Strattera Deaths with Strattera as Primary Suspect Drug

This table shows all adverse reactions and indications (the condition being treated) reported to the FDA's Adverse Event Reporting System between 2004 and 2007 where Strattera (atomoxetine) was identified as the Primary Suspect Drug (FDA's term) responsible for causing these reactions in those ISRs (Individual Safety Reports) that had "Abortion Spontaneous", "Cardiac Arrest", "Completed Suicide", "Death" or "Stillbirth" as an Adverse Reaction. Where an Age, Date of Event, Date of Death, Rpt'd By or Indication isn't shown, none was provided in the report.

Rpt'd by: CN-Consumer, LW-Lawyer, MD-Physician, OT-Other Healthcare Provider, PH-Pharmacist, Blank-Not Reported in ISR (Individual Safety Report).

Rpt Code is the type of report submitted: DIRect reports from Consumers or Doctor to the FDA; EXPedited reports to the FDA from Eli Lilly; PERiodic reports from Eli Lilly to the FDA.

Reports highlighted in grey are DIRect reports that appear to be for the same Case/Event of an adjacent EXPedited report. The four Completed Suicides in these DIR reports are not included in the Deaths tally.

The 12 Case Reports highlighted in green do not contain one of the above Adverse Reactions, but the Outcome for these Events is listed as "Death" and the Date of Death matches the Event Date (or is one day after for Case 5655897 and Case 6234939). These 12 deaths are included in the Deaths tally.

The 4 Case Reports highlighted in yellow also have an Outcome of "Death", but their Date of Death is from 4 to 8 days after the Event Date. These 4 deaths are included in the Deaths tally as no other drug is identified as the Primary Suspect for the Outcome, but they may not have been caused by the patient taking Strattera.

Where a Case number does repeat, the Case number is bolded and any repeating Adverse Reactions (Suicides, Deaths, etc) are not added to tallies.

That said, note that Case 5952177 appears in the table twice, once with a Patient Age of 15 and once with an Age of 16. This may be two Cases as the Event Dates for Completed Suicide are different, although those could be a transposition error: 01/01/2005 and 10/01/2005.


Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Rpt'd By Indications Reactions Rpt Code
4148345 4364662 05/21/2004 Strattera X MD Anencephaly, Intra-Uterine Death, Transmission of Drug Via Semen EXP
4148345 4464694 04/01/2004 09/29/2004 Strattera X MD Abortion Induced, Anencephaly, Drug Exposure During Pregnancy, Transmission of Drug Via Semen EXP
F 4205958 4441500 07/28/2004 Strattera X Attention Deficit/Hyperactivity Disorder Abortion Spontaneous PER
M 5744981 4579512 02/09/2005 Strattera X MD Completed Suicide EXP
F 5764249 4607026 02/21/2005 03/09/2005 02/21/2005 Strattera X MD Death EXP
F 5892273 4786807 02/21/2005 10/03/2005 02/21/2005 Strattera X CN Attention Deficit/Hyperactivity Disorder Completed Suicide DIR
M 5897087 4789848 04/28/2005 10/05/2005 Strattera X Attention Deficit/Hyperactivity Disorder Completed Suicide DIR
M 5919125 4815742 05/28/2004 10/26/2005 05/28/2004 Strattera X Completed Suicide EXP
M 5939430 4814268 10/18/2004 10/26/2005 10/18/2004 Strattera X Completed Suicide, Drug Ineffective EXP
M 6014238 4949708 02/01/2006 03/15/2006 02/01/2006 Strattera X MD Closed Head Injury Coma EXP
