This table shows all adverse reactions and indications (the condition being treated) reported to the FDA's Adverse Event Reporting System (MedWatch) between 2004 and the third quarter of 2008 where Strattera (atomoxetine) was identified in any role (Concomitant, Secondary Suspect Drug or Primary Suspect Drug) in those ISRs (Individual Safety Reports) that had "Abortion Spontaneous" (miscarriage), "Cardic Arrest", "Cardiac Failure", "Completed Suicide", "Death" or "Stillbirth" as an Adverse Reaction, or where the Date of Death equaled the Date of the Event, or where the Outcome was reported as Death. Where an Indication isn't shown, none was provided in the report. Likewise with Country - where none is shown, none was provided in the report. See this page for a table that lists only those reports where Strattera was identified as the Primary Suspect Drug.
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 appear to be for the same Case/Event/Death shown in the preceding row, but were submitted by a different reporter and assigned a different Case Number by the FDA. The Case, Gender, Completed Suicides and Deaths in these greyed reports are not included in the tallies. Note: The second and third ISR for Case 6018744 may be for a different Patient than Case 6179782 and the first ISR for 6018744 as the Patient Age and Date of Death are different from the first ISR.
The three Case Reports highlighted in yellow have an Outcome of "Death", but their Date of Death is from 4 to 8 days after the Event Date. These three deaths are included in the Deaths tally as no other drug is identified as the Primary Suspect for the Outcome, but it is acknowledged that these deaths may not have been caused by the patient taking Strattera.
The Oxford English Dictionary defines a poison as "a substance that causes death or harm when introduced into or absorbed by a living organism." This psychiatric drug fit that definition.
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | Outcome | Rpt Code | Country | Role | |
| 4148345 | 4364662 | 05/21/2004 | Strattera | MD | Anencephaly, Intra-Uterine Death, Transmission of Drug Via Semen | Congenital Anomaly | EXP | PS | |||||||
| 4148345 | 4464694 | 04/01/2004 | 09/29/2004 | Strattera | MD | Abortion Induced, Anencephaly, Drug Exposure During Pregnancy, Transmission of Drug Via Semen | Congenital Anomaly | EXP | PS | ||||||
| F | 4205958 | 4441500 | 07/28/2004 | Strattera | Attention Deficit/Hyperactivity Disorder | Abortion Spontaneous | PER | PS | |||||||
| M | 5701390 | 4536192 | 01/01/2004 | 12/23/2004 | 01/01/2004 | Strattera | CN | Drug Use for Unknown Indication | Completed Suicide | Death | EXP | SS | |||
| M | 5744981 | 4579512 | 02/09/2005 | Strattera | MD | Completed Suicide | Death | EXP | PS | ||||||
| F | 5764249 | 4607026 | 02/21/2005 | 03/09/2005 | 02/21/2005 | Strattera | MD | Death | Death | EXP | PS | ||||
| F | 5892273 | 4786807 | 02/21/2005 | 10/03/2005 | 02/21/2005 | Strattera | CN | Attention Deficit/Hyperactivity Disorder | Completed Suicide | Death | DIR | United States | PS | ||
| M | 5897087 | 4789848 | 04/28/2005 | 10/05/2005 | Strattera | Attention Deficit/Hyperactivity Disorder | Completed Suicide | Other | DIR | United States | PS | ||||
| F | 5905025 | 4831190 | 05/28/2005 | 11/18/2005 | 05/28/2005 | Strattera | MD | Drug Use for Unknown Indication | Accidental Overdose, Acute Pulmonary Oedema, Hepatosplenomegaly, Respiratory Depression | Death | EXP | United States | C | ||
| M | 5919125 | 4815742 | 05/28/2004 | 10/26/2005 | 05/28/2004 | Strattera | Completed Suicide | Death | EXP | United States | PS | ||||
| M | 5939430 | 4814268 | 10/18/2004 | 10/26/2005 | 10/18/2004 | Strattera | Completed Suicide, Drug Ineffective | Death | EXP | United States | PS | ||||
| M | 6014238 | 4949708 | 02/01/2006 | 03/15/2006 | 02/01/2006 | Strattera | MD | Closed Head Injury | Coma | Death | EXP | United States | PS | ||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | Outcome | Rpt Code | Country | Role | |
| 6041125 | 4985900 | 04/19/2006 | Strattera | MD | Drug Exposure During Pregnancy, Stillbirth | Death | EXP | United Kingdom | PS | ||||||
| 6041125 | 5022685 | 06/01/2005 | 06/05/2006 | 02/18/2006 | Strattera | MD | Drug Exposure During Pregnancy, Intra-Uterine Death, Labour Complication, Stillbirth | Death | EXP | United Kingdom | PS | ||||
| 6041125 | 5053558 | 06/01/2005 | 07/12/2006 | 02/18/2006 | Strattera | MD | Anoxia, Drug Exposure During Pregnancy, Labour Complication, Stillbirth | Death | EXP | United Kingdom | PS | ||||
| F | 6043198 | 4991479 | 01/11/2006 | 05/02/2006 | 01/11/2006 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Convulsion, Neuroleptic Malignant Syndrome | Death | DIR | United States | PS | ||
| 6045434 | 4990718 | 02/01/2006 | 04/28/2006 | 02/01/2006 | Strattera | Drug Exposure During Pregnancy, Stillbirth | Death | EXP | United Kingdom | PS | |||||
| 6045434 | 5053551 | 02/01/2006 | 07/12/2006 | 02/01/2006 | Strattera | Drug Exposure During Pregnancy, Stillbirth | Death | EXP | United Kingdom | PS | |||||
| M | 6168850 | 5144654 | 10/31/2006 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Completed Suicide | Death | EXP | Mexico | PS | ||||
| M | 6237403 | 5237339 | 02/13/2007 | Strattera | CN | Death | Death | EXP | Puerto Rico | PS | |||||
| M | 6371858 | 5401716 | 05/01/2007 | 07/31/2007 | 05/01/2007 | Strattera | MD | Anxiety | Completed Suicide | Death | EXP | United States | PS | ||
| F | 6508341 | 5565406 | 01/11/2006 | 12/18/2007 | 01/11/2006 | Strattera | CN | Death | Death | EXP | United States | PS | |||
| M | 6551202 | 5623675 | 02/12/2008 | Strattera | MD | Death | Death | EXP | United States | PS | |||||
| M | 6579175 | 5662047 | 02/27/2008 | 03/12/2008 | 02/27/2008 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Asphyxia, Completed Suicide | Death | EXP | United States | PS | ||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | Outcome | Rpt Code | Country | Role | |
| M | 6371858 | 5713601 | 06/02/2007 | 04/22/2008 | 06/02/2007 | Strattera | MD | Anxiety | Completed Suicide | Death | EXP | United States | PS | ||
