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 2006 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 "Completed Suicide", "Death" or "Stillbirth" as an Adverse Reaction. Where an Indication isn't shown, none was provided in the report.

No age was entered for 13 of the 73 reports in this table; therefore, Black Box Warning and Increased Risk of Suicide may not be applicable for these where patient age and indication were unknown. (According to the Black Box Warning, Atomoxetine is approved for ADHD in pediatric and adult patients. It is not approved for major depressive disorder.)

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. There are 6 "DIR" (Direct) reports: 3 from Consumers (CN), one from a Medical Doctor (MD) and 2 from unknown reporters. All others are "EXP" (Expedited) reported to the FDA by Eli Lilly and Company.

The first row (4148345-4364662) was added to this table on 4/17/2008 after confirming with a medical research doctor that drug transmission to a fetus via semen was possible. This increases the death tally of the earlier table by 1.

Reports for those Cases highlighted in yellow may have been for the same patient/incident listed in the preceeding or following row as the patient Age (where given), Gender, Date of Event and Date of Death match and (except for 6164639.5151819 which may be a different Case from the 6079094 entries above it) are DIRect reports from the Consumer or MD with (apparently) corresponding EXPedited reports from Lilly. The four yellow-highlighted reports of Completed Suicides and the one Accidental Death are not added to the summary totals.

Where a Case number does repeat, the Case number is bolded and any repeating Adverse Reactions (Suicides, Deaths, etc) are not added to tallies. (Note: Case 5744981 in the second row is bolded because that Case number appears at Age 39.)

An updated table that includes the FDA reports for 2007 can be viewed here.


Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions Rpt Code
4148345 4364662 05/21/04 Strattera X √ MD Anencephaly, Intra-Uterine Death, Transmission of Drug Via Semen EXP
M 5744981 4579512 02/09/05 Strattera X √ MD Completed Suicide EXP
F 5764249 4607026 02/21/05 03/09/05 02/21/05 Strattera X √ MD Death EXP
F 5892273 4786807 02/21/05 10/03/05 02/21/05 Strattera X √ CN Attention Deficit/Hyperactivity Disorder Completed Suicide DIR
M 5897087 4789848 04/28/05 10/05/05 Strattera X √ Attention Deficit/Hyperactivity Disorder Completed Suicide DIR
M 5919125 4815742 05/28/04 10/26/05 05/28/04 Strattera X √ Completed Suicide EXP
M 5939430 4814268 10/18/04 10/26/05 10/18/04 Strattera X √ Drug Ineffective, Completed Suicide EXP
6041125 4985900 04/19/06 Strattera X √ MD Drug Exposure During Pregnancy, Pregnancy, Stillbirth EXP
Unk 6041125 5022685 06/01/05 06/05/06 02/18/06 Strattera X √ MD Drug Exposure During Pregnancy, Intra-Uterine Death, Labour Complication, Stillbirth EXP
Unk 6041125 5053558 06/01/05 07/12/06 02/18/06 Strattera X √ MD Anoxia, Drug Exposure During Pregnancy, Labour Complication, Stillbirth EXP
Unk 6045434 4990718 02/01/06 04/28/06 02/01/06 Strattera X √ Drug Exposure During Pregnancy, Stillbirth EXP
Unk 6045434 5053551 02/01/06 07/12/06 02/01/06 Strattera X √ Drug Exposure During Pregnancy, Stillbirth EXP
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions Rpt Code
M 6168850 5144654 10/31/06 Strattera X √ MD Attention Deficit/Hyperactivity Disorder Completed Suicide EXP
5 Years M 5882337 4771184 08/01/05 09/14/05 Strattera X √ Accidental Drug Intake By Child, Accidental Overdose, Brain Death EXP
6 Years M 5876785 4813560 10/26/05 Strattera X √ MD Attention Deficit/Hyperactivity Disorder Cardiac Arrest, Cardiac Failure Congestive, Cardiac Valve Disease, Cardiomegaly, Congestive Cardiomyopathy, Dilatation Ventricular, Haemodynamic Instability, Hypotension, Organ Failure, Therapy Non-Responder, Brain Death EXP
8 Years M 4199197 4432619 08/09/04 08/20/04 08/09/04 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 08/09/04 08/25/04 08/09/04 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 08/09/04 09/17/04 08/09/04 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 08/09/04 10/13/04 08/09/04 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 08/09/04 11/24/04 08/09/04 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
8 Years M 4199197 4517495 08/09/04 11/30/04 08/09/04 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 08/09/04 02/02/05 08/09/04 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 6079094 5039400 06/02/04 06/23/06 06/02/04 Strattera X √ LW Attention Deficit/Hyperactivity Disorder Cyanosis, Injury Asphyxiation, Loss of Consciousness, Vomiting, Completed Suicide EXP
9 Years M 6079094 5102041 06/02/04 09/07/06 06/02/04 Strattera X √ LW Attention Deficit/Hyperactivity Disorder Accidental Death, Aspiration, Electromechanical Dissociation, Injury Asphyxiation, Vomiting EXP
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions Rpt Code
9 Years M 6164639 5151819 06/02/04 11/07/06 06/02/04 Strattera X √ LW Attention Deficit/Hyperactivity Disorder Accidental Death, Injury Asphyxiation, Pupil Fixed, Resuscitation, Vomiting EXP
10 Years M 5952974 4867728 03/01/05 12/22/05 03/01/05 Strattera X √ MD Attention Deficit/Hyperactivity Disorder Injury Asphyxiation, Completed Suicide DIR
10 Years M 5983572 4898978 03/01/05 01/27/06 03/01/05 Strattera X √ MD Injury Asphyxiation, Completed Suicide EXP
10 Years M 5983572 4948979 03/01/05 03/15/06 03/01/05 Strattera X √ MD Accidental Death, Injury Asphyxiation EXP
10 Years M 6109466 5076953 02/02/06 08/07/06 02/02/06 Strattera X √ MD Attention Deficit/Hyperactivity Disorder Accidental Death, Balance Disorder, Injury Asphyxiation EXP
10 Years M 6109466 5089885 02/02/06 08/23/06 02/02/06 Strattera X √ MD Attention Deficit/Hyperactivity Disorder Accidental Death EXP
10 Years M 6109466 5097478 02/02/06 09/01/06 02/02/06 Strattera X √ MD Attention Deficit/Hyperactivity Disorder Accidental Death, Injury Asphyxiation EXP
12 Years M 5910416 4805983 10/23/04 10/19/05 10/23/04 Strattera X √ Attention Deficit/Hyperactivity Disorder Completed Suicide EXP
12 Years M 6030367 4973569 10/23/04 04/13/06 10/23/04 Strattera X √ CN Attention Deficit/Hyperactivity Disorder Completed Suicide DIR
14 Years M 5913951 4806582 09/01/05 10/19/05 Strattera X √ MD Attention Deficit/Hyperactivity Disorder Injury Asphyxiation, Completed Suicide EXP
14 Years M 6183286 5169928 01/03/05 12/12/06 01/03/05 Strattera X √ CN Attention Deficit/Hyperactivity Disorder Injury Asphyxiation, Completed Suicide EXP
15 Years M 5671703 4501050 10/14/04 11/09/04 10/14/04 Strattera X √ MD Attention Deficit/Hyperactivity Disorder Injury Asphyxiation, Self Injurious Behaviour, Completed Suicide EXP
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions Rpt Code
15 Years M 5671703 4538814 10/14/04 12/22/04 10/14/04 Strattera X √ MD Attention Deficit/Hyperactivity Disorder Completed Suicide EXP
15 Years M 5952177 4860774 01/01/05 12/16/05 Strattera X √ MD Completed Suicide EXP
16 Years M 5671703 4493571 09/01/04 11/02/04 Strattera X √ MD Attention Deficit/Hyperactivity Disorder Injury Asphyxiation, Completed Suicide EXP