6041125 4985900 04/19/2006 Strattera X MD Drug Exposure During Pregnancy, Pregnancy, Stillbirth EXP
Unk 6041125 5022685 06/01/2005 06/05/2006 02/18/2006 Strattera X MD Drug Exposure During Pregnancy, Intra-Uterine Death, Labour Complication, Stillbirth EXP
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Rpt'd By Indications Reactions Rpt Code
Unk 6041125 5053558 06/01/2005 07/12/2006 02/18/2006 Strattera X MD Anoxia, Drug Exposure During Pregnancy, Labour Complication, Stillbirth EXP
F 6043198 4991479 01/11/2006 05/02/2006 01/11/2006 Strattera X MD Attention Deficit/Hyperactivity Disorder Convulsion, Neuroleptic Malignant Syndrome DIR
Unk 6045434 4990718 02/01/2006 04/28/2006 02/01/2006 Strattera X Drug Exposure During Pregnancy, Stillbirth EXP
Unk 6045434 5053551 02/01/2006 07/12/2006 02/01/2006 Strattera X Drug Exposure During Pregnancy, Stillbirth EXP
M 6168850 5144654 10/31/2006 Strattera X MD Attention Deficit/Hyperactivity Disorder Completed Suicide EXP
M 6237403 5237339 02/13/2007 Strattera X CN Death EXP
M 6371858 5401716 05/01/2007 07/31/2007 05/01/2007 Strattera X MD Anxiety Completed Suicide EXP
F 6508341 5565406 01/11/2006 12/18/2007 01/11/2006 Strattera X CN Death EXP
3 Years F 6355915 5385850 07/12/2007 Strattera X MD Death EXP
5 Years M 4112478 4319609 02/01/2004 03/16/2004 02/01/2004 Strattera X Attention Deficit/Hyperactivity Disorder Drowning EXP
5 Years M 4112478 4341947 02/07/2004 04/15/2004 02/07/2004 Strattera X MD Attention Deficit/Hyperactivity Disorder Drowning, Victim of Homicide EXP
5 Years M 5882337 4771184 08/01/2005 09/14/2005 Strattera X Accidental Drug Intake By Child, Accidental Overdose, Brain Death EXP
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Rpt'd By Indications Reactions Rpt Code
5 Years M 5882337 4803083 08/12/2005 10/13/2005 Strattera X MD Accidental Drug Intake By Child, Accidental Overdose, Hypoxia EXP
5 Years M 5882337 4824283 08/12/2005 11/08/2005 Strattera X MD Accidental Drug Intake By Child, Accidental Overdose, Brain Hypoxia, Cerebral Ischaemia, Convulsion, Hypoxia, Musculoskeletal Stiffness, Pupil Fixed, Respiratory Depression, Staphylococcal Infection EXP
5 Years M 5882337 4834985 08/12/2005 11/14/2005 Strattera X MD Accidental Drug Intake By Child, Accidental Overdose, Atrophy, Brain Hypoxia, Cerebral Ventricle Dilatation, Convulsion, Ischaemia, Metabolic Disorder, Musculoskeletal Stiffness, Pupil Fixed, Respiratory Depression, Staphylococcal Infection EXP
5 Years M 5882337 4935264 08/12/2005 03/02/2006 Strattera X CN Accidental Overdose, Cerebral Atrophy, Cerebral Ischaemia, Convulsion, Hypoxia, Medication Error, Musculoskeletal Stiffness, Nuclear Magnetic Resonance Imaging Brain Abnormal, Pupil Fixed, Respiratory Depression, Staphylococcal Infection EXP
6 Years M 5876785 4765195 09/06/2005 Strattera X MD Cardiac Arrest EXP
6 Years M 5876785 4773300 09/16/2005 Strattera X MD Attention Deficit/Hyperactivity Disorder Cardiac Arrest, Cardiac Valve Disease, Congestive Cardiomyopathy EXP
6 Years M 5876785 4813560 10/26/2005 Strattera X MD Attention Deficit/Hyperactivity Disorder Brain Death, Cardiac Arrest, Cardiac Failure Congestive, Cardiac Valve Disease, Cardiomegaly, Congestive Cardiomyopathy, Dilatation Ventricular, Haemodynamic Instability, Hypotension, Organ Failure, Therapy Non-Responder EXP