| M | 6516259 | 5724588 | 05/01/2008 | 11/01/2004 | Strattera | OT | Completed Suicide | Death | EXP | United States | C | ||||
| M | 6516259 | 5775343 | 06/17/2008 | 11/27/2004 | Strattera | OT | Completed Suicide | Death | EXP | United States | C | ||||
| M | 6516259 | 5796702 | 06/01/2003 | 07/01/2008 | 11/27/2004 | Strattera | OT | Completed Suicide, Headache | Death | EXP | United States | C | |||
| M | 6516259 | 5802146 | 06/01/2003 | 07/07/2008 | 11/27/2004 | Strattera | OT | Completed Suicide, Headache | Death | EXP | United States | C | |||
| M | 6516259 | 5804756 | 06/01/2003 | 07/09/2008 | 11/27/2004 | Strattera | OT | Attention Deficit/Hyperactivity Disorder | Completed Suicide, Headache | Death | EXP | United States | C | ||
| M | 6516259 | 5839638 | 06/01/2003 | 08/11/2008 | 11/27/2004 | Strattera | OT | Attention Deficit/Hyperactivity Disorder | Completed Suicide, Headache | Death | EXP | United States | C | ||
| M | 6516259 | 5858495 | 06/01/2003 | 08/26/2008 | 11/27/2004 | Strattera | OT | Attention Deficit/Hyperactivity Disorder | Completed Suicide, Headache | Death | EXP | United States | C | ||
| F | 6610971 | 5700125 | 01/11/2006 | 04/10/2008 | 01/11/2006 | Strattera | MD | Circulatory Collapse, Convulsion, Death, Dizziness, Euphoric Mood, Fall, Heart Rate Increased, Lung Infiltration, Neck Pain, Pyrexia, Ventricular Fibrillation | Death | EXP | United States | PS | |||
| F | 6610971 | 5700238 | 01/11/2006 | 04/10/2008 | 01/11/2006 | Strattera | MD | Beckwith-Wiedemann Syndrome, Circulatory Collapse, Convulsion, Dizziness, Drug Toxicity, Euphoric Mood, Fall, Hot Flush, Lung Infiltration, Neck Pain, Neuroleptic Malignant Syndrome, Phaeochromocytoma, Pyrexia, Tachycardia, Unresponsive To Stimuli, Ventricular Fibrillation, White Blood Cell Count Increased | Death | EXP | United States | PS | |||
| F | 6610971 | 5763198 | 01/11/2006 | 06/09/2008 | 01/11/2006 | Strattera | MD | Beckwith-Wiedemann Syndrome, Circulatory Collapse, Convulsion, Dizziness, Drug Toxicity, Euphoric Mood, Fall, Hot Flush, Lung Infiltration, Neck Pain, Neuroleptic Malignant Syndrome, Phaeochromocytoma, Pyrexia, Tachycardia, Unresponsive To Stimuli, Ventricular Fibrillation, White Blood Cell Count Increased | Death | EXP | United States | PS | |||
| M | 6642208 | 5740814 | 07/24/2007 | 05/16/2008 | 07/24/2007 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Cardiomegaly, Mitral Valve Disease, Muscle Strain, Unresponsive To Stimuli, Ventricular Fibrillation, Ventricular Hypertrophy | Death | EXP | United States | PS | ||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | Outcome | Rpt Code | Country | Role | |
| M | 6731814 | 5851557 | 07/23/2007 | 08/20/2008 | 07/23/2007 | Strattera | CN | Attention Deficit/Hyperactivity Disorder | Completed Suicide | Death | EXP | United States | PS | ||
| 3 | Years | F | 6355915 | 5385850 | 07/12/2007 | Strattera | MD | Death | Death | EXP | Germany | PS | |||
| 5 | Years | M | 4112478 | 4319609 | 02/01/2004 | 03/16/2004 | 02/01/2004 | Strattera | Attention Deficit/Hyperactivity Disorder | Drowning | Death | EXP | PS | ||
| 5 | Years | M | 4112478 | 4341947 | 02/07/2004 | 04/15/2004 | 02/07/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Drowning, Victim of Homicide | Death | EXP | PS | |
| 5 | Years | M | 5882337 | 4771184 | 08/01/2005 | 09/14/2005 | Strattera | Accidental Drug Intake By Child, Accidental Overdose, Brain Death | Hospitalization - Initial or Prolonged | EXP | United States | PS | |||
| 5 | Years | M | 5882337 | 4803083 | 08/12/2005 | 10/13/2005 | Strattera | MD | Accidental Drug Intake By Child, Accidental Overdose, Hypoxia | Hospitalization - Initial or Prolonged | EXP | United States | PS | ||
| 5 | Years | M | 5882337 | 4824283 | 08/12/2005 | 11/08/2005 | Strattera | MD | Accidental Drug Intake By Child, Accidental Overdose, Brain Hypoxia, Cerebral Ischaemia, Convulsion, Hypoxia, Musculoskeletal Stiffness, Pupil Fixed, Respiratory Depression, Staphylococcal Infection | Hospitalization - Initial or Prolonged | EXP | United States | PS | ||
| 5 | Years | M | 5882337 | 4834985 | 08/12/2005 | 11/14/2005 | Strattera | 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 | Hospitalization - Initial or Prolonged | EXP | United States | PS | ||
| 5 | Years | M | 5882337 | 4935264 | 08/12/2005 | 03/02/2006 | Strattera | CN | Accidental Overdose, Cerebral Atrophy, Cerebral Ischaemia, Convulsion, Hypoxia, Musculoskeletal Stiffness, Nuclear Magnetic Resonance Imaging Brain Abnormal, Pupil Fixed, Respiratory Depression, Staphylococcal Infection | Hospitalization - Initial or Prolonged | EXP | United States | PS | ||
| 5 | Years | M | 6102860 | 5068614 | 07/28/2006 | Strattera | MD | Cardiac Disorder | Death | EXP | Mexico | PS | |||
| 5 | Years | M | 6102860 | 5074771 | 08/07/2006 | Strattera | MD | Cardiac Disorder, Heart Rate Increased | Death | EXP | Mexico | PS | |||
| 5 | Years | M | 6102860 | 5090677 | 08/23/2006 | Strattera | MD | Cardiac Disorder, Fall | Death | EXP | Mexico | PS | |||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | Outcome | Rpt Code | Country | Role | |
| 5 | Years | M | 6102860 | 5106682 | 08/10/2005 | 09/13/2006 | Strattera | MD | Aspiration Bronchial, Bronchial Obstruction, Fall, Heart Rate Increased | Death | EXP | Mexico | PS | ||
| 6 | Years | M | 5876785 | 4765195 | 09/06/2005 | Strattera | MD | Cardiac Arrest | Death | EXP | United States | PS | |||
| 6 | Years | M | 5876785 | 4773300 | 09/16/2005 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Cardiac Arrest, Cardiac Valve Disease, Congestive Cardiomyopathy | Death | EXP | United States | PS | ||
| 6 | Years | M | 5876785 | 4813560 | 10/26/2005 | Strattera | 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 | Death | EXP | United States | PS | ||
| 7 | Years | M | 5890841 | 4781860 | 09/01/2005 | 09/27/2005 | Strattera | MD | Brain Herniation, Somnolence | Death | EXP | United States | PS | ||
| 8 | Years | M | 4199197 | 4432619 | 08/09/2004 | 08/20/2004 | 08/09/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Aspiration, Cardiac Arrest, Cough, Dyspnoea, Faecal Incontinence, Food Allergy, Sudden Death, Urinary Incontinence | Death | EXP | PS | |
