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Strattera (Atomoxetine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Strattera (Atomoxetine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (357)
Death (10)
Life Threatening Events (20)
Disability (8)

Reports by Reaction Type

Suicidal Ideation (54)Aggression (28)Electrocardiogram QT Prolonged (20)Nausea (18)Headache (16)Vomiting (16)Off Label Use (15)Anxiety (15)Depression (14)Irritability (13)Agitation (12)Drug Ineffective (12)

Below are a few examples of reports where side effects / adverse reactions may be related to Strattera (Atomoxetine). For a complete list or a specific selection of reports, please use the links above.

Possible Strattera side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male, weighing 29.9 kg (65.9 pounds)

Reactions: Psychotic Disorder, Arachnophobia

Drug(s) suspected as cause:
Strattera
    Dosage: 25 mg, unk
    Start date: 2012-07-21

Strattera
    Dosage: 10 mg, qd
    Administration route: Oral
    Start date: 2012-07-27

Strattera
    Dosage: 25 mg, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2012-02-16
    End date: 2012-06-28

Other drugs received by patient: Zyrtec



Possible Strattera side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 54 year old female

Reactions: Impaired Driving Ability, Anger, Impulsive Behaviour, Aggression

Drug(s) suspected as cause:
Strattera
    Dosage: 10 mg
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-09-01
    End date: 2011-09-01

Viibryd
    Dosage: 20 mg
    Start date: 2011-09-01
    End date: 2011-09-01

Viibryd
    Dosage: 10 mg
    Start date: 2011-09-01
    End date: 2011-09-01

Viibryd
    Dosage: 40 mg
    Start date: 2011-09-01
    End date: 2011-09-01

Viibryd
    Dosage: 40 mg
    Start date: 2011-10-01
    End date: 2011-10-01

Other drugs received by patient: Hydroxyzine; Diphenhydramine Hydrochloride



Possible Strattera side effects in

Reported by a physician from Germany on 2012-08-27

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Strattera



Possible Strattera side effects in 16 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 16 year old male

Reactions: Pancreatic Insufficiency

Drug(s) suspected as cause:
Strattera



Possible Strattera side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female

Reactions: Back Pain, Suicide Attempt, Depression, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Strattera

Other drugs received by patient: Claravis; Zoloft



Possible Strattera side effects in 47 year old female

Reported by a physician from United States on 2012-08-22

Patient: 47 year old female

Reactions: Agitation, Anxiety, Drug Interaction, Serotonin Syndrome, Depression, Headache, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prozac
    Dosage: 20 mg, unk
    Indication: Depression

Prozac
    Dosage: 40 mg, unk

Strattera
    Dosage: 18 mg, unk
    Indication: Attention Deficit / Hyperactivity Disorder

Strattera
    Dosage: 25 mg, unk

Other drugs received by patient: Lexapro



Possible Strattera side effects in 10 year old male

Reported by a physician from United States on 2012-08-22

Patient: 10 year old male, weighing 28.6 kg (62.9 pounds)

Reactions: Heart Rate Increased, Feeling Abnormal

Drug(s) suspected as cause:
Strattera



Possible Strattera side effects in 7 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 7 year old male

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Strattera



Possible Strattera side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: male

Reactions: Negative Thoughts, Bipolar Disorder, Drug Ineffective, Self Injurious Behaviour, Suicidal Ideation

Drug(s) suspected as cause:
Strattera
    Dosage: 35 mg, unk

Strattera
    Dosage: 25 mg, unk
    Indication: Attention Deficit / Hyperactivity Disorder



Possible Strattera side effects in male

Reported by a physician from Sweden on 2012-08-21

Patient: male, weighing 50.0 kg (110.0 pounds)

Reactions: Syncope, Potentiating Drug Interaction

Drug(s) suspected as cause:
Strattera

Other drugs received by patient: Fluoxetine HCL



Possible Strattera side effects in 12 year old

Reported by a consumer/non-health professional from Spain on 2012-08-21

Patient: 12 year old

Reactions: Supraventricular Tachycardia

Drug(s) suspected as cause:
Strattera



Possible Strattera side effects in female

Reported by a physician from United States on 2012-08-17

Patient: female, weighing 46.7 kg (102.8 pounds)