8 Years M 4199197 4432619 08/09/2004 08/20/2004 08/09/2004 Strattera X MD Attention Deficit/Hyperactivity Disorder Aspiration, Cardiac Arrest, Cough, Dyspnoea, Faecal Incontinence, Food Allergy, Sudden Death, Urinary Incontinence EXP
8 Years M 4199197 4433960 08/09/2004 08/25/2004 08/09/2004 Strattera X MD Attention Deficit/Hyperactivity Disorder Aspiration, Cardiac Arrest, Cough, Faecal Incontinence, Food Allergy, Respiratory Arrest, Sudden Death, Urinary Incontinence EXP
8 Years M 4199197 4455032 08/09/2004 09/17/2004 08/09/2004 Strattera X MD Attention Deficit/Hyperactivity Disorder Aspiration, Cardiac Arrest, Cough, Dyskinesia, Faecal Incontinence, Food Allergy, Respiration Abnormal, Sudden Death, Urinary Incontinence EXP
8 Years M 4199197 4476508 08/09/2004 10/13/2004 08/09/2004 Strattera X MD Attention Deficit/Hyperactivity Disorder Aspiration, Cardio-Respiratory Arrest, Cough, Faecal Incontinence, Food Allergy, Respiratory Disorder, Sepsis, Sudden Death, Urinary Incontinence, Viral Infection EXP
8 Years 4199197 4512534 08/09/2004 11/24/2004 08/09/2004 Strattera X OT Attention Deficit/Hyperactivity Disorder Aspiration, Cardio-Respiratory Arrest, Faecal Incontinence, Food Allergy, Pneumonia, Sepsis, Sudden Death, Urinary Incontinence, Victim of Child Abuse, Viral Infection EXP
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Rpt'd By Indications Reactions Rpt Code
8 Years M 4199197 4517495 08/09/2004 11/30/2004 08/09/2004 Strattera X MD Attention Deficit/Hyperactivity Disorder Aspiration, Bronchitis Chronic, Cardio-Respiratory Arrest, Dyspnoea, Faecal Incontinence, Food Allergy, Lung Infection, Pneumonia, Sepsis, Sudden Death, Urinary Incontinence, Viral Infection EXP
8 Years M 4199197 4572167 08/09/2004 02/02/2005 08/09/2004 Strattera X MD Attention Deficit/Hyperactivity Disorder Aspiration, Cardio-Respiratory Arrest, Cough, Drug Toxicity, Dyskinesia, Dyspnoea, Faecal Incontinence, Pneumonia, Sepsis, Somnolence, Sudden Death, Urinary Incontinence, Viral Infection EXP
9 Years M 6164639 5456690 06/02/2004 09/18/2007 06/02/2004 Strattera X CN Attention Deficit/Hyperactivity Disorder Asphyxia, Cardiac Arrest EXP
9 Years M 6237403 5241893 12/01/2005 02/20/2007 12/01/2005 Strattera X MD Attention Deficit/Hyperactivity Disorder Completed Suicide EXP
9 Years M 6237403 5271392 12/05/2005 03/21/2007 12/05/2005 Strattera X MD Attention Deficit/Hyperactivity Disorder Completed Suicide, Injury Asphyxiation EXP
9 Years M 6079094 5039400 06/02/2004 06/23/2006 06/02/2004 Strattera X LW Attention Deficit/Hyperactivity Disorder Completed Suicide, Cyanosis, Injury Asphyxiation, Loss of Consciousness, Vomiting EXP
9 Years M 6079094 5102041 06/02/2004 09/07/2006 06/02/2004 Strattera X LW Attention Deficit/Hyperactivity Disorder Accidental Death, Aspiration, Electromechanical Dissociation, Injury Asphyxiation, Vomiting EXP
9 Years M 6164639 5147049 06/02/2004 11/09/2006 06/02/2004 Strattera X CN Attention Deficit/Hyperactivity Disorder Cardiac Arrest, Injury Asphyxiation, Ocular Hyperaemia, Vomiting EXP
9 Years M 6164639 5151819 06/02/2004 11/07/2006 06/02/2004 Strattera X LW Attention Deficit/Hyperactivity Disorder Accidental Death, Injury Asphyxiation, Pupil Fixed, Resuscitation, Vomiting EXP