| 8 | Years | M | 4199197 | 4433960 | 08/09/2004 | 08/25/2004 | 08/09/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Aspiration, Cardiac Arrest, Cough, Faecal Incontinence, Food Allergy, Respiratory Arrest, Sudden Death, Urinary Incontinence | Death | EXP | PS | |
| 8 | Years | M | 4199197 | 4455032 | 08/09/2004 | 09/17/2004 | 08/09/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Aspiration, Cardiac Arrest, Cough, Dyskinesia, Faecal Incontinence, Food Allergy, Respiration Abnormal, Sudden Death, Urinary Incontinence | Death | EXP | PS | |
| 8 | Years | M | 4199197 | 4476508 | 08/09/2004 | 10/13/2004 | 08/09/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Aspiration, Cardio-Respiratory Arrest, Cough, Faecal Incontinence, Food Allergy, Respiratory Disorder, Sepsis, Sudden Death, Urinary Incontinence, Viral Infection | Death | EXP | PS | |
| 8 | Years | 4199197 | 4512534 | 08/09/2004 | 11/24/2004 | 08/09/2004 | Strattera | 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 | Death | EXP | PS | ||
| 8 | Years | M | 4199197 | 4517495 | 08/09/2004 | 11/30/2004 | 08/09/2004 | Strattera | 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 | Death | EXP | PS | |
| 8 | Years | M | 4199197 | 4572167 | 08/09/2004 | 02/02/2005 | 08/09/2004 | Strattera | 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 | Death | EXP | PS | |
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | Outcome | Rpt Code | Country | Role | |
| 9 | Years | M | 6164639 | 5456690 | 06/02/2004 | 09/18/2007 | 06/02/2004 | Strattera | CN | Attention Deficit/Hyperactivity Disorder | Asphyxia, Cardiac Arrest | Death | EXP | United States | PS |
| 9 | Years | M | 6164639 | 5456690 | 06/02/2004 | 09/18/2007 | 06/02/2004 | Strattera | CN | Asphyxia, Cardiac Arrest | Death | EXP | United States | SS | |
| 9 | Years | M | 6237403 | 5241893 | 12/01/2005 | 02/20/2007 | 12/01/2005 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Completed Suicide | Death | EXP | Puerto Rico | PS |
| 9 | Years | M | 6237403 | 5241893 | 12/01/2005 | 02/20/2007 | 12/01/2005 | Strattera | MD | Completed Suicide | Death | EXP | Puerto Rico | SS | |
| 9 | Years | M | 6237403 | 5271392 | 12/05/2005 | 03/21/2007 | 12/05/2005 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Completed Suicide, Injury Asphyxiation | Death | EXP | Puerto Rico | PS |
| 9 | Years | M | 6237403 | 5271392 | 12/05/2005 | 03/21/2007 | 12/05/2005 | Strattera | MD | Completed Suicide, Injury Asphyxiation | Death | EXP | Puerto Rico | SS | |
| 9 | Years | M | 6079094 | 5039400 | 06/02/2004 | 06/23/2006 | 06/02/2004 | Strattera | LW | Attention Deficit/Hyperactivity Disorder | Completed Suicide, Cyanosis, Injury Asphyxiation, Loss of Consciousness, Vomiting | Death | EXP | United States | PS |
| 9 | Years | M | 6079094 | 5102041 | 06/02/2004 | 09/07/2006 | 06/02/2004 | Strattera | LW | Attention Deficit/Hyperactivity Disorder | Accidental Death, Aspiration, Electromechanical Dissociation, Injury Asphyxiation, Vomiting | Death | EXP | United States | PS |
| 9 | Years | M | 6164639 | 5147049 | 06/02/2004 | 11/09/2006 | 06/02/2004 | Strattera | CN | Attention Deficit/Hyperactivity Disorder | Cardiac Arrest, Injury Asphyxiation, Ocular Hyperaemia, Vomiting | Death | EXP | United States | PS |
| 9 | Years | M | 6164639 | 5147049 | 06/02/2004 | 11/09/2006 | 06/02/2004 | Strattera | CN | Cardiac Arrest, Injury Asphyxiation, Ocular Hyperaemia, Vomiting | Death | EXP | United States | SS | |
| 9 | Years | M | 6164639 | 5151819 | 06/02/2004 | 11/07/2006 | 06/02/2004 | Strattera | LW | Attention Deficit/Hyperactivity Disorder | Accidental Death, Injury Asphyxiation, Pupil Fixed, Resuscitation, Vomiting | Death | EXP | United States | PS |
| 10 | Years | M | 5983572 | 4898978 | 03/01/2005 | 01/27/2006 | 03/01/2005 | Strattera | MD | Completed Suicide, Injury Asphyxiation | Death | EXP | United States | PS | |
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | Outcome | Rpt Code | Country | Role | |
| 10 | Years | M | 5983572 | 4948979 | 03/01/2005 | 03/15/2006 | 03/01/2005 | Strattera | MD | Accidental Death, Injury Asphyxiation | Death | EXP | United States | PS | |
| 10 | Years | M | 5952974 | 4867728 | 03/01/2005 | 12/22/2005 | 03/01/2005 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Completed Suicide, Injury Asphyxiation | Death | DIR | United States | PS |
| 10 | Years | M | 6109466 | 5076953 | 02/02/2006 | 08/07/2006 | 02/02/2006 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Accidental Death, Balance Disorder, Injury Asphyxiation | Death | EXP | United States | PS |
| 10 | Years | M | 6109466 | 5089885 | 02/02/2006 | 08/23/2006 | 02/02/2006 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Accidental Death | Death | EXP | United States | PS |
| 10 | Years | M | 6109466 | 5097478 | 02/02/2006 | 09/01/2006 | 02/02/2006 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Accidental Death, Injury Asphyxiation | Death | EXP | United States | PS |
| 11 | Years | M | 5754653 | 4595538 | 10/08/2004 | 02/24/2005 | 10/08/2004 | Strattera | Depression | Cardio-Respiratory Arrest | Death | EXP | PS | ||
| 11 | Years | M | 5754653 | 4638248 | 10/08/2004 | 04/15/2005 | 10/08/2004 | Strattera | MD | Cardio-Respiratory Arrest, Fatigue, Suicidal Ideation | Death | EXP | PS | ||
| 11 | Years | M | 5735775 | 4578717 | 10/08/2004 | 02/11/2005 | 10/08/2004 | Strattera | CN | Cardio-Respiratory Arrest | Death | EXP | C | ||
| 11 | Years | M | 5735775 | 4617153 | 10/08/2004 | 03/23/2005 | 10/08/2004 | Strattera | CN | Cardio-Respiratory Arrest | Death | EXP | SS | ||
| 11 | Years | M | 5757877 | 4599589 | 10/08/2004 | 03/03/2005 | 10/08/2004 | Strattera | OT | Cardio-Respiratory Arrest, Coma, Fatigue | Death | EXP | SS | ||
| 11 | Years | F | 6014130 | 4949480 | 03/15/2006 | Strattera | Attention Deficit/Hyperactivity Disorder | Arrhythmogenic Right Ventricular Dysplasia, Attention Deficit Hyperactivity Disorder, Cardiac Failure, Circulatory Collapse, Dilatation Ventricular, Loss of Consciousness, Malaise, Mydriasis, Pericardial Effusion, Social Avoidant Behaviour | Death | EXP | United States | PS | |||
| 12 | Years | M | 4041277 | 4356760 | 11/04/2003 | 05/07/2004 | 11/04/2003 | Strattera | 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 | Death | EXP | PS | |