Reactions: Dysgeusia, Gastroenteritis Viral

Drug(s) suspected as cause:
Strattera

Other drugs received by patient: Zoloft



Possible Strattera side effects in 16 year old male

Reported by a consumer/non-health professional from Sweden on 2012-08-15

Patient: 16 year old male, weighing 75.5 kg (166.1 pounds)

Reactions: Syncope, Presyncope

Drug(s) suspected as cause:
Strattera
    Dosage: 25 mg, qd
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-11-01

Strattera
    Dosage: 25 mg, qd

Strattera
    Dosage: 50 mg, qd

Other drugs received by patient: Concerta



Possible Strattera side effects in 17 year old male

Reported by a physician from Spain on 2012-08-15

Patient: 17 year old male

Reactions: Cerebral Infarction

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Strattera



Possible Strattera side effects in 8 year old male

Reported by a physician from United Kingdom on 2012-08-15

Patient: 8 year old male, weighing 24.0 kg (52.8 pounds)

Reactions: Confusional State, Logorrhoea

Drug(s) suspected as cause:
Strattera
    Dosage: 40 mg, unk

Strattera
    Dosage: 25 mg, unk
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-12-15



Possible Strattera side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: female, weighing 113.4 kg (249.5 pounds)

Reactions: Blood Pressure Increased, Vision Blurred

Drug(s) suspected as cause:
Strattera



Possible Strattera side effects in 19 year old female

Reported by a physician from Germany on 2012-08-14

Patient: 19 year old female

Reactions: Laparoscopy, Appendicectomy, Gastric Disorder, Gastric Ulcer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Strattera



Possible Strattera side effects in male

Reported by a physician from Japan on 2012-08-14

Patient: male, weighing 29.0 kg (63.8 pounds)

Reactions: Electrocardiogram QT Prolonged

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Strattera
    Dosage: 10 mg, bid
    Administration route: Oral
    Start date: 2012-05-23

Strattera
    Dosage: 35 mg, qd
    Administration route: Oral
    End date: 2011-09-20

Strattera
    Dosage: 5 mg, bid
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-07-06
    End date: 2012-07-15

Strattera
    Dosage: unk unk, bid
    Administration route: Oral
    Start date: 2012-07-12
    End date: 2012-07-15

Strattera
    Dosage: 5 mg, bid
    Administration route: Oral
    Start date: 2012-05-14



Possible Strattera side effects in 18 year old female

Reported by a consumer/non-health professional from United Kingdom on 2012-08-14

Patient: 18 year old female

Reactions: Syncope, Nausea, Head Injury, Dizziness, Cough

Drug(s) suspected as cause:
Strattera
    Dosage: 25mg, unk

Strattera
    Dosage: 1.2 mg/kg, unk

Strattera
    Dosage: 0.5 mg/kg, qd
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-09-19

Other drugs received by patient: Methylphenidate HCL



Possible Strattera side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: male

Reactions: TIC, Dystonia

Drug(s) suspected as cause:
Abilify
    Dosage: 40 mg, qd

Clonidine
    Dosage: 0.02 mg, bid

Clozaril
    Indication: Schizophrenia

Depakote
    Dosage: 125 mg, qd

Klonopin
    Dosage: 1 mg, qd (mrn)

Lithium Carbonate
    Dosage: 900 mg, qd

Metadate CD
    Dosage: 25 mg

Risperidone
    Dosage: 50 mg, bid

Seroquel
    Dosage: 25 mg, qd

Strattera
    Dosage: 50 mg, qd

Tegretol
    Dosage: 150 mg, tid

Trileptal
    Dosage: 25 mg, qd

Zoloft
    Dosage: 25 mg, qd

Other drugs received by patient: Zyprexa



Possible Strattera side effects in 19 year old male

Reported by a physician from Mexico on 2012-08-13

Patient: 19 year old male

Reactions: Nausea, Headache, Intentional Drug Misuse, Suicidal Ideation, Anxiety, Depression, Attention Deficit / Hyperactivity Disorder, Rebound Effect