10 Years M 5952974 4867728 03/01/2005 12/22/2005 03/01/2005 Strattera X MD Attention Deficit/Hyperactivity Disorder Completed Suicide, Injury Asphyxiation DIR
10 Years M 5983572 4898978 03/01/2005 01/27/2006 03/01/2005 Strattera X MD Completed Suicide, Injury Asphyxiation EXP
10 Years M 5983572 4948979 03/01/2005 03/15/2006 03/01/2005 Strattera X MD Accidental Death, Injury Asphyxiation EXP
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Rpt'd By Indications Reactions Rpt Code
10 Years M 6109466 5076953 02/02/2006 08/07/2006 02/02/2006 Strattera X MD Attention Deficit/Hyperactivity Disorder Accidental Death, Balance Disorder, Injury Asphyxiation EXP
10 Years M 6109466 5089885 02/02/2006 08/23/2006 02/02/2006 Strattera X MD Attention Deficit/Hyperactivity Disorder Accidental Death EXP
10 Years M 6109466 5097478 02/02/2006 09/01/2006 02/02/2006 Strattera X MD Attention Deficit/Hyperactivity Disorder Accidental Death, Injury Asphyxiation EXP
11 Years M 5754653 4595538 10/08/2004 02/24/2005 10/08/2004 Strattera X Depression Cardio-Respiratory Arrest EXP
11 Years M 5754653 4638248 10/08/2004 04/15/2005 10/08/2004 Strattera X MD Cardio-Respiratory Arrest, Fatigue, Medication Error, Suicidal Ideation EXP
12 Years M 4041277 4356760 11/04/2003 05/07/2004 11/04/2003 Strattera X MD 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 EXP
12 Years M 4041277 4368795 11/04/2003 05/27/2004 11/04/2003 Strattera X MD 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 EXP
12 Years M 5910416 4805983 10/23/2004 10/19/2005 10/23/2004 Strattera X Attention Deficit/Hyperactivity Disorder Completed Suicide EXP
12 Years M 6030367 4973569 10/23/2004 04/13/2006 10/23/2004 Strattera X CN Attention Deficit/Hyperactivity Disorder Completed Suicide DIR
12 Years M 6370501 5400755 07/30/2007 Strattera X CN Completed Suicide EXP
12 Years 6447235 5493420 10/23/2007 Strattera X MD Death EXP
14 Years M 5913951 4806582 09/01/2005 10/19/2005 Strattera X MD Attention Deficit/Hyperactivity Disorder Completed Suicide, Injury Asphyxiation EXP
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Rpt'd By Indications Reactions Rpt Code
14 Years M 6183286 5169928 01/03/2005 12/12/2006 01/03/2005 Strattera X CN Attention Deficit/Hyperactivity Disorder Completed Suicide, Injury Asphyxiation EXP
14 Years M 6315638 5328731 01/01/2004 05/18/2007 05/06/2007 Strattera X MD Attention Deficit/Hyperactivity Disorder Completed Suicide EXP
14 Years M 6411933 5450107 07/01/2007 09/12/2007 07/01/2007 Strattera X MD Attention Deficit/Hyperactivity Disorder Ventricular Fibrillation EXP
14 Years M 6411933 5485865 07/01/2007 10/15/2007 07/01/2007 Strattera X MD Attention Deficit/Hyperactivity Disorder Ventricular Fibrillation EXP
14 Years M 6411933 5486349 07/01/2007 10/16/2007 07/01/2007 Strattera X MD Attention Deficit/Hyperactivity Disorder Ventricular Fibrillation EXP
15 Years M 5671703 4501050 10/14/2004 11/09/2004 10/14/2004 Strattera X MD Attention Deficit/Hyperactivity Disorder Completed Suicide, Injury Asphyxiation, Self Injurious Behaviour EXP
15 Years M 5671703 4538814 10/14/2004 12/22/2004 10/14/2004 Strattera X MD Attention Deficit/Hyperactivity Disorder Completed Suicide EXP
15 Years M 5952177 4860774 01/01/2005 12/16/2005 Strattera X MD Completed Suicide EXP
16 Years M 3970831 4501064 06/12/2003 11/09/2004 06/16/2003 Strattera X MD 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 EXP