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | Outcome | Rpt Code | Country | Role | |
| 12 | Years | M | 4041277 | 4368795 | 11/04/2003 | 05/27/2004 | 11/04/2003 | Strattera | 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 | Death | EXP | PS | |
| 12 | Years | F | 5778437 | 4634344 | 04/11/2005 | Strattera | Sudden Cardiac Death | Death | EXP | C | |||||
| 12 | Years | F | 5778437 | 4638163 | 04/15/2005 | Strattera | MD | Heart Rate Increased, Sudden Cardiac Death | Death | EXP | C | ||||
| 12 | Years | F | 5789937 | 4648776 | 04/27/2005 | Strattera | MD | Heart Rate Increased, Sudden Cardiac Death | Death | EXP | C | ||||
| 12 | Years | M | 5910416 | 4805983 | 10/23/2004 | 10/19/2005 | 10/23/2004 | Strattera | Attention Deficit/Hyperactivity Disorder | Completed Suicide | Death | EXP | United States | PS | |
| 12 | Years | M | 6030367 | 4973569 | 10/23/2004 | 04/13/2006 | 10/23/2004 | Strattera | CN | Attention Deficit/Hyperactivity Disorder | Completed Suicide | Death | DIR | United States | PS |
| 12 | Years | M | 6019492 | 4955055 | 03/22/2006 | Strattera | MD | Brain Scan Abnormal, Cerebrovascular Accident | Hospitalization - Initial or Prolonged | EXP | United States | PS | |||
| 12 | Years | M | 6019492 | 5051657 | 07/11/2006 | Strattera | MD | Brain Scan Abnormal, Cerebrovascular Accident | Death | EXP | United States | PS | |||
| 12 | Years | 6042142 | 4987691 | 04/24/2006 | Strattera | MD | Nervous System Disorder | Death | EXP | United States | PS | ||||
| 12 | Years | M | 6370501 | 5400755 | 07/30/2007 | Strattera | CN | Completed Suicide | Death | EXP | United States | PS | |||
| 12 | Years | 6447235 | 5493420 | 10/23/2007 | Strattera | MD | Death | Death | EXP | United States | PS | ||||
| 13 | Years | M | 6694620 | 5804885 | 07/09/2008 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Cardiac Failure | Death | EXP | United States | PS | ||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | Outcome | Rpt Code | Country | Role | |
| 14 | Years | 5891395 | 4780541 | 01/01/2004 | 09/26/2005 | 01/01/2004 | Atomoxetine | PH | Ill-Defined Disorder | Cardiac Arrest, Respiratory Arrest | Death | EXP | United States | SS | |
| 14 | Years | 6287601 | 5285503 | 01/01/2004 | 03/28/2007 | Atomoxetine | PH | Cardio-Respiratory Arrest | Death | EXP | United States | SS | |||
| 14 | Years | M | 5913951 | 4806582 | 09/01/2005 | 10/19/2005 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Completed Suicide, Injury Asphyxiation | Death | EXP | United States | PS | |
| 14 | Years | 5923700 | 4823532 | 11/07/2005 | 01/01/2004 | Strattera | MD | Cardiac Arrest, Multiple Drug Overdose, Respiratory Arrest | Death | EXP | United States | PS | |||
| 14 | Years | M | 6183286 | 5169928 | 01/03/2005 | 12/12/2006 | 01/03/2005 | Strattera | CN | Attention Deficit/Hyperactivity Disorder | Completed Suicide, Injury Asphyxiation | Death | EXP | United States | PS |
| 14 | Years | M | 6617515 | 5708721 | 12/01/2007 | 04/17/2008 | 12/01/2007 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Completed Suicide | Death | EXP | Canada | PS |
| 14 | Years | M | 6315638 | 5328731 | 01/01/2004 | 05/18/2007 | 05/06/2007 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Completed Suicide | Death | EXP | United States | PS |
| 14 | Years | M | 6315638 | 5328731 | 01/01/2004 | 05/18/2007 | 05/06/2007 | Strattera | MD | Completed Suicide | Death | EXP | United States | SS | |
| 14 | Years | M | 6411933 | 5450107 | 07/01/2007 | 09/12/2007 | 07/01/2007 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Ventricular Fibrillation | Death | EXP | Chile | PS |
| 14 | Years | M | 6411933 | 5485865 | 07/01/2007 | 10/15/2007 | 07/01/2007 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Ventricular Fibrillation | Death | EXP | Chile | PS |
| 14 | Years | M | 6411933 | 5486349 | 07/01/2007 | 10/16/2007 | 07/01/2007 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Ventricular Fibrillation | Death | EXP | Chile | PS |
| 16 | Years | M | 3970831 | 4501064 | 06/12/2003 | 11/09/2004 | 06/16/2003 | Strattera | 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 | Death | EXP | PS | |
| 15 | Years | M | 5671703 | 4501050 | 10/14/2004 | 11/09/2004 | 10/14/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Completed Suicide, Injury Asphyxiation, Self Injurious Behaviour | Death | EXP | PS | |
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | Outcome | Rpt Code | Country | Role | |
| 15 | Years | M | 5671703 | 4538814 | 10/14/2004 | 12/22/2004 | 10/14/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Completed Suicide | Death | EXP | PS | |
| 15 | Years | M | 5952177 | 4860774 | 01/01/2005 | 12/16/2005 | Strattera | MD | Completed Suicide | Death | EXP | Germany | PS | ||
| 16 | Years | M | 5671703 | 4493571 | 09/01/2004 | 11/02/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Completed Suicide, Injury Asphyxiation | Death | EXP | PS | ||
| 16 | Years | M | 5951902 | 4860620 | 01/01/2005 | 12/16/2005 | Strattera | Attention Deficit/Hyperactivity Disorder | Completed Suicide, Gun Shot Wound | Death | EXP | United States | PS | ||
| 16 | Years | M | 5951902 | 4861048 | 01/01/2005 | 12/16/2005 | Strattera | Attention Deficit/Hyperactivity Disorder | Completed Suicide, Gun Shot Wound | Death | EXP | United States | PS | ||
| 16 | Years | M | 5951902 | 4883799 | 01/01/2005 | 01/13/2006 | Strattera | OT | Attention Deficit/Hyperactivity Disorder | Completed Suicide, Drug Abuser, Gun Shot Wound, Intentional Self-Injury | Death | EXP | United States | PS | |
| 16 | Years | M | 5952177 | 4882987 | 10/01/2005 | 01/13/2006 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Completed Suicide | Death | EXP | Germany | PS | |
| 16 | Years | 6322828 | 5338855 | 10/03/2004 | 05/30/2007 | 10/03/2004 | Strattera | CN | Disturbance In Attention | Completed Suicide | Death | EXP | United States | PS | |
| 16 | Years | M | 6393534 | 5429168 | 01/01/2007 | 08/29/2007 | 01/01/2007 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Completed Suicide | Death | EXP | United States | PS |
