunction
5799915 4637333 7 Years M 12/3/2004 3/28/2005 115 PER Strattera Abnormal Behaviour, Aggression
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5799917 4637338 10 Years F 12/4/2004 12/6/2004 3/28/2005 112 PER Strattera Erythema, Pruritus, Swelling Face, Urticaria
5799918 4637339 60 Years F 12/6/2004 3/28/2005 112 PER Strattera Apathy, Somnolence
5799919 4637341 12 Years M 12/6/2004 3/28/2005 112 PER Strattera Vein Disorder
5799920 4637344 25 Years F 12/4/2004 12/6/2004 3/28/2005 112 PER Strattera Anxiety, Heart Rate Increased, Insomnia, Nausea, Vomiting
5799921 4637345 34 Years M 11/1/2004 2/10/2005 3/28/2005 46 MD PER Strattera Tachycardia, Tremor
5799921 4726711 34 Years M 11/1/2004 2/11/2005 7/25/2005 164 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Tachycardia, Tremor
5800608 4636600     M 12/8/2004 3/28/2005 110 MD PER Strattera Penile Pain, Testicular Pain
5800614 4636607 6 Years F 12/13/2004 3/28/2005 105 PER Strattera Abdominal Pain Upper, Decreased Appetite, Headache, Rash
5800616 4636609 8 Years F 12/13/2004 3/28/2005 105 PER Strattera Abdominal Pain Upper, Cardiac Disorder, Decreased Appetite, Headache, Rash
5800617 4636613 16 Years F 12/8/2004 12/8/2004 3/28/2005 110 MD PER Strattera Panic Attack
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5800622 4636614 14 Years 12/8/2004 3/28/2005 110 MD PER Strattera Panic Attack
5800701 4636620 8 Years F 12/9/2004 3/28/2005 109 PER Strattera Retching, Somnolence
5800706 4636623 23 Years F 12/9/2004 12/9/2004 3/28/2005 109 PER Strattera Feeling Abnormal, Stomach Discomfort
5800710 4636625 9 Years M 12/9/2004 3/28/2005 109 PER Strattera Dysuria, Headache
5800715 4636626 47 Years M 12/9/2004 12/9/2004 3/28/2005 109 PER Strattera Dizziness, Feeling Abnormal, Feeling Jittery, Hyperhidrosis
5800730 4637325 11 Years F 8/1/2004 11/22/2004 3/28/2005 126 MD PER Strattera Hallucination
5800742 4636629 47 Years F 12/5/2004 12/7/2004 3/28/2005 111 PER Strattera Decreased Appetite, Excitability
5800743 4636636 49 Years F 12/8/2004 12/8/2004 3/28/2005 110 PER Strattera Asthenia, Nasopharyngitis, Nausea, Nervousness
5800745 4636638 9 Years M 12/8/2004 3/28/2005 110 MD PER Strattera Obsessive-Compulsive Disorder
5800759 4636640 16 Years M 12/8/2004 3/28/2005 110 PER Strattera Drug Screen Positive, Dry Mouth, Irritability
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5800762 4636641 51 Years F 12/1/2004 12/8/2004 3/28/2005 110 PH PER Strattera Dissociation, Drug Withdrawal Syndrome, Fatigue, Nausea
5800763 4636643 34 Years M 11/1/2004 12/8/2004 3/28/2005 110 PER Strattera Prostatic Pain, Sexual Dysfunction
5800766 4636645 11 Years F 12/8/2004 3/28/2005 110 PH PER Strattera Orthodontic Procedure
5800789 4636647 37 Years F 12/1/2004 12/8/2004 3/28/2005 110 PER Strattera Abnormal Dreams, Crying, Diarrhoea, Mood Swings
5800790 4636649     12/8/2004 3/28/2005 110 PER Strattera Dysuria
5800796 4636652 13 Years M 1/1/2003 12/9/2004 3/28/2005 109 PER Strattera Anger
5800999 4638706 31 Years F 10/4/2004 3/28/2005 175 OT PER Strattera Libido Decreased, Sexual Dysfunction
5801000 4638708 10 Years F 12/1/2004 12/21/2004 3/28/2005 97 MD PER Strattera Arterial Spasm
5801001 4638710 8 Years M 1/26/2005 3/28/2005 61 CN PER Strattera Heart Rate Increased Other
5801002 4638719 50 Years M 12/10/2004 1/3/2005 3/28/2005 84 MD PER Strattera Diarrhoea, Erythema, Paraesthesia, Pruritus, Stomach Discomfort
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5801004 4638724 9 Years M 1/26/2005 3/28/2005 61 PER Strattera Attention Deficit Hyperactivity Disorder, Drug Ineffective
5801004 4727777 9 Years M 1/1/2005 1/26/2005 7/25/2005 180 PER Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder
5801005 4638727 12 Years 1/10/2005 3/28/2005 77 MD PER Strattera Acne
5801006 4638728 12 Years 1/10/2005 3/28/2005 77 MD PER Strattera Disturbance in Attention
5801007 4638731 9 Years F 1/5/2005 3/28/2005 82 MD PER Strattera Weight Increased
5801008 4638733 12 Years 1/10/2005 3/28/2005 77 MD PER Strattera Oedema Peripheral
5801009 4638735 22 Years F 1/7/2005 1/17/2005 3/28/2005 70 PER Strattera Abnormal Dreams, Feeling Abnormal, Palpitations, Urticaria
5801010 4638669     M 1/4/2005 3/28/2005 83 MD PER Strattera Genital Discharge, Testicular Atrophy, Urinary Hesitation
5801011 4638671     M 1/19/2005 3/28/2005 68 OT PER Strattera Rash Macular
5801013 4638672 8 Years M 1/17/2005 3/28/2005 70 OT PER Strattera Myokymia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5801014 4638674     M 1/24/2005 3/28/2005 63 MD PER Strattera Testicular Pain
5801015 4638687     M 1/24/2005 3/28/2005 63 MD PER Strattera Memory Impairment
5801016 4638688 12 Years 1/21/2005 3/28/2005 66 MD PER Strattera
5801017 4638689     F 1/26/2005 1/26/2005 3/28/2005 61 PER Strattera Paraesthesia
5801020 4638690 72 Years F 1/27/2005 3/28/2005 60 PER Strattera Balance Disorder, Constipation, Metabolic Disorder, Vision Blurred, Weight Decreased
5801021 4638692     F 1/1/2005 1/27/2005 3/28/2005 60 PER Strattera Anxiety, Heart Rate Increased
5801023 4638694 6 Years F 1/26/2005 3/28/2005 61 PER Strattera Stomach Discomfort, Therapeutic Response Decreased
5801041 4637897 20 Years F 1/19/2005 3/28/2005 68 PER Strattera Disturbance in Attention, Drug Ineffective, Stomach Discomfort
5801043 4637900 43 Years F 12/27/2004 2/6/2005 3/28/2005 50 PER Strattera Drug Interaction, Urine Analysis Abnormal
5801045 4637906     2/22/2005 3/28/2005 34 PER Strattera Drug Screen Positive
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5801045 4726717     2/22/2005 7/25/2005 153 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
5801046 4637907 9 Years F 1/20/2005 3/28/2005 67 OT PER Strattera Disturbance in Attention
5801049 4637908 12 Years F 1/20/2005 3/28/2005 67 PER Strattera Gastrooesophageal Reflux Disease, Retching
5801061 4637910 28 Years M 1/19/2005 1/20/2005 3/28/2005 67 PER Strattera Chills, Dysuria, Feeling Abnormal, Heart Rate Increased, Hot Flush, Hyperhidrosis, Paraesthesia, Piloerection, Prostatic Pain, Somnolence
5801062 4637912     F 1/20/2005 3/28/2005 67 PER Strattera Stomach Discomfort
5801063 4637913 12 Years M 1/20/2005 3/28/2005 67 PER Strattera Drug Ineffective
5801065 4637915 21 Years M 1/19/2005 3/28/2005 68 MD PER Strattera Suicidal Ideation
5801073 4637295 10 Years M 11/1/2004 11/24/2004 3/28/2005 124 PER Strattera Dizziness, Insomnia, Nightmare, Somnolence
5801074 4637296 88 Years F 11/29/2004 3/28/2005 119 PER Strattera Muscle Spasms
5801075 4637297 7 Years F 11/27/2004 11/29/2004 3/28/2005 119 PER Strattera Fatigue, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5801077 4637298     F 11/23/2004 11/24/2004 3/28/2005 124 PER Strattera Anxiety, Constipation, Crying, Depression, Drug Ineffective, Gastrooesophageal Reflux Disease, Hangover, Insomnia, Psychomotor Hyperactivity
5801078 4637299 10 Years F 11/29/2004 12/8/2004 3/28/2005 110 PH PER Strattera Tonsillectomy
5801082 4637300 21 Years M 8/20/2003 11/25/2004 3/28/2005 123 MD PER Strattera Drug Ineffective, Scrotal Pain, Testicular Atrophy
5801084 4637301     M 11/25/2004 3/28/2005 123 MD PER Strattera Testicular Atrophy
5801086 4637302     M 11/25/2004 3/28/2005 123 MD PER Strattera Testicular Atrophy
5801087 4637303     F 11/23/2004 3/28/2005 125 MD PER Strattera Abdominal Discomfort, Drug Ineffective, Nausea
5801088 4637304 7 Years F 11/28/2004 11/29/2004 3/28/2005 119 PER Strattera Rash Papular
5801095 4638739 12 Years 12/1/2004 3/28/2005 117 OT PER Strattera Weight Increased
5801096 4638740 12 Years 12/2/2004 3/28/2005 116 OT PER Strattera Weight Increased
5801097 4638742 12 Years 12/1/2004 3/28/2005 117 MD PER Strattera Psychomotor Hyperactivity
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5801098 4638746 20 Years M 12/8/2004 3/28/2005 110 MD PER Strattera Drug Ineffective
5801099 4638749 12 Years 12/10/2004 3/28/2005 108 MD PER Strattera Affect Lability
5801106 4638752 12 Years M 12/16/2004 3/28/2005 102 PER Strattera Dyspnoea, Feeling Abnormal, Nasal Congestion
5801107 4638754 8 Years M 12/23/2004 3/28/2005 95 PER Strattera Choking
5801110 4638756 10 Years M 1/26/2005 3/28/2005 61 MD PER Strattera Libido Increased
5801111 4638762 41 Years M 10/4/2004 3/28/2005 175 MD PER Strattera Drug Ineffective, Ejaculation Delayed, Orgasmic Sensation Decreased
5801112 4638763 28 Years F 10/4/2004 3/28/2005 175 MD PER Strattera Libido Decreased, Sexual Dysfunction
5801113 4637922 16 Years M 1/18/2005 3/28/2005 69 MD PER Strattera Priapism
5801114 4637930     M 1/18/2005 3/28/2005 69 PER Strattera Dry Throat, Rash, Rash Pruritic, Urticaria
5801116 4637934     F 1/19/2005 3/28/2005 68 MD PER Strattera Blood Cholesterol Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5801117 4637935 7 Years F 1/1/2005 1/19/2005 3/28/2005 68 PER Strattera Dysphagia, Retching
5801118 4637936 12 Years M 1/18/2005 3/28/2005 69 CN PER Strattera Amino Acid Level Abnormal
5801120 4637939 46 Years F 1/1/2005 1/19/2005 3/28/2005 68 MD PER Strattera Mania
5801121 4637940     F 1/19/2005 3/28/2005 68 PER Strattera Somnolence
5801123 4637952 6 Years F 1/15/2005 1/19/2005 3/28/2005 68 PER Strattera Cough, Nasal Congestion, Nasopharyngitis, Pyrexia
5801125 4637953 36 Years M 1/17/2005 1/19/2005 3/28/2005 68 PER Strattera Chills, Dysuria, Erectile Dysfunction
5801128 4637244 10 Years 11/30/2004 3/28/2005 118 OT PER Strattera Tic
5801129 4637245 9 Years M 11/30/2004 3/28/2005 118 MD PER Strattera Anxiety, Depression, Suicidal Ideation
5801131 4637246 38 Years F 12/1/2004 3/28/2005 117 MD PER Strattera Rash, Urticaria
5801132 4637247 25 Years F 11/29/2004 12/1/2004 3/28/2005 117 MD PER Strattera Drug Screen Positive, Nervousness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5801135 4637248 9 Years M 12/1/2004 3/28/2005 117 PER Strattera Fatigue, Pallor
5801136 4637249 15 Years M 11/29/2004 3/28/2005 119 MD PER Strattera Headache, Malaise
5801137 4637250 15 Years M 1/1/2004 2/4/2005 3/28/2005 52 MD PER Strattera White Blood Cell Count Decreased
5801139 4637251 4 Years M 12/1/2004 3/28/2005 117 MD PER Strattera Mania
5801142 4637252     M 12/1/2004 3/28/2005 117 MD PER Strattera Mania
5801143 4637253     F 12/1/2004 3/28/2005 117 MD PER Strattera Mania
5801710 4662224 13 Years M 4/1/2005 4/22/2005 5/12/2005 20 MD EXP Strattera Abdominal Tenderness, Blood Bilirubin Increased, Influenza Like Illness, Nausea
5801715 4662227 15 Years M 4/22/2005 4/22/2005 5/12/2005 20 CN EXP Strattera Abnormal Behaviour, Dissociation, Fatigue, Homicidal Ideation, Lethargy, Memory Impairment, Somnolence, Speech Disorder Other
5801717 4662229     F 4/21/2005 5/12/2005 21 MD EXP Strattera Partial Seizures, Vertigo Other
5802196 4662754 13 Years M 10/9/2004 4/26/2005 5/12/2005 16 OT EXP Strattera Blood Alkaline Phosphatase Increased, Decreased Appetite, Sleep Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5802208 4639582 13 Years M 1/1/2004 2/9/2005 3/28/2005 47 OT PER Strattera Communication Disorder, Feeling Abnormal, Growth Retardation, Insomnia, Somnolence
5802209 4639583     M 2/9/2005 3/28/2005 47 PER Strattera
5802211 4639586     F 2/9/2005 3/28/2005 47 PER Strattera Sedation
5802215 4639587 6 Years F 2/9/2005 2/10/2005 3/28/2005 46 PER Strattera Feeling Abnormal, Mydriasis, Vomiting
5802219 4639589 8 Years F 2/10/2005 3/28/2005 46 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Nausea
5802229 4662654 10 Years M 4/20/2005 4/25/2005 5/12/2005 17 OT EXP Strattera Aggression, Condition Aggravated, Physical Assault Other
5802229 4664190 10 Years M 4/20/2005 4/25/2005 5/16/2005 21 OT EXP Strattera Aggression, Feeling Abnormal, Physical Assault Other
5802229 4681885 10 Years M 4/20/2005 5/12/2005 6/2/2005 21 OT EXP Strattera Aggression, Feeling Abnormal, Physical Assault Other
5802230 4662656 10 Years M 3/20/2005 4/21/2005 5/12/2005 21 MD EXP Strattera Abdominal Pain Upper, Blood Lactate Dehydrogenase Increased, Constipation, Decreased Interest, Food Aversion, Headache, Nausea, Pyrexia, Viral Infection, Weight Decreased Hospitalization - Initial or Prolonged
5802230 4681868 10 Years M 3/20/2005 5/18/2005 6/2/2005 15 MD EXP Strattera Abdominal Pain Upper, Anorexia, Blood Lactate Dehydrogenase Increased, Constipation, Decreased Interest, Headache, Ill-Defined Disorder, Nausea, Viral Infection, Weight Decreased Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5802231 4662659 15 Years F 4/21/2005 5/12/2005 21 MD EXP Strattera Decreased Appetite, Headache, Peripheral Coldness, Raynaud's Phenomenon, Skin Discolouration, Weight Decreased Other
5802231 4681871     F 12/1/2004 5/16/2005 6/2/2005 17 MD EXP Strattera Condition Aggravated, Decreased Appetite, Raynaud's Phenomenon, Weight Decreased
5802235 4662661 13 Years M 1/1/2005 4/27/2005 5/12/2005 15 MD EXP Strattera Depression, Nausea, Suicidal Ideation, Weight Decreased Other
5802236 4662662     M 4/22/2005 5/12/2005 20 MD EXP Strattera Chromaturia, Hepatotoxicity, Jaundice Other
5802236 4673846 17 Years M 3/8/2005 5/11/2005 5/24/2005 13 MD EXP Strattera Chromaturia, Hepatotoxicity, Jaundice, Malaise, Nausea, Ocular Icterus, Somnolence Other
5802236 4681843 17 Years M 3/8/2005 5/18/2005 6/2/2005 15 MD EXP Strattera Chromaturia, Hepatotoxicity Other
5802240 4662663 6 Years M 12/1/2004 4/22/2005 5/12/2005 20 MD EXP Strattera Nightmare, Therapy Non-Responder, Tic Other
5802240 4737444 6 Years M 12/1/2004 7/15/2005 8/3/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Nightmare, Tic Disability, Other
5802270 4637374 12 Years 12/23/2004 3/28/2005 95 MD PER Strattera Fatigue
5802272 4637387 36 Years F 9/25/2004 10/1/2004 3/28/2005 178 PER Strattera Migraine
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5802649 4662552 16 Years M 4/1/2005 4/20/2005 5/12/2005 22 MD EXP Strattera Blood Bilirubin Increased, Jaundice Other
5802649 4710710 16 Years M 2/1/2005 6/15/2005 7/7/2005 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Anorexia, Aspartate Aminotransferase Increased, Bedridden, Blood Alkaline Phosphatase Abnormal, Chromaturia, Gamma-Glutamyltransferase Increased, Gilbert's Syndrome, Influenza Like Illness, Malaise, Nausea, Prothrombin Time Prolonged, Pruritus, Rash Other
5802649 4724451 16 Years M 2/1/2005 6/30/2005 7/21/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Alanine Aminotransferase Increased, Anorexia, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Blood Bilirubin Unconjugated Increased, Chromaturia, Fatigue, Gamma-Glutamyltransferase Increased, Gilbert's Syndrome, Influenza Like Illness, Jaundice, Malaise, Nausea, Prothrombin Time Prolonged, Pruritus, Rash, Vomiting Other
5802649 4742404 16 Years M 2/1/2005 7/22/2005 8/8/2005 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Alanine Aminotransferase Increased, Anorexia, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Abnormal, Blood Bilirubin Increased, Blood Bilirubin Unconjugated Increased, Chromaturia, Fatigue, Gamma-Glutamyltransferase Increased, Influenza Like Illness, Jaundice, Malaise, Nausea, Prothrombin Time Prolonged, Pruritus, Rash, Vomiting Other
5802698 4637316     M 11/1/2004 11/22/2004 3/28/2005 126 CN PER Strattera Constipation, Dysuria
5802746 4637317 45 Years M 11/22/2004 3/28/2005 126 CN PER Strattera Dry Mouth, Erectile Dysfunction, Libido Decreased, Pollakiuria, Testicular Pain
5802756 4637318 11 Years M 11/23/2004 3/28/2005 125 CN PER Strattera Skin Discolouration
5802759 4637319 6 Years 11/23/2004 3/28/2005 125 CN PER Strattera Skin Discolouration
5802765 4637320 47 Years F 11/20/2004 11/23/2004 3/28/2005 125 CN PER Strattera Abnormal Dreams, Dyspnoea, Fatigue, Heart Rate Abnormal, Influenza Like Illness, Insomnia, Nausea
5802806 4637321     M 11/23/2004 3/28/2005 125 OT PER Strattera Dysphonia, Dyspnoea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5802808 4637322 35 Years M 11/23/2004 3/28/2005 125 CN PER Strattera Blood Pressure Increased, Drug Ineffective, Fatigue, Feeling Jittery, Hyperhidrosis
5802817 4637323 60 Years F 11/20/2004 11/23/2004 3/28/2005 125 CN PER Strattera Drug Ineffective, Fatigue, Hunger, Increased Appetite, Somnolence
5802822 4637324 55 Years M 8/10/2004 11/23/2004 3/28/2005 125 CN PER Strattera Drug Screen Positive
5802904 4637424 53 Years F 7/28/2004 1/25/2005 3/28/2005 62 MD PER Strattera Blood Glucose Increased, Hypertension
5802942 4637480 68 Years F 2/11/2004 2/14/2005 3/28/2005 42 PER Strattera Abnormal Dreams, Constipation, Drug Ineffective, Fatigue, Hyperhidrosis, Memory Impairment, Nausea, Sleep Disorder, Sneezing, Stomach Discomfort, Vomiting
5802942 4726696 68 Years F 2/11/2004 2/14/2005 7/25/2005 161 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Constipation, Drug Ineffective, Fatigue, Hyperhidrosis, Memory Impairment, Nausea, Sleep Disorder, Sneezing, Stomach Discomfort, Vomiting
5802956 4637492 27 Years F 3/4/2004 1/18/2005 3/28/2005 69 PER Strattera Anger, Cough, Drug Ineffective, Feeling Abnormal, Hypertension, Irritability, Judgement Impaired, Memory Impairment, Mood Swings, Nasopharyngitis, Nausea
5802967 4665238 8 Years F 4/28/2005 4/29/2005 5/17/2005 18 MD EXP Strattera Alpha-1 Anti-Trypsin Increased, Antinuclear Antibody Positive, Cholestasis, Drug Level Below Therapeutic, Food Poisoning, Hepatic Necrosis, Hepatitis, Pain in Extremity Hospitalization - Initial or Prolonged, Other
5802967 4723854 8 Years F 4/28/2005 7/13/2005 7/21/2005 8 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alpha-1 Anti-Trypsin Increased, Antinuclear Antibody Positive, Cholestasis, Drug Level Below Therapeutic, Food Poisoning, Hepatic Necrosis, Hepatitis, Pain in Extremity, Pruritus, Viral Infection Hospitalization - Initial or Prolonged, Other
5802970 4637497 14 Years M 12/1/2004 1/27/2005 3/28/2005 60 OT PER Strattera Anger, Disturbance in Attention, Drug Ineffective, Mood Swings
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5802980 4637500 13 Years M 11/1/2004 12/6/2004 3/28/2005 112 OT PER Strattera Chest Pain, Drug Interaction, Tachycardia
5803027 4664155 8 Years M 4/26/2005 5/16/2005 CN DIR Strattera Liver Function Test Abnormal Other
5803126 4638789 48 Years M 2/10/2005 2/15/2005 3/28/2005 41 PER Strattera Chest Discomfort, Heart Rate Increased Other
5803126 4784023 48 Years M 2/10/2005 6/22/2005 9/27/2005 97 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Chest Discomfort, Feeling Jittery, Heart Rate Increased, Palpitations Other
5803127 4638811 2 Years M 2/16/2005 2/16/2005 3/28/2005 40 PER Strattera
5803128 4638815 55 Years F 2/16/2004 3/28/2005 406 PER Strattera Hypersomnia, Nausea, Stomach Discomfort
5803130 4638816 66 Years F 2/22/2005 3/28/2005 34 PER Strattera Anorexia, Insomnia, Somnolence
5803132 4638818 39 Years M 10/1/2004 2/22/2005 3/28/2005 34 PER Strattera Diabetes Mellitus Non-Insulin-Dependent, Fatigue, Headache, Pyrexia, Somnolence
5803134 4638820 8 Years M 2/8/2005 3/28/2005 48 MD PER Strattera Mood Altered, Somnolence
5803136 4637864 16 Years M 1/26/2005 3/28/2005 61 PER Strattera Throat Irritation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5803140 4637865 11 Years M 1/25/2005 3/28/2005 62 PER Strattera Drug Ineffective
5803143 4637866 15 Years M 1/26/2005 3/28/2005 61 MD PER Strattera Gastrointestinal Pain
5803145 4637868 8 Years M 1/25/2005 3/28/2005 62 PER Strattera Aggression, Anger, Insomnia
5803147 4637869 9 Years M 1/25/2005 3/28/2005 62 OT PER Strattera Agitation, Crying, Depression, Irritability
5803149 4637871 11 Years M 1/25/2005 3/28/2005 62 PER Strattera Agitation, Anger, Depression, Irritability
5803151 4637873 14 Years F 1/15/2005 3/28/2005 72 MD PER Strattera Weight Increased
5803154 4637878 10 Years M 2/1/2005 3/28/2005 55 MD PER Strattera Weight Increased
5803160 4637885 47 Years F 1/1/2005 1/26/2005 3/28/2005 61 PER Strattera Dizziness, Epistaxis
5803161 4638827 55 Years F 11/17/2004 3/28/2005 131 PER Strattera Chest Discomfort, Constipation, Diplopia, Nausea
5803163 4637890     M 1/26/2005 3/28/2005 61 PER Strattera Epistaxis
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5803164 4637694     F 12/9/2004 3/28/2005 109 MD PER Strattera Affect Lability
5803166 4637695 8 Years M 12/13/2004 3/28/2005 105 PER Strattera Depression, Spontaneous Penile Erection, Suicidal Ideation
5803168 4637697 11 Years M 12/14/2004 12/14/2004 3/28/2005 104 PER Strattera Feeling Abnormal, Hypoaesthesia, Somnolence
5803169 4637698 8 Years F 2/3/2005 3/28/2005 53 PER Strattera Abnormal Behaviour, Decreased Appetite, Headache, Irritability, Malaise, Vomiting
5803171 4637891     F 1/26/2005 3/28/2005 61 PER Strattera Epistaxis
5803172 4637700 13 Years M 12/14/2004 3/28/2005 104 PER Strattera Anger, Drug Ineffective, Mood Swings
5803173 4637701 36 Years M 1/28/2005 3/28/2005 59 PER Strattera Erectile Dysfunction, Male Sexual Dysfunction
5803175 4637703     M 12/8/2004 3/28/2005 110 MD PER Strattera Premature Ejaculation
5803176 4637892 14 Years M 2/1/2005 3/28/2005 55 MD PER Strattera Bleeding Time Prolonged, Epistaxis
5803179 4637707 12 Years M 12/15/2004 3/28/2005 103 PER Strattera Retching, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5803180 4637714 8 Years M 1/1/2003 2/1/2005 3/28/2005 55 PER Strattera Suicidal Ideation
5803181 4637894 10 Years F 1/31/2005 3/28/2005 56 MD PER Strattera Menstruation Irregular
5803182 4637718 9 Years M 1/1/2004 12/15/2004 3/28/2005 103 PER Strattera Agitation, Anger, Decreased Appetite, Depression, Mood Swings, Somnolence
5803183 4637723 35 Years F 12/9/2004 3/28/2005 109 MD PER Strattera Urinary Tract Infection
5803184 4637724 12 Years M 12/13/2004 3/28/2005 105 OT PER Strattera Drug Ineffective
5803185 4637727 12 Years 12/13/2004 3/28/2005 105 MD PER Strattera Tic
5803190 4637729 30 Years F 1/1/2004 12/13/2004 3/28/2005 105 PER Strattera Bipolar Disorder
5803191 4637741     F 12/1/2004 12/13/2004 3/28/2005 105 PER Strattera Feeling Abnormal
5803192 4637752 66 Years F 12/10/2004 2/8/2005 3/28/2005 48 PER Strattera Dizziness, Hyperhidrosis, Palpitations, Sensation of Heaviness
5803194 4637753 13 Years M 12/13/2004 3/28/2005 105 MD PER Strattera Impulsive Behaviour
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5803195 4637756     F 12/13/2004 3/28/2005 105 PER Strattera Fatigue, Feeling Abnormal, Lethargy
5803196 4637757 14 Years M 12/9/2004 3/28/2005 109 MD PER Strattera Urinary Hesitation
5803197 4637759 10 Years M 12/7/2004 3/28/2005 111 OT PER Strattera Bruxism, Drug Ineffective, Dysgeusia