Drug(s) suspected as cause:
Cymbalta
    Dosage: 60 mg, qd
    Indication: Depression

Strattera
    Dosage: 100 mg, qd
    Indication: Attention Deficit / Hyperactivity Disorder



Possible Strattera side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: male

Reactions: Dystonia, TIC

Drug(s) suspected as cause:
Abilify
    Dosage: 40 mg, qd

Clonidine
    Dosage: 0.02 mg, bid

Clozaril
    Indication: Schizophrenia

Depakote
    Dosage: 125 mg, qd

Klonopin
    Dosage: 1 mg, qd (mrn)

Lithium Carbonate
    Dosage: 900 mg, qd

Metadate CD
    Dosage: 25 mg

Risperidone
    Dosage: 50 mg, bid

Seroquel
    Dosage: 25 mg, qd

Strattera
    Dosage: 50 mg, qd

Tegretol
    Dosage: 150 mg, tid

Trileptal
    Dosage: 25 mg, qd

Zoloft
    Dosage: 25 mg, qd

Other drugs received by patient: Zyprexa



Possible Strattera side effects in male

Reported by a consumer/non-health professional from Japan on 2012-08-10

Patient: male, weighing 19.7 kg (43.3 pounds)

Reactions: Overdose, Parkinsonism

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Strattera
    Dosage: 5 mg, bid
    Administration route: Oral
    Start date: 2012-02-01

Strattera
    Dosage: 15 mg, bid
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-03-01
    End date: 2012-02-01

Other drugs received by patient: Allegra; IPD



Possible Strattera side effects in 43 year old male

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 43 year old male, weighing 95.3 kg (209.6 pounds)

Reactions: Irritability, Obsessive-Compulsive Disorder, Insomnia, Mood Swings, Decreased Appetite, Aggression

Drug(s) suspected as cause:
Strattera



Possible Strattera side effects in male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-08

Patient: male

Reactions: Asperger's Disorder, Dyspnoea, Functional Gastrointestinal Disorder, Abnormal Behaviour, Self Injurious Behaviour, Arrhythmia, Palpitations, Heart Rate Increased, Bladder Disorder, Lethargy

Drug(s) suspected as cause:
Strattera
    Dosage: 30 mg, unknown
    Start date: 2011-03-22

Strattera
    Dosage: 40 mg, qd



Possible Strattera side effects in female

Reported by a physician from United States on 2012-08-06

Patient: female

Reactions: Back Pain, Suicide Attempt, Depression, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Claravis
    Indication: Acne
    Start date: 2011-12-01
    End date: 2012-05-01

Strattera
    Dosage: 80 milligram daily;
    Indication: Depression

Other drugs received by patient: Zoloft



Possible Strattera side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: male

Reactions: Muscle Disorder

Drug(s) suspected as cause:
Strattera

Other drugs received by patient: Wellbutrin



Possible Strattera side effects in male

Reported by a physician from Spain on 2012-08-02

Patient: male, weighing 38.0 kg (83.6 pounds)

Reactions: Dysgeusia, Tachycardia, Somnolence, Decreased Appetite

Drug(s) suspected as cause:
Strattera
    Dosage: 25 mg, qd
    Administration route: Oral
    Start date: 2011-09-05
    End date: 2011-09-11

Strattera
    Dosage: 40 mg, qd
    Administration route: Oral
    Start date: 2011-09-12

Strattera
    Dosage: 18 mg, qd
    Administration route: Oral
    Start date: 2011-08-29
    End date: 2011-09-04

Strattera
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-08-22
    End date: 2011-08-28

Other drugs received by patient: Calcio



Possible Strattera side effects in 54 year old male

Reported by a physician from United States on 2012-08-02

Patient: 54 year old male

Reactions: Mania

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Strattera

Other drugs received by patient: Lamictal



Possible Strattera side effects in 10 year old male

Reported by a consumer/non-health professional from Japan on 2012-08-02

Patient: 10 year old male

Reactions: Bradycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Strattera
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder

Strattera
    Dosage: unk
    Administration route: Oral

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