| 17 | Years | M | 4152711 | 4371054 | 04/01/2004 | 05/27/2004 | 04/01/2004 | Strattera | OT | Completed Suicide | Death | EXP | PS | ||
| 17 | Years | M | 4152711 | 4456276 | 04/01/2004 | 09/17/2004 | 04/01/2004 | Strattera | MD | Completed Suicide, Injury Asphyxiation, Intentional Self-Injury | Death | EXP | PS | ||
| 17 | Years | M | 5737094 | 4580229 | 11/13/2004 | 02/14/2005 | 11/13/2004 | Strattera | CN | Overdose | Death | EXP | SS | ||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | Outcome | Rpt Code | Country | Role | |
| 17 | Years | M | 5737094 | 4588167 | 11/13/2004 | 02/21/2005 | 11/13/2004 | Strattera | CN | Overdose | Death | EXP | SS | ||
| 17 | Years | M | 5738728 | 4571988 | 11/11/2004 | 02/02/2005 | 11/11/2004 | Strattera | MD | Completed Suicide, Treatment Noncompliance | Death | EXP | PS | ||
| 17 | Years | M | 5738728 | 4588762 | 11/11/2004 | 02/16/2005 | 11/11/2004 | Strattera | MD | Completed Suicide, Parent-Child Problem, Treatment Noncompliance | Death | EXP | PS | ||
| 17 | Years | M | 5738728 | 4613142 | 11/11/2004 | 03/16/2005 | 11/11/2004 | Strattera | MD | Completed Suicide, Intentional Misuse, Treatment Noncompliance | Death | EXP | PS | ||
| 17 | Years | M | 5738728 | 4709545 | 11/11/2004 | 07/07/2005 | 11/11/2004 | Strattera | MD | Completed Suicide, Treatment Noncompliance | Death | EXP | United States | PS | |
| 17 | Years | M | 5738728 | 4847949 | 11/11/2004 | 12/06/2005 | 11/11/2004 | Strattera | MD | Depression | Completed Suicide, Drug Interaction, Myocardial Infarction, Overdose, Treatment Noncompliance | Death | EXP | United States | PS |
| 17 | Years | M | 5924684 | 4823966 | 05/12/2005 | 11/08/2005 | 05/12/2005 | Strattera | Disturbance In Attention | Completed Suicide | Death | EXP | United States | PS | |
| 17 | Years | M | 5924684 | 4870641 | 05/12/2005 | 12/28/2005 | 05/12/2005 | Strattera | Disturbance In Attention | Completed Suicide, Overdose | Death | EXP | United States | PS | |
| 17 | Years | M | 5903501 | 4797440 | 05/12/2005 | 10/07/2005 | 05/12/2005 | Strattera | CN | Completed Suicide | Death | DIR | United States | PS | |
| 18 | Years | M | 4168987 | 4392012 | 07/01/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Completed Suicide, Depression, Disturbance In Attention, Emotional Disorder, Gun Shot Wound | Death | EXP | PS | |||
| 18 | Years | M | 6026869 | 4964237 | 12/14/2005 | 03/31/2006 | 12/14/2005 | Strattera | CN | Completed Suicide, Injury Asphyxiation, Intentional Self-Injury, Skin Laceration | Death | EXP | United States | PS | |
| 18 | Years | F | 6169250 | 5152336 | 11/16/2006 | Atomoxetine | OT | Drug Toxicity, Overdose | Death | EXP | United States | SS | |||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | Outcome | Rpt Code | Country | Role | |
| 18 | Years | F | 6169250 | 5155155 | 11/21/2006 | Atomoxetine | OT | Completed Suicide, Drug Toxicity, Overdose | Death | EXP | United States | SS | |||
| 18 | Years | F | 6191766 | 5179148 | 12/19/2006 | Atomoxetine | OT | Bipolar Disorder | Completed Suicide, Drug Toxicity | Death | EXP | United States | SS | ||
| 19 | Years | M | 6524629 | 5588261 | 01/11/2008 | Atomoxetine | OT | Completed Suicide | Death | EXP | United States | SS | |||
| 19 | Years | M | 6558554 | 5622986 | 02/08/2008 | Atomoxetine | OT | Completed Suicide, Drug Toxicity | Death | EXP | Denmark | SS | |||
| 19 | Years | M | 6558554 | 5651861 | 03/05/2008 | Atomoxetine | OT | Completed Suicide, Drug Toxicity, Multiple Drug Overdose | Death | EXP | Denmark | SS | |||
| 19 | Years | 5923694 | 4823523 | 11/07/2005 | 01/01/2004 | Strattera | MD | Cardiac Arrest, Completed Suicide, Multiple Drug Overdose, Respiratory Arrest | Death | EXP | United States | PS | |||
| 19 | Years | F | 5923694 | 4938631 | 03/06/2006 | 01/01/2004 | Strattera | MD | Cardiac Arrest, Completed Suicide, Drug Toxicity, Multiple Drug Overdose Intentional, Pulmonary Congestion, Respiration Abnormal, Respiratory Arrest, Somnolence | Death | EXP | United States | PS | ||
| 19 | Years | 5891372 | 4782860 | 01/01/2004 | 09/27/2005 | 01/01/2004 | Atomoxetine | PH | Ill-Defined Disorder | Cardio-Respiratory Arrest, Completed Suicide, Drug Toxicity, Multiple Drug Overdose | Death | EXP | United States | SS | |
| 20 | Years | F | 5796217 | 4655387 | 05/05/2005 | Strattera | OT | Completed Suicide | Death | EXP | PS | ||||
| 20 | Years | M | 6096346 | 5067785 | 07/01/2004 | 08/02/2006 | 07/27/2004 | Strattera | CN | Drug Use for Unknown Indication | Coma, Completed Suicide, Suicidal Ideation | Death | EXP | United States | SS |
| 20 | Years | M | 6096346 | 5150486 | 07/01/2004 | 11/14/2006 | 07/27/2004 | Strattera | CN | Drug Use for Unknown Indication | Coma, Completed Suicide, Suicidal Ideation | Death | EXP | United States | SS |
| 20 | Years | M | 6164621 | 5147021 | 07/17/2004 | 11/09/2006 | 07/25/2004 | Strattera | CN | Coma, Injury Asphyxiation, Suicide Attempt | Death | EXP | United States | PS | |
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | Outcome | Rpt Code | Country | Role | |
| 21 | Years | F | 6385870 | 5418472 | 05/18/2007 | 08/17/2007 | 05/18/2007 | Strattera | CN | Attention Deficit/Hyperactivity Disorder | Completed Suicide | Death | EXP | Sweden | SS |
| 21 | Years | M | 6054812 | 5006862 | 01/01/2004 | 05/16/2006 | 09/23/2004 | Strattera | PH | Attention Deficit/Hyperactivity Disorder | Completed Suicide, Gun Shot Wound, Head Injury, Intentional Self-Injury, Suicidal Ideation | Death | EXP | United States | PS |
| 21 | Years | M | 6157560 | 5133886 | 03/15/2005 | 10/23/2006 | 03/15/2005 | Strattera | Completed Suicide, Injury Asphyxiation | Death | DIR | United States | C | ||
| 21 | Years | M | 6157560 | 5133886 | 03/15/2005 | 10/23/2006 | 03/15/2005 | Strattera | Depression | Completed Suicide, Injury Asphyxiation | Death | DIR | United States | PS | |
| 22 | Years | F | 5752581 | 4580254 | 12/16/2003 | 01/27/2005 | Strattera | OT | Attention Deficit/Hyperactivity Disorder | Abortion Spontaneous | PER | PS | |||
| 24 | Years | F | 5796217 | 4713671 | 04/27/2005 | 07/13/2005 | Strattera | OT | Intentional Misuse, Intentional Self-Injury, Overdose, Suicide Attempt | Hospitalization - Initial or Prolonged | EXP | United States | PS | ||
