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