16 Years M 5671703 4493571 09/01/2004 11/02/2004 Strattera X MD Attention Deficit/Hyperactivity Disorder Completed Suicide, Injury Asphyxiation EXP
16 Years M 5951902 4860620 01/01/2005 12/16/2005 Strattera X Attention Deficit/Hyperactivity Disorder Completed Suicide, Gun Shot Wound EXP
16 Years M 5951902 4861048 01/01/2005 12/16/2005 Strattera X Attention Deficit/Hyperactivity Disorder Completed Suicide, Gun Shot Wound EXP
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Rpt'd By Indications Reactions Rpt Code
16 Years M 5951902 4883799 01/01/2005 01/13/2006 Strattera X OT Attention Deficit/Hyperactivity Disorder Alcohol Use, Completed Suicide, Drug Abuser, Gun Shot Wound, Intentional Self-Injury EXP
16 Years M 5952177 4882987 10/01/2005 01/13/2006 Strattera X MD Attention Deficit/Hyperactivity Disorder Completed Suicide EXP
16 Years 6322828 5338855 10/03/2004 05/30/2007 10/03/2004 Strattera X CN Disturbance In Attention Completed Suicide EXP
16 Years M 6393534 5429168 01/01/2007 08/29/2007 01/01/2007 Strattera X MD Attention Deficit/Hyperactivity Disorder Completed Suicide EXP
17 Years M 4152711 4371054 04/01/2004 05/27/2004 04/01/2004 Strattera X OT Completed Suicide EXP
17 Years M 4152711 4456276 04/01/2004 09/17/2004 04/01/2004 Strattera X MD Completed Suicide, Injury Asphyxiation, Intentional Self-Injury EXP
17 Years M 5738728 4571988 11/11/2004 02/02/2005 11/11/2004 Strattera X MD Completed Suicide, Drug Level Increased, Treatment Noncompliance EXP
17 Years M 5738728 4588762 11/11/2004 02/16/2005 11/11/2004 Strattera X MD Completed Suicide, Drug Level Increased, Parent-Child Problem, Treatment Noncompliance EXP
17 Years M 5738728 4613142 11/11/2004 03/16/2005 11/11/2004 Strattera X MD Completed Suicide, Intentional Misuse, Treatment Noncompliance EXP
17 Years M 5738728 4709545 11/11/2004 07/07/2005 11/11/2004 Strattera X MD Completed Suicide, Drug Level Increased, Treatment Noncompliance EXP
17 Years M 5738728 4847949 11/11/2004 12/06/2005 11/11/2004 Strattera X MD Depression Completed Suicide, Drug Interaction, Myocardial Infarction, Overdose, Treatment Noncompliance EXP
17 Years M 5903501 4797440 05/12/2005 10/07/2005 05/12/2005 Strattera X CN Completed Suicide DIR
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Rpt'd By Indications Reactions Rpt Code
17 Years M 5924684 4823966 05/12/2005 11/08/2005 05/12/2005 Strattera X Disturbance In Attention Completed Suicide EXP
17 Years M 5924684 4870641 05/12/2005 12/28/2005 05/12/2005 Strattera X Disturbance In Attention Completed Suicide, Overdose EXP
18 Years M 4168987 4392012 07/01/2004 Strattera X MD Attention Deficit/Hyperactivity Disorder Completed Suicide, Depression, Disturbance In Attention, Emotional Disorder, Gun Shot Wound EXP
18 Years M 6026869 4964237 12/14/2005 03/31/2006 12/14/2005 Strattera X CN Completed Suicide, Injury Asphyxiation, Intentional Self-Injury, Skin Laceration EXP
19 Years 5923694 4823523 11/07/2005 01/01/2004 Strattera X MD Cardiac Arrest, Completed Suicide, Multiple Drug Overdose, Respiratory Arrest EXP
19 Years F 5923694 4938631 03/06/2006 01/01/2004 Strattera X MD Cardiac Arrest, Completed Suicide, Drug Toxicity, Multiple Drug Overdose Intentional, Pulmonary Congestion, Respiration Abnormal, Respiratory Arrest, Somnolence EXP