5803198 4637791 8 Years M 2/6/2005 2/7/2005 3/28/2005 49 PER Strattera Decreased Appetite, Stomach Discomfort
5803199 4637792     M 2/7/2005 3/28/2005 49 MD PER Strattera Feeling Abnormal
5803200 4637793 8 Years M 1/1/2004 2/7/2005 3/28/2005 49 PER Strattera Dysphagia, Vomiting
5803201 4637795 8 Years M 1/27/2005 2/7/2005 3/28/2005 49 MD PER Strattera Blood Triglycerides Increased
5803201 4726726 8 Years M 1/27/2005 4/28/2005 7/25/2005 88 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blood Triglycerides Increased
5803202 4637796 5 Years M 1/1/2004 2/3/2005 3/28/2005 53 PER Strattera Vomiting
5803202 4726727 5 Years M 1/1/2004 2/3/2005 7/25/2005 172 PER Strattera Attention Deficit/Hyperactivity Disorder Dysphagia, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5803203 4637806     F 2/7/2005 3/28/2005 49 MD PER Strattera Tic
5803204 4637807 7 Years M 2/7/2005 2/8/2005 3/28/2005 48 PER Strattera Retching, Vomiting
5803205 4637809 10 Years M 1/25/2005 2/8/2005 3/28/2005 48 PER Strattera Blepharospasm, Eye Rolling, Mood Swings, Social Avoidant Behaviour
5803206 4637811 13 Years F 2/7/2005 2/8/2005 3/28/2005 48 PER Strattera Asthenia, Fall, Fatigue, Feeling Abnormal, Feeling Hot, Hot Flush, Lethargy, Visual Disturbance
5803208 4637812 56 Years F 2/8/2005 3/28/2005 48 MD PER Strattera Flushing
5803209 4638767 34 Years F 11/17/2004 3/28/2005 131 PER Strattera Feeling Abnormal, Hypokinesia, Somnolence
5803211 4638780 8 Years M 11/17/2004 3/28/2005 131 MD PER Strattera Obsessive-Compulsive Disorder
5803212 4638781 32 Years M 11/1/2004 1/4/2005 3/28/2005 83 MD PER Strattera Discomfort, Ejaculation Disorder, Erectile Dysfunction, Orgasm Abnormal, Sexual Dysfunction, Sinusitis
5803213 4638782 17 Years M 11/17/2004 3/28/2005 131 OT PER Strattera Disturbance in Attention
5803214 4638783 10 Years M 11/16/2004 3/28/2005 132 MD PER Strattera Abnormal Sleep-Related Event, Fatigue
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5803215 4638766 45 Years M 11/1/2004 1/25/2005 3/28/2005 62 PER Strattera Asthenia, Constipation, Dry Mouth, Dysarthria, Erectile Dysfunction, Nasopharyngitis, Stomach Discomfort
5803216 4638784     F 11/17/2004 3/28/2005 131 PER Strattera Dizziness, Dry Mouth, Dysuria, Nausea, Urinary Retention, Vision Blurred
5803218 4638785 7 Years F 1/1/2003 11/16/2004 3/28/2005 132 PER Strattera Abdominal Pain Upper, Discomfort, Mydriasis, Nausea
5803219 4638786 6 Years M 11/22/2004 3/28/2005 126 MD PER Strattera Contusion
5803220 4638787 9 Years F 11/5/2004 11/23/2004 3/28/2005 125 PER Strattera Drug Interaction, Feeling Jittery, Insomnia, Middle Insomnia, Sleep Disorder, Sleep Walking
5803220 4727775 9 Years F 11/5/2004 6/2/2005 7/25/2005 53 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Feeling Jittery, Insomnia, Middle Insomnia, Pharyngitis Streptococcal, Sleep Walking
5803220 4782199 9 Years F 11/5/2004 6/2/2005 9/27/2005 117 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Feeling Jittery, Insomnia, Middle Insomnia, Pharyngitis Streptococcal, Sleep Walking
5803223 4637663 8 Years M 12/4/2004 1/28/2005 3/28/2005 59 CN PER Strattera Anorexia, Disturbance in Attention, Educational Problem, Fatigue, Feeling Jittery, Nasopharyngitis, Nervousness, Somnolence
5803223 4784017 8 Years M 11/1/2004 6/1/2005 9/27/2005 118 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Crying, Distractibility, Disturbance in Attention, Educational Problem, Fatigue, Feeling Jittery, Nasopharyngitis, Nervousness, Somnolence
5803224 4637670 10 Years M 12/10/2004 12/10/2004 3/28/2005 108 CN PER Strattera Crying, Dry Mouth, Dysphagia, Dyspnoea, Emotional Distress
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5803225 4637671 12 Years M 12/8/2004 3/28/2005 110 CN PER Strattera Increased Tendency to Bruise
5803226 4637672 21 Years F 12/1/2004 12/10/2004 3/28/2005 108 CN PER Strattera Abnormal Behaviour, Dizziness, Feeling Abnormal
5803227 4637675 49 Years F 12/1/2004 12/13/2004 3/28/2005 105 CN PER Strattera Anxiety, Irritability, Nervousness, Psychomotor Hyperactivity
5803228 4637676 36 Years M 1/1/2003 12/10/2004 3/28/2005 108 CN PER Strattera Eye Pain, Vision Blurred
5803425 4637677 17 Years M 12/13/2004 3/28/2005 105 OT PER Strattera Amphetamines Positive
5803430 4637678 9 Years M 12/13/2004 3/28/2005 105 PER Strattera Fatigue, Retching, Somnolence
5803433 4664951 9 Years M 4/1/2005 4/28/2005 5/17/2005 19 MD EXP Strattera Fatigue, Hallucination, Incoherent, Nausea, Syncope, Unresponsive to Verbal Stimuli Other
5803434 4637679 6 Years M 10/1/2004 12/13/2004 3/28/2005 105 PER Strattera Tic
5803437 4637680 14 Years M 12/12/2004 12/13/2004 3/28/2005 105 PER Strattera Pharyngolaryngeal Pain, Somnolence, Stomach Discomfort
5803439 4664952 10 Years M 5/2/2005 5/17/2005 15 MD EXP Strattera Urinary Retention Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5803439 4686776 10 Years M 5/23/2005 6/6/2005 14 MD EXP Strattera Dysuria, Urinary Retention Hospitalization - Initial or Prolonged
5803441 4637683 52 Years F 12/7/2004 12/13/2004 3/28/2005 105 OT PER Strattera Dizziness, Dyspnoea, Feeling Hot, Insomnia, Palpitations, Pruritus
5803441 4726712 52 Years F 12/7/2004 2/22/2005 7/25/2005 153 OT PER Strattera Attention Deficit/Hyperactivity Disorder Bradycardia, Dizziness, Dyspnoea, Feeling Hot, Gallop Rhythm Present, Insomnia, Palpitations, Pruritus
5803456 4637684 12 Years F 12/10/2004 12/13/2004 3/28/2005 105 MD PER Strattera Emotional Disorder, Headache, Hyperacusis, Photophobia, Suicidal Ideation
5803469 4637685 3 Years M 12/13/2004 3/28/2005 105 PER Strattera Anger, Mood Swings, Somnolence
5803636 4665645 12 Years F 5/2/2005 5/17/2005 15 MD EXP Strattera Drug Interaction, Orthostatic Hypotension Hospitalization - Initial or Prolonged
5803636 4681583 12 Years F 5/18/2005 6/2/2005 15 MD EXP Strattera Drug Interaction, Orthostatic Hypotension Hospitalization - Initial or Prolonged
5803636 4693352 12 Years F 10/1/2004 5/25/2005 6/15/2005 21 MD EXP Strattera Drug Interaction, Fall, Heart Rate Increased, Orthostatic Hypotension, Syncope Hospitalization - Initial or Prolonged
5803641 4665647 15 Years F 5/2/2005 5/17/2005 15 EXP Strattera Anxiety, Derealisation, Obsessive Thoughts, Thinking Abnormal Hospitalization - Initial or Prolonged
5803666 4665649 8 Years 4/27/2005 4/28/2005 5/17/2005 19 MD EXP Strattera Convulsion Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5803666 4687182 8 Years 4/27/2005 5/23/2005 6/7/2005 15 MD EXP Strattera Blood Pressure Systolic Decreased, Confusional State, Convulsion, Headache, Heart Rate Increased Other
5803669 4665651 16 Years M 5/3/2005 5/17/2005 14 OT EXP Strattera Chromaturia, Faeces Discoloured, Fatigue, Headache
5803669 4687161 16 Years M 5/18/2005 6/7/2005 20 OT EXP Strattera Blood Albumin Decreased, Chromaturia, Faeces Pale, Fatigue, Headache
5803671 4665653 8 Years F 4/30/2005 5/3/2005 5/17/2005 14 MD EXP Strattera Extrapyramidal Disorder Other
5803671 4674514 8 Years F 4/30/2005 5/12/2005 5/24/2005 12 MD EXP Strattera Buccoglossal Syndrome, Dysarthria, Extrapyramidal Disorder, Eye Rolling, Oculogyration, Torticollis Other
5803671 4697559 8 Years F 4/30/2005 6/7/2005 6/21/2005 14 MD EXP Strattera Extrapyramidal Disorder, Oculogyration, Torticollis Other
5803673 4665655 11 Years 5/3/2005 5/17/2005 14 PH EXP Strattera Hepatic Enzyme Increased
5803675 4665660 23 Years F 4/24/2005 4/28/2005 5/17/2005 19 EXP Strattera Agitation, Dizziness, Dyskinesia, Fatigue, Feeling Abnormal, Impaired Driving Ability, Petit Mal Epilepsy, Somnolence Other
5803675 4697549 23 Years F 4/24/2005 6/2/2005 6/21/2005 19 EXP Strattera Agitation, Blood Alkaline Phosphatase Decreased, Blood Creatinine Decreased, Convulsion, Dizziness, Fatigue, Somnolence, Weight Fluctuation Other
5803675 4737829 23 Years F 4/24/2005 7/7/2005 8/3/2005 27 EXP Strattera Attention Deficit/Hyperactivity Disorder Agitation, Blood Alkaline Phosphatase Decreased, Blood Creatinine Decreased, Convulsion, Depressed Level of Consciousness, Dizziness, Dyskinesia, Fatigue, Impaired Driving Ability, Petit Mal Epilepsy, Somnolence Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5803720 4664979 15 Years M 4/28/2005 5/17/2005 19 MD EXP Strattera Arrhythmia Other
5803723 4664980     M 4/28/2005 5/17/2005 19 MD EXP Strattera Epilepsy Other
5804017 4664871 14 Years F 4/1/2005 5/3/2005 5/17/2005 14 MD EXP Strattera Alanine Aminotransferase Increased
5804045 4664953 21 Years F 4/25/2005 5/2/2005 5/17/2005 15 MD EXP Strattera Convulsion Other
5804045 4673901 21 Years F 4/25/2005 5/11/2005 5/24/2005 13 MD EXP Strattera Convulsion, Dizziness, Electroencephalogram Abnormal, Loss of Consciousness, Vomiting Life-Threatening
5804071 4664954 10 Years M 1/1/2005 4/29/2005 5/17/2005 18 MD EXP Strattera Migraine, Vomiting Hospitalization - Initial or Prolonged
5804450 4666355     F 11/1/2004 5/2/2005 5/17/2005 15 PH EXP Strattera CSF Pressure Increased, Headache, Nausea, Papilloedema, Paralysis, Vomiting Hospitalization - Initial or Prolonged, Other
5804451 4666357 13 Years M 2/1/2005 5/3/2005 5/17/2005 14 PH EXP Strattera Blood Alkaline Phosphatase Increased
5808172 4673962 15 Years M 4/27/2005 5/4/2005 5/24/2005 20 MD EXP Strattera Abdominal Pain, Autoimmune Disorder, Condition Aggravated, Disturbance in Attention, Dizziness, Fatigue, Feeling Abnormal, Polyglandular Disorder, Skin Discolouration, Vasoconstriction Other
5808176 4673964     4/14/2005 5/10/2005 5/24/2005 14 EXP Strattera Blood Bilirubin Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5808235 4673921 13 Years M 1/1/2005 5/5/2005 5/24/2005 19 MD EXP Strattera Blood Alkaline Phosphatase Increased, Blood Creatinine Decreased, Disease Recurrence, Haemoglobin Decreased, Jaundice
5808235 4726234 13 Years M 1/1/2005 5/9/2005 7/25/2005 77 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased, Blood Creatinine Decreased, Haemoglobin Decreased, Jaundice
5808235 4870676 13 Years M 1/1/2005 12/13/2005 12/28/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased, Blood Creatinine Decreased, Haemoglobin Decreased, Jaundice, Listless
5808236 4673922 25 Years M 4/27/2005 5/4/2005 5/24/2005 20 MD EXP Strattera Alanine Aminotransferase Increased
5808527 4673159 12 Years F 10/7/2004 5/24/2005 PH DIR Atomoxetine Hepatitis Acute Hospitalization - Initial or Prolonged, Required Intervention to Prevent Permanent Impairment/Damage
5808532 4673160 11 Years F 9/30/2004 5/24/2005 PH DIR Atomoxetine Autoimmune Hepatitis, Chronic Hepatitis, Hepatic Fibrosis, Hepatitis Acute Hospitalization - Initial or Prolonged, Required Intervention to Prevent Permanent Impairment/Damage
5808860 4673087 7 Years M 11/15/2004 5/24/2005 MD DIR Strattera Electrocardiogram QT Corrected Interval Prolonged Other
5809852 4674199 19 Month M 5/5/2005 5/24/2005 19 PH EXP Strattera Myoclonus, Somnolence Other
5810039 4674267 15 Years F 5/9/2005 5/24/2005 15 EXP Strattera Convulsion Other
5810040 4674268 6 Years M 5/11/2005 5/24/2005 13 MD EXP Strattera Aggression, Insomnia, Mania, Physical Assault, Pyromania Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5810042 4674270 24 Years M 5/6/2005 5/24/2005 18 EXP Strattera Hepatic Enzyme Abnormal
5810043 4674237 7 Years M 5/6/2005 5/24/2005 18 MD EXP Strattera Skin Laceration, Suicide Attempt Other
5810043 4697967 9 Years M 6/7/2005 6/21/2005 14 MD EXP Strattera Intentional Self-Injury, Skin Laceration Other
5810046 4674240     F 1/1/2003 5/6/2005 5/24/2005 18 EXP Strattera Depression, Suicide Attempt Hospitalization - Initial or Prolonged, Other
5810046 4687160     F 1/1/2003 5/25/2005 6/7/2005 13 EXP Strattera Insomnia, Overdose, Suicidal Ideation, Suicide Attempt Hospitalization - Initial or Prolonged, Other
5810048 4674242 8 Years M 4/1/2005 5/5/2005 5/24/2005 19 EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased
5810048 4747051 8 Years M 4/1/2005 7/27/2005 8/15/2005 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased
5810049 4674243 16 Years F 5/4/2005 5/24/2005 20 MD EXP Strattera Gilbert's Syndrome
5810055 4674244 10 Years M 2/1/2005 5/6/2005 5/24/2005 18 MD EXP Strattera Convulsion Other
5810055 4753373 10 Years M 2/1/2005 8/9/2005 8/23/2005 14 MD EXP Strattera Anxiety Asthenia, Convulsion, Loss of Consciousness, Postictal Paralysis, Tonic Clonic Movements Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5810055 4785029 10 Years M 2/1/2005 9/12/2005 9/28/2005 16 MD EXP Strattera Anxiety Grand Mal Convulsion Other
5810065 4674246 50 Years M 2/1/2005 5/4/2005 5/24/2005 20 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5810071 4674247 6 Years M 5/1/2005 5/5/2005 5/24/2005 19 OT EXP Strattera Confusional State, Petit Mal Epilepsy Other
5810089 4674248 4 Years M 5/5/2005 5/24/2005 19 PH EXP Strattera Convulsion, Loss of Consciousness, Overdose Other
5810272 4676553     F 4/26/2005 5/26/2005 PH DIR Strattera Cholestasis, Gallbladder Disorder, Hepatic Necrosis, Hepatitis, Hepatitis Infectious, Hypertension Hospitalization - Initial or Prolonged, Other, Required Intervention to Prevent Permanent Impairment/Damage
5811116 4675913     F 4/26/2005 5/26/2005 PH DIR Strattera Cholestasis, Gallbladder Disorder, Hepatic Necrosis, Hepatitis, Hepatitis Viral, Hepatomegaly, Hepatotoxicity, Hypertension, Prothrombin Time Prolonged, Pruritus Hospitalization - Initial or Prolonged, Other, Required Intervention to Prevent Permanent Impairment/Damage
5814590 4680418 11 Years M 5/13/2005 6/1/2005 19 EXP Strattera Abdominal Pain, Jaundice
5814627 4680419 15 Years F 1/1/2005 5/11/2005 6/1/2005 21 MD EXP Atomoxetine Band Neutrophil Count Decreased, Blood Bilirubin Increased, Lymphocyte Count Increased
5814627 4737745 15 Years F 1/1/2005 7/19/2005 8/3/2005 15 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Blood Bilirubin Increased, Lymphocyte Percentage Increased, Neutrophil Percentage Decreased
5815718 4680445 6 Years F 11/24/2004 5/17/2005 6/1/2005 15 EXP Strattera Condition Aggravated, Disturbance in Attention, Psychomotor Hyperactivity, Tearfulness Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5815720 4680447 11 Years M 4/21/2005 5/19/2005 6/1/2005 13 MD EXP Strattera Aggression, Alanine Aminotransferase Increased, Hypertension Other
5815721 4680449     F 5/13/2005 6/1/2005 19 MD EXP Strattera Difficulty in Walking, Dysmenorrhoea, Fatigue, Raynaud's Phenomenon Other
5815721 4698451 34 Years F 3/19/2005 6/7/2005 6/21/2005 14 MD EXP Strattera Condition Aggravated, Difficulty in Walking, Dysmenorrhoea, Fatigue, Raynaud's Phenomenon Other
5815723 4680450 12 Years M 4/1/2005 5/16/2005 6/1/2005 16 EXP Strattera Lymphadenopathy Other
5815723 4698418 12 Years M 4/1/2005 6/3/2005 6/21/2005 18 EXP Strattera Lymphadenopathy Other
5817057 4684597 29 Years F 2/12/2005 2/15/2005 5/31/2005 105 PER Strattera Disorientation, Headache, Hypersomnia, Loss of Employment
5817057 4730494 29 Years F 2/12/2005 2/15/2005 7/25/2005 160 PER Strattera Affective Disorder Disorientation, Headache, Hypersomnia, Loss of Employment
5817283 4680878 65 Years M 3/17/2005 5/31/2005 MD DIR Strattera Blood Pressure Decreased, Procedural Complication Life-Threatening
5817716 4681474 10 Years M 5/11/2005 6/1/2005 21 OT EXP Strattera Liver Function Test Abnormal, Mental Disorder
5817726 4681475 8 Years M 5/12/2005 6/1/2005 20 EXP Strattera Hepatocellular Damage Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5817731 4681476 10 Years F 5/1/2005 5/12/2005 6/1/2005 20 EXP Strattera Aspartate Aminotransferase Increased, Hepatomegaly
5817734 4681477 14 Years F 5/14/2005 6/1/2005 18 EXP Strattera Cholelithiasis, Hyperphagia, Weight Increased Hospitalization - Initial or Prolonged
5817955 4681137 12 Years 5/12/2005 6/1/2005 20 MD EXP Strattera Alanine Aminotransferase Increased
5817955 4709678 8 Years M 6/21/2005 7/7/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Decreased, Aspartate Aminotransferase Increased
5818821 4685321     M 1/1/2005 6/7/2005 MD DIR Strattera Hepatic Enzyme Increased Other
5820161 4687028 14 Years M 5/11/2005 5/19/2005 6/6/2005 18 MD EXP Strattera Electrocardiogram T Wave Abnormal, Fatigue Other
5820161 4698415 14 Years M 5/11/2005 6/2/2005 6/21/2005 19 MD EXP Strattera Electrocardiogram T Wave Inversion, Fatigue Other
5821326 4686173 9 Years F 5/24/2005 6/6/2005 13 MD EXP Strattera Alanine Aminotransferase Increased, Eating Disorder, Irritability
5821529 4687016 11 Years F 5/23/2005 6/8/2005 16 MD EXP Strattera Electrocardiogram QT Corrected Interval Prolonged Other
5821533 4687022 45 Years F 5/18/2005 6/8/2005 21 MD EXP Strattera Aspartate Aminotransferase Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5821533 4898233 45 Years F 5/1/2005 1/11/2006 1/27/2006 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aspartate Aminotransferase Increased
5821641 4687108 16 Years 5/18/2005 6/7/2005 20 MD EXP Strattera Liver Function Test Abnormal
5821646 4687110 26 Years M 4/1/2005 5/23/2005 6/7/2005 15 MD EXP Strattera Arteriospasm Coronary, Myocardial Infarction Life-Threatening, Other
5821646 4709552 28 Years M 4/1/2005 6/17/2005 7/7/2005 20 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Arteriospasm Coronary, Blood Pressure Systolic Increased, Myocardial Infarction Life-Threatening, Other
5821650 4687111 27 Years F 4/1/2005 5/24/2005 6/7/2005 14 EXP Strattera Acne, Convulsion, Mood Swings, Weight Decreased Other
5821653 4687113 15 Years M 5/6/2005 5/23/2005 6/7/2005 15 EXP Strattera Bilirubin Conjugated Increased, Blood Bilirubin Increased
5821653 4709551 15 Years M 5/6/2005 6/15/2005 7/7/2005 22 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Bilirubin Conjugated Increased, Blood Bilirubin Increased, Infectious Mononucleosis
5821683 4686427 12 Years M 5/19/2005 6/6/2005 18 MD EXP Strattera Blood Alkaline Phosphatase Increased Other
5821683 4724443 12 Years M 7/4/2005 7/21/2005 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased, Hyperparathyroidism Other
5821683 4827620 13 Years M 10/18/2005 11/10/2005 23 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5821805 4686948 15 Years M 3/1/2005 5/24/2005 6/8/2005 15 MD EXP Strattera Hepatic Enzyme Increased
5821811 4686949 26 Years F 5/24/2005 6/8/2005 15 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5821811 4697968 26 Years F 6/6/2005 6/21/2005 15 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5821811 4741115 26 Years F 7/20/2005 8/8/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5821822 4686954 16 Years M 5/18/2005 6/8/2005 21 MD EXP Strattera Alanine Aminotransferase Increased, Hepatic Enzyme Increased
5822042 4686956     F 5/18/2005 6/8/2005 21 OT EXP Strattera Hepatic Enzyme Increased
5822046 4686957 7 Years M 11/15/2004 5/20/2005 6/8/2005 19 MD EXP Strattera Electrocardiogram QT Corrected Interval Prolonged Other
5822046 4697966 7 Years M 11/15/2004 6/7/2005 6/21/2005 14 MD EXP Strattera Asthenia, Electrocardiogram QT Corrected Interval Prolonged, Sinus Arrhythmia Other
5822046 4723855 7 Years M 11/15/2004 7/13/2005 7/21/2005 8 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Electrocardiogram QT Corrected Interval Prolonged, Heart Rate Increased, Sinus Arrhythmia Other
5822046 4747050 7 Years M 11/15/2004 8/1/2005 8/15/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Decreased, Electrocardiogram QT Corrected Interval Prolonged, Fatigue, Heart Rate Increased, Sinus Arrhythmia Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5822244 4690451 55 Years F 11/1/2004 6/14/2005 CN DIR Strattera Activities of Daily Living Impaired, Arthralgia, Difficulty in Walking, Fatigue, Myalgia, Poisoning, Renal Pain Other
5822298 4689871 26 Years F 5/20/2005 6/13/2005 CN DIR Strattera Burns Second Degree, Burns Third Degree, Drug Hypersensitivity, Erythema, Hypersensitivity, Photosensitivity Reaction, Rash Macular
5823593 4582270 13 Years F 9/24/2004 9/24/2004 1/27/2005 125 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Crying, Fatigue, Irritability, Screaming
5823704 4690211 12 Years M 5/24/2005 6/13/2005 20 MD EXP Strattera Convulsion Other
5825207 4692384 18 Years F 5/1/2005 5/25/2005 6/15/2005 21 MD EXP Strattera Ocular Icterus
5825207 4710640 18 Years F 5/1/2005 6/15/2005 7/7/2005 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Ocular Icterus
5825208 4692386 18 Years M 5/27/2005 6/15/2005 19 MD EXP Strattera Hepatic Enzyme Increased
5825210 4692387     M 5/30/2005 6/15/2005 16 EXP Strattera Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Blood Bilirubin Unconjugated Increased, White Blood Cell Count Decreased
5826470 4693257 15 Years M 1/1/2005 5/25/2005 6/15/2005 21 MD EXP Strattera Liver Function Test Abnormal
5826482 4693263 14 Years F 5/19/2005 5/31/2005 6/15/2005 15 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatine Increased, Dehydration, Nausea, Vomiting Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5826482 4703912 14 Years F 5/19/2005 6/14/2005 6/28/2005 14 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Creatine Increased, Dehydration, Hepatic Enzyme Increased, Nausea, Vomiting Hospitalization - Initial or Prolonged
5826482 4747183 14 Years F 5/19/2005 8/1/2005 8/15/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Blood Creatinine Increased, Dehydration, Nausea, Vomiting Hospitalization - Initial or Prolonged
5826488 4693265 14 Years M 5/26/2005 6/15/2005 20 MD EXP Strattera Hepatic Enzyme Increased
5826499 4693269 17 Years M 5/10/2005 5/26/2005 6/15/2005 20 OT EXP Strattera Amnesia, Loss of Consciousness Other
5826509 4693290     M 2/5/2005 5/31/2005 6/15/2005 15 MD EXP Strattera Cerebrovascular Accident, Cerebrovascular Spasm, Crying, Ear Pain, Headache, Screaming Disability, Hospitalization - Initial or Prolonged, Life-Threatening, Other
5826509 4723852 6 Years M 2/5/2005 7/1/2005 7/21/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Arterial Spasm, Cerebrovascular Accident, Crying, Drooling, Dysarthria, Ear Pain, Facial Palsy, Headache, Hemiparesis, Screaming Disability, Hospitalization - Initial or Prolonged, Life-Threatening, Other
5826509 4821711 6 Years M 2/5/2005 10/12/2005 11/3/2005 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Immunoglobulin M Increased, Cerebrovascular Accident, Cerebrovascular Spasm, Ear Pain, Granulocyte Count Decreased, Laboratory Test Abnormal, Nervous System Disorder, Prothrombin Level Increased Disability, Hospitalization - Initial or Prolonged, Life-Threatening, Other
