Serious Adverse Reactions, Outcomes and Reporting Violations are highlighted in red.
Case |
ISR |
Age |
M/F |
Date 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 |