20 Years F 5796217 4655387 05/05/2005 Strattera X OT Completed Suicide EXP
20 Years M 6164621 5147021 07/17/2004 11/09/2006 07/25/2004 Strattera X CN Coma, Injury Asphyxiation, Suicide Attempt EXP
21 Years M 6054812 5006862 01/01/2004 05/16/2006 09/23/2004 Strattera X PH Attention Deficit/Hyperactivity Disorder Completed Suicide, Gun Shot Wound, Head Injury, Intentional Self-Injury, Suicidal Ideation EXP
21 Years M 6157560 5133886 03/15/2005 10/23/2006 03/15/2005 Strattera X Depression Completed Suicide, Injury Asphyxiation DIR
22 Years F 5752581 4580254 12/16/2003 01/27/2005 Strattera X OT Attention Deficit/Hyperactivity Disorder Abortion Spontaneous PER
24 Years F 5796217 4713671 04/27/2005 07/13/2005 Strattera X OT Intentional Misuse, Intentional Self-Injury, Overdose, Suicide Attempt EXP
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Rpt'd By Indications Reactions Rpt Code
25 Years F 6384021 5415914 01/01/2007 08/15/2007 Strattera X CN Attention Deficit/Hyperactivity Disorder Abortion Spontaneous, Drug Exposure During Pregnancy EXP
25 Years M 6440228 5482913 08/01/2007 10/11/2007 Strattera X MD Completed Suicide EXP
25 Years M 6440228 5565381 08/01/2007 12/18/2007 Strattera X MD Attention Deficit/Hyperactivity Disorder Completed Suicide EXP
26 Years M 5731386 4567102 11/18/2004 01/26/2005 11/18/2004 Strattera X MD Attention Deficit/Hyperactivity Disorder Drug Toxicity, Hepatic Failure, International Normalised Ratio Increased, Malaise, Overdose, Prothrombin Time Prolonged, Renal Failure, Vomiting EXP
26 Years M 5731386 4576930 11/18/2004 02/08/2005 11/18/2004 Strattera X MD Attention Deficit/Hyperactivity Disorder Drug Toxicity, Hepatic Failure, Malaise, Renal Failure, Treatment Noncompliance, Vomiting EXP
27 Years M 5899462 4791061 01/01/2005 10/05/2005 01/01/2005 Strattera X MD Attention Deficit/Hyperactivity Disorder Completed Suicide EXP
27 Years F 5996604 4915956 01/01/2006 02/14/2006 Strattera X MD Blood Pressure Decreased, Pyrexia, Tachycardia EXP
27 Years F 5996604 4932051 01/11/2006 02/28/2006 01/11/2006 Strattera X MD Back Pain, Circulatory Collapse, Convulsion, Dizziness, Euphoric Mood, Fall, Lung Infiltration, Neck Pain, Pyrexia, Ventricular Fibrillation EXP
28 Years M 6183275 5169919 04/13/2005 12/12/2006 04/13/2005 Strattera X CN Completed Suicide EXP
32 Years F 5651144 4476584 01/01/2004 10/13/2004 01/01/2004 Strattera X MD Medication Error, Overdose, Vomiting EXP
33 Years F 6373005 5397636 06/25/2007 07/23/2007 06/25/2007 Strattera X Bipolar Disorder Completed Suicide, Drug Intolerance DIR
35 Years F 4101722 4306022 01/01/2004 02/25/2004 01/01/2004 Strattera X MD Completed Suicide EXP
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Rpt'd By Indications Reactions Rpt Code
35 Years F 4101722 4373135 06/29/2003 06/03/2004 06/29/2003 Strattera X MD Completed Suicide, Contusion, Drug Toxicity, Multiple Drug Overdose EXP
35 Years M 4141401 4356942 04/01/2004 05/07/2004 03/08/2004 Strattera X MD Attention Deficit/Hyperactivity Disorder Completed Suicide, Intentional Overdose EXP
35 Years M 4141401 4956847 03/08/2004 03/23/2006 03/08/2004 Strattera X MD Attention Deficit/Hyperactivity Disorder Bronchopneumonia, Completed Suicide, Hepatic Steatosis, Intentional Drug Misuse, Multiple Drug Overdose Intentional EXP