| 25 | Years | F | 6384021 | 5415914 | 01/01/2007 | 08/15/2007 | Strattera | CN | Attention Deficit/Hyperactivity Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy | Other | EXP | United States | PS | |
| 25 | Years | M | 6440228 | 5482913 | 08/01/2007 | 10/11/2007 | Strattera | MD | Completed Suicide | Death | EXP | Canada | PS | ||
| 25 | Years | M | 6440228 | 5565381 | 08/01/2007 | 12/18/2007 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Completed Suicide | Death | EXP | Canada | PS | |
| 25 | Years | F | 6543533 | 5613887 | 02/05/2008 | Strattera | CN | Disturbance In Attention | Abortion Spontaneous, Drug Exposure During Pregnancy | Other | EXP | United States | PS | ||
| 26 | Years | M | 4210354 | 4451321 | 09/01/2004 | 09/16/2004 | Strattera | CN | Completed Suicide | Death | EXP | C | |||
| 26 | Years | M | 5731386 | 4567102 | 11/18/2004 | 01/26/2005 | 11/18/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Drug Toxicity, Hepatic Failure, International Normalised Ratio Increased, Malaise, Overdose, Prothrombin Time Prolonged, Renal Failure, Vomiting | Death | EXP | PS | |
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | Outcome | Rpt Code | Country | Role | |
| 26 | Years | M | 5731386 | 4576930 | 11/18/2004 | 02/08/2005 | 11/18/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Drug Toxicity, Hepatic Failure, Malaise, Renal Failure, Treatment Noncompliance, Vomiting | Death | EXP | PS | |
| 27 | Years | M | 5899462 | 4791061 | 01/01/2005 | 10/05/2005 | 01/01/2005 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Completed Suicide | Death | EXP | United States | PS |
| 27 | Years | F | 5996604 | 4932051 | 01/11/2006 | 02/28/2006 | 01/11/2006 | Strattera | MD | Back Pain, Circulatory Collapse, Convulsion, Dizziness, Euphoric Mood, Fall, Lung Infiltration, Neck Pain, Pyrexia, Ventricular Fibrillation | Death | EXP | United States | PS | |
| 28 | Years | M | 6183275 | 5169919 | 04/13/2005 | 12/12/2006 | 04/13/2005 | Strattera | CN | Completed Suicide | Death | EXP | United States | PS | |
| 31 | Years | M | 4210354 | 4464186 | 07/29/2004 | 10/01/2004 | 07/29/2004 | Strattera | CN | Attention Deficit/Hyperactivity Disorder | Completed Suicide | Death | EXP | C | |
| 32 | Years | F | 5651144 | 4476584 | 01/01/2004 | 10/13/2004 | 01/01/2004 | Strattera | MD | Overdose, Vomiting | Death | EXP | PS | ||
| 33 | Years | F | 6373005 | 5397636 | 06/25/2007 | 07/23/2007 | 06/25/2007 | Strattera | Bipolar Disorder | Completed Suicide, Drug Intolerance | Death | DIR | United States | PS | |
| 33 | Years | M | 6076514 | 5033089 | 07/23/2005 | 06/20/2006 | Strattera | CN | Anaphylactic Reaction, Hypotension | Death | EXP | United States | PS | ||
| 35 | Years | F | 6571904 | 5653907 | 08/10/2007 | 03/06/2008 | 08/10/2007 | Strattera | CN | Completed Suicide | Death | EXP | United States | PS | |
| 35 | Years | F | 4101722 | 4306022 | 01/01/2004 | 02/25/2004 | 01/01/2004 | Strattera | MD | Completed Suicide | Death | EXP | PS | ||
| 35 | Years | F | 4101722 | 4373135 | 06/29/2003 | 06/03/2004 | 06/29/2003 | Strattera | MD | Completed Suicide, Contusion, Drug Toxicity, Multiple Drug Overdose | Death | EXP | PS | ||
| 35 | Years | M | 4141401 | 4356942 | 04/01/2004 | 05/07/2004 | 03/08/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Completed Suicide, Intentional Overdose | Death | EXP | PS | |
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | Outcome | Rpt Code | Country | Role | |
| 35 | Years | M | 4141401 | 4956847 | 03/08/2004 | 03/23/2006 | 03/08/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Bronchopneumonia, Completed Suicide, Hepatic Steatosis, Intentional Drug Misuse, Multiple Drug Overdose Intentional | Death | EXP | United States | PS |
| 37 | Years | F | 5905025 | 4804263 | 07/01/2005 | 10/20/2005 | 07/01/2005 | Strattera | MD | Drug Use for Unknown Indication | Acute Pulmonary Oedema, Overdose | Death | EXP | United States | C |
| 38 | Years | F | 5752476 | 4580213 | 01/01/2004 | 01/27/2005 | Strattera | CN | Attention Deficit/Hyperactivity Disorder | Abortion Spontaneous | PER | PS | |||
| 38 | Years | F | 6229654 | 5260837 | 03/09/2007 | Strattera | OT | Death | Death | EXP | United States | C | |||
| 39 | Years | M | 5744981 | 4772991 | 09/15/2005 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Completed Suicide | Death | EXP | Finland | PS | ||
| 41 | Years | M | 4157588 | 4378206 | 12/19/2003 | 06/09/2004 | 12/19/2003 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Myocardial Infarction | Death | EXP | PS | |
| 41 | Years | F | 5738584 | 4572119 | 07/01/2004 | 02/02/2005 | 07/02/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Attention Deficit Hyperactivity Disorder, Completed Suicide | Death | EXP | SS | |
| 42 | Years | M | 6353706 | 5399156 | 07/27/2007 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Death, Sleep Disorder, Somnolence | Death | EXP | United States | PS | ||
| 42 | Years | M | 5658262 | 4488221 | 10/26/2004 | 10/03/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Age Indeterminate Myocardial Infarction, Arteriosclerosis, Cardio-Respiratory Arrest, Cerebral Haematoma, Chest Pain, Circulatory Collapse, Coronary Artery Disease, Coronary Artery Occlusion, Excoriation | Death | EXP | PS | ||
| 42 | Years | F | 5788809 | 4645968 | 01/01/2004 | 04/25/2005 | Strattera | OT | Abortion Spontaneous, Drug Exposure During Pregnancy, Lethargy | Other | EXP | SS | |||
| 44 | Years | M | 6296730 | 5307984 | 03/31/2007 | 04/26/2007 | 04/02/2007 | Strattera | OT | Blood Triglycerides Increased, Death, Dyslipidaemia, Pancreatitis | Death | EXP | United States | C | |
| 44 | Years | M | 6296730 | 5430605 | 03/31/2007 | 08/30/2007 | 04/02/2007 | Strattera | OT | Blood Triglycerides Increased, Death, Dyslipidaemia, Pancreatitis | Death | EXP | United States | C | |
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | Outcome | Rpt Code | Country | Role | |
| 45 | Years | F | 4148360 | 4364664 | 04/26/2004 | 05/21/2004 | 04/26/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Agitation, Anxiety, Brain Death, Cardiac Arrest, Loss of Consciousness | Death | EXP | PS | |