5828416 4697382 36 Years M 6/5/2005 6/6/2005 6/21/2005 15 MD EXP Strattera Myocardial Infarction, Myocarditis Hospitalization - Initial or Prolonged
5828416 4741119 33 Years M 6/5/2005 7/21/2005 8/8/2005 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Dizziness, Headache, Nausea, Viral Myocarditis Hospitalization - Initial or Prolonged
5828416 4790306 33 Years M 6/5/2005 9/15/2005 10/5/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Decreased, Chest Pain, Dizziness, Fatigue, Headache, Nausea, Viral Myocarditis Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5828420 4697384 34 Years F 1/1/2005 6/7/2005 6/21/2005 14 MD EXP Strattera Malignant Hypertension, Metanephrine Urine Increased, Normetanephrine Urine Increased Other
5828421 4697385 13 Years M 6/8/2005 6/21/2005 13 MD EXP Strattera Dizziness, Feeling Abnormal, Headache, Loss of Consciousness, Visual Disturbance Other
5828436 4697389 6 Years M 4/22/2003 6/7/2005 6/21/2005 14 MD EXP Strattera Convulsion, Tachycardia Hospitalization - Initial or Prolonged, Other
5828441 4697390     M 6/2/2005 6/21/2005 19 MD EXP Strattera Abdominal Pain, Alanine Aminotransferase Increased
5828441 4713700     M 6/24/2005 7/13/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Alanine Aminotransferase Increased, Albumin Globulin Ratio Decreased, Blood Alkaline Phosphatase Increased
5828442 4697393 13 Years M 5/1/2005 6/6/2005 6/21/2005 15 MD EXP Strattera Hepatic Enzyme Abnormal
5828447 4697395 9 Years M 1/1/2005 4/8/2005 6/21/2005 74 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Diarrhoea, Haemoglobin Decreased, Platelet Count Abnormal, Vomiting, Weight Decreased
5828447 4723853 9 Years M 1/1/2005 6/30/2005 7/21/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Diarrhoea, Eosinophil Count Increased, Haemoglobin Decreased, Monocyte Count Increased, Nausea, Platelet Count Increased, Red Blood Cell Sedimentation Rate Increased, Vomiting, Weight Decreased
5828447 4728033 9 Years M 1/1/2005 4/8/2005 7/25/2005 108 MD PER Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Diarrhoea, Vomiting, Weight Decreased
5828930 4697687 52 Years M 5/1/2005 6/22/2005 52 MD EXP Strattera Hepatic Function Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5828930 4741113 52 Years M 7/22/2005 8/8/2005 17 MD EXP Strattera Feeling Hot, Liver Function Test Abnormal, Rash Erythematous
5828930 4753371 54 Years M 5/3/2005 8/9/2005 8/23/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder, Major Depression Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Rash Maculo-Papular
5828930 4784570 54 Years M 5/3/2005 9/7/2005 9/28/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder, Major Depression Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Hypersensitivity, Rash Maculo-Papular
5830066 4698508 14 Years M 6/7/2005 6/21/2005 14 MD EXP Strattera Abdominal Pain Upper, Chromaturia
5830067 4698509 11 Years M 5/5/2005 6/2/2005 6/21/2005 19 MD EXP Strattera Fear, Injury Asphyxiation, Suicide Attempt Hospitalization - Initial or Prolonged, Life-Threatening
5830086 4700174 10 Years M 12/3/2003 6/24/2005 MD DIR Atomoxetine Abnormal Behaviour, Aggression, Anger, Drug Ineffective, Hypomania, Judgement Impaired, Mania, Negativism, Rebound Effect Other
5832298 4704961 15 Years M 6/13/2005 6/30/2005 MD DIR Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Laboratory Test Abnormal Other
5832671 4703449 51 Years M 6/14/2005 6/29/2005 15 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Gamma-Glutamyltransferase Increased
5832671 4713703 51 Years M 6/27/2005 7/13/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Gamma-Glutamyltransferase Increased
5834321 4704434 10 Years M 3/1/2005 6/15/2005 6/28/2005 13 MD EXP Strattera Anorexia, Chromaturia, Fatigue, Influenza Like Illness, Tenderness Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5834961 4704016 10 Years F 6/3/2005 6/14/2005 6/28/2005 14 OT EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Malaise, Platelet Count Increased
5834972 4704020     M 6/10/2005 6/28/2005 18 MD EXP Strattera Hepatic Enzyme Increased, Vomiting
5836798 4710567 14 Years M 4/1/2005 7/6/2005 MD DIR Strattera Liver Function Test Abnormal Other
5837493 4709784 11 Years M 6/20/2005 7/7/2005 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5837493 4760175 11 Years M 8/10/2005 8/31/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5837493 4824284 11 Years M 10/24/2005 11/8/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Glucose Increased
5837495 4709793 16 Years M 6/16/2005 7/7/2005 21 MD EXP Strattera Jaundice, Liver Function Test Abnormal
5837495 4747145 16 Years M 8/1/2005 8/15/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Autoimmune Hepatitis, Hepatic Steatosis Other
5837495 4781767 16 Years M 9/9/2005 9/27/2005 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Autoimmune Hepatitis, Hepatic Fibrosis, Hepatic Steatosis, Weight Decreased Other
5837495 4815334 16 Years M 10/10/2005 10/26/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Autoimmune Hepatitis, Hepatic Fibrosis, Hepatic Steatosis Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5837495 4821688 16 Years M 10/18/2005 11/3/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Autoimmune Hepatitis, Hepatic Fibrosis, Hepatic Steatosis Other
5837496 4709823 12 Years M 12/1/2003 6/17/2005 7/7/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased
5837496 4747188 12 Years M 5/1/2005 8/1/2005 8/15/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Hepatic Enzyme Increased
5837496 4824078 12 Years M 5/1/2005 11/1/2005 11/8/2005 7 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Hepatic Enzyme Increased
5837496 4853748 12 Years M 5/1/2005 11/21/2005 12/12/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Hepatic Enzyme Increased
5837498 4709850     F 5/1/2005 6/21/2005 7/7/2005 16 MD EXP Strattera Cerebrovascular Accident Hospitalization - Initial or Prolonged, Other
5837524 4709729 9 Years M 6/1/2005 6/22/2005 7/7/2005 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Bone Disorder, Decreased Appetite, Fall, Weight Decreased Other
5837525 4709731     M 6/21/2005 7/7/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Hyperventilation, Syncope Other
5837527 4709732 17 Years M 4/1/2005 6/20/2005 7/7/2005 17 OT EXP Strattera Aspartate Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Gamma-Glutamyltransferase Decreased
5837782 4711758 11 Years F 7/6/2005 7/11/2005 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Headache, Laboratory Test Abnormal Required Intervention to Prevent Permanent Impairment/Damage
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5838147 4709546 9 Years F 6/15/2005 7/7/2005 22 MD EXP Strattera Alanine Aminotransferase Increased, Anorexia, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Chromaturia, Confusional State, Fatigue, Influenza Like Illness, Irritability, Nausea, Pruritus, Somnolence, Vomiting
5838284 4711395 17 Years M 6/21/2005 7/8/2005 17 MD EXP Strattera Alanine Aminotransferase Increased
5839358 4710713 8 Years M 6/16/2005 6/17/2005 7/7/2005 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Aspartate Aminotransferase Increased, Dysphoria, Pharyngitis Bacterial
5839358 4724441 8 Years M 6/16/2005 7/5/2005 7/21/2005 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Aspartate Aminotransferase Increased, Bacterial Infection, Drug Ineffective, Dysphoria, Pharyngitis
5839375 4710725 8 Years M 5/22/2005 6/16/2005 7/7/2005 21 EXP Strattera Attention Deficit/Hyperactivity Disorder Psoriasis Other
5839377 4710734 9 Years M 6/1/2005 6/21/2005 7/7/2005 16 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Nephrotic Syndrome Hospitalization - Initial or Prolonged
5839377 4724273 9 Years M 6/10/2005 7/4/2005 7/22/2005 18 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Nephrotic Syndrome Hospitalization - Initial or Prolonged
5839377 4724448 9 Years M 6/10/2005 7/4/2005 7/21/2005 17 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Nephrotic Syndrome Hospitalization - Initial or Prolonged
5839377 4742408 9 Years M 6/10/2005 7/26/2005 8/8/2005 13 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Albumin Increased, Glomerulonephritis, Nephrotic Syndrome, Pharyngolaryngeal Pain Hospitalization - Initial or Prolonged
5839454 4710751 11 Years M 5/13/2005 6/16/2005 7/7/2005 21 MD EXP Strattera Blood Alkaline Phosphatase Increased, Cyclic Neutropenia, Orthostatic Hypotension, Urticaria Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5839456 4710758 14 Years M 6/13/2005 6/16/2005 7/7/2005 21 MD EXP Strattera Appendicitis, Hepatitis
5839456 4742402 14 Years M 6/13/2005 6/26/2005 8/8/2005 43 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatitis, Influenza Like Illness
5839588 4533961 25 Years M 12/15/2004 12/21/2004 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anorexia, Arthritis, Arthropathy, Back Pain, Chills, Chromaturia, Dysuria, Erectile Dysfunction, Headache, Hyperhidrosis, Insomnia, Lethargy, Orgasm Abnormal, Pruritus, Yawning
5839624 4578014     M 8/27/2004 8/31/2004 1/27/2005 149 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Chills, Piloerection
5841192 4708335 9 Years M 12/1/2004 7/5/2005 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Depression, Morbid Thoughts, Oral Intake Reduced, Suicidal Ideation Other
5841198 4640069 41 Years M 8/1/2004 1/4/2005 3/28/2005 83 PER Strattera Depression, Insomnia, Lethargy, Mood Swings
5841730 4713702     M 6/23/2005 7/12/2005 19 OT EXP Strattera Hepatic Enzyme Increased
5841854 4713634 12 Years M 1/1/2005 6/27/2005 7/12/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Suicidal Ideation, Suicide Attempt Other
5841854 4738508 10 Years M 1/1/2005 7/13/2005 8/3/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Adenoidectomy, Aggression, Anger, Anhedonia, Depressed Mood, No Therapeutic Response, Somnolence, Stress, Suicidal Ideation, Therapeutic Response Decreased Other
5841854 4759242 10 Years M 1/1/2005 8/15/2005 8/31/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Adenoidectomy, Aggression, Anger, Anhedonia, Depressed Mood, No Therapeutic Response, Restlessness, Somnolence, Stress, Suicidal Ideation Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5841857 4713635 12 Years M 6/27/2005 6/29/2005 7/12/2005 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Weight Decreased Other
5841857 4752432 12 Years M 6/27/2005 8/4/2005 8/23/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Weight Decreased Other
5841860 4713636 15 Years M 6/28/2005 6/29/2005 7/12/2005 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Epilepsy Hospitalization - Initial or Prolonged
5841860 4752434 15 Years M 6/28/2005 8/9/2005 8/23/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Epilepsy Hospitalization - Initial or Prolonged
5846324 4719181 7 Years M 6/29/2005 7/1/2005 7/20/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased
5846324 4737742 7 Years M 6/29/2005 7/14/2005 8/3/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased
5846338 4719182 13 Years M 6/15/2005 7/6/2005 7/20/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Haematuria, Headache Hospitalization - Initial or Prolonged
5846338 4737743 13 Years M 6/15/2005 7/18/2005 8/3/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Haematuria, Headache Hospitalization - Initial or Prolonged
5846338 4738680 13 Years M 6/15/2005 7/18/2005 8/3/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Haematuria, Headache Hospitalization - Initial or Prolonged
5846338 4746313 13 Years M 6/15/2005 8/1/2005 8/15/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Haematuria, Headache, Protein Urine Present Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5846338 4791169 13 Years M 6/15/2005 9/21/2005 10/5/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Haematuria, Headache Hospitalization - Initial or Prolonged
5846341 4719183 13 Years M 5/29/2005 6/22/2005 7/20/2005 28 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Crying, Dizziness, Headache, Nausea, Social Avoidant Behaviour Other
5846341 4738509 13 Years M 5/29/2005 7/7/2005 8/3/2005 27 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Crying, Dizziness, Headache, Nausea, Social Avoidant Behaviour Other
5846341 4822044 13 Years M 5/29/2005 10/17/2005 11/3/2005 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Crying, Dizziness, Headache, Nausea, Social Avoidant Behaviour Other
5846344 4719184 15 Years M 7/4/2005 7/20/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Anger, Anorexia, Gastric Disorder, Hyperhidrosis, Somnolence Other
5846344 4791167 15 Years M 9/16/2005 10/5/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Anorexia, Condition Aggravated, Feeling Abnormal, Gastric Disorder, Hyperhidrosis, Somnolence
5847106 4718756 14 Years F 7/6/2005 7/19/2005 13 EXP Strattera Abdominal Pain, Hepatic Enzyme Increased Hospitalization - Initial or Prolonged, Other
5847114 4718757 12 Years M 6/30/2005 7/19/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Bilirubin Increased
5847118 4718759 23 Years M 6/30/2005 7/19/2005 19 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Hepatic Enzyme Increased
5847118 4747186 23 Years M 6/23/2005 7/29/2005 8/15/2005 17 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5847118 4784806 23 Years M 6/23/2005 9/13/2005 9/28/2005 15 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Bilirubin Conjugated Increased, Blood Bilirubin Increased, Liver Function Test Abnormal
5847118 4824077 23 Years M 6/23/2005 11/1/2005 11/8/2005 7 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Albumin Increased, Blood Bilirubin Increased, Liver Function Test Abnormal
5847137 4718760 16 Years M 6/29/2005 6/29/2005 7/19/2005 20 MD EXP Strattera Aspartate Aminotransferase Increased, Hepatic Enzyme Increased
5847143 4718762 54 Years F 6/30/2005 7/5/2005 7/19/2005 14 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Electrocardiogram QRS Complex Prolonged, Fatigue, Middle Insomnia, Supraventricular Tachycardia, Wolff-Parkinson-White Syndrome Hospitalization - Initial or Prolonged
5847144 4718763 15 Years M 6/1/2005 6/29/2005 7/19/2005 20 MD EXP Strattera Blood Bilirubin Increased
5847144 4741117 15 Years M 6/1/2005 7/20/2005 8/8/2005 19 MD EXP Strattera Abdominal Pain, Anorexia, Blood Alkaline Phosphatase Increased, Constipation, Hyperbilirubinaemia, Rectal Haemorrhage
5847144 4853750 15 Years M 6/1/2005 11/21/2005 12/12/2005 21 MD EXP Strattera Abdominal Pain, Anorexia, Blood Alkaline Phosphatase Increased, Constipation, Hyperbilirubinaemia, Rectal Haemorrhage
5847281 4718873 7 Years M 6/30/2005 7/1/2005 7/19/2005 18 EXP Strattera Attention Deficit/Hyperactivity Disorder Anhedonia, Decreased Appetite, Headache, Pain, Psychomotor Hyperactivity, Screaming Disability, Other
5847281 4791176 7 Years M 6/30/2005 9/15/2005 10/5/2005 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Bipolar Disorder, Blood Pressure Increased, Decreased Appetite, Headache, Overdose, Psychomotor Hyperactivity, Screaming Disability, Other
5847282 4718875     F 7/6/2005 7/19/2005 13 MD EXP Strattera Ileus Paralytic Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5847282 4759243 52 Years F 8/11/2005 8/31/2005 20 MD EXP Strattera Disturbance in Attention Ileus Paralytic Other
5847360 4726489     F 5/3/2005 7/25/2005 83 MD PER Strattera Irritability, Nervousness
5847366 4726492 10 Years M 5/5/2005 5/5/2005 7/25/2005 81 OT PER Strattera Attention Deficit/Hyperactivity Disorder Odynophagia, Throat Irritation
5847369 4726494 6 Years M 5/3/2005 5/5/2005 7/25/2005 81 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Crying
5847372 4726495     F 5/5/2005 7/25/2005 81 PER Strattera Stomach Discomfort
5847382 4726496 13 Years M 3/1/2005 5/6/2005 7/25/2005 80 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Micturition Disorder
5847391 4726498 28 Years M 5/6/2005 5/6/2005 7/25/2005 80 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Paraesthesia, Stomach Discomfort
5847394 4726499 10 Years M 5/23/2005 7/25/2005 63 MD PER Strattera Anger, Depression, Flat Affect, Hostility
5847398 4726501 47 Years F 5/6/2005 7/25/2005 80 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Drug Ineffective, Thinking Abnormal, Weight Decreased
5847401 4726504 13 Years M 5/2/2005 5/6/2005 7/25/2005 80 PER Strattera Abdominal Pain Upper, Headache, Malaise
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5847409 4726648 10 Years M 10/1/2004 5/5/2005 7/25/2005 81 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Dizziness, Haematochezia
5847412 4726655 7 Years M 4/1/2005 5/5/2005 7/25/2005 81 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
5847414 4726660 25 Years M 5/4/2005 7/25/2005 82 PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity, Somnolence
5847428 4726661 39 Years M 5/5/2005 7/25/2005 81 PER Strattera Psychomotor Hyperactivity Drug Ineffective, Fatigue, Tremor
5847434 4726662 26 Years M 5/24/2005 7/25/2005 62 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dizziness, Dry Mouth, Dysuria, Ejaculation Disorder, Genital Pain Male, Hyperhidrosis, Insomnia, Testicular Pain, Weight Decreased
5847434 4783675 26 Years M 5/24/2005 9/27/2005 126 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dizziness, Dry Mouth, Dysuria, Ejaculation Disorder, Genital Pain, Hyperhidrosis, Insomnia, Testicular Pain, Weight Decreased
5847443 4726663 48 Years F 5/5/2005 7/25/2005 81 MD PER Strattera Stomach Discomfort
5847448 4726664 7 Years M 5/5/2005 7/25/2005 81 OT PER Strattera Contusion
5847450 4726665 8 Years M 5/5/2005 7/25/2005 81 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Nausea, Nervousness
5847454 4726666 27 Years M 5/4/2005 5/5/2005 7/25/2005 81 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5847458 4726677     M 1/1/2005 5/3/2005 7/25/2005 83 MD PER Strattera Abdominal Pain Upper
5847464 4726730     M 4/18/2005 7/25/2005 98 PER Strattera Attention Deficit/Hyperactivity Disorder Diarrhoea
5847517 4726731 27 Years M 4/13/2005 4/18/2005 7/25/2005 98 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Distension, Dizziness, Dry Mouth, Ejaculation Disorder, Erectile Dysfunction, Sexual Dysfunction
5847519 4726732 11 Years M 4/18/2005 7/25/2005 98 PER Strattera Emotional Distress, Retching
5847520 4726733 7 Years M 4/18/2005 7/25/2005 98 PER Strattera Speech Disorder Constipation
5847521 4726734 8 Years M 1/1/2004 4/18/2005 7/25/2005 98 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety Disorder, Depressed Mood, Depression, Mental Disorder, Negativism, Self-Injurious Ideation, Weight Increased
5847524 4726735 27 Years M 4/13/2005 4/18/2005 7/25/2005 98 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Feeling Abnormal, Logorrhoea
5847525 4726736     F 4/18/2005 7/25/2005 98 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Irritability, Vision Blurred
5847531 4726737 9 Years M 4/18/2005 7/25/2005 98 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Weight Increased
5847533 4726738 13 Years M 4/14/2005 7/25/2005 102 MD PER Strattera Urticaria
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5847534 4726739 8 Years M 4/25/2005 7/25/2005 91 PER Strattera Attention Deficit/Hyperactivity Disorder Skin Discolouration, Weight Decreased
5847542 4726740 7 Years F 4/17/2005 4/18/2005 7/25/2005 98 PER Strattera Attention Deficit/Hyperactivity Disorder Emotional Distress, Retching
5847547 4726741     M 4/19/2005 7/25/2005 97 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Somnolence
5847550 4726742 21 Years M 1/1/2005 4/19/2005 7/25/2005 97 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Feeling Abnormal, Flushing, Headache, Hypoaesthesia, Somnolence
5847556 4726743 11 Years M 3/1/2005 4/19/2005 7/25/2005 97 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Sluggishness
5847558 4726744 6 Years M 4/19/2005 7/25/2005 97 PER Strattera Skin Discolouration, Somnolence
5847560 4726745 9 Years M 4/20/2005 7/25/2005 96 CN PER Strattera Dyskinesia, Muscle Twitching, Somnolence
5847579 4726746     M 4/19/2005 7/25/2005 97 PER Strattera Attention Deficit/Hyperactivity Disorder
5847581 4726747 12 Years M 4/1/2005 4/20/2005 7/25/2005 96 PER Strattera Dizziness, Eructation, Headache, Stomach Discomfort
5847585 4726748 11 Years F 1/1/2003 4/20/2005 7/25/2005 96 PER Strattera Gastrointestinal Disorder, Mood Swings
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5847609 4726749 28 Years F 4/14/2005 4/19/2005 7/25/2005 97 PER Strattera Attention Deficit/Hyperactivity Disorder Contusion, Erythema, Mood Swings, Skin Exfoliation
5847620 4726534 16 Years M 3/8/2005 7/25/2005 139 MD PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity
5847630 4726535 15 Years F 3/8/2005 7/25/2005 139 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Fatigue
5847631 4726536 9 Years M 2/1/2005 3/9/2005 7/25/2005 138 PH PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Suicidal Ideation
5847649 4726537 54 Years M 3/1/2005 3/8/2005 7/25/2005 139 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Feeling Abnormal, Speech Disorder, Tremor
5847653 4726538 54 Years F 3/9/2005 7/25/2005 138 PER Strattera Attention Deficit/Hyperactivity Disorder Therapeutic Response Decreased, Vision Blurred
5847693 4724714 15 Years F 4/11/2005 7/20/2005 PH DIR Strattera Attention Deficit/Hyperactivity Disorder Fall, Loss of Consciousness, Syncope Other
5847736 4726750 35 Years M 4/19/2005 7/25/2005 97 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dry Mouth, Fatigue, Feeling Hot, Nausea
5847738 4726751 7 Years F 3/3/2005 4/20/2005 7/25/2005 96 PER Strattera Disturbance in Attention Dysphagia, Mood Swings, Stomach Discomfort, Therapeutic Response Decreased
5847740 4726752 50 Years F 4/20/2005 7/25/2005 96 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Agitation, Irritability
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5847742 4726753 24 Years M 4/19/2005 7/25/2005 97 PER Strattera Penile Discharge, Protein Urine
5847743 4726754 32 Years M 4/20/2005 7/25/2005 96 PER Strattera Attention Deficit/Hyperactivity Disorder Restlessness, Sleep Disorder
5847744 4726755 55 Years F 4/20/2005 7/25/2005 96 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Skin, Erythema, Photosensitivity Reaction, Rash, Skin Exfoliation
5847746 4726756 14 Years M 4/20/2005 7/25/2005 96 MD PER Strattera Attention Deficit/Hyperactivity Disorder Rash Papular