16 Years M 5951902 4860620 01/01/05 12/16/05 Strattera X √ Attention Deficit/Hyperactivity Disorder Gun Shot Wound, Completed Suicide EXP
16 Years M 5951902 4861048 01/01/05 12/16/05 Strattera X √ Attention Deficit/Hyperactivity Disorder Gun Shot Wound, Completed Suicide EXP
16 Years M 5951902 4883799 01/01/05 01/13/06 Strattera X √ OT Attention Deficit/Hyperactivity Disorder Alcohol Use, Drug Abuser, Gun Shot Wound, Intentional Self-Injury, Completed Suicide EXP
16 Years M 5952177 4882987 10/01/05 01/13/06 Strattera X √ MD Attention Deficit/Hyperactivity Disorder Completed Suicide EXP
17 Years M 4152711 4371054 04/01/04 05/27/04 04/01/04 Strattera X √ OT Completed Suicide EXP
17 Years M 4152711 4456276 04/01/04 09/17/04 04/01/04 Strattera X √ MD Injury Asphyxiation, Intentional Self-Injury, Completed Suicide EXP
17 Years M 5738728 4571988 11/11/04 02/02/05 11/11/04 Strattera X √ MD Drug Level Increased, Treatment Noncompliance, Completed Suicide EXP
17 Years M 5738728 4588762 11/11/04 02/16/05 11/11/04 Strattera X √ MD Drug Level Increased, Parent-Child Problem, Treatment Noncompliance, Completed Suicide EXP
17 Years M 5738728 4613142 11/11/04 03/16/05 11/11/04 Strattera X √ MD Intentional Misuse, Treatment Noncompliance, Completed Suicide EXP
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions Rpt Code
17 Years M 5738728 4709545 11/11/04 07/07/05 11/11/04 Strattera X √ MD Drug Level Increased, Treatment Noncompliance, Completed Suicide EXP
17 Years M 5738728 4847949 11/11/04 12/06/05 11/11/04 Strattera X √ √ MD Depression Drug Interaction, Myocardial Infarction, Overdose, Treatment Noncompliance, Completed Suicide EXP
17 Years M 5903501 4797440 05/12/05 10/07/05 05/12/05 Strattera X √ CN Completed Suicide DIR
17 Years M 5924684 4823966 05/12/05 11/08/05 05/12/05 Strattera X √ √ Disturbance In Attention Completed Suicide EXP
17 Years M 5924684 4870641 05/12/05 12/28/05 05/12/05 Strattera X √ √ Disturbance In Attention Overdose, Completed Suicide EXP
18 Years M 4168987 4392012 07/01/04 Strattera X √ MD Attention Deficit/Hyperactivity Disorder Depression, Disturbance In Attention, Emotional Disorder, Gun Shot Wound, Completed Suicide EXP
18 Years M 6026869 4964237 12/14/05 03/31/06 12/14/05 Strattera X √ CN Injury Asphyxiation, Intentional Self-Injury, Skin Laceration, Completed Suicide EXP
19 Years 5923694 4823523 11/07/05 01/01/04 Strattera X √ MD Cardiac Arrest, Multiple Drug Overdose, Respiratory Arrest, Completed Suicide EXP
19 Years F 5923694 4938631 03/06/06 01/01/04 Strattera X √ MD Cardiac Arrest, Drug Toxicity, Multiple Drug Overdose Intentional, Pulmonary Congestion, Respiration Abnormal, Respiratory Arrest, Somnolence, Completed Suicide EXP
20 Years F 5796217 4655387 05/05/05 Strattera X √ OT Completed Suicide EXP
21 Years M 6054812 5006862 01/01/04 05/16/06 09/23/04 Strattera X √ PH Attention Deficit/Hyperactivity Disorder Gun Shot Wound, Head Injury, Intentional Self-Injury, Completed Suicide EXP
21 Years M 6157560 5133886 03/15/05 10/23/06 03/15/05 Strattera X √ Depression Injury Asphyxiation, Completed Suicide DIR
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions Rpt Code
27 Years M 5899462 4791061 01/01/05 10/05/05 01/01/05 Strattera X MD Attention Deficit/Hyperactivity Disorder Completed Suicide EXP
28 Years M 6183275 5169919 04/13/05 12/12/06 04/13/05 Strattera X CN Completed Suicide EXP
35 Years F 4101722 4306022 01/01/04 02/25/04 01/01/04 Strattera X MD Completed Suicide EXP
35 Years F 4101722 4373135 06/29/03 06/03/04 06/29/03 Strattera X MD Contusion, Drug Toxicity, Multiple Drug Overdose, Completed Suicide EXP
35 Years M 4141401 4356942 04/01/04 05/07/04 03/08/04 Strattera X MD Attention Deficit/Hyperactivity Disorder Intentional Overdose, Completed Suicide EXP
35 Years M 4141401 4956847 03/08/04 03/23/06 03/08/04 Strattera X MD Attention Deficit/Hyperactivity Disorder Bronchopneumonia, Hepatic Steatosis, Intentional Drug Misuse, Multiple Drug Overdose Intentional, Completed Suicide EXP
39 Years M 5744981 4772991 09/15/05 Strattera X MD Attention Deficit/Hyperactivity Disorder Completed Suicide EXP
45 Years F 4148360 4364664 04/26/04 05/21/04 04/26/04 Strattera X MD Attention Deficit/Hyperactivity Disorder Agitation, Anxiety, Cardiac Arrest, Loss of Consciousness, Brain Death EXP
45 Years F 4148360 4449074 09/09/04 04/26/04 Strattera X MD Attention Deficit/Hyperactivity Disorder Agitation, Anoxic Encephalopathy, Anxiety, Cardiac Arrest, Loss of Consciousness, Brain Death EXP
45 Years F 4148360 4456279 09/17/04 04/26/04 Strattera X MD Attention Deficit/Hyperactivity Disorder Agitation, Anoxic Encephalopathy, Anxiety, Cardiac Arrest, Brain Death EXP
46 Years M 6046261 4991393 04/06/06 04/28/06 04/06/06 Strattera X MD Death EXP
51 Years M 6018744 4954842 10/01/05 03/22/06 10/01/05 Strattera X MD Death EXP
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions Rpt Code
65 Years F 5862506 4741355 08/08/05 Strattera X MD Attention Deficit/Hyperactivity Disorder Adverse Event, Sudden Death EXP
36 Males 6 Females 46 Cases (Gender was not reported for 4 Cases) 73 Individual Safety Reports