| 45 | Years | F | 4148360 | 4449074 | 09/09/2004 | 04/26/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Agitation, Anoxic Encephalopathy, Anxiety, Brain Death, Cardiac Arrest, Loss of Consciousness | Death | EXP | PS | ||
| 45 | Years | F | 4148360 | 4456279 | 09/17/2004 | 04/26/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Agitation, Anoxic Encephalopathy, Anxiety, Brain Death, Cardiac Arrest | Death | EXP | PS | ||
| 45 | Years | F | 4201758 | 4434006 | 08/25/2004 | 01/01/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Anoxic Encephalopathy, Cardiac Arrest, Coma, Mitral Valve Prolapse, Ventricular Fibrillation | Death | EXP | SS | ||
| 46 | Years | M | 6046261 | 4991393 | 04/06/2006 | 04/28/2006 | 04/06/2006 | Strattera | MD | Death | Death | EXP | United States | PS | |
| 46 | Years | M | 6106576 | 5074704 | 11/19/2004 | 08/03/2006 | 11/19/2004 | Strattera | MD | Sudden Death | Death | EXP | United States | C | |
| 46 | Years | M | 6106576 | 5085010 | 11/19/2004 | 08/15/2006 | 11/19/2004 | Strattera | MD | Sudden Death | Death | EXP | United States | C | |
| 47 | Years | F | 5655897 | 4483431 | 08/27/2004 | 10/20/2004 | 08/28/2004 | Strattera | MD | Abnormal Behaviour, Contusion, Excoriation, Overdose | Death | EXP | PS | ||
| 47 | Years | F | 5655897 | 4512529 | 08/27/2004 | 11/24/2004 | 08/28/2004 | Strattera | OT | Abnormal Behaviour, Contusion, Drug Screen Positive, Overdose, Scratch | Death | EXP | PS | ||
| 47 | Years | F | 5655897 | 4538791 | 08/28/2004 | 12/22/2004 | 08/28/2004 | Strattera | MD | Abnormal Behaviour, Drug Toxicity, Excoriation | Death | EXP | PS | ||
| 48 | Years | M | 6169382 | 5152548 | 11/16/2006 | Atomoxetine | Accidental Death, Accidental Poisoning, Drug Toxicity, Mouth Haemorrhage | Death | EXP | SS | |||||
| 49 | Years | M | 6179782 | 5164912 | 06/29/2005 | 12/05/2006 | 07/06/2005 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Coronary Artery Disease, Coronary Artery Occlusion, Loss of Consciousness, Myocardial Infarction, Prescribed Overdose | Death | EXP | Canada | PS |
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | Outcome | Rpt Code | Country | Role | |
| 49 | Years | M | 6179782 | 5164912 | 06/29/2005 | 12/05/2006 | 07/06/2005 | Strattera | MD | Coronary Artery Disease, Coronary Artery Occlusion, Loss of Consciousness, Myocardial Infarction, Prescribed Overdose | Death | EXP | Canada | SS | |
| 49 | Years | M | 6018744 | 5048538 | 06/29/2005 | 07/05/2006 | 07/06/2005 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Loss of Consciousness, Myocardial Infarction, Prescribed Overdose | Death | EXP | Canada | PS |
| 50 | Years | F | 6234939 | 5234538 | 05/09/2006 | 02/09/2007 | 05/10/2006 | Strattera | MD | Depression | Drug Toxicity, Gallbladder Disorder | Death | EXP | United States | PS |
| 50 | Years | F | 6234939 | 5234546 | 02/09/2007 | Strattera | MD | Arrhythmia, Drug Interaction | Death | EXP | United States | PS | |||
| 50 | Years | F | 6238431 | 5238517 | 05/09/2006 | 02/15/2007 | 05/10/2006 | Strattera | CN | Arteriosclerosis Coronary Artery, Death, Drug Toxicity, Gallbladder Disorder | Death | EXP | United States | SS | |
| 50 | Years | F | 6238431 | 5271064 | 05/09/2006 | 03/21/2007 | 05/10/2006 | Strattera | CN | Arteriosclerosis Coronary Artery, Death, Drug Toxicity, Gallbladder Disorder | Death | EXP | United States | SS | |
| 50 | Years | F | 4220166 | 4499272 | 11/11/2004 | Atomoxetine | MD | Drug Use for Unknown Indication | Cardiac Arrest, Coma, Completed Suicide, Hepatic Failure, Hypotension, Multiple Drug Overdose Intentional, Renal Failure | Death | EXP | SS | |||
| 51 | Years | M | 6018744 | 4954842 | 10/01/2005 | 03/22/2006 | 10/01/2005 | Strattera | MD | Death | Death | EXP | Canada | PS | |
| 51 | Years | M | 6018744 | 5022704 | 07/01/2005 | 06/05/2006 | 10/01/2005 | Strattera | MD | Prescribed Overdose | Death | EXP | Canada | PS | |
| 59 | Years | M | 4112662 | 4337516 | 08/24/2003 | 04/13/2004 | 08/24/2003 | Strattera | LW | Depression, Gun Shot Wound | Death | EXP | C | ||
| 59 | Years | M | 4112662 | 4339431 | 08/24/2003 | 04/15/2004 | 08/24/2003 | Strattera | LW | Gun Shot Wound, Major Depression, Suicidal Ideation | Death | EXP | C | ||
| 59 | Years | M | 4112662 | 4352711 | 08/24/2003 | 05/04/2004 | 08/24/2003 | Strattera | LW | Completed Suicide, Gun Shot Wound, Major Depression, Suicidal Ideation | Death | EXP | C | ||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | Outcome | Rpt Code | Country | Role | |
| 59 | Years | M | 4112662 | 4364433 | 08/24/2003 | 05/25/2004 | 08/24/2003 | Strattera | LW | Completed Suicide, Gun Shot Wound, Suicidal Ideation | Death | EXP | C | ||
| 65 | Years | F | 5862506 | 4741355 | 08/08/2005 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Sudden Death | Death | EXP | United States | PS | ||
| 67 | Years | F | 5862506 | 4747181 | 01/01/2005 | 08/15/2005 | 01/01/2005 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Ejection Fraction Decreased | Death | EXP | United States | PS |
| 71 | Years | M | 5769652 | 4898688 | 01/04/2005 | 01/27/2006 | 01/04/2005 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Acute Myocardial Infarction, Cardiac Arrest, Loss of Consciousness, Ventricular Fibrillation | Death | EXP | United States | PS |
| 76 | Years | M | 6353706 | 5383349 | 07/10/2007 | Strattera | MD | Death | Death | EXP | United States | PS | |||
| 69 Males | 32 Females | 110 Cases (Gender was not reported for 9 Cases) | 203 Individual Safety Reports | ||||||||||||
| Suicides and Deaths | Reported By | ||||||
| Total | MD | CN | OT | PH | LW | NR | |
| Completed Suicides: | 50 | 38 | 17 | 17 | 2 | 6 | 10 |
| Deaths (not from Suicide): | 60 | 78 | 15 | 8 | 2 | 1 | 9 |
The combined Reported By column total in the above table may exceed the Case Total if there was more than one reporter of that Adverse Reaction for a Case. Multiple ISRs for a Case (usually follow-ups) are identified by bolding the Case for subsequent ISRs. Eleven ISRs reported mutiple Roles for Strattera. These are identified by bolding the repeating ISR number. 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, and each unique ISR is only counted once in the Total Reports and Reported By tallies.