5847748 4726757 65 Years M 4/1/2005 5/11/2005 7/25/2005 75 PER Strattera Attention Deficit/Hyperactivity Disorder Balance Disorder, Dizziness, Dry Mouth, Dysuria, Eye Irritation, Eye Pruritus, Memory Impairment, Vision Blurred
5847748 4910158 65 Years M 4/1/2005 1/23/2006 2/9/2006 17 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Balance Disorder, Contusion, Diplopia, Dizziness, Dry Mouth, Dysuria, Eye Irritation, Eye Pruritus, Fall, Feeling Abnormal, Gait Disturbance, Headache, Insomnia, Memory Impairment, Self Mutilation, Vision Blurred Other
5847748 4964241 65 Years M 4/1/2005 3/14/2006 3/31/2006 17 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Balance Disorder, Contusion, Diplopia, Dizziness, Dry Mouth, Dysuria, Eye Irritation, Eye Pruritus, Fall, Feeling Abnormal, Gait Disturbance, Headache, Insomnia, Memory Impairment, Muscle Contracture, Pain in Extremity, Vision Blurred Other
5847748 4989393 65 Years M 4/1/2005 4/7/2006 4/26/2006 19 CN EXP Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Balance Disorder, Contusion, Convulsion, Diplopia, Dizziness Postural, Dry Mouth, Dupuytren's Contracture, Dysuria, Eating Disorder, Eye Irritation, Eye Pruritus, Fall, Feeling Abnormal, Gait Disturbance, Headache, Hypotension, Insomnia, Loss of Consciousness, Memory Impairment, Orthostatic Hypotension, Pain in Extremity, Vision Blurred, Weight Increased Other
5847750 4726758 15 Years M 4/19/2005 7/25/2005 97 MD PER Strattera Mydriasis, Sexual Dysfunction
5847751 4726759 15 Years M 4/19/2005 7/25/2005 97 MD PER Strattera Mydriasis, Sexual Dysfunction
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5847752 4726506     M 3/7/2005 7/25/2005 140 MD PER Strattera Muscle Twitching
5847753 4726509     M 3/10/2005 7/25/2005 137 PER Strattera Aggression, Depression, Intentional Self-Injury
5847754 4726511 62 Years F 3/10/2005 7/25/2005 137 OT PER Strattera Fatigue, Therapeutic Response Decreased, Vomiting
5847755 4726513 42 Years M 2/21/2005 3/7/2005 7/25/2005 140 MD PER Strattera Serotonin Syndrome
5847758 4726514 38 Years M 3/1/2005 3/25/2005 7/25/2005 122 PER Strattera Attention Deficit/Hyperactivity Disorder Cough, Hangover, Headache, Hyperacusis, Nausea, Photophobia, Sinus Disorder, Testicular Pain, Tinnitus, Wheezing
5847763 4726515 11 Years M 2/1/2005 3/10/2005 7/25/2005 137 OT PER Strattera Abdominal Pain Upper
5847765 4726516 50 Years M 3/10/2005 7/25/2005 137 MD PER Strattera Feeling of Despair
5847766 4726519 17 Years F 3/7/2005 3/11/2005 7/25/2005 136 OT PER Strattera Attention Deficit/Hyperactivity Disorder Blood Follicle Stimulating Hormone Increased, Blood Luteinising Hormone Increased
5847767 4726521 13 Years M 3/11/2005 7/25/2005 136 MD PER Strattera Attention Deficit/Hyperactivity Disorder Weight Decreased
5847770 4726523 28 Years F 3/8/2005 7/25/2005 139 MD PER Strattera Abnormal Behaviour, Drug Withdrawal Syndrome, Irritability
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5847771 4726448 11 Years M 5/9/2005 7/25/2005 77 PER Strattera Flatulence, Hypertension
5847772 4726451 54 Years F 5/10/2005 7/25/2005 76 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
5847773 4726454 62 Years M 2/1/2005 5/10/2005 7/25/2005 76 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Gastroenteritis Viral, Nausea, Somnolence
5847774 4726457 55 Years F 1/1/2005 5/23/2005 7/25/2005 63 PER Strattera Depression Confusional State, Constipation, Depression, Drug Ineffective, Dry Mouth, Feeling of Despair, Insomnia, Suicidal Ideation
5847775 4726460 39 Years F 3/7/2005 5/11/2005 7/25/2005 75 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dehydration, Ketonuria, Malnutrition, Nausea, Vomiting
5847776 4726461 34 Years M 5/10/2005 7/25/2005 76 MD PER Strattera Penile Pain
5847777 4726462 7 Years M 5/10/2005 7/25/2005 76 MD PER Strattera Hypoaesthesia, Pain in Extremity
5847778 4726463 49 Years M 5/2/2005 5/10/2005 7/25/2005 76 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Insomnia, Irritability, Paraesthesia, Restlessness
5847779 4726465     M 5/10/2005 7/25/2005 76 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
5847781 4726466 13 Years M 5/27/2005 7/25/2005 59 MD PER Strattera Tic
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5847781 4783677 13 Years M 5/27/2005 9/27/2005 123 MD PER Strattera Tic
5848112 4726714 38 Years M 1/8/2005 3/17/2005 7/25/2005 130 PER Strattera Attention Deficit/Hyperactivity Disorder Dependence, Sperm Count Decreased, Spermatozoa Progressive Motility Decreased
5848136 4726470 31 Years M 5/9/2005 7/25/2005 77 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
5848137 4726472     M 5/9/2005 7/25/2005 77 OT PER Strattera Abnormal Behaviour
5848139 4726474 9 Years 5/6/2005 7/25/2005 80 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression
5848140 4726476 6 Years M 5/16/2005 7/25/2005 70 MD PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Fatigue, Feeling Cold, Heart Rate Irregular, Hyperhidrosis, Tachycardia Other
5848142 4726478 18 Years 5/13/2005 7/25/2005 73 MD PER Strattera Visual Disturbance
5848144 4726479     M 5/6/2005 7/25/2005 80 MD PER Strattera Arthralgia, Chromaturia, Myalgia, Palpitations, Tachycardia
5848146 4726481 18 Years 5/5/2005 7/25/2005 81 MD PER Strattera Depression
5848148 4726482 36 Years M 5/5/2005 7/25/2005 81 MD PER Strattera Dizziness, Nausea, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5848150 4726483 8 Years M 5/9/2005 7/25/2005 77 MD PER Strattera
5848153 4726485 14 Years F 4/29/2005 5/9/2005 7/25/2005 77 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Rapid Eye Movements Sleep Abnormal
5848154 4726820     M 2/9/2005 7/25/2005 166 MD PER Strattera Decreased Appetite, Insomnia, Sexual Dysfunction, Weight Decreased
5848156 4726821 19 Years M 3/1/2005 3/17/2005 7/25/2005 130 MD PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Jittery, Heart Rate Increased
5848161 4726822 17 Years F 3/18/2005 7/25/2005 129 PH PER Strattera Aggression, Anger, Antisocial Behaviour
5848166 4726823 8 Years M 1/1/2004 3/18/2005 7/25/2005 129 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Affect Lability, Crying, Drug Ineffective, Vomiting, Weight Decreased
5848170 4726824 8 Years M 3/18/2005 3/18/2005 7/25/2005 129 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Social Avoidant Behaviour
5848175 4726825 6 Years M 3/18/2005 3/18/2005 7/25/2005 129 OT PER Strattera Retching
5848188 4726826 31 Years F 3/1/2005 4/14/2005 7/25/2005 102 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Alopecia, Asthenia, Tongue Discolouration
5848191 4726827 36 Years M 2/1/2005 3/21/2005 7/25/2005 126 PER Strattera Attention Deficit/Hyperactivity Disorder Speech Disorder, Tremor
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5848205 4726828 8 Years M 3/21/2005 7/25/2005 126 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5848226 4726829 40 Years M 3/1/2005 3/21/2005 7/25/2005 126 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
5848231 4726629     M 4/1/2005 7/25/2005 115 PER Strattera Abnormal Behaviour, Aggression, Anger, Flat Affect, Social Avoidant Behaviour
5848236 4726631     M 5/2/2005 7/25/2005 84 MD PER Strattera Gastrooesophageal Reflux Disease
5848241 4726645     M 5/2/2005 7/25/2005 84 PER Strattera Delusional Disorder (Persecutory Type)
5848245 4726646     F 4/28/2005 7/25/2005 88 MD PER Strattera Agitation, Hypomania, Mania
5848253 4726647 9 Years M 5/9/2005 7/25/2005 77 PER Strattera Abnormal Behaviour, Weight Increased
5848258 4726571 11 Years M 5/1/2005 5/11/2005 7/25/2005 75 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression Other
5848996 4728035 3 Years M 4/7/2005 4/8/2005 7/25/2005 108 PER Strattera Attention Deficit/Hyperactivity Disorder
5848999 4728036 14 Years M 4/8/2005 4/11/2005 7/25/2005 105 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849001 4728037 7 Years F 1/1/2005 4/11/2005 7/25/2005 105 PER Strattera Disturbance in Attention Vomiting, Weight Decreased
5849003 4728038 49 Years M 3/28/2005 4/8/2005 7/25/2005 108 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dry Eye, Dry Mouth, Endodontic Procedure, Procedural Pain, Shoulder Operation
5849004 4728039 7 Years M 4/11/2005 7/25/2005 105 PER Strattera Pruritus, Wound
5849007 4728040 6 Years M 4/8/2005 7/25/2005 108 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
5849008 4728041 38 Years M 4/1/2005 5/20/2005 7/25/2005 66 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenopia, Drug Ineffective, Eye Pain, Irritability
5849009 4728042     F 4/11/2005 7/25/2005 105 PER Strattera
5849011 4728043 4 Years M 4/6/2005 7/25/2005 110 MD PER Strattera Attention Deficit/Hyperactivity Disorder Rash, Vasodilation Procedure
5849014 4728044 47 Years M 1/1/2005 4/11/2005 7/25/2005 105 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Insomnia, Libido Disorder
5849015 4728024     M 4/6/2005 7/25/2005 110 MD PER Strattera Drug Screen Positive
5849018 4728025 52 Years F 4/7/2005 7/25/2005 109 PER Strattera Feeling Hot and Cold
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849019 4728026     M 4/7/2005 7/25/2005 109 MD PER Strattera Tinnitus
5849020 4728027 53 Years M 3/1/2005 4/7/2005 7/25/2005 109 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria
5849021 4728028 9 Years F 4/7/2005 7/25/2005 109 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Drug Ineffective, Weight Decreased
5849023 4728029 18 Years F 4/4/2005 4/6/2005 7/25/2005 110 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Depression, Suicidal Ideation
5849025 4728031 14 Years M 6/1/2004 4/7/2005 7/25/2005 109 PER Strattera Attention Deficit/Hyperactivity Disorder Deafness, Labyrinthitis, Middle Ear Effusion, Protein Urine
5849026 4728032     M 1/1/2005 4/8/2005 7/25/2005 108 PH PER Strattera Drug Screen Positive
5849028 4728034 39 Years M 1/1/2005 4/8/2005 7/25/2005 108 PER Strattera Attention Deficit/Hyperactivity Disorder Epididymitis, Groin Pain, Urinary Hesitation
5849031 4727994 30 Years M 3/30/2005 3/31/2005 7/25/2005 116 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Feeling Drunk, Initial Insomnia, Nasal Discomfort, Nasal Dryness
5849033 4727995 43 Years M 3/31/2005 3/31/2005 7/25/2005 116 OT PER Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Increased
5849033 4783654 43 Years M 3/31/2005 6/14/2005 9/27/2005 105 OT PER Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849034 4727996     M 3/31/2005 7/25/2005 116 MD PER Strattera Attention Deficit/Hyperactivity Disorder Psoriasis
5849035 4727997     M 3/31/2005 7/25/2005 116 MD PER Strattera Attention Deficit/Hyperactivity Disorder Psoriasis
5849037 4727998 9 Years M 1/1/2005 3/31/2005 7/25/2005 116 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Somnolence
5849038 4727999 66 Years F 4/1/2005 7/25/2005 115 PER Strattera Fatigue, Musculoskeletal Pain, Pain, Vein Pain
5849039 4728000 29 Years F 4/1/2005 7/25/2005 115 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Urticaria
5849040 4728001 40 Years F 3/31/2005 7/25/2005 116 MD PER Strattera Attention Deficit/Hyperactivity Disorder Weight Increased
5849042 4728002 35 Years F 3/24/2005 4/1/2005 7/25/2005 115 PER Strattera Oedema Peripheral
5849044 4728003 4 Years M 4/1/2005 7/25/2005 115 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Drug Ineffective, Headache, Nasopharyngitis, Somnolence
5849045 4728004 32 Years M 3/31/2005 4/1/2005 7/25/2005 115 PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Diarrhoea, Feeling Abnormal, Mood Swings, Screaming, Vomiting
5849047 4728005 26 Years F 4/4/2005 7/25/2005 112 PER Strattera Attention Deficit/Hyperactivity Disorder Mood Swings, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849048 4728006 20 Years M 4/4/2005 7/25/2005 112 PER Strattera Agitation, Mood Swings, Mydriasis, Nervousness
5849049 4728007 12 Years F 4/4/2005 7/25/2005 112 OT PER Strattera Abnormal Behaviour
5849050 4728008 8 Years M 4/1/2005 7/25/2005 115 MD PER Strattera Feeling Hot, Pallor, Peripheral Coldness, Pulse Pressure Decreased
5849052 4728009     F 4/4/2005 4/4/2005 7/25/2005 112 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Malaise, Nausea, Panic Attack, Tremor
5849053 4728010 11 Years M 4/2/2005 4/5/2005 7/25/2005 111 PER Strattera Attention Deficit/Hyperactivity Disorder Lethargy
5849054 4728011 12 Years M 4/4/2005 7/25/2005 112 MD PER Strattera Attention Deficit/Hyperactivity Disorder Hallucination, Psychotic Disorder
5849055 4728012     M 4/4/2005 7/25/2005 112 PER Strattera Mydriasis, Nausea, Vomiting
5849056 4728013 7 Years F 11/1/2004 5/31/2005 7/25/2005 55 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Disturbance in Attention, Growth Retardation, Tachycardia
5849056 4783657 7 Years F 11/1/2004 5/31/2005 9/27/2005 119 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Disturbance in Attention, Growth Retardation, Tachycardia
5849058 4727962 12 Years M 3/23/2005 7/25/2005 124 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Palpitations
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849061 4727963 16 Years F 3/28/2005 7/25/2005 119 MD PER Strattera Night Sweats
5849064 4727964 45 Years F 3/24/2005 3/25/2005 7/25/2005 122 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Dizziness, Dry Mouth, Feeling Abnormal, Flatulence, Pain in Extremity
5849066 4727965 54 Years M 4/15/2005 7/25/2005 101 MD PER Strattera Attention Deficit/Hyperactivity Disorder Photosensitivity Reaction
5849067 4727966 9 Years M 3/25/2005 7/25/2005 122 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
5849068 4727967 42 Years F 3/15/2005 3/28/2005 7/25/2005 119 PER Strattera Attention Deficit/Hyperactivity Disorder Genital Pruritus Female
5849070 4727968 55 Years M 3/28/2005 7/25/2005 119 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria
5849073 4727969 8 Years F 1/1/2004 3/28/2005 7/25/2005 119 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Urinary Hesitation
5849075 4727970 52 Years F 3/23/2005 3/28/2005 7/25/2005 119 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Decreased Appetite, Drug Ineffective, Insomnia, Nausea, Weight Decreased
5849076 4727971 16 Years M 3/28/2005 7/25/2005 119 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Dependence
5849077 4727952 7 Years M 3/23/2005 7/25/2005 124 PH PER Strattera Attention Deficit/Hyperactivity Disorder Retching
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849078 4727953 11 Years F 3/19/2005 3/24/2005 7/25/2005 123 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Feeling Abnormal, Hypogeusia, Nervousness, Sensory Loss
5849080 4727954 41 Years M 3/24/2005 7/25/2005 123 OT PER Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Disorder, Feeling Cold, Penis Disorder, Urine Abnormality
5849082 4727955 5 Years M 3/1/2005 3/24/2005 7/25/2005 123 PH PER Strattera Attention Deficit/Hyperactivity Disorder
5849084 4727956 10 Years M 3/24/2005 7/25/2005 123 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting, Weight Increased
5849086 4727957 14 Years F 3/22/2005 7/25/2005 125 MD PER Strattera Angle Closure Glaucoma
5849088 4727958 49 Years M 3/24/2005 3/25/2005 7/25/2005 122 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Dizziness, Feeling Abnormal, Influenza Like Illness, Lethargy, Sensation of Heaviness, Tremor
5849091 4727959     M 3/25/2005 7/25/2005 122 OT PER Strattera Drug Screen Positive
5849092 4727960 7 Years M 3/25/2005 7/25/2005 122 PER Strattera Retching, Vomiting
5849098 4727961 14 Years M 3/23/2005 7/25/2005 124 MD PER Strattera Tic
5849099 4728014 56 Years F 1/1/2005 4/5/2005 7/25/2005 111 PER Strattera Disturbance in Attention Sensation of Heaviness, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849101 4728015 10 Years M 4/5/2005 7/25/2005 111 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5849102 4728016     M 4/1/2005 4/6/2005 7/25/2005 110 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Groin Pain, Urinary Hesitation, Urine Flow Decreased
5849103 4728017 31 Years F 4/6/2005 7/25/2005 110 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Hot, Middle Insomnia, Toothache
5849104 4728018 31 Years F 4/6/2005 7/25/2005 110 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
5849105 4728019     M 4/2/2005 4/5/2005 7/25/2005 111 MD PER Strattera Panic Attack
5849106 4728020 5 Years M 2/1/2005 4/7/2005 7/25/2005 109 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Mood Swings, Personality Change
5849107 4728021 5 Years M 4/4/2005 7/25/2005 112 MD PER Strattera Attention Deficit/Hyperactivity Disorder Enuresis
5849108 4728022 7 Years F 1/1/2004 4/6/2005 7/25/2005 110 PER Strattera Heart Rate Increased, Weight Decreased, Weight Increased
5849109 4728023 7 Years M 4/6/2005 7/25/2005 110 PER Strattera Attention Deficit/Hyperactivity Disorder Dysgeusia, Panic Attack
5849110 4727759 8 Years M 5/24/2005 7/25/2005 62 OT PER Strattera Attention Deficit/Hyperactivity Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849111 4727760 12 Years F 5/24/2005 7/25/2005 62 OT PER Strattera Attention Deficit/Hyperactivity Disorder Affective Disorder, Bipolar Disorder, Irritability
5849112 4727762 8 Years M 5/25/2005 7/25/2005 61 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Crying, Drug Ineffective, Nasopharyngitis, Stress
5849113 4727771 48 Years F 12/2/2004 6/1/2005 7/25/2005 54 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Agitation, Anxiety, Constipation, Crying, Depression, Drug Ineffective, Dry Mouth, Fatigue, Frequent Bowel Movements, Irritability, Malaise, Nausea, Pollakiuria, Psychomotor Hyperactivity, Somnolence, Tremor, Weight Increased
5849113 4782198 48 Years F 12/2/2004 6/1/2005 9/27/2005 118 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Agitation, Anxiety, Constipation, Crying, Depression, Drug Ineffective, Dry Mouth, Fatigue, Frequent Bowel Movements, Irritability, Malaise, Nausea, Pollakiuria, Psychomotor Hyperactivity, Somnolence, Tremor, Weight Increased
5849114 4727779 60 Years M 2/1/2004 2/23/2005 7/25/2005 152 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Drug Interaction
5849115 4727780     M 2/24/2005 7/25/2005 151 MD PER Strattera Chest Discomfort, Drug Interaction
5849116 4727781 12 Years 3/1/2005 7/25/2005 146 MD PER Strattera Anxiety
5849118 4727789 9 Years M 3/7/2005 7/25/2005 140 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Fatigue
5849119 4727792 7 Years F 3/7/2005 7/25/2005 140 MD PER Strattera Contusion, Platelet Function Test Abnormal
5849120 4727794 12 Years M 3/2/2005 7/25/2005 145 MD PER Strattera Attention Deficit/Hyperactivity Disorder Weight Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849121 4727796     M 3/14/2005 7/25/2005 133 MD PER Strattera Affective Disorder, Decreased Appetite, Somnolence, Weight Decreased
5849122 4727806     F 3/14/2005 7/25/2005 133 MD PER Strattera Abdominal Discomfort, Dizziness, Headache, Nausea, Vomiting
5849123 4727807     M 2/16/2005 7/25/2005 159 MD PER Strattera Abdominal Discomfort, Sexual Dysfunction
5849124 4727808     M 2/24/2005 7/25/2005 151 MD PER Strattera Decreased Appetite, Muscle Spasms, Nausea, Somnolence, Vomiting, Weight Decreased
5849125 4727810     M 2/24/2005 7/25/2005 151 MD PER Strattera Abdominal Discomfort, Dizziness, Headache
5849126 4727812     M 2/24/2005 7/25/2005 151 MD PER Strattera Asthenia
5849130 4727815     M 2/24/2005 7/25/2005 151 MD PER Strattera Abdominal Discomfort, Affective Disorder, Confusional State, Decreased Appetite, Dizziness, Headache, Nausea, Vomiting, Weight Decreased
5849131 4727836     M 2/22/2005 7/25/2005 153 OT PER Strattera Abdominal Discomfort
5849136 4727837     M 2/22/2005 7/25/2005 153 MD PER Strattera Abdominal Discomfort, Lethargy
5849143 4727838 45 Years M 3/31/2005 7/25/2005 116 MD PER Strattera Abnormal Behaviour, Anger, Hostility, Personality Change
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849144 4727839     M 2/15/2005 7/25/2005 160 MD PER Strattera Abdominal Discomfort, Somnolence
5849145 4727902 12 Years F 2/18/2005 7/25/2005 157 MD PER Strattera Abdominal Discomfort
5849147 4727903     M 3/8/2005 7/25/2005 139 MD PER Strattera Prostatitis
5849148 4727904     M 3/9/2005 7/25/2005 138 MD PER Strattera Affective Disorder
5849149 4727905     M 3/10/2005 7/25/2005 137 MD PER Strattera Affective Disorder, Nausea, Somnolence, Vomiting
5849150 4727972 44 Years M 3/1/2005 3/28/2005 7/25/2005 119 PH PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
5849152 4727906     F 2/18/2005 7/25/2005 157 MD PER Strattera
5849153 4727908     M 2/14/2005 7/25/2005 161 MD PER Strattera Abdominal Discomfort, Mood Altered
5849154 4727973 49 Years F 3/14/2005 3/28/2005 7/25/2005 119 PER Strattera Attention Deficit/Hyperactivity Disorder Eye Swelling, Fatigue, Feeling Abnormal
5849155 4727974 9 Years F 3/28/2005 7/25/2005 119 PH PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Disturbance in Attention
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849156 4727975     M 3/24/2005 7/25/2005 123 MD PER Strattera Urinary Retention
5849157 4727976 11 Years M 3/28/2005 7/25/2005 119 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Fall
5849158 4727977 16 Years M 1/1/2005 3/28/2005 7/25/2005 119 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Depressed Mood, Drug Ineffective, Educational Problem, Fatigue
5849159 4727978 13 Years M 3/29/2005 7/25/2005 118 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria
5849160 4727979 19 Years M 1/1/2004 3/29/2005 7/25/2005 118 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Discomfort, Insomnia, Malaise, Palpitations, Sexual Dysfunction
5849161 4727980     F 3/25/2005 3/29/2005 7/25/2005 118 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Mood Swings
5849162 4727921     M 2/22/2005 7/25/2005 153 MD PER Strattera Abdominal Discomfort
5849163 4727922 30 Years F 3/2/2005 7/25/2005 145 MD PER Strattera Suicidal Ideation
5849164 4727923 10 Years F 3/31/2005 7/25/2005 116 MD PER Strattera Hallucination (Auditory)
5849165 4727924     M 3/28/2005 7/25/2005 119 MD PER Strattera Feeling Drunk
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849166 4727926     M 4/6/2005 7/25/2005 110 MD PER Strattera Agitation
5849167 4727927 12 Years M 4/6/2005 7/25/2005 110 MD PER Strattera Abdominal Discomfort, Dizziness, Headache
5849168 4727928 57 Years F 3/30/2005 7/25/2005 117 PER Strattera Depression, Disorientation, Feeling Abnormal