38 Years F 5752476 4580213 01/01/2004 01/27/2005 Strattera X CN Attention Deficit/Hyperactivity Disorder Abortion Spontaneous PER
39 Years M 5744981 4772991 09/15/2005 Strattera X MD Attention Deficit/Hyperactivity Disorder Completed Suicide EXP
41 Years M 4157588 4378206 12/19/2003 06/09/2004 12/19/2003 Strattera X MD Attention Deficit/Hyperactivity Disorder Myocardial Infarction EXP
42 Years M 6353706 5399156 07/27/2007 Strattera X MD Attention Deficit/Hyperactivity Disorder Death, Sleep Disorder, Somnolence EXP
45 Years F 4148360 4364664 04/26/2004 05/21/2004 04/26/2004 Strattera X MD Attention Deficit/Hyperactivity Disorder Agitation, Anxiety, Brain Death, Cardiac Arrest, Loss of Consciousness EXP
45 Years F 4148360 4449074 09/09/2004 04/26/2004 Strattera X MD Attention Deficit/Hyperactivity Disorder Agitation, Anoxic Encephalopathy, Anxiety, Brain Death, Cardiac Arrest, Loss of Consciousness EXP
45 Years F 4148360 4456279 09/17/2004 04/26/2004 Strattera X MD Attention Deficit/Hyperactivity Disorder Agitation, Anoxic Encephalopathy, Anxiety, Brain Death, Cardiac Arrest EXP
46 Years M 6046261 4991393 04/06/2006 04/28/2006 04/06/2006 Strattera X MD Death EXP
47 Years F 5655897 4483431 08/27/2004 10/20/2004 08/28/2004 Strattera X MD Abnormal Behaviour, Contusion, Excoriation, Overdose EXP
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Rpt'd By Indications Reactions Rpt Code
47 Years F 5655897 4512529 08/27/2004 11/24/2004 08/28/2004 Strattera X OT Abnormal Behaviour, Contusion, Drug Screen Positive, Overdose, Scratch EXP
47 Years F 5655897 4538791 08/28/2004 12/22/2004 08/28/2004 Strattera X MD Abnormal Behaviour, Drug Toxicity, Excoriation EXP
49 Years M 6018744 5048538 06/29/2005 07/05/2006 07/06/2005 Strattera X MD Attention Deficit/Hyperactivity Disorder Loss of Consciousness, Myocardial Infarction, Prescribed Overdose EXP
49 Years M 6179782 5164912 06/29/2005 12/05/2006 07/06/2005 Strattera X MD Attention Deficit/Hyperactivity Disorder Coronary Artery Disease, Coronary Artery Occlusion, Loss of Consciousness, Myocardial Infarction, Prescribed Overdose EXP
50 Years F 6234939 5234538 05/09/2006 02/09/2007 05/10/2006 Strattera X MD Depression Drug Toxicity, Gallbladder Disorder EXP
50 Years F 6234939 5234546 02/09/2007 Strattera X MD Arrhythmia, Drug Interaction EXP
51 Years M 6018744 4954842 10/01/2005 03/22/2006 10/01/2005 Strattera X MD Death EXP
51 Years M 6018744 5022704 07/01/2005 06/05/2006 10/01/2005 Strattera X MD Prescribed Overdose EXP
65 Years F 5862506 4741355 08/08/2005 Strattera X MD Attention Deficit/Hyperactivity Disorder Adverse Event, Sudden Death EXP
67 Years F 5862506 4747181 01/01/2005 08/15/2005 01/01/2005 Strattera X MD Attention Deficit/Hyperactivity Disorder Ejection Fraction Decreased EXP
71 Years M 5769652 4898688 01/04/2005 01/27/2006 01/04/2005 Strattera X MD Attention Deficit/Hyperactivity Disorder Acute Myocardial Infarction, Cardiac Arrest, Loss of Consciousness, Ventricular Fibrillation EXP
76 Years M 6353706 5383349 07/10/2007 Strattera X MD Death EXP
48 Males 17 Females 71 Cases (Gender was not reported for 6 Cases) 132 Individual Safety Reports

Completed Suicide/Death Totals Reported By
Reaction SSRIs SNRIs Atypicals Antidepressants Antipsychotics Stimulants Others Totals MD CN OT PH LW NR
Completed Suicides: 34 34 31 5 3 1 1 10
Deaths (not from Suicide): 37 37 57 8 4 2 6