MD = Physician, CN = Consumer, OT = Other Health-Provider, PH = Pharmacist, LW = Lawyer, NR = Author Not Reported.
The Deaths (not from Suicide) tally is 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). The reported Deaths include the highlighted Abortions.
Completed Suicides Reported By Consumer (CN) tallies are what is in the FDA data. Obviously not from the consumer (who committed suicide), these reports were likely submitted by family, friends or other associates of the patient.
Atomoxetine (atomoxetine), Strattera (atomoxetine)
Abnormal Behaviour, Abortion Induced, Abortion Spontaneous, Accidental Death, Accidental Drug Intake By Child, Accidental Overdose, Accidental Poisoning, Acute Myocardial Infarction, Acute Pulmonary Oedema, Age Indeterminate Myocardial Infarction, Agitation, Alanine Aminotransferase Increased, Anaphylactic Reaction, Anencephaly, Anoxia, Anoxic Encephalopathy, Anxiety, Arrhythmia, Arrhythmogenic Right Ventricular Dysplasia, Arteriosclerosis, Arteriosclerosis Coronary Artery, Aspartate Aminotransferase Increased, Asphyxia, Aspiration, Aspiration Bronchial, Atelectasis, Atrophy, Attention Deficit Hyperactivity Disorder, Back Pain, Balance Disorder, Beckwith-Wiedemann Syndrome, Blood Bilirubin Increased, Blood Lactate Dehydrogenase Increased, Blood Pressure Decreased, Blood Triglycerides Increased, Blood Urea Increased, Blood Uric Acid Increased, Brain Death, Brain Herniation, Brain Hypoxia, Brain Scan Abnormal, Bronchial Obstruction, Bronchitis Chronic, Bronchopneumonia, Cardiac Arrest, Cardiac Disorder, Cardiac Failure, Cardiac Failure Congestive, Cardiac Valve Disease, Cardiomegaly, Cardio-Respiratory Arrest, Cerebral Atrophy, Cerebral Haematoma, Cerebral Ischaemia, Cerebral Ventricle Dilatation, Cerebrovascular Accident, Chest Pain, Circulatory Collapse, Coma, Completed Suicide, Congestive Cardiomyopathy, Contusion, Convulsion, Coronary Artery Disease, Coronary Artery Occlusion, Cough, Cyanosis, Death, Depression, Dilatation Ventricular, Disturbance In Attention, Dizziness, Drowning, Drug Abuser, Drug Exposure During Pregnancy, Drug Ineffective, Drug Interaction, Drug Intolerance, Drug Screen Positive, Drug Toxicity, Dyskinesia, Dyslipidaemia, Dyspnoea, Ejection Fraction Decreased, Electromechanical Dissociation, Emotional Disorder, Euphoric Mood, Excoriation, Faecal Incontinence, Fall, Fatigue, Feeling Drunk, Foaming at Mout, Food Allergy, Gallbladder Disorder, Gun Shot Wound, Haemodynamic Instability, Head Injury, Headache, Heart Rate Increased, Hepatic Failure, Hepatic Steatosis, Hepatosplenomegaly, Hot Flush, Hypotension, Hypoxia, Injury Asphyxiation, Intentional Drug Misuse, Intentional Misuse, Intentional Overdose, Intentional Self-Injury, International Normalised Ratio Increased, Intra-Uterine Death, Ischaemia, Labour Complication, Lethargy, Loss of Consciousness, Lung Infection, Lung Infiltration, Major Depression, Malaise, Metabolic Disorder, Mitral Valve Disease, Mitral Valve Prolapse, Mouth Haemorrhage, Multiple Drug Overdose, Multiple Drug Overdose Intentional, Muscle Strain, Musculoskeletal Stiffness, Mydriasis, Myocardial Infarction, Neck Pain, Nervous System Disorder, Neuroleptic Malignant Syndrome, Ocular Hyperaemia, Organ Failure, Overdose, Pancreatitis, Parent-Child Problem, Pericardial Effusion, Phaeochromocytoma, Pneumonia, Prescribed Overdose, Prothrombin Time Prolonged, Pulmonary Congestion, Pupil Fixed, Pyrexia, Renal Failure, Respiration Abnormal, Respiratory Arrest, Respiratory Depression, Respiratory Disorder, Resuscitation, Scratch, Self Injurious Behaviour, Sepsis, Skin Laceration, Sleep Disorder, So, Social Avoidant Behaviour, Somnolence, Stillbirth, Sudden Cardiac Death, Sudden Death, Suicidal Ideation, Suicide Attempt, Tachycardia, Therapy Non-Responder, Transmission of Drug Via Semen, Treatment Noncompliance, Unresponsive To Stimuli, Ventricular Fibrillation, Ventricular Hypertrophy, Victim of Homicide, Vomiting
| Top 10 Adverse Reactions | |
| Adverse Reaction | Cases |
| Completed Suicide | 51 |
| Injury Asphyxiation | 13 |
| Drug Toxicity | 13 |
| Death | 13 |
| Cardiac Arrest | 10 |
| Overdose | 9 |
| Cardio-Respiratory Arrest | 7 |
| Loss of Consciousness | 6 |
| Drug Exposure During Pregnancy | 6 |
| Coma | 6 |
MedWatch is the Food and Drug Administration's program for reporting any undesirable experience associated with the use of a medical product. If you think you or someone in your family has experienced an adverse reaction from taking Strattera (atomoxetine) and it has not been reported to the FDA, see this page for instructions on reporting the adverse event through your doctor or directly to the FDA using an online form.