5849169 4727929 20 Years F 3/2/2005 4/5/2005 7/25/2005 111 MD PER Strattera Attention Deficit/Hyperactivity Disorder Pulse Abnormal, Tachycardia
5849170 4727930     F 4/1/2005 7/25/2005 115 PER Strattera Emotional Disorder
5849171 4727931     F 4/1/2005 7/25/2005 115 PER Strattera Heart Rate Irregular
5849172 4727909     M 3/10/2005 7/25/2005 137 MD PER Strattera Abdominal Discomfort, Somnolence
5849173 4727910     M 3/10/2005 7/25/2005 137 MD PER Strattera Nausea, Urinary Hesitation, Vomiting
5849174 4727913     M 3/10/2005 7/25/2005 137 MD PER Strattera Abdominal Discomfort, Dizziness, Headache, Mood Altered, Sexual Dysfunction
5849175 4727914     M 3/10/2005 7/25/2005 137 MD PER Strattera Abdominal Discomfort, Dizziness, Headache, Mood Altered, Sexual Dysfunction
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849176 4727915 12 Years M 3/11/2005 7/25/2005 136 MD PER Strattera Abdominal Discomfort, Dizziness
5849177 4727916     M 3/10/2005 7/25/2005 137 MD PER Strattera Abdominal Discomfort, Dizziness, Headache, Sedation
5849178 4727917     M 3/10/2005 7/25/2005 137 MD PER Strattera Abdominal Discomfort, Dizziness, Headache, Nausea, Vomiting
5849179 4727918 42 Years M 3/16/2005 7/25/2005 131 MD PER Strattera Sexual Dysfunction
5849180 4727919 12 Years F 2/15/2005 7/25/2005 160 MD PER Strattera
5849181 4727920     F 2/15/2005 7/25/2005 160 MD PER Strattera Affective Disorder, Dizziness, Headache, Nausea, Vomiting
5849182 4727932 51 Years F 3/21/2005 7/25/2005 126 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Disturbance in Attention, Somnolence, Therapeutic Response Decreased
5849183 4727933 45 Years M 3/21/2005 7/25/2005 126 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Fatigue, Insomnia, Sleep Disorder
5849184 4727934 8 Years F 3/18/2005 7/25/2005 129 MD PER Strattera Anorexia, Depressed Mood, Tic
5849185 4727935     F 3/21/2005 7/25/2005 126 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anxiety, Emotional Disorder, Irritability
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849186 4727936 8 Years M 1/1/2005 3/21/2005 7/25/2005 126 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Fatigue, Impulsive Behaviour, Lacrimation Increased, Pallor
5849188 4727937 8 Years F 11/1/2004 3/21/2005 7/25/2005 126 PER Strattera Vomiting
5849189 4727938 10 Years M 3/21/2005 7/25/2005 126 MD PER Strattera Attention Deficit/Hyperactivity Disorder Glaucoma
5849190 4727939     F 3/18/2005 7/25/2005 129 PER Strattera Throat Irritation
5849195 4727940 14 Years M 3/1/2005 3/22/2005 7/25/2005 125 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Dizziness, Eructation, Fatigue, Feeling Abnormal, Flatulence, Malaise, Nausea, Sleep Disorder
5849199 4727941 62 Years F 3/22/2005 7/25/2005 125 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Drug Ineffective, Psychomotor Hyperactivity
5849257 4727984 62 Years F 3/1/2005 4/21/2005 7/25/2005 95 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Dry Mouth, Headache, Insomnia, Nervousness, Pruritus, Stomach Discomfort, Tremor
5849260 4727985 37 Years M 3/29/2005 7/25/2005 118 PER Strattera Psychomotor Hyperactivity Asthenia, Blood Pressure Increased, Chest Discomfort, Dysuria, Ejaculation Disorder, Nausea, Somnolence, Urine Flow Decreased
5849265 4727986 43 Years F 3/30/2005 7/25/2005 117 PER Strattera Feeling Abnormal
5849268 4727987 24 Years M 3/31/2005 7/25/2005 116 PER Strattera Cognitive Disorder Blood Cholesterol Increased, Weight Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849270 4727988 6 Years M 3/1/2005 3/30/2005 7/25/2005 117 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Fatigue, Pallor, Restlessness, Somnolence
5849272 4727989 23 Years F 3/30/2005 7/25/2005 117 MD PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Scotoma
5849274 4727990 5 Years M 3/31/2005 7/25/2005 116 PER Strattera Retching
5849276 4727991 20 Years M 3/31/2005 7/25/2005 116 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Sexual Dysfunction
5849278 4727992 8 Years M 1/1/2004 3/31/2005 7/25/2005 116 PER Strattera Attention Deficit/Hyperactivity Disorder Dysgeusia, Vomiting
5849284 4727993 15 Years F 3/31/2005 7/25/2005 116 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
5849328 4726770 61 Years M 1/1/2005 4/21/2005 7/25/2005 95 PER Strattera Depression Dry Mouth, Tinnitus, Urinary Retention
5849330 4726771 5 Years M 3/1/2005 4/21/2005 7/25/2005 95 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Regressive Behaviour
5849330 4783664 5 Years M 3/1/2005 8/18/2005 9/27/2005 40 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Regressive Behaviour
5849331 4726772 10 Years M 3/1/2005 4/21/2005 7/25/2005 95 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Dermatitis Contact, Growth Retardation, Increased Tendency to Bruise, Nasopharyngitis, Skin Discolouration, Viral Infection
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849331 4783670 10 Years M 3/1/2005 8/31/2005 9/27/2005 27 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Dermatitis Contact, Disturbance in Attention, Growth Retardation, Increased Tendency to Bruise, Nasopharyngitis, Skin Discolouration, Tachycardia, Thyroid Function Test Abnormal, Viral Infection, Weight Increased
5849334 4726773 8 Years M 9/1/2004 4/21/2005 7/25/2005 95 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Negativism
5849336 4726774 23 Years M 4/21/2005 7/25/2005 95 PER Strattera Disturbance in Attention Anger, Anorexia, Anxiety, Dysarthria, Insomnia, Mood Swings
5849338 4726775 6 Years M 4/22/2005 7/25/2005 94 PER Strattera Attention Deficit/Hyperactivity Disorder Vomiting
5849339 4726776 39 Years F 4/18/2005 4/22/2005 7/25/2005 94 CN PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Hypoaesthesia
5849341 4726777 10 Years M 4/21/2005 4/22/2005 7/25/2005 94 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Fatigue, Hot Flush, Irritability, Somnolence
5849342 4726778 50 Years M 4/20/2005 7/25/2005 96 MD PER Strattera Benign Prostatic Hyperplasia
5849345 4726779 59 Years M 4/21/2005 4/22/2005 7/25/2005 94 PER Strattera Apathy Abdominal Pain Upper, Initial Insomnia, Malaise, Piloerection
5849349 4726760     M 4/20/2005 7/25/2005 96 MD PER Strattera Drug Ineffective
5849351 4726761     F 4/1/2005 4/20/2005 7/25/2005 96 PER Strattera Dizziness, Dry Mouth, Dyspnoea, Heart Rate Increased, Middle Insomnia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849352 4726762 7 Years M 4/20/2005 7/25/2005 96 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Emotional Distress
5849354 4726763 9 Years F 4/20/2005 7/25/2005 96 PER Strattera Attention Deficit/Hyperactivity Disorder Cough, Wheezing
5849356 4726764 37 Years M 4/18/2005 4/20/2005 7/25/2005 96 PER Strattera Attention Deficit/Hyperactivity Disorder Mania, Muscle Spasms, Psychomotor Hyperactivity
5849357 4726765 18 Years F 4/18/2005 7/25/2005 98 MD PER Strattera Fatigue, Headache, Mood Swings, Nausea, Somnolence
5849359 4726766 58 Years M 4/20/2005 7/25/2005 96 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Antisocial Behaviour, Depression, Dry Mouth, Erectile Dysfunction, Insomnia, Somnolence
5849360 4726767 9 Years M 4/20/2005 7/25/2005 96 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Skin Discolouration
5849361 4726768 7 Years M 3/1/2005 4/21/2005 7/25/2005 95 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Fatigue
5849362 4726769     M 4/18/2005 7/25/2005 98 OT PER Strattera Premature Ejaculation, Urethral Discharge
5849366 4726800     M 1/1/2005 4/26/2005 7/25/2005 90 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Urine Present, Epididymitis, General Symptom, Headache, Insomnia, Stomach Discomfort, Testicular Mass, Testicular Pain
5849368 4726801 65 Years M 4/26/2005 4/26/2005 7/25/2005 90 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Hypokinesia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849371 4726802     M 4/27/2005 7/25/2005 89 MD PER Strattera Dysuria, Ejaculation Disorder
5849372 4726803     F 4/26/2005 7/25/2005 90 MD PER Strattera Raynaud's Phenomenon
5849375 4726804 31 Years M 4/26/2005 7/25/2005 90 OT PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Heart Rate Increased, Nervousness, Panic Disorder
5849376 4726805 12 Years M 4/27/2005 7/25/2005 89 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort, Flatulence, Vomiting
5849378 4727693 60 Years M 4/27/2005 4/29/2005 7/25/2005 87 PH PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Dyspnoea, Feeling Abnormal, Hypotension
5849379 4726806 9 Years M 4/25/2005 4/26/2005 7/25/2005 90 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Feeling Hot, Flushing, Pallor, Skin Discolouration, Tachycardia, Vomiting
5849380 4727695 7 Years M 1/1/2005 4/28/2005 7/25/2005 88 CN PER Strattera Psychomotor Hyperactivity Conduct Disorder, Decreased Appetite, Lethargy, Nausea
5849381 4727697 10 Years M 1/1/2005 4/29/2005 7/25/2005 87 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Tic, Vomiting
5849383 4727699 7 Years M 4/27/2005 7/25/2005 89 MD PER Strattera Irritability, Restlessness, Tic
5849384 4726807 9 Years M 4/1/2005 4/27/2005 7/25/2005 89 PH PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anxiety, Arthralgia, Asthenia, Drug Ineffective, Dyspepsia, Micturition Urgency, Pain
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849385 4727701     F 5/3/2005 7/25/2005 83 MD PER Strattera
5849386 4726808     M 4/1/2005 4/22/2005 7/25/2005 94 MD PER Strattera Attention Deficit/Hyperactivity Disorder Suicidal Ideation
5849387 4727703 7 Years F 4/29/2005 7/25/2005 87 MD PER Strattera Hallucination
5849388 4727704 49 Years M 4/29/2005 7/25/2005 87 PER Strattera Attention Deficit/Hyperactivity Disorder Psychomotor Hyperactivity
5849389 4727705 10 Years M 4/29/2005 7/25/2005 87 MD PER Strattera Fracture
5849390 4726809     M 4/28/2005 4/28/2005 7/25/2005 88 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Dizziness, Nausea, Tremor
5849391 4727706 49 Years F 4/29/2005 7/25/2005 87 PER Strattera Anxiety, Blood Pressure Increased, Stomach Discomfort
5849392 4727707     M 5/19/2005 7/25/2005 67 PER Strattera Anger, Depression, Diarrhoea, Insomnia, Verbal Abuse, Vomiting
5849393 4726790 7 Years M 4/14/2005 7/25/2005 102 MD PER Strattera Irritability, Mood Swings, Suicidal Ideation
5849394 4726791 9 Years M 4/14/2005 7/25/2005 102 MD PER Strattera Irritability, Mood Swings, Suicidal Ideation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849398 4726792     F 4/26/2005 7/25/2005 90 PER Strattera Disturbance in Attention, Drug Ineffective, Nervousness
5849400 4726793 17 Years M 5/3/2005 7/25/2005 83 PER Strattera Disturbance in Attention, Drug Ineffective, Nervousness
5849402 4726794 26 Years M 2/15/2005 4/25/2005 7/25/2005 91 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Feeling Abnormal, Heart Rate Increased, Mydriasis, Psychomotor Hyperactivity
5849403 4726795 16 Years M 1/1/2003 4/26/2005 7/25/2005 90 CN PER Strattera Attention Deficit/Hyperactivity Disorder Antisocial Behaviour, Crying, Depression, Educational Problem, Excitability, Feeling Abnormal, Insomnia, Mood Swings, Obsessive-Compulsive Disorder
5849404 4727709 28 Years M 5/2/2005 7/25/2005 84 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Anorexia, Faeces Discoloured, Stomach Discomfort
5849405 4727711 5 Years 5/3/2005 7/25/2005 83 MD PER Strattera Tic
5849406 4727713 11 Years F 5/3/2005 5/3/2005 7/25/2005 83 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation
5849408 4726796 8 Years F 4/26/2005 7/25/2005 90 PH PER Strattera Abdominal Pain Upper, Headache, Mydriasis
5849409 4727715 13 Years M 5/3/2005 7/25/2005 83 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective
5849410 4727717 38 Years M 5/1/2005 5/4/2005 7/25/2005 82 OT PER Strattera Attention Deficit/Hyperactivity Disorder Panic Attack, Pruritus
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849412 4727719     M 4/27/2005 7/25/2005 89 MD PER Strattera Dysuria, Ejaculation Disorder
5849414 4726797 8 Years M 4/26/2005 7/25/2005 90 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5849415 4727720 53 Years F 1/1/2005 5/5/2005 7/25/2005 81 PER Strattera Attention Deficit/Hyperactivity Disorder Gingival Swelling, Hallucination, Hallucination (Auditory), Libido Decreased
5849416 4727722 7 Years M 5/2/2005 7/25/2005 84 MD PER Strattera Psychotic Disorder
5849417 4726798 8 Years M 4/26/2005 7/25/2005 90 PER Strattera Attention Deficit/Hyperactivity Disorder Growth Retardation, Nausea
5849418 4727724 10 Years M 5/4/2005 7/25/2005 82 PER Strattera Attention Deficit/Hyperactivity Disorder Hirsutism, Somnolence, Vomiting, Weight Increased
5849420 4726799 35 Years F 4/26/2005 7/25/2005 90 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Nausea, Pharyngeal Oedema, Vomiting
5849421 4727730 32 Years M 5/1/2005 5/20/2005 7/25/2005 66 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Road Traffic Accident, Sexual Dysfunction, Somnolence
5849423 4727732 15 Years F 1/1/2005 5/23/2005 7/25/2005 63 PER Strattera Attention Deficit/Hyperactivity Disorder Hot Flush
5849425 4727733 9 Years M 1/1/2004 5/23/2005 7/25/2005 63 PER Strattera Attention Deficit/Hyperactivity Disorder Depressed Mood, Lethargy
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849426 4727734 8 Years M 5/23/2005 7/25/2005 63 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Irritability, Lethargy
5849427 4726780 29 Years M 4/20/2005 5/5/2005 7/25/2005 81 PER Strattera Disturbance in Attention Abdominal Tenderness, Decreased Appetite, Dry Mouth, Dysuria
5849428 4727736 7 Years F 5/1/2005 5/23/2005 7/25/2005 63 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5849429 4727738 33 Years F 5/10/2005 5/23/2005 7/25/2005 63 PER Strattera Activities of Daily Living Impaired, Constipation, Drug Ineffective, Drug Intolerance, Drug Tolerance Decreased, Feeling Abnormal, Hypoaesthesia, Libido Disorder, Somnolence, Thinking Abnormal
5849430 4726781 5 Years M 4/12/2005 4/25/2005 7/25/2005 91 PER Strattera Attention Deficit/Hyperactivity Disorder Compulsions
5849431 4727741 11 Years F 5/24/2005 7/25/2005 62 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Headache
5849431 4783683 11 Years F 5/24/2005 9/27/2005 126 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Abnormal Behaviour, Headache
5849432 4727743 19 Years M 5/24/2005 7/25/2005 62 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blepharospasm
5849433 4727745 9 Years M 5/27/2005 7/25/2005 59 PER Strattera Abnormal Behaviour, Decreased Appetite, Malaise, Somnolence
5849433 4783685 9 Years M 5/27/2005 9/27/2005 123 PER Strattera Abnormal Behaviour, Decreased Appetite, Malaise, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849434 4726782 52 Years F 4/22/2005 7/25/2005 94 PER Strattera Attention Deficit/Hyperactivity Disorder Chills, Dry Mouth, Feeling Cold
5849435 4727747 43 Years F 5/24/2005 7/25/2005 62 MD PER Strattera Panic Attack, Tremor
5849439 4726783 50 Years F 4/21/2005 7/25/2005 95 MD PER Strattera Arrhythmia
5849440 4726784 50 Years F 4/21/2005 7/25/2005 95 MD PER Strattera Arrhythmia
5849442 4726785 9 Years M 4/1/2005 4/25/2005 7/25/2005 91 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hypersensitivity Hospitalization - Initial or Prolonged
5849443 4726707 6 Years F 3/22/2005 7/25/2005 125 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Drug Ineffective, Hypersomnia, Insomnia, Psychomotor Hyperactivity
5849444 4726786 19 Years M 4/25/2005 7/25/2005 91 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention
5849445 4726708 36 Years F 4/15/2005 7/25/2005 101 OT PER Strattera Attention Deficit/Hyperactivity Disorder Hypertension, Vision Blurred
5849448 4726788 16 Years M 4/22/2005 4/22/2005 7/25/2005 94 MD PER Strattera Blood Pressure Orthostatic, Drug Interaction, Hypotension
5849450 4726789 19 Years M 4/1/2005 4/26/2005 7/25/2005 90 PER Strattera
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849452 4726810 59 Years M 4/25/2005 5/13/2005 7/25/2005 73 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Feeling Abnormal, Nocturia, Psychomotor Hyperactivity, Testicular Pain
5849453 4726689 8 Years F 5/26/2003 5/11/2005 7/25/2005 75 PER Strattera Attention Deficit/Hyperactivity Disorder Arthralgia, Blood Alkaline Phosphatase Increased, Neutrophil Count Increased, Oedema, Pyrexia, Rash, Red Blood Cell Sedimentation Rate Increased
5849454 4726690 11 Years M 1/1/2003 3/21/2005 7/25/2005 126 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Disturbance in Attention, Erythema, Fatigue, Stomach Discomfort, Tachycardia
5849455 4726811 35 Years M 2/1/2005 4/27/2005 7/25/2005 89 PER Strattera Attention Deficit/Hyperactivity Disorder Rash, Urticaria
5849457 4726812 33 Years M 4/1/2005 5/17/2005 7/25/2005 69 PER Strattera Attention Deficit/Hyperactivity Disorder Crying, Depression, Diarrhoea, Feeling Abnormal, Insomnia, Mood Swings, Paranoia, Somnolence, Suicidal Ideation, Verbal Abuse
5849458 4726813 12 Years M 4/28/2005 7/25/2005 88 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Educational Problem
5849461 4726814 43 Years F 4/27/2005 4/28/2005 7/25/2005 88 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Flushing, Headache
5849463 4726815 23 Years F 4/27/2005 7/25/2005 89 MD PER Strattera Photosensitivity Reaction
5849464 4726816 17 Years M 4/28/2005 7/25/2005 88 PER Strattera Disturbance in Attention Anger, Irritability
5849465 4726817 62 Years F 4/28/2005 7/25/2005 88 PER Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849467 4726818     M 4/28/2005 7/25/2005 88 MD PER Strattera Semen Abnormal
5849469 4726819 31 Years M 4/22/2005 4/28/2005 7/25/2005 88 PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Nausea, Somnolence
5849486 4727670 12 Years M 5/2/2005 7/25/2005 84 MD PER Strattera Attention Deficit/Hyperactivity Disorder Delusional Disorder (Persecutory Type), Sleep Walking
5849487 4727673     M 1/1/2005 5/2/2005 7/25/2005 84 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Dry Mouth, Dysuria, Insomnia
5849488 4727675 34 Years M 5/2/2005 7/25/2005 84 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective
5849489 4727678     M 1/1/2005 5/3/2005 7/25/2005 83 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Tinnitus
5849490 4727679 12 Years M 5/3/2005 7/25/2005 83 PER Strattera Abdominal Pain Upper
5849492 4727680 10 Years M 5/3/2005 5/3/2005 7/25/2005 83 OT PER Strattera Attention Deficit/Hyperactivity Disorder Varicella
5849494 4727682 49 Years F 5/2/2005 7/25/2005 84 MD PER Strattera
5849495 4727683 14 Years M 5/3/2005 7/25/2005 83 PH PER Strattera Attention Deficit/Hyperactivity Disorder Hypoaesthesia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849497 4727685 8 Years M 5/2/2005 7/25/2005 84 MD PER Strattera Attention Deficit/Hyperactivity Disorder Akathisia, Irritability
5849498 4727687     F 5/3/2005 7/25/2005 83 PER Strattera Performance Status Decreased
5849528 4727943 7 Years F 3/22/2005 3/23/2005 7/25/2005 124 PER Strattera Malaise, Pallor, Palpitations, Somnolence, Tremor
5849529 4727944 8 Years M 3/23/2005 7/25/2005 124 PER Strattera Attention Deficit/Hyperactivity Disorder Malaise, Somnolence, Vomiting
5849529 4783652 8 Years M 7/20/2005 9/27/2005 69 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Malaise, Mood Swings, Social Avoidant Behaviour, Somnolence, Vomiting
5849531 4727945 7 Years M 3/1/2005 3/23/2005 7/25/2005 124 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Increased Appetite, Weight Increased
5849532 4727946 26 Years F 3/23/2005 3/23/2005 7/25/2005 124 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Blepharospasm, Fatigue, Paraesthesia, Piloerection
5849534 4727947 29 Years F 3/23/2005 3/24/2005 7/25/2005 123 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Dizziness, Dyspnoea, Nausea, Stomach Discomfort, Tremor
5849536 4727948     F 3/23/2005 7/25/2005 124 PER Strattera Hypersensitivity, Lacrimation Increased, Rhinorrhoea, Sneezing
5849538 4727949 16 Years M 3/24/2005 7/25/2005 123 MD PER Strattera Attention Deficit/Hyperactivity Disorder Galactorrhoea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5849540 4727950 6 Years M 3/23/2005 7/25/2005 124 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dysphagia, Early Morning Awakening, Mood Altered, Somnolence, Vomiting
5849542 4727951     F 3/23/2005 3/23/2005 7/25/2005 124 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
5850074 4726539 12 Years 2/23/2005 7/25/2005 152 OT PER Strattera
5850076 4726543 8 Years M 3/10/2005 7/25/2005 137 OT PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Nervousness, Tic
5850077 4726550 8 Years M 3/9/2005 7/25/2005 138 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Decreased Appetite, Nausea
5850079 4726555 7 Years F 2/1/2005 3/9/2005 7/25/2005 138 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Fluid Intake Reduced, Hyperphagia, Pollakiuria, Urine Abnormality
5850090 4726559 8 Years F 3/7/2005 7/25/2005 140 MD PER Strattera Muscle Twitching
5850648 4725157 65 Years M 3/17/2005 7/5/2005 7/25/2005 20 MD EXP Strattera Anaesthetic Complication, Blood Pressure Decreased, Therapy Non-Responder Other
5851596 4724683 9 Years M 6/18/2005 7/19/2005 CN DIR Strattera Bone Density Decreased, Fall, Injury, Weight Decreased
5853530 4730390 5 Years M 4/12/2005 7/25/2005 104 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Drug Ineffective, Nausea
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5853533 4730399 48 Years M 4/13/2005 7/25/2005 103 PER Strattera Attention Deficit/Hyperactivity Disorder Change of Bowel Habit, Dysuria, Insomnia
5853536 4730408 46 Years M 4/1/2005 4/13/2005 7/25/2005 103 CN PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
5853539 4730417 6 Years M 1/1/2005 4/13/2005 7/25/2005 103 PER Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder, Drug Ineffective
5853540 4730420 4 Years F 6/7/2005 7/25/2005 48 OT PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain
5853540 4783659 4 Years F 6/13/2005 9/27/2005 106 OT PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain
5853548 4730422 30 Years F 4/6/2005 4/13/2005 7/25/2005 103 PER Strattera Attention Deficit/Hyperactivity Disorder Amenorrhoea
5853551 4730441 15 Years M 4/20/2005 7/25/2005 96 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased, Electrocardiogram Abnormal