Homicidal/Suicidal/Death/Mania Reactions Reported By
Reaction SSRIs SNRIs Atypicals Antidepressants Antipsychotics Stimulants Others Totals MD CN OT PH LW NR
Depression Suicidal/Suicidal Ideations:
Attempted Suicides (not completed):
Completed Suicides: 28 28 16 3 3 1 1 6
Deaths (not from Suicide): 12 12 11 2 1 1
Homicidal Ideations:
Homicides/Murders:
Hypomania/Mania:

This table shows the homicidal/suicidal/death/mania reaction, drug category and report author totals. The Totals column lists the total for a row's Reaction; the Reported By combined column total may exceed this Reaction Total if there was more than one reporter of that Adverse Reaction for a Case. Multiple ISRs for a Case are identified by bolding the Case for subsequent ISRs. Each unique Adverse Reaction for a Case is only counted once in the tally regardless of the number of ISRs it appears in for a Case.

MD = Physician, CN = Consumer, OT = Other Health-Provider, PH = Pharmacist, LW = Lawyer, NR = Author Not Reported.

The Death (not from Suicide) tallies are comprised of the Death and Cardiac Arrest/Failure reactions where the Date of Death was not blank and equaled the Event Date (since cardiac arrest may not have resulted in death). Completed Suicides/Deaths Reported By Consumer (CN) tallies are what is in the FDA data. Obviously not from the consumer (who died taking the drug), these reports were likely submitted by family, friends or other associates of the patient.

This is a list of all Primary Suspect Psychiatric Drugs reported in the Detail Table

Other Psychiatric Drugs

Strattera (atomoxetine)

(Note: SNRIs in the above summary table is for Sertonin-Norepinephrine Reuptake Inhibitors such as Effexor and Serzone. Strattera is a Norepinephrine Reuptake Inhibitor which doesn't have its own column.)

These are the Adverse Reactions culled from the Individual Safety Reports where the above Psychiatric Drug was identified as the Primary Suspect Drug

Abortion Induced, Accidental Death, Accidental Drug Intake By Child, Accidental Overdose, Adverse Event, Agitation, Alcohol Use, Anencephaly, Anoxia, Anoxic Encephalopathy, Anxiety, Aspiration, Atrophy, Balance Disorder, Brain Death, Brain Hypoxia, Bronchitis Chronic, Bronchopneumonia, Cardiac Arrest, Cardiac Failure Congestive, Cardiac Valve Disease, Cardiomegaly, Cardio-Respiratory Arrest, Cerebral Atrophy, Cerebral Ischaemia, Cerebral Ventricle Dilatation, Completed Suicide, Congestive Cardiomyopathy, Contusion, Convulsion, Cough, Cyanosis, Death, Depression, Dilatation Ventricular, Disturbance In Attention, Drug Abuser, Drug Exposure During Pregnancy, Drug Ineffective, Drug Interaction, Drug Level Increased, Drug Toxicity, Dyskinesia, Dyspnoea, Ejection Fraction Decreased, Electromechanical Dissociation, Emotional Disorder, Faecal Incontinence, Food Allergy, Gun Shot Wound, Haemodynamic Instability, Head Injury, Hepatic Steatosis, Hypotension, Hypoxia, Injury Asphyxiation, Intentional Drug Misuse, Intentional Misuse, Intentional Overdose, Intentional Self-Injury, Intra-Uterine Death, Ischaemia, Labour Complication, Loss of Consciousness, Lung Infection, Medication Error, Metabolic Disorder, Multiple Drug Overdose, Multiple Drug Overdose Intentional, Musculoskeletal Stiffness, Myocardial Infarction, Nuclear Magnetic Resonance Imaging Brain Abnormal, Ocular Hyperaemia, Organ Failure, Overdose, Parent-Child Problem, Pneumonia, Pregnancy, Prescribed Overdose, Pulmonary Congestion, Pupil Fixed, Respiration Abnormal, Respiratory Arrest, Respiratory Depression, Respiratory Disorder, Resuscitation, Self Injurious Behaviour, Sepsis, Skin Laceration, Somnolence, Staphylococcal Infection, Stillbirth, Sudden Death, Suicidal Ideation, Suicide Attempt, Therapy Non-Responder, Transmission of Drug Via Semen, Treatment Noncompliance, Urinary Incontinence, Victim of Child Abuse, Viral Infection, Vomiting


Top 10
Reaction Cases
Completed Suicide 33
Injury Asphyxiation 12
Intentional Self-Injury 5
Cardiac Arrest 5
Accidental Death 4
Overdose 3
Loss of Consciousness 3
Gun Shot Wound 3
Drug Toxicity 3
Drug Exposure During Pregnancy 3