5853551 4783663 15 Years M 7/20/2005 9/27/2005 69 MD PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Increased
5853555 4730445 51 Years F 4/13/2005 4/14/2005 7/25/2005 102 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Drunk
5853568 4730447 15 Years M 4/13/2005 7/25/2005 103 MD PER Strattera Suicidal Ideation
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5853572 4730449 16 Years M 4/1/2005 4/14/2005 7/25/2005 102 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspepsia, Nausea, Oesophageal Pain
5855090 4733643     M 7/12/2005 7/29/2005 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Condition Aggravated, Epilepsy Hospitalization - Initial or Prolonged
5855235 4730596     M 3/11/2005 7/25/2005 136 PER Strattera Attention Deficit/Hyperactivity Disorder
5855247 4730597 22 Years F 3/11/2005 3/11/2005 7/25/2005 136 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Heart Rate Increased
5855251 4730598 5 Years M 2/1/2005 3/14/2005 7/25/2005 133 PER Strattera Nightmare
5855255 4730599 13 Years F 3/14/2005 7/25/2005 133 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5855267 4730600 13 Years M 7/25/2005 PER Strattera Retching
5855268 4730601 12 Years M 3/10/2005 7/25/2005 137 MD PER Strattera Mydriasis
5855272 4730602 6 Years M 3/14/2005 7/25/2005 133 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Depression, Mood Swings, Skin Discolouration
5855287 4730607 6 Years M 3/14/2005 7/25/2005 133 PER Strattera Abnormal Behaviour, Mood Swings
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5855291 4730615 7 Years F 12/1/2004 3/14/2005 7/25/2005 133 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Fatigue, Feeling Abnormal, Hypersomnia, Lethargy, Mononucleosis Syndrome, Restlessness, Somnolence
5855302 4730616 4 Years F 3/8/2005 7/25/2005 139 PER Strattera Retching
5855305 4730617 37 Years M 3/11/2005 7/25/2005 136 OT PER Strattera Ejaculation Disorder, Orchitis, Scrotal Disorder, Urinary Hesitation
5855311 4730618 24 Years F 1/1/2005 3/8/2005 7/25/2005 139 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Headache, Menstruation Irregular, Neurological Symptom
5855314 4730619 32 Years F 3/7/2004 7/25/2005 505 OT PER Strattera
5855317 4730620 22 Years M 3/8/2005 3/8/2005 7/25/2005 139 PER Strattera Attention Deficit/Hyperactivity Disorder Disorientation, Dizziness, Fatigue, Nausea
5855318 4730621 63 Years M 3/8/2005 7/25/2005 139 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Feeling Abnormal, Memory Impairment
5855321 4730627 35 Years M 3/8/2005 7/25/2005 139 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Balance Disorder, Blood Pressure Increased, Central Nervous System Stimulation, Dizziness, Feeling Abnormal, Hypoaesthesia, Insomnia
5855323 4730628 7 Years F 3/17/2005 7/25/2005 130 PER Strattera Gastrointestinal Disorder
5855325 4730629 44 Years M 2/1/2005 3/8/2005 7/25/2005 139 PER Strattera Disturbance in Attention Back Pain, Dyspnoea, Dysuria, Testicular Pain, Weight Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5855327 4730630 8 Years M 3/8/2005 3/8/2005 7/25/2005 139 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour
5856728 4733575 15 Years M 7/13/2005 7/29/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Appetite Disorder, Liver Function Test Abnormal
5856728 4746312 15 Years M 7/28/2005 8/15/2005 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Anorexia, Blood Albumin Increased, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Cough, Globulins Decreased, Liver Function Test Abnormal, Lower Respiratory Tract Infection, Nausea, White Blood Cell Count Decreased
5856728 4822136 15 Years M 10/13/2005 11/3/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Anorexia, Blood Albumin Increased, Cough, Globulins Decreased, Liver Function Test Abnormal, Lower Respiratory Tract Infection, Nausea, Pyrexia, Weight Decreased
5856849 4730640 15 Years F 12/1/2004 3/4/2005 7/25/2005 143 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Dyspnoea, Fatigue, Pallor
5856857 4730641 44 Years M 2/1/2005 3/4/2005 7/25/2005 143 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dry Mouth, Dysuria, Heart Rate Increased, Libido Disorder, Nervousness, Testicular Pain
5856860 4730642     M 3/4/2005 7/25/2005 143 PER Strattera Affective Disorder, Aggression, Agitation
5856861 4730643 8 Years M 3/7/2005 7/25/2005 140 PER Strattera Attention Deficit/Hyperactivity Disorder Oral Discomfort, Retching, Vomiting
5856866 4730644 51 Years F 3/3/2005 3/4/2005 7/25/2005 143 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Middle Insomnia, Psychomotor Hyperactivity, Somnolence
5856869 4730647 8 Years M 3/1/2005 3/7/2005 7/25/2005 140 PER Strattera Dysphagia, Retching, Vomiting
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5856895 4730648 15 Years M 3/7/2005 7/25/2005 140 OT PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Educational Problem, Stomach Discomfort, Vomiting
5856913 4730649 58 Years F 2/26/2005 3/7/2005 7/25/2005 140 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Disturbance in Attention, Dry Mouth
5856919 4730650 10 Years F 3/25/2005 7/25/2005 122 MD PER Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Increased, Palpitations
5856924 4730651 8 Years F 2/28/2005 3/25/2005 7/25/2005 122 MD PER Strattera Attention Deficit/Hyperactivity Disorder Heart Rate Increased, Palpitations Other
5857172 4734297 15 Years M 7/7/2005 7/29/2005 22 MD EXP Strattera Alanine Aminotransferase Increased
5857175 4734300 9 Years F 7/8/2005 7/29/2005 21 MD EXP Strattera Convulsion Hospitalization - Initial or Prolonged
5857175 4784567 9 Years F 9/13/2005 9/28/2005 15 MD EXP Strattera Convulsion Hospitalization - Initial or Prolonged
5857175 4870640 9 Years F 12/16/2005 12/28/2005 12 MD EXP Strattera Convulsion, Drug Ineffective, Hypertensive Encephalopathy, Pyrexia, Sleep Disorder Hospitalization - Initial or Prolonged
5857178 4734304 72 Years M 4/1/2005 7/7/2005 7/29/2005 22 MD EXP Strattera Dyspnoea, Fatigue, Liver Function Test Abnormal, Pyrexia, Urinary Tract Infection Hospitalization - Initial or Prolonged
5857397 4733667 11 Years F 7/13/2005 7/29/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Apathy, Asthenia, Chills, Depression, Feeling Cold, Flat Affect Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5857400 4733669 16 Years M 7/11/2005 7/29/2005 18 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased
5857406 4733671 15 Years F 7/6/2005 7/7/2005 7/29/2005 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Breast Pain, C-Reactive Protein Increased, Malaise, Myocarditis, Respiratory Tract Infection, Ventricular Extrasystoles Hospitalization - Initial or Prolonged, Other
5857406 4746315 15 Years F 7/6/2005 8/1/2005 8/15/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Potassium Increased, Blood Pressure Decreased, Breast Pain, Lymphadenopathy, Myocarditis, Respiratory Tract Infection, Ventricular Extrasystoles Hospitalization - Initial or Prolonged
5857406 4765624 15 Years F 7/6/2005 8/22/2005 9/6/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Calcium Decreased, Blood Potassium Increased, Blood Pressure Diastolic Decreased, Breast Pain, Infection, Lymphadenopathy, Malaise, Myocarditis, Pharyngeal Erythema, Respiratory Tract Infection, Rhinitis, Ventricular Extrasystoles Hospitalization - Initial or Prolonged
5857508 4730545 9 Years M 2/16/2005 7/25/2005 159 CN PER Strattera Attention Deficit/Hyperactivity Disorder Communication Disorder, Impulsive Behaviour, Logorrhoea, Restlessness
5857509 4730548     M 2/16/2005 7/25/2005 159 MD PER Strattera Abdominal Discomfort, Decreased Appetite, Insomnia
5857513 4735118 17 Years F 7/18/2005 8/4/2005 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Educational Problem, Learning Disorder, Overdose, Stress, Suicide Attempt Hospitalization - Initial or Prolonged
5857513 4747184 17 Years F 7/28/2005 8/15/2005 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Overdose, Suicide Attempt Hospitalization - Initial or Prolonged
5857515 4730549 50 Years F 11/1/2004 2/16/2005 7/25/2005 159 CN PER Strattera Attention Deficit/Hyperactivity Disorder Lower Limb Fracture
5857518 4735119 24 Years F 7/19/2005 8/4/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Amnesia, Dizziness, Hallucination, Loss of Consciousness Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5857518 4747182 24 Years F 5/15/2005 8/1/2005 8/15/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Amnesia, Dizziness, Drug Withdrawal Syndrome, Haematocrit Decreased, Haemoglobin Decreased, Hallucination, Loss of Consciousness, White Blood Cell Count Decreased Hospitalization - Initial or Prolonged, Other
5857519 4730550 40 Years F 2/2/2005 5/18/2005 7/25/2005 68 CN PER Strattera Heart Rate Increased, Insomnia, Middle Insomnia, Palpitations, Restlessness
5857519 4784024 40 Years F 2/2/2005 5/18/2005 9/27/2005 132 PER Strattera Heart Rate Increased, Insomnia, Middle Insomnia, Palpitations, Restlessness
5857522 4730555 47 Years F 2/3/2005 2/17/2005 7/25/2005 158 CN PER Strattera Anxiety, Constipation, Dizziness, Drug Ineffective, Fatigue, Nervousness
5857527 4735120     M 7/13/2005 8/4/2005 22 MD EXP Strattera Hepatic Function Abnormal
5857533 4730559 56 Years F 2/7/2005 4/29/2005 7/25/2005 87 CN PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Dizziness, Dry Eye, Dry Mouth, Dysgeusia, Eructation, Nausea, Tongue Coated, Urine Flow Decreased
5857537 4730562 45 Years M 2/16/2005 7/25/2005 159 PH PER Strattera Attention Deficit/Hyperactivity Disorder
5857547 4730565 10 Years M 2/16/2005 2/17/2005 7/25/2005 158 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Blood Pressure Increased, Erythema, Heart Rate Increased, Pyrexia, Stomach Discomfort
5857550 4735121 25 Years F 12/1/2004 7/15/2005 8/4/2005 20 MD EXP Strattera Liver Disorder
5857550 4785028 25 Years F 12/1/2004 9/14/2005 9/28/2005 14 MD EXP Strattera Autoimmune Hepatitis Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5857590 4730567 54 Years M 2/11/2005 2/17/2005 7/25/2005 158 CN PER Strattera Anger, Dizziness, Feeling Abnormal, Mydriasis
5857594 4730568 27 Years M 2/3/2005 2/17/2005 7/25/2005 158 CN PER Strattera Attention Deficit/Hyperactivity Disorder Blood Glucose Decreased, Feeling Abnormal
5857644 4730452 4 Years M 4/11/2005 4/15/2005 7/25/2005 101 CN PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Decreased Appetite, Lethargy, Somnolence
5857645 4730459 7 Years F 4/1/2005 4/15/2005 7/25/2005 101 CN PER Strattera Abdominal Pain Upper, Mydriasis, Nausea
5857646 4730461 15 Years M 4/13/2005 7/25/2005 103 MD PER Strattera Muscle Spasms, Muscular Weakness
5857648 4730463 12 Years F 4/15/2005 7/25/2005 101 MD PER Strattera Attention Deficit/Hyperactivity Disorder Tic, Tremor
5857650 4730469 8 Years M 2/1/2005 4/12/2005 7/25/2005 104 MD PER Strattera Urinary Hesitation
5857656 4735122 10 Years M 7/15/2005 8/4/2005 20 EXP Strattera Asperger's Disorder Grand Mal Convulsion Other
5857659 4730478 33 Years F 4/13/2005 7/25/2005 103 MD PER Strattera Attention Deficit/Hyperactivity Disorder Raynaud's Phenomenon
5857662 4730479 12 Years F 4/15/2005 7/25/2005 101 MD PER Strattera Attention Deficit/Hyperactivity Disorder Flushing, Mydriasis, Peripheral Coldness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5857663 4735123 6 Years F 7/14/2005 8/4/2005 21 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5857664 4730480     F 4/15/2005 7/25/2005 101 CN PER Strattera Fibromyalgia Pain in Extremity
5857665 4730481 9 Years M 4/18/2005 7/25/2005 98 MD PER Strattera Attention Deficit/Hyperactivity Disorder Emotional Distress, Erythema, Heart Rate Increased, Hypertension
5857668 4730531     M 2/9/2005 7/25/2005 166 MD PER Strattera
5857670 4735124 14 Years M 7/15/2005 7/19/2005 8/4/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased, Jaundice, Monocyte Count Increased, White Blood Cell Count Decreased
5857671 4730533     F 2/9/2005 7/25/2005 166 MD PER Strattera Affective Disorder, Somnolence
5857673 4730534     M 2/9/2005 7/25/2005 166 MD PER Strattera Abdominal Discomfort, Decreased Appetite, Nausea, Vomiting
5857675 4730536     M 2/10/2005 7/25/2005 165 MD PER Strattera Abdominal Discomfort
5857679 4735125 11 Years M 7/14/2005 8/4/2005 21 EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5857682 4730537     M 2/10/2005 7/25/2005 165 OT PER Strattera Blood Cholesterol Increased, Low Density Lipoprotein, Total Cholesterol/HDL Ratio Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5857686 4735126 12 Years M 7/19/2005 8/4/2005 16 MD EXP Strattera Convulsion Other
5857686 4759958 11 Years M 7/7/2005 8/11/2005 8/31/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Pyrexia Other
5857687 4730539 24 Years F 1/1/2005 2/10/2005 7/25/2005 165 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Feeling Cold, Sluggishness
5857689 4730540     M 2/10/2005 7/25/2005 165 OT PER Strattera Blood Cholesterol Increased, Low Density Lipoprotein, Total Cholesterol/HDL Ratio Abnormal
5857693 4730544 41 Years F 2/2/2005 2/10/2005 7/25/2005 165 PER Strattera Conjunctivitis Allergic, Eye Irritation
5857694 4730546 11 Years M 2/10/2005 7/25/2005 165 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Fatigue, Mood Swings, Weight Increased
5857696 4730547 34 Years F 2/11/2005 7/25/2005 164 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort
5857698 4730508 32 Years M 2/11/2005 7/25/2005 164 PER Strattera Attention Deficit/Hyperactivity Disorder Anorgasmia, Dry Mouth, Erectile Dysfunction, Testicular Pain
5857699 4730509 13 Years F 3/4/2005 7/25/2005 143 MD PER Strattera Attention Deficit/Hyperactivity Disorder Back Pain, Systemic Lupus Erythematosus
5857700 4730511 11 Years M 2/14/2005 2/14/2005 7/25/2005 161 PER Strattera
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5857701 4730512 11 Years F 2/10/2005 7/25/2005 165 MD PER Strattera Attention Deficit/Hyperactivity Disorder Flat Affect
5857704 4730514     F 2/4/2005 2/14/2005 7/25/2005 161 PER Strattera Constipation, Nausea, Retching
5857705 4730515 38 Years M 2/1/2005 3/4/2005 7/25/2005 143 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Dysphonia, Musculoskeletal Discomfort, Nausea
5857707 4730517 24 Years M 2/1/2005 2/14/2005 7/25/2005 161 PER Strattera Anorexia, Dry Mouth, Dysuria, Erectile Dysfunction, Scrotal Disorder, Scrotal Irritation, Sleep Disorder, Urinary Incontinence
5857710 4730518 8 Years M 1/1/2004 2/15/2005 7/25/2005 160 PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Mood Swings, Pruritus, Weight Decreased
5857714 4730520 7 Years M 2/1/2005 2/15/2005 7/25/2005 160 PER Strattera Dyskinesia
5857717 4730525 5 Years F 3/3/2005 7/25/2005 144 MD PER Strattera Attention Deficit/Hyperactivity Disorder Raynaud's Phenomenon, Skin Discolouration
5857748 4730551 8 Years M 2/1/2005 3/17/2005 7/25/2005 130 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Drug Ineffective
5857753 4730552 63 Years F 3/16/2005 3/16/2005 7/25/2005 131 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
5857755 4730553 8 Years M 10/1/2004 3/16/2005 7/25/2005 131 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5857758 4730557 53 Years F 2/1/2005 3/16/2005 7/25/2005 131 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Hypersomnia
5857759 4730558 20 Years M 3/1/2005 3/17/2005 7/25/2005 130 PER Strattera Attention Deficit/Hyperactivity Disorder Nasopharyngitis
5857761 4730560 41 Years F 3/13/2005 3/16/2005 7/25/2005 131 PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Disturbance in Attention, Fatigue, Lethargy, Malaise, Nausea, Somnolence, Vomiting
5857763 4730561 19 Years M 3/16/2005 3/17/2005 7/25/2005 130 OT PER Strattera Decreased Activity, Dizziness, Fatigue, Feeling Abnormal, Heart Rate Increased, Heart Rate Irregular, Pallor
5857763 4783650 19 Years M 3/16/2005 6/20/2005 9/27/2005 99 OT PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Activity, Dizziness, Fatigue, Feeling Abnormal, Heart Rate Increased, Heart Rate Irregular, Hyperhidrosis, Pallor, Palpitations, Sinus Tachycardia
5857766 4730563 21 Years M 12/1/2003 3/17/2005 7/25/2005 130 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Aggression, Weight Decreased
5857768 4730564 8 Years M 3/17/2005 7/25/2005 130 PER Strattera Attention Deficit/Hyperactivity Disorder Stomach Discomfort
5857769 4730566 8 Years M 3/17/2005 3/18/2005 7/25/2005 129 PER Strattera Disturbance in Attention, Psychomotor Hyperactivity Chest Pain
5857771 4730569 8 Years M 1/25/2005 3/16/2005 7/25/2005 131 PER Strattera Attention Deficit/Hyperactivity Disorder Erythema, Migraine
5857774 4730570 12 Years M 3/15/2005 3/16/2005 7/25/2005 131 CN PER Strattera Attention Deficit/Hyperactivity Disorder Herpes Simplex, Pharyngitis Streptococcal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5857776 4730571 53 Years F 3/1/2005 3/22/2005 7/25/2005 125 PER Strattera Attention Deficit/Hyperactivity Disorder Bladder Spasm, Blood Pressure Diastolic Increased, Dysuria, Insomnia, Sexual Dysfunction, Urinary Hesitation
5857778 4730572 20 Years M 3/16/2005 7/25/2005 131 MD PER Strattera Abdominal Discomfort, Somnolence
5857780 4730573 43 Years F 3/16/2005 7/25/2005 131 MD PER Strattera Abdominal Discomfort
5857782 4730574     M 2/8/2005 7/25/2005 167 MD PER Strattera
5857785 4730575     F 3/15/2005 7/25/2005 132 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Influenza Like Illness, Nausea
5857786 4730576 63 Years M 3/16/2005 7/25/2005 131 MD PER Strattera Abdominal Discomfort, Urinary Hesitation
5857791 4730577 69 Years F 5/31/2005 7/25/2005 55 PER Strattera Abnormal Behaviour, Drug Ineffective, Dry Mouth, Mood Swings, Paraesthesia, Rash, Suicidal Ideation, Thinking Abnormal
5857791 4783648 69 Years F 5/31/2005 9/27/2005 119 PER Strattera Abnormal Behaviour, Drug Ineffective, Dry Mouth, Mood Swings, Paraesthesia, Rash, Suicidal Ideation, Thinking Abnormal
5857793 4730578 26 Years M 3/16/2005 7/25/2005 131 PER Strattera Crying, Mood Swings, Suicidal Ideation
5858217 4730579 28 Years F 8/1/2004 3/14/2005 7/25/2005 133 PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Nervousness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5858226 4730580 66 Years F 3/15/2005 3/28/2005 7/25/2005 119 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Rectal Haemorrhage
5858232 4730581 11 Years M 3/1/2005 3/14/2005 7/25/2005 133 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anger, Chapped Lips, Emotional Disorder, Emotional Disorder of Childhood, Lip Pain, Middle Insomnia, Mood Swings, Nightmare, Sleep Talking
5858244 4730582 55 Years M 3/15/2005 7/25/2005 132 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Dehydration, Drug Screen Positive, Fatigue, Feeling Abnormal, Lip Dry, Palpitations, Stress, Thirst
5858245 4734938 33 Years F 7/8/2005 7/29/2005 21 MD EXP Strattera Alanine Aminotransferase Increased Other
5858253 4730583 4 Years M 1/1/2005 3/15/2005 7/25/2005 132 PER Strattera Disturbance in Attention Anorexia, Constipation, Ear Infection, Pharyngitis
5858263 4730584 8 Years M 3/31/2005 7/25/2005 116 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance in Attention, Drug Ineffective, Educational Problem, Logorrhoea, Restlessness
5858274 4730585 30 Years F 3/15/2005 7/25/2005 132 OT PER Strattera Dysmenorrhoea, Somnolence, Vaginal Discharge
5858285 4730586 46 Years F 3/11/2005 3/15/2005 7/25/2005 132 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Dry Mouth, Nocturia, Sleep Disorder, Thirst
5858291 4730587     M 3/15/2005 7/25/2005 132 PH PER Strattera Thermal Burn
5858297 4730588 45 Years F 3/16/2005 7/25/2005 131 MD PER Strattera Tremor
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5858545 4735738 16 Years M 7/19/2005 8/2/2005 14 OT EXP Strattera Hepatic Enzyme Increased
5858718 4730743 58 Years F 3/17/2005 7/25/2005 130 PER Strattera Disturbance in Attention, Memory Impairment Abdominal Distension, Chills, Constipation, Insomnia, Lethargy, Somnolence
5858739 4730744 8 Years M 3/18/2005 7/25/2005 129 MD PER Strattera Myalgia
5858741 4730745 22 Years F 3/16/2005 3/18/2005 7/25/2005 129 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Initial Insomnia
5858745 4730746 60 Years F 3/18/2005 7/25/2005 129 PER Strattera Attention Deficit/Hyperactivity Disorder Acne, Dizziness, Influenza Like Illness, Middle Ear Effusion, Nightmare, Sensory Disturbance, Tinnitus
5858746 4730747     M 3/18/2005 7/25/2005 129 PH PER Strattera
5858754 4730748 17 Years F 5/18/2005 7/25/2005 68 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Dreams, Confusional State, Dissociation, Feeling Abnormal, Malaise, Somnolence, Stomach Discomfort
5858762 4730749 12 Years M 5/18/2005 7/25/2005 68 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Sleep-Related Event, Nightmare, Somnolence
5858767 4730750 20 Years M 5/1/2005 5/18/2005 7/25/2005 68 PH PER Strattera Attention Deficit/Hyperactivity Disorder Tinnitus
5858774 4730751 11 Years M 5/16/2005 7/25/2005 70 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5858785 4730752 56 Years M 5/19/2005 7/25/2005 67 PER Strattera Attention Deficit/Hyperactivity Disorder Erectile Dysfunction, Micturition Urgency
5858787 4730297 11 Years F 4/10/2005 4/11/2005 7/25/2005 105 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea
5858822 4730755 46 Years M 5/15/2005 5/17/2005 7/25/2005 69 PER Strattera Anxiety, Confusional State, Fatigue, Fear, Feeling Abnormal, Feeling Guilty, Immobile, Insomnia, Nervousness, Obsessive-Compulsive Disorder
5858824 4730756     F 5/17/2005 7/25/2005 69 PER Strattera Abdominal Pain Upper, Mood Swings
5858827 4730757 9 Years M 5/13/2005 7/25/2005 73 PER Strattera Mania, Throat Irritation, Tic
5858832 4730758     M 5/13/2005 7/25/2005 73 OT PER Strattera Drug Ineffective, Euphoric Mood, Feeling Abnormal, Malaise, Thinking Abnormal
5858834 4730759 14 Years F 5/13/2005 7/25/2005 73 PER Strattera Disturbance in Attention, Polymenorrhoea
5858837 4730760 46 Years M 5/14/2005 7/25/2005 72 PER Strattera Abnormal Behaviour, Drug Ineffective, Hypersensitivity, Oedema, Pruritus
5858840 4730761     F 5/18/2005 7/25/2005 68 OT PER Strattera Drug Screen Positive
5858844 4730762     F 5/18/2005 5/18/2005 7/25/2005 68 PER Strattera
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5858847 4730763 9 Years F 5/17/2005 5/19/2005 7/25/2005 67 PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5858850 4730764 10 Years M 8/1/2004 5/18/2005 7/25/2005 68 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Muscle Twitching
5858854 4730765     F 5/16/2005 7/25/2005 70 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Skin, Guttate Psoriasis, Rash, Scab, Skin Depigmentation
5858856 4730505     F 2/18/2005 7/25/2005 157 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Weight Increased
5858857 4730766 43 Years F 5/13/2005 7/25/2005 73 OT PER Strattera Oedema Peripheral
5858859 4730507 48 Years F 2/18/2005 7/25/2005 157 PER Strattera Attention Deficit/Hyperactivity Disorder Chromaturia, Nausea, Urine Odour Abnormal
5858861 4730767 57 Years F 5/12/2005 7/25/2005 74 PH PER Strattera Hot Flush
5858862 4730510 67 Years M 2/18/2005 7/25/2005 157 PER Strattera Attention Deficit/Hyperactivity Disorder Muscle Spasms
5858864 4730768     M 5/12/2005 7/25/2005 74 MD PER Strattera Sexual Dysfunction
5858866 4730513     F 2/21/2005 7/25/2005 154 PER Strattera Depression Anxiety, Palpitations, Sleep Disorder
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5858869 4730769 43 Years M 5/14/2005 5/17/2005 7/25/2005 69 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Pyrexia, Somnolence
5858871 4730516 7 Years M 2/18/2005 7/25/2005 157 MD PER Strattera Retching, Vomiting
5858873 4730770 47 Years F 5/12/2005 7/25/2005 74 PER Strattera Amnesia, Feeling Abnormal
5858875 4730519 11 Years M 11/1/2004 2/18/2005 7/25/2005 157 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Depressed Mood, Drug Ineffective, Dysphonia, Restlessness
5858876 4730771 42 Years M 5/12/2005 7/25/2005 74 PH PER Strattera Grandiosity, Mania
5858881 4730772 12 Years M 5/16/2005 7/25/2005 70 OT PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Constipation, Nervousness, Panic Attack, Trichotillomania
5858883 4730527 44 Years F 1/1/2005 2/18/2005 7/25/2005 157 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Decreased Appetite, Musculoskeletal Discomfort, Weight Decreased
5858888 4730530 8 Years M 1/1/2005 2/15/2005 7/25/2005 160 MD PER Strattera Attention Deficit/Hyperactivity Disorder Mania
5858895 4730532 41 Years F 2/21/2005 2/22/2005 7/25/2005 153 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Hot, Hyperhidrosis, Insomnia, Malaise
5858901 4730535 47 Years M 2/21/2005 7/25/2005 154 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Fluctuation, Blood Pressure Increased, Dry Mouth, Dysuria, Nausea, Pain, Sexual Dysfunction, Urinary Incontinence, Urinary Retention
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5858908 4730538 6 Years M 2/21/2005 7/25/2005 154 PER Strattera Attention Deficit/Hyperactivity Disorder Agitation
5858912 4730484 12 Years 5/16/2005 7/25/2005 70 MD PER Strattera Contusion, Platelet Count Decreased
5858914 4730485 10 Years M 5/19/2005 7/25/2005 67 PER Strattera Retching, Vomiting
5858916 4730486 9 Years M 5/19/2005 7/25/2005 67 PER Strattera Attention Deficit/Hyperactivity Disorder
5858922 4730487 31 Years F 5/23/2005 7/25/2005 63 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Fatigue, Irritability, Nausea, Pruritus
5858925 4730489     F 5/19/2005 7/25/2005 67 PER Strattera Abdominal Pain Upper, Somnolence, Tooth Abscess
5858930 4730493 10 Years M 5/17/2005 5/20/2005 7/25/2005 66 OT PER Strattera Attention Deficit/Hyperactivity Disorder Rash Papular, Rash Pruritic
5858934 4730495 39 Years F 5/20/2005 7/25/2005 66 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Jittery, Tremor
5858936 4730774 69 Years F 5/15/2005 7/25/2005 71 OT PER Strattera Nausea, Nervousness, Stomach Discomfort
5858937 4730498 51 Years F 5/20/2005 7/25/2005 66 PER Strattera Anorexia, Asthenia, Depression, Sexual Dysfunction
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5858939 4730500 30 Years F 5/20/2005 7/25/2005 66 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Mood Swings
5858942 4730503     M 5/20/2005 7/25/2005 66 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective
5858944 4730488 40 Years M 2/13/2005 2/14/2005 7/25/2005 161 PER Strattera Attention Deficit/Hyperactivity Disorder Tremor
5858947 4730490     F 2/10/2005 2/15/2005 7/25/2005 160 PER Strattera Attention Deficit/Hyperactivity Disorder Musculoskeletal Discomfort, Somnolence
5858949 4730491     M 1/1/2004 2/15/2005 7/25/2005 160 PER Strattera Attention Deficit/Hyperactivity Disorder
5858956 4730496 12 Years M 2/15/2005 7/25/2005 160 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Retching
5858957 4730497     M 2/15/2005 7/25/2005 160 MD PER Strattera Abdominal Discomfort, Nausea, Vomiting
5858960 4730499 10 Years M 2/14/2005 2/15/2005 7/25/2005 160 PH PER Strattera Cognitive Disorder Hyperhidrosis, Mydriasis
5858962 4730501 11 Years F 2/15/2005 7/25/2005 160 PER Strattera Middle Insomnia, Mood Swings
5858963 4730502 39 Years M 2/1/2005 2/15/2005 7/25/2005 160 PER Strattera Drug Ineffective, Dysuria, Micturition Urgency, Nausea, Nervousness, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5858964 4730504     M 3/14/2005 7/25/2005 133 MD PER Strattera Irritability, Mood Altered
5858967 4730303 6 Years M 3/1/2005 4/11/2005 7/25/2005 105 PER Strattera Attention Deficit/Hyperactivity Disorder Vomiting
5858969 4730324 16 Years F 3/28/2005 7/25/2005 119 MD PER Strattera Night Sweats
5858970 4730327 11 Years M 3/1/2005 4/12/2005 7/25/2005 104 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Belligerence
5858971 4730329 49 Years F 4/7/2005 7/25/2005 109 MD PER Strattera Attention Deficit/Hyperactivity Disorder Agitation, Irritability
5858973 4730331     M 3/30/2005 7/25/2005 117 OT PER Strattera Drug Screen Positive
5858975 4730335 65 Years F 4/12/2005 7/25/2005 104 PER Strattera Abdominal Distension, Constipation, Weight Increased
5858977 4730339 8 Years M 4/19/2005 7/25/2005 97 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Body Height Below Normal, Headache, Heart Rate Increased, Lethargy, Underweight
5858978 4730775 18 Years 5/13/2005 7/25/2005 73 MD PER Strattera Visual Disturbance
5858979 4730340 41 Years F 3/1/2005 4/13/2005 7/25/2005 103 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Hot Flush, Night Sweats
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5858981 4730365 8 Years M 4/13/2005 7/25/2005 103 PER Strattera Psychomotor Hyperactivity Asthenia, Facial Palsy, Nausea
5858982 4730776 51 Years M 4/1/2005 5/18/2005 7/25/2005 68 PER Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Decreased, Blood Pressure Increased, Chest Pain, Drug Ineffective, Electrocardiogram Abnormal, Heart Rate Increased, Upper Respiratory Tract Infection
5858984 4730777 8 Years M 5/12/2005 5/13/2005 7/25/2005 73 OT PER Strattera Attention Deficit/Hyperactivity Disorder Retching
5858986 4730778     M 5/13/2005 7/25/2005 73 MD PER Strattera
5858987 4730779 8 Years F 5/16/2005 7/25/2005 70 MD PER Strattera Hallucination, Insomnia
5858989 4730780 10 Years M 5/11/2005 7/25/2005 75 MD PER Strattera Hallucination, Heart Rate Increased, Hypertension
5858991 4730781 10 Years M 5/10/2005 7/25/2005 76 MD PER Strattera Clumsiness, Therapeutic Response Unexpected
5858993 4730782 19 Years M 5/16/2005 7/25/2005 70 PER Strattera Attention Deficit/Hyperactivity Disorder Depression, Insomnia, Night Sweats
5858994 4730783 8 Years M 3/1/2005 5/16/2005 7/25/2005 70 PER Strattera Attention Deficit/Hyperactivity Disorder Fear
5858995 4730784 38 Years M 5/1/2005 5/16/2005 7/25/2005 70 PER Strattera Attention Deficit/Hyperactivity Disorder Dysuria, Piloerection
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5858996 4730785 35 Years F 5/11/2005 7/25/2005 75 OT PER Strattera Attention Deficit/Hyperactivity Disorder Asthenia, Fall, Feeling Abnormal, Paraesthesia, Sensation of Heaviness
5858997 4730652 37 Years F 3/1/2005 3/2/2005 7/25/2005 145 PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue, Feeling Abnormal, Headache, Insomnia
5858998 4730653 11 Years F 3/2/2005 7/25/2005 145 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Skin, Sinus Disorder
5858999 4730786 50 Years F 5/1/2005 5/12/2005 7/25/2005 74 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Bruxism, Dry Mouth, Feeling Abnormal, Feeling Jittery, Insomnia, Respiratory Disorder
5859002 4730655 38 Years F 3/3/2005 7/25/2005 144 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Skin, Pruritus, Skin Injury
5859003 4730787     M 4/1/2005 5/11/2005 7/25/2005 75 PER Strattera Disturbance in Attention Anorexia, Anxiety, Bronchitis, Distractibility, Erectile Dysfunction, Heart Rate Increased, Insomnia, Paraesthesia
5859004 4730656 13 Years M 9/1/2004 3/3/2005 7/25/2005 144 MD PER Strattera Weight Increased
5859006 4730657 13 Years M 3/3/2005 7/25/2005 144 PER Strattera Attention Deficit/Hyperactivity Disorder Blepharospasm, Dizziness, Drug Ineffective, Fatigue, Hyperhidrosis, Irritability, Mood Altered, Pharyngitis Streptococcal, Tic, Vision Blurred
5859007 4730658 27 Years M 3/2/2005 3/4/2005 7/25/2005 143 PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Feeling Abnormal, Tremor
5859008 4730788 21 Years M 5/1/2005 5/16/2005 7/25/2005 70 PH PER Strattera Attention Deficit/Hyperactivity Disorder Insomnia, Nervousness
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5859009 4730659 37 Years M 3/4/2005 7/25/2005 143 OT PER Strattera Attention Deficit/Hyperactivity Disorder Micturition Disorder, Semen Volume Decreased, Stomach Discomfort, Testicular Disorder
5859010 4730789     F 4/1/2005 5/11/2005 7/25/2005 75 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Nervousness, Psychomotor Hyperactivity
5859011 4730660     F 2/28/2005 7/25/2005 147 OT PER Strattera Mydriasis
5859013 4730661 49 Years F 1/1/2005 3/23/2005 7/25/2005 124 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Flushing, Rash, Rash Papular, Skin Discolouration
5859015 4730790 8 Years F 5/23/2005 7/25/2005 63 PH PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia, Onychophagia, Poor Peripheral Circulation, Weight Decreased
5859016 4730791 8 Years M 5/12/2005 7/25/2005 74 PER Strattera Anorexia, Dysgeusia, Weight Decreased
5859018 4730792 40 Years F 3/1/2005 5/12/2005 7/25/2005 74 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Hypersomnia, Somnolence
5859020 4730793 7 Years F 5/20/2005 7/25/2005 66 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aphasia, Psychomotor Hyperactivity, Thirst, Tongue Disorder, Tongue Dry
5859021 4730662 62 Years M 2/24/2005 3/1/2005 7/25/2005 146 PER Strattera Attention Deficit/Hyperactivity Disorder Pollakiuria
5859022 4730663 6 Years M 3/1/2005 7/25/2005 146 PER Strattera Attention Deficit/Hyperactivity Disorder Tic
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5859023 4730794 20 Years M 5/7/2005 5/13/2005 7/25/2005 73 PH PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Dizziness, Drug Ineffective, Irritability, Nervousness
5859024 4730664 58 Years M 1/1/2005 3/1/2005 7/25/2005 146 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Interaction, Dysuria, Testicular Pain
5859026 4730665 28 Years M 1/1/2005 3/1/2005 7/25/2005 146 PER Strattera Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder, Bradyphrenia, Feeling Jittery, Heart Rate Increased, Muscle Tightness, Muscle Twitching, Somnolence
5859027 4730666 8 Years F 3/2/2005 7/25/2005 145 PER Strattera Attention Deficit/Hyperactivity Disorder Cold Sweat, Drug Ineffective, Nausea
5859028 4730667     M 2/1/2005 3/1/2005 7/25/2005 146 PER Strattera Attention Deficit/Hyperactivity Disorder Excitability, Heart Rate Increased
5859029 4730668 33 Years M 3/2/2005 7/25/2005 145 MD PER Strattera Attention Deficit/Hyperactivity Disorder Fatigue
5859031 4730669 6 Years M 3/2/2005 7/25/2005 145 PER Strattera Attention Deficit/Hyperactivity Disorder Disturbance in Attention, Drug Ineffective, Initial Insomnia, Psychomotor Hyperactivity, Restlessness, Somnolence, Stomach Discomfort
5859033 4730670 6 Years M 2/24/2005 3/2/2005 7/25/2005 145 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Pain
5859034 4730671 8 Years M 2/1/2005 3/2/2005 7/25/2005 145 PER Strattera Distractibility Abnormal Behaviour, Anorexia, Drug Ineffective, Stomach Discomfort
5859046 4730682 10 Years M 3/8/2005 7/25/2005 139 MD PER Strattera Drug Ineffective, Drug Interaction
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5859047 4730683 12 Years M 3/8/2005 7/25/2005 139 MD PER Strattera Drug Ineffective, Drug Interaction
5859048 4730685 24 Years F 2/25/2005 7/25/2005 150 PER Strattera Attention Deficit/Hyperactivity Disorder Flushing, Palpitations
5859049 4730686 18 Years M 2/25/2005 7/25/2005 150 PER Strattera Attention Deficit/Hyperactivity Disorder Gastrooesophageal Reflux Disease
5859050 4730687 62 Years F 2/1/2005 2/28/2005 7/25/2005 147 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Somnolence
5859051 4730688 6 Years M 2/28/2005 7/25/2005 147 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression
5859052 4730689 29 Years F 2/1/2005 2/28/2005 7/25/2005 147 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Somnolence
5859053 4730690     M 3/1/2005 3/1/2005 7/25/2005 146 MD PER Strattera
5859054 4730691 12 Years M 2/28/2005 7/25/2005 147 PH PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Fatigue, Malaise
5859055 4730672 7 Years M 2/28/2005 7/25/2005 147 PER Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Disturbance in Attention, Weight Gain Poor
5859056 4730673 56 Years M 3/1/2005 3/1/2005 7/25/2005 146 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Dysuria, Feeling Abnormal, Lethargy, Somnolence
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5859057 4730674 21 Years F 2/1/2005 2/28/2005 7/25/2005 147 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Urine Odour Abnormal
5859058 4730675 40 Years M 2/25/2005 7/25/2005 150 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anxiety, Panic Attack, Tachycardia
5859059 4730676 46 Years F 3/1/2005 3/1/2005 7/25/2005 146 PER Strattera Attention Deficit/Hyperactivity Disorder Confusional State, Nervousness, Tremor
5859060 4730677 11 Years F 12/1/2004 2/28/2005 7/25/2005 147 PER Strattera Attention Deficit/Hyperactivity Disorder Memory Impairment, Mood Swings, Tic
5859061 4730678 7 Years F 2/28/2005 7/25/2005 147 PER Strattera Attention Deficit/Hyperactivity Disorder Retching, Vomiting
5859062 4730679     M 2/10/2005 7/25/2005 165 OT PER Strattera Blood Cholesterol Increased, Low Density Lipoprotein, Total Cholesterol/HDL Ratio Abnormal
5859063 4730680 10 Years M 2/25/2005 3/1/2005 7/25/2005 146 OT PER Strattera Attention Deficit/Hyperactivity Disorder Headache, Retching, Vomiting, Weight Decreased
5859065 4730681 59 Years M 3/3/2005 4/13/2005 7/25/2005 103 PER Strattera Attention Deficit/Hyperactivity Disorder Dry Mouth, Heart Rate Increased, Hyperhidrosis, Insomnia, Muscle Spasms, Palpitations, Sexual Dysfunction, Urinary Hesitation
5859189 4730692 8 Years M 3/14/2005 7/25/2005 133 MD PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Hallucination (Auditory)
5859191 4730693     M 2/1/2005 2/25/2005 7/25/2005 150 PER Strattera Attention Deficit/Hyperactivity Disorder Chest Pain, Cough, Nasopharyngitis
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5859198 4730695     F 2/24/2005 7/25/2005 151 LW PER Strattera
5859200 4730696 17 Years M 2/22/2005 2/25/2005 7/25/2005 150 PER Strattera Attention Deficit/Hyperactivity Disorder Peripheral Coldness
5859201 4730697 11 Years F 2/24/2005 7/25/2005 151 CN PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger
5859204 4730698 11 Years M 1/1/2004 2/22/2005 7/25/2005 153 MD PER Strattera Psychomotor Hyperactivity Psychomotor Hyperactivity, Tic, Tremor
5859207 4730699 9 Years M 1/25/2005 2/25/2005 7/25/2005 150 PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Dyspnoea, Heart Rate Increased
5859208 4730700     F 2/25/2005 7/25/2005 150 PH PER Strattera Attention Deficit/Hyperactivity Disorder Libido Increased
5859223 4730701 10 Years F 3/8/2005 7/25/2005 139 MD PER Strattera Drug Ineffective, Drug Interaction
5859229 4730702 12 Years 3/7/2005 7/25/2005 140 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Drug Interaction
5859231 4730703 5 Years M 2/18/2005 2/23/2005 7/25/2005 152 PER Strattera Attention Deficit/Hyperactivity Disorder Enuresis, Nocturia, Pollakiuria, Somnolence, Thirst, Urinary Incontinence
5859234 4730704 10 Years M 2/24/2005 7/25/2005 151 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Nervousness, Social Problem
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5859236 4730705 7 Years M 2/24/2005 7/25/2005 151 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Disturbance In Social Behaviour, Insomnia, Psychomotor Hyperactivity, Restlessness
5859238 4730706 14 Years M 2/24/2005 2/24/2005 7/25/2005 151 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression
5859245 4730707 16 Years M 2/24/2005 7/25/2005 151 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Impulse-Control Disorder
5859247 4730708 6 Years M 2/1/2005 2/24/2005 7/25/2005 151 PER Strattera Attention Deficit/Hyperactivity Disorder Aggression, Emotional Disorder
5859248 4730709 5 Years F 2/24/2005 7/25/2005 151 MD PER Strattera Attention Deficit/Hyperactivity Disorder Enuresis
5859256 4730710     M 2/24/2005 7/25/2005 151 MD PER Strattera Dystonia
5859262 4730711 10 Years M 3/11/2005 7/25/2005 136 MD PER Strattera Attention Deficit/Hyperactivity Disorder Anger, Disturbance in Attention, Psychomotor Hyperactivity
5859265 4730712 11 Years M 2/22/2005 7/25/2005 153 PER Strattera Diarrhoea, Eye Movement Disorder, Tic
5859268 4730713 17 Years M 2/23/2005 7/25/2005 152 MD PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
5859276 4730716 12 Years M 2/22/2005 7/25/2005 153 MD PER Strattera Attention Deficit/Hyperactivity Disorder Alopecia
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5859282 4730726 7 Years M 1/1/2005 4/25/2005 7/25/2005 91 PER Strattera Attention Deficit/Hyperactivity Disorder Mydriasis
5859284 4730727 8 Years F 2/22/2005 2/23/2005 7/25/2005 152 PER Strattera Somnolence, Stomach Discomfort
5859302 4730728 59 Years F 2/24/2005 7/25/2005 151 PER Strattera Attention Deficit/Hyperactivity Disorder Intraocular Pressure Increased
5859306 4730729 16 Years F 2/22/2005 2/23/2005 7/25/2005 152 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Ineffective, Fatigue, Hunger, Somnolence
5859307 4730730 10 Years 2/23/2005 7/25/2005 152 PER Strattera Muscle Twitching
5859311 4730731     M 2/23/2005 7/25/2005 152 PER Strattera Attention Deficit/Hyperactivity Disorder Dizziness, Drug Ineffective, Insomnia, Nervousness
5859313 4730732     F 2/23/2005 7/25/2005 152 PER Strattera Visual Acuity Reduced
5859319 4730733 52 Years M 2/21/2005 7/25/2005 154 PER Strattera Attention Deficit/Hyperactivity Disorder Constipation, Dry Mouth, Middle Insomnia, Somnolence
5859322 4730734 5 Years M 2/18/2005 7/25/2005 157 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Balance Disorder, Muscle Twitching
5859329 4730735 13 Years M 1/1/2004 3/22/2005 7/25/2005 125 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abdominal Discomfort, Arthralgia, Decreased Appetite, Dysuria, Fatigue, Feeling Abnormal, Influenza Like Illness, Malaise, Mononucleosis Syndrome, Mood Swings, Pruritus, Urinary Tract Infection
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5859331 4730736 38 Years M 2/22/2005 3/14/2005 7/25/2005 133 PER Strattera Attention Deficit/Hyperactivity Disorder
5859332 4730737 16 Years M 12/17/2004 2/22/2005 7/25/2005 153 MD PER Strattera Attention Deficit/Hyperactivity Disorder Dermatitis Contact
5859335 4730738 48 Years M 2/22/2005 7/25/2005 153 PER Strattera Attention Deficit/Hyperactivity Disorder Erectile Dysfunction
5859342 4730739 40 Years M 2/19/2005 2/22/2005 7/25/2005 153 PER Strattera Attention Deficit/Hyperactivity Disorder Feeling Abnormal, Sexual Dysfunction, Sleep Disorder
5859348 4730740 4 Years F 1/1/2004 2/22/2005 7/25/2005 153 PER Strattera Attention Deficit/Hyperactivity Disorder Sluggishness
5859350 4730741 13 Years M 2/22/2005 7/25/2005 153 PER Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Heart Rate Increased, Lethargy, Somnolence
5859362 4730742 17 Years M 2/23/2005 7/25/2005 152 PER Strattera Attention Deficit/Hyperactivity Disorder Drug Screen Positive
5860390 4730773 31 Years M 5/17/2005 7/25/2005 69 PER Strattera Drug Ineffective, Weight Increased
5860675 4737427 16 Years F 7/19/2005 8/5/2005 17 MD EXP Strattera Liver Function Test Abnormal, Polymyositis Other
5860675 4784950 16 Years F 9/8/2005 9/28/2005 20 MD EXP Strattera Polymyositis Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5860675 4860663 16 Years F 11/29/2005 12/16/2005 17 MD EXP Strattera Alanine Aminotransferase Increased, Aldolase Increased, Aspartate Aminotransferase Increased, Blood Creatine Phosphokinase Increased, Blood Lactate Dehydrogenase Increased, Muscular Weakness, Polymyositis, White Blood Cell Count Increased Other
5860862 4738519 18 Years F 3/1/2005 7/27/2005 8/3/2005 7 MD EXP Strattera Abnormal Behaviour Disease Recurrence, Petit Mal Epilepsy Other
5860870 4738521 15 Years M 3/4/2005 7/27/2005 8/3/2005 7 MD EXP Strattera Learning Disorder Condition Aggravated, Convulsion Other
5860895 4738522 10 Years F 5/1/2005 7/27/2005 8/3/2005 7 MD EXP Strattera Abnormal Behaviour Condition Aggravated, Partial Seizures, Petit Mal Epilepsy Other
5861524 4738128 12 Years M 7/19/2005 8/3/2005 15 MD EXP Atomoxetine Hyperpyrexia Hospitalization - Initial or Prolonged
5861527 4738129 10 Years M 7/10/2005 7/13/2005 8/3/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Fall, Grand Mal Convulsion Other
5861637 4741375 19 Years F 7/21/2005 8/8/2005 18 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5861639 4741377     F 7/22/2005 8/8/2005 17 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatic Enzyme Increased
5861639 4824076 22 Years M 11/1/2005 11/8/2005 7 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased
5861639 4848284 22 Years M 11/21/2005 12/6/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Hepatic Enzyme Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5861734 4741640 48 Years M 7/25/2005 7/26/2005 8/8/2005 13 MD EXP Strattera Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Nephrolithiasis Hospitalization - Initial or Prolonged
5861734 4746333 48 Years M 7/25/2005 8/3/2005 8/15/2005 12 MD EXP Strattera Bile Duct Stone, Nephrolithiasis Hospitalization - Initial or Prolonged
5862506 4741355 65 Years F 7/20/2005 8/8/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Adverse Event, Sudden Death Death
5862506 4747181 67 Years F 1/1/2005 1/1/2005 8/3/2005 8/15/2005 12 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Ejection Fraction Decreased Death
5862507 4741357 12 Years M 7/24/2005 7/26/2005 8/8/2005 13 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Dyspnoea, Pharyngeal Oedema Other
5862509 4741359 10 Years M 7/26/2005 8/8/2005 13 OT EXP Strattera Convulsion Other
5862509 4833401 10 Years M 11/7/2005 11/18/2005 11 OT EXP Strattera Convulsion Hospitalization - Initial or Prolonged, Other
5862509 4848000 10 Years F 11/16/2005 12/6/2005 20 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Grand Mal Convulsion Hospitalization - Initial or Prolonged, Other
5862826 4742481 16 Years M 7/20/2005 8/8/2005 19 MD EXP Strattera Hepatic Enzyme Increased
5862826 4784951 16 Years M 9/7/2005 9/28/2005 21 MD EXP Strattera Laboratory Test Abnormal
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5865386 4727708 53 Years M 9/1/2005 5/3/2005 7/25/2005 83 MD PER Strattera Attention Deficit/Hyperactivity Disorder Ejaculation Failure, Semenuria
5865690 4747139 11 Years F 7/6/2005 8/1/2005 8/15/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Haematocrit Decreased, Headache, Lymphocyte Count Increased
5865690 4773301 11 Years F 7/6/2005 8/24/2005 9/16/2005 23 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Decreased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Fatigue, Haematocrit Decreased, Headache, Lymphocyte Count Increased
5865690 4784955 11 Years F 7/6/2005 9/13/2005 9/28/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Fatigue, Haematocrit Decreased, Headache
5865691 4747140 12 Years M 7/28/2005 8/15/2005 18 MD EXP Strattera Hepatic Function Abnormal
5865692 4747142     F 7/27/2005 8/15/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Liver Function Test Abnormal
5865693 4747143 14 Years M 7/26/2005 7/27/2005 8/15/2005 19 PH EXP Strattera Attention Deficit/Hyperactivity Disorder Appendicitis, Constipation
5865694 4746452 14 Years M 8/1/2005 8/15/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Rash
5866265 4746413 8 Years M 2/7/2005 7/28/2005 8/15/2005 18 EXP Strattera Attention Deficit/Hyperactivity Disorder Anaphylactic Reaction Other
5866267 4746415 10 Years M 4/1/2005 7/29/2005 8/15/2005 17 MD EXP Atomoxetine Communication Disorder, Social Avoidant Behaviour Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5866267 4806937 10 Years M 4/1/2005 10/3/2005 10/19/2005 16 MD EXP Atomoxetine Attention Deficit/Hyperactivity Disorder Impulsive Behaviour, Mood Altered, Psychomotor Hyperactivity, Social Avoidant Behaviour Other
5866621 4731933 32 Years F 3/10/2005 8/2/2005 CN DIR Strattera Attention Deficit/Hyperactivity Disorder Agitation, Heart Rate Increased, Hypoaesthesia, Mydriasis, Palpitations, Tension, Urinary Incontinence Hospitalization - Initial or Prolonged, Required Intervention to Prevent Permanent Impairment/Damage
5867816 4751513 7 Years F 7/14/2005 8/23/2005 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Hepatocellular Damage, Urinary Tract Infection
5867899 4751363 39 Years F 8/19/2005 8/23/2005 OT DIR Strattera Depression Abdominal Pain Upper, Alanine Aminotransferase Abnormal, Aspartate Aminotransferase Abnormal, Fatigue, Stress Life-Threatening
5867951 4751713 12 Years M 8/19/2005 8/22/2005 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain, Aspartate Aminotransferase Increased, Hepatic Enzyme Increased Other
5868095 4751365 10 Years M 8/15/2005 8/23/2005 OT DIR Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased Life-Threatening
5868437 4751207 50 Years M 5/30/2005 8/23/2005 DIR Strattera Attention Deficit/Hyperactivity Disorder Retinal Tear, Visual Disturbance Hospitalization - Initial or Prolonged, Required Intervention to Prevent Permanent Impairment/Damage
5870322 4752581     F 8/4/2005 8/24/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Narcolepsy Other
5870332 4752582     F 8/5/2005 8/24/2005 19 MD EXP Strattera Convulsion, Loss of Consciousness, Tongue Biting Other
5871120 4753400 11 Years M 6/28/2005 8/4/2005 8/24/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Neutropenia, White Blood Cell Count Decreased Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5871120 4783633 12 Years M 6/28/2005 9/14/2005 9/28/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Neutropenia Other
5871123 4753404 10 Years M 8/9/2005 8/9/2005 8/24/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Fall, Malaise, Syncope Other
5871123 4791165 10 Years M 8/6/2005 9/15/2005 10/5/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Fall, Feeling Hot, Hyperhidrosis, Malaise, Pallor, Syncope Hospitalization - Initial or Prolonged, Other
5871123 4848682 10 Years M 8/6/2005 11/24/2005 12/6/2005 12 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Pressure Diastolic Decreased, Fall, Feeling Hot, Hyperhidrosis, Malaise, Nausea, Pallor, Syncope Other
5871127 4753406 6 Years M 3/13/2005 8/10/2005 8/24/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder, Tourette's Disorder Anorexia, Constipation, Dyspnoea, Headache, Parosmia, Tic, Urine Flow Decreased, Weight Decreased Other
5873633 4759172 8 Years M 1/1/2005 8/11/2005 8/31/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Anger, Condition Aggravated Other
5873633 4896964 8 Years M 1/1/2005 1/18/2006 1/27/2006 9 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anger, Condition Aggravated, Physical Assault Other
5873634 4759173 10 Years 7/24/2005 8/11/2005 8/31/2005 20 EXP Strattera Coordination Abnormal, Headache, Simple Partial Seizures, Somnolence Other
5873635 4759174 9 Years M 7/1/2005 8/16/2005 8/31/2005 15 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Balance Disorder, Depressed Level of Consciousness, Fall, Malaise, Nausea, Pallor, Somnolence, Vomiting Hospitalization - Initial or Prolonged
5873635 4791164 9 Years M 7/31/2005 9/21/2005 10/5/2005 14 OT EXP Strattera Attention Deficit/Hyperactivity Disorder, Decreased Appetite, Insomnia Amnesia, Balance Disorder, Depressed Level of Consciousness, Fall, Malaise, Nausea, Pallor, Somnolence, Syncope, Viral Infection, Vomiting, Weight Decreased Hospitalization - Initial or Prolonged
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5873635 4821977 9 Years M 7/1/2005 10/19/2005 11/3/2005 15 OT EXP Strattera Attention Deficit/Hyperactivity Disorder, Decreased Appetite, Sleep Disorder Amnesia, Blood Pressure Orthostatic Decreased, Depressed Level of Consciousness, Extrasystoles, Fall, Heart Rate Decreased, Heart Rate Increased, Sinus Arrhythmia, Somnolence, Syncope Vasovagal, Viral Infection, Weight Decreased Hospitalization - Initial or Prolonged
5873652 4759318 7 Years F 7/14/2005 8/10/2005 8/31/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Hepatic Trauma, Nasal Congestion, Urinary Tract Infection
5873652 4790523 7 Years F 7/14/2005 9/15/2005 10/5/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Hepatocellular Damage, Nasal Congestion, Urinary Tract Infection
5873659 4759323 14 Years M 8/15/2005 8/15/2005 0 OT EXP Strattera Hepatic Enzyme Increased
5873737 4759188 8 Years M 7/7/2005 8/11/2005 8/31/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Electrocardiogram QT Prolonged, Hyperhidrosis, Malaise, Tachycardia Other
5873737 4776370 8 Years M 7/7/2005 9/1/2005 9/21/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abdominal Pain Upper, Electrocardiogram Delta Waves Abnormal, Electrocardiogram QT Prolonged, Hyperhidrosis, Malaise, Tachycardia Other
5874890 4759972 6 Years M 1/1/2005 8/15/2005 8/31/2005 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Chromaturia, Dermatitis Contact, Fatigue, Pruritus, Rash, Skin Discolouration
5876004 4763474 40 Years F 9/7/2005 MD DIR Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Nausea
5876626 4764486 22 Years M 8/23/2005 9/6/2005 14 MD EXP Strattera Alanine Aminotransferase Increased
5876626 4837232 22 Years M 11/4/2005 11/22/2005 18 MD EXP Strattera Alanine Aminotransferase Increased
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5876678 4765191 15 Years M 8/1/2005 8/18/2005 9/6/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased
5876678 4898748 15 Years M 8/1/2005 1/5/2006 1/27/2006 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Blood Alkaline Phosphatase Increased, Protein Total Decreased
5876759 4765192 12 Years 8/22/2005 9/6/2005 15 PH EXP Strattera Dysphagia, Gastric Operation Hospitalization - Initial or Prolonged
5876767 4765193 9 Years M 8/19/2005 9/6/2005 18 EXP Strattera Erythema Multiforme Other
5876767 4776761 9 Years M 8/6/2005 9/7/2005 9/21/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Erythema Multiforme, Pruritus, Rash Generalised, Viral Upper Respiratory Tract Infection Other
5876767 4784952 9 Years M 8/8/2005 9/14/2005 9/28/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Erythema Multiforme, Haematocrit Decreased, Viral Upper Respiratory Tract Infection Other
5876767 4898750 9 Years M 8/6/2005 1/5/2006 1/27/2006 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Cough, Erythema Multiforme, Nasal Congestion, Pruritus, Viral Upper Respiratory Tract Infection Other
5876768 4764559 11 Years M 5/7/2005 8/16/2005 9/6/2005 21 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Aggression, Feeling Abnormal, Hallucination (Auditory), Impulsive Behaviour, Insomnia, Personality Change, Pyromania, Suicide Attempt Life-Threatening, Other
5876768 4776762 11 Years M 5/7/2005 9/7/2005 9/14/2005 7 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Anger, Feeling Abnormal, Fight In School, Hallucination (Auditory), Impulsive Behaviour, Insomnia, Performance Status Decreased, Personality Change, Pyromania, Suicide Attempt Life-Threatening, Other
5876768 4821714 11 Years M 5/7/2005 10/12/2005 11/3/2005 22 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Fight In School, Hallucination (Auditory), Impulsive Behaviour, Insomnia, Legal Problem, Pyromania, Suicidal Ideation, Suicide Attempt Life-Threatening, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5876770 4765194 25 Years M 8/22/2005 9/6/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased
5876785 4765195 6 Years M 8/24/2005 9/6/2005 13 MD EXP Strattera Cardiac Arrest Death
5876785 4773300 6 Years M 8/31/2005 9/16/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Cardiac Arrest, Cardiac Valve Disease, Congestive Cardiomyopathy Death, Hospitalization - Initial or Prolonged
5876785 4813560 6 Years M 10/7/2005 10/26/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Brain Death, Cardiac Arrest, Cardiac Failure Congestive, Cardiac Valve Disease, Cardiomegaly, Congestive Cardiomyopathy, Dilatation Ventricular, Haemodynamic Instability, Hypotension, Organ Failure, Therapy Non-Responder Death, Hospitalization - Initial or Prolonged
5876787 4765196 12 Years M 8/13/2005 8/24/2005 9/6/2005 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Benign Intracranial Hypertension, CSF Pressure Decreased, Headache Other
5876787 4805963 12 Years M 8/13/2005 9/30/2005 10/19/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Benign Intracranial Hypertension, Blood Glucose Decreased, Middle Insomnia, Protein Total Increased Other
5880054 4765940 12 Years M 7/15/2005 8/22/2005 9/6/2005 15 MD EXP Strattera Pruritus, Skin Swelling Other
5880054 4939506 12 Years M 7/15/2005 2/17/2006 3/6/2006 17 MD EXP Strattera Acne, Pruritus Generalised, Skin Swelling Other
5880403 4730684 9 Years F 2/1/2005 2/25/2005 7/25/2005 150 PER Strattera Attention Deficit/Hyperactivity Disorder Distractibility, Drug Ineffective, Somnolence
5882326 4771178 18 Years F 8/31/2005 9/14/2005 14 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Psychotic Disorder Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5882329 4771179 12 Years M 8/30/2005 9/14/2005 15 MD EXP Strattera Hepatic Enzyme Increased
5882329 4824293 5 Years M 8/24/2005 10/24/2005 11/8/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
5882331 4771181 6 Years M 8/30/2005 9/14/2005 15 MD EXP Strattera Alanine Aminotransferase Increased, Blood Bilirubin Increased, Hepatic Enzyme Increased, Overweight
5882331 4784953 6 Years M 9/12/2005 9/28/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Blood Bilirubin Increased, Overweight
5882335 4771182     M 6/1/2005 8/29/2005 9/14/2005 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Diarrhoea, Dizziness, Hallucination (Auditory), Hallucination (Visual), Hyperhidrosis, Psychotic Disorder Hospitalization - Initial or Prolonged
5882337 4771184 5 Years M 8/1/2005 8/29/2005 9/14/2005 16 EXP Strattera Brain Death Hospitalization - Initial or Prolonged, Life-Threatening
5882337 4803083 5 Years M 8/12/2005 9/27/2005 10/13/2005 16 MD EXP Strattera Hypoxia Hospitalization - Initial or Prolonged, Life-Threatening
5882337 4824283 5 Years M 8/12/2005 10/21/2005 11/8/2005 18 MD EXP Strattera Brain Hypoxia, Cerebral Ischaemia, Convulsion, Hypoxia, Musculoskeletal Stiffness, Pupil Fixed, Respiratory Depression, Staphylococcal Infection Hospitalization - Initial or Prolonged, Life-Threatening, Other
5882337 4834985 5 Years M 8/12/2005 11/3/2005 11/14/2005 11 MD EXP Strattera Atrophy, Brain Hypoxia, Cerebral Ventricle Dilatation, Convulsion, Ischaemia, Metabolic Disorder, Musculoskeletal Stiffness, Pupil Fixed, Respiratory Depression, Staphylococcal Infection Hospitalization - Initial or Prolonged, Life-Threatening, Other
5882337 4935264 5 Years M 8/12/2005 2/13/2006 3/2/2006 17 CN EXP Strattera Cerebral Atrophy, Cerebral Ischaemia, Convulsion, Hypoxia, Musculoskeletal Stiffness, Nuclear Magnetic Resonance Imaging Brain Abnormal, Pupil Fixed, Respiratory Depression, Staphylococcal Infection Hospitalization - Initial or Prolonged, Life-Threatening, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5882339 4771186 53 Years F 8/29/2005 9/14/2005 16 EXP Strattera Attention Deficit/Hyperactivity Disorder Depression, Intentional Self-Injury, Laceration, Suicidal Ideation, Suicide Attempt Other
5882339 4876840 53 Years F 11/1/2005 12/6/2005 35 PER Strattera Attention Deficit/Hyperactivity Disorder Intentional Self-Injury, Suicidal Ideation, Suicide Attempt Other
5882339 4948977 53 Years F 2/21/2006 3/15/2006 22 EXP Strattera Attention Deficit/Hyperactivity Disorder Intentional Self-Injury, Stress, Suicidal Ideation, Suicide Attempt Other
5882339 5036852 53 Years F 2/21/2006 6/1/2006 100 CN PER Strattera Attention Deficit/Hyperactivity Disorder Intentional Self-Injury, Suicidal Ideation, Suicide Attempt Other
5882831 4770639 9 Years M 3/18/2005 8/25/2005 9/14/2005 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Agitation, Anxiety, Malaise, Mood Altered, Pallor, Urticaria Other
5882837 4770641 5 Years M 1/1/2005 8/25/2005 9/14/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Haemorrhagic Diathesis Other
5882837 4806935 5 Years M 1/1/2005 10/4/2005 10/19/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Haematoma Other
5886808 4777657 11 Years F 8/1/2005 9/2/2005 9/21/2005 19 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Petit Mal Epilepsy Other
5886808 4832363 11 Years F 8/1/2005 11/4/2005 11/17/2005 13 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Cardiac Disorder, Petit Mal Epilepsy, Syncope Life-Threatening, Other
5886808 4853024 11 Years F 8/1/2005 11/23/2005 12/12/2005 19 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Petit Mal Epilepsy, Syncope Life-Threatening, Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5886822 4777662 10 Years M 6/1/2005 9/2/2005 9/21/2005 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Epilepsy, Grand Mal Convulsion Other
5886843 4777663 49 Years F 8/1/2005 9/2/2005 9/21/2005 19 EXP Strattera Attention Deficit/Hyperactivity Disorder Anaplastic Choroid Plexus Papilloma, Cholecystectomy, Headache, Hydrocephalus, Incontinence, Road Traffic Accident Hospitalization - Initial or Prolonged, Other
5886843 4806677 49 Years F 8/1/2005 9/30/2005 10/19/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Choroid Plexus Papilloma, Gait Disturbance, Gallbladder Operation, Hydrocephalus, Incontinence, Pain, Road Traffic Accident, Urinary Tract Infection Hospitalization - Initial or Prolonged, Other
5886843 4834986 49 Years F 8/1/2005 11/1/2005 11/14/2005 13 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Cholecystectomy, Choroid Plexus Papilloma, Headache, Hydrocephalus, Incontinence, Road Traffic Accident, Urinary Tract Infection Hospitalization - Initial or Prolonged, Other
5886849 4777664 8 Years M 8/1/2005 9/7/2005 9/21/2005 14 OT EXP Strattera Attention Deficit/Hyperactivity Disorder Diabetes Mellitus Insulin-Dependent Other
5886849 4833398 8 Years M 8/1/2005 11/7/2005 11/18/2005 11 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Diabetes Mellitus Insulin-Dependent, Weight Increased Other
5887115 4777665 13 Years F 9/1/2005 9/7/2005 9/21/2005 14 EXP Strattera Attention Deficit/Hyperactivity Disorder Convulsion, Headache, Hypotension Other
5887115 4852955 13 Years F 9/1/2005 11/29/2005 12/12/2005 13 EXP Strattera Attention Deficit/Hyperactivity Disorder Agitation, Blood Magnesium Increased, Blood Phosphorus Decreased, Confusional State, Convulsion, Grand Mal Convulsion, Headache, Heart Rate Increased, Hypotension, Loss of Consciousness, Postictal State Other
5887115 4995087 13 Years F 9/1/2005 4/18/2006 5/3/2006 15 EXP Strattera Attention Deficit/Hyperactivity Disorder Agitation, Blood Magnesium Increased, Blood Phosphorus Decreased, Confusional State, Grand Mal Convulsion, Headache, Hypotension, Loss of Consciousness, Postictal State Other
5887847 4777936 16 Years M 9/1/2005 9/21/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alcohol Use, Convulsion Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5887847 4815034 16 Years M 7/12/2005 10/10/2005 10/26/2005 16 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alcohol Use, Epilepsy Other
5888316 4777990 19 Years F 8/31/2005 9/1/2005 9/21/2005 20 CN EXP Strattera Multiple Drug Overdose Hospitalization - Initial or Prolonged
5888330 4777991     M 9/1/2005 9/21/2005 20 PH EXP Atomoxetine Condition Aggravated, Drug Interaction, Epilepsy Other
5889385 4777992 13 Years M 8/1/2005 9/2/2005 9/21/2005 19 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Leukopenia
5889385 4854453 13 Years M 8/1/2005 12/2/2005 12/13/2005 11 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Alcohol Use, Aspartate Aminotransferase Increased, Gamma-Glutamyltransferase Increased
5889431 4777993 13 Years M 1/1/2005 9/5/2005 9/21/2005 16 MD EXP Strattera Aspartate Aminotransferase Increased, Blood Bilirubin Increased
5889431 4843728 13 Years M 1/1/2005 11/8/2005 11/29/2005 21 MD EXP Strattera Aspartate Aminotransferase Increased, Blood Bilirubin Increased
5889442 4777994 18 Years F 8/25/2005 9/1/2005 9/21/2005 20 EXP Strattera Attention Deficit/Hyperactivity Disorder Constipation, Lethargy, Social Avoidant Behaviour, Syncope, Urinary Retention Other
5890159 4783993 16 Years M 8/10/2005 8/11/2005 9/27/2005 47 PER Strattera Attention Deficit/Hyperactivity Disorder Decreased Appetite, Flatulence, Nausea, Pain
5890160 4783994 8 Years M 8/9/2005 9/27/2005 49 MD PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Decreased Appetite
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5890161 4783995 15 Years M 8/10/2005 9/27/2005 48 OT PER Strattera Acne, Rash Pruritic
5890165 4783996 45 Years F 8/1/2005 8/11/2005 9/27/2005 47 PER Strattera Attention Deficit/Hyperactivity Disorder Akathisia, Restless Legs Syndrome
5890170 4783997 11 Years F 8/11/2005 9/27/2005 47 PER Strattera Disturbance in Attention Abdominal Pain Upper, Drug Ineffective, Headache, Memory Impairment
5890191 4783998 6 Years M 8/10/2005 8/12/2005 9/27/2005 46 PER Strattera Attention Deficit/Hyperactivity Disorder Abnormal Behaviour, Aggression, Anger, Anxiety, Mood Swings
5890246 4783999 14 Years M 8/12/2005 9/27/2005 46 MD PER Strattera Hot Flush
5890259 4784000     M 8/10/2005 9/27/2005 48 MD PER Strattera Dizziness, Dysuria, Erectile Dysfunction
5890262 4784001     M 8/11/2005 9/27/2005 47 MD PER Strattera Ejaculation Delayed, Sexual Dysfunction
5890263 4784002 48 Years M 8/11/2005 8/15/2005 9/27/2005 43 PER Strattera Attention Deficit/Hyperactivity Disorder Somnolence
5890655 4781552 9 Years M 8/15/2005 8/26/2005 9/20/2005 25 EXP Strattera Attention Deficit/Hyperactivity Disorder, Oppositional Defiant Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Cough, Decreased Appetite, Drug Ineffective, Fatigue, Influenza Like Illness, Nausea, Personality Change Other
5890655 4781691 9 Years M 8/15/2005 9/13/2005 9/27/2005 14 EXP Strattera Attention Deficit/Hyperactivity Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Decreased Appetite, Drug Ineffective, Fatigue, Influenza Like Illness, Nausea, Personality Change Other
Case ISR Age M/F Date of Event Date of Death Recvd by Mfr Recvd by FDA Days to Report Rptd By Rpt Type Drug Name Indications Adverse Reactions Outcome
5890655 4804954 9 Years M 8/15/2005 9/27/2005 10/17/2005 20 MD EXP Strattera Attention Deficit/Hyperactivity Disorder, Oppositional Defiant Disorder Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Cough, Decreased Appetite, Drug Ineffective, Fatigue, Influenza Like Illness, Nausea, Personality Change Other
5890840 4781859 14 Years F 9/8/2005 9/9/2005 9/27/2005 18 EXP Strattera Attention Deficit/Hyperactivity Disorder Chest Discomfort, Jaundice, Oedema Mouth, Swelling Face, White Blood Cell Count Increased
5890840 4813522 14 Years F 9/8/2005 10/11/2005 10/26/2005 15 MD EXP Strattera Attention Deficit/Hyperactivity Disorder Anorexia, Chest Discomfort, Confusional State, Jaundice, Local Swelling, Mouth Ulceration, Nausea, Ocular Icterus, Oedema Mouth, Somnolence, Swelling Face, Vomiting, White Blood Cell Count Increased
5890841 4781860 7 Years M 9/1/2005 9/12/2005 9/27/2005 15 MD EXP Strattera Brain Herniation, Somnolence Death
5890844 4781861 40 Years F 9/9/2005 9/27/2005 18 MD EXP Strattera Encephalitis Hospitalization - Initial or Prolonged
5890857 4781862 9 Years M 2/18/2005 9/12/2005 9/27/2005 15 OT EXP Strattera Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased
5890857 4813866 9 Years M 2/18/2005 10/10/2005 10/26/2005 16 OT EXP