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Abilify (Aripiprazole) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Abilify (Aripiprazole) 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 (2774)
Death (114)
Life Threatening Events (107)
Disability (68)

Reports by Reaction Type

Weight Increased (234)Tardive Dyskinesia (173)Tremor (133)Dyskinesia (113)Akathisia (96)Drug Ineffective (83)Insomnia (81)Pregnancy (80)Psychotic Disorder (75)Suicidal Ideation (72)Anxiety (67)Depression (64)

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

Possible Abilify side effects in 63 year old male

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

Patient: 63 year old male

Reactions: Drug Level Increased

Drug(s) suspected as cause:
Abilify
    Dosage: dose increased to 30 mg

Zyprexa



Possible Abilify side effects in 55 year old male

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

Patient: 55 year old male, weighing 84.0 kg (184.8 pounds)

Reactions: Wrong Technique in Drug Usage Process, Parkinson's Disease, Cardiac Operation, Treatment Noncompliance, Constipation

Drug(s) suspected as cause:
Abilify



Possible Abilify side effects in female

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

Patient: female

Reactions: Thyroid Cancer

Drug(s) suspected as cause:
Abilify



Possible Abilify side effects in 63 year old male

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

Patient: 63 year old male

Reactions: Drug Level Increased

Drug(s) suspected as cause:
Abilify
    Dosage: dose increased to 30 mg

Zyprexa



Possible Abilify side effects in male

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

Patient: male

Reactions: Completed Suicide, Suicide Attempt, Coma

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Abilify



Possible Abilify side effects in 31 year old male

Reported by a pharmacist from Japan on 2012-08-27

Patient: 31 year old male, weighing 59.0 kg (129.8 pounds)

Reactions: Eosinophilic Pneumonia, Pulmonary Alveolar Haemorrhage, Acute Respiratory Distress Syndrome, Neuroleptic Malignant Syndrome, Pneumonia Staphylococcal

Adverse event resulted in: death

Drug(s) suspected as cause:
Abilify
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-06-23
    End date: 2012-06-29

Levotomin
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-06-01
    End date: 2012-06-29

Methotrimeprazine Maleate

Risperdal
    Dosage: 4mg: 4jun-11jun12(8days) 2mg:12jun-29jun12(18days)
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-06-04
    End date: 2012-06-29

Rohypnol
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-06-01
    End date: 2012-06-29

Other drugs received by patient: Diazepam; Promethazine HCL; Miya-BM



Possible Abilify side effects in 75 year old female

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

Patient: 75 year old female

Reactions: Lymphopenia, Anaemia, Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abilify



Possible Abilify side effects in 31 year old male

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

Patient: 31 year old male, weighing 59.0 kg (129.8 pounds)

Reactions: Eosinophilic Pneumonia, Pulmonary Alveolar Haemorrhage, Acute Respiratory Distress Syndrome, Neuroleptic Malignant Syndrome, Pneumonia Staphylococcal

Adverse event resulted in: death

Drug(s) suspected as cause:
Abilify
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-06-23
    End date: 2012-06-29

Levotomin
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-06-01
    End date: 2012-06-29

Methotrimeprazine Maleate

Risperdal
    Dosage: 4mg: 4jun-11jun12(8days) 2mg:12jun-29jun12(18days)
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-06-04
    End date: 2012-06-29

Rohypnol
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-06-01
    End date: 2012-06-29

Other drugs received by patient: Diazepam; Promethazine HCL; Miya-BM



Possible Abilify side effects in 75 year old female

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

Patient: 75 year old female

Reactions: Anaemia, Lymphopenia, Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abilify



Possible Abilify side effects in female

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

Patient: female

Reactions: Thyroid Cancer

Drug(s) suspected as cause:
Abilify



Possible Abilify side effects in 47 year old male

Reported by a physician from Sweden on 2012-08-26

Patient: 47 year old male

Reactions: Schizophrenia

Drug(s) suspected as cause:
Abilify



Possible Abilify side effects in 36 year old male

Reported by a physician from France on 2012-08-26

Patient: 36 year old male

Reactions: Haemolytic Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abilify
    Dosage: reduced to 15 mg from 30jun2012
    Start date: 2012-06-29

Fragmin
    Dosage: 5000 ui anti xa/0.2 ml, solution for injection in prefilled syringe

Lorazepam
    Dosage: scored tablet

Tercian
    Dosage: 1df: 50 mg/5 ml injectable solution in ampoule



Possible Abilify side effects in 60 year old female

Reported by a consumer/non-health professional from Japan on 2012-08-24

Patient: 60 year old female

Reactions: Blood Creatine Phosphokinase Increased, Pyrexia, Stupor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abilify

Other drugs received by patient: Lithium Carbonate; Amlodipine



Possible Abilify side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female, weighing 46.3 kg (101.8 pounds)

Reactions: Arthralgia, Conversion Disorder, Musculoskeletal Stiffness, Depression, Joint Stiffness, Crying, Suicidal Ideation

Drug(s) suspected as cause:
Abilify
    Dosage: tab 1 qd
    Indication: Major Depression
    Start date: 2012-01-04
    End date: 2012-02-15

Abilify
    Dosage: tab 1 qd
    Indication: Major Depression
    Start date: 2012-02-28

Other drugs received by patient: Cymbalta



Possible Abilify side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Fatigue, Insomnia, Mental Disorder, Depression

Drug(s) suspected as cause:
Abilify
    Indication: Mental Disorder

Abilify
    Dosage: unk
    Indication: Depression
    Start date: 2012-01-01

Oxycontin
    Dosage: 320 mg, hs
    Administration route: Oral

Oxycontin
    Dosage: 160 mg, pm
    Administration route: Oral

Oxycontin
    Dosage: 320 mg, am
    Administration route: Oral
    Indication: Pain



Possible Abilify side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female, weighing 54.4 kg (119.7 pounds)

Reactions: Tardive Dyskinesia, Akinaesthesia

Drug(s) suspected as cause:
Abilify



Possible Abilify side effects in

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

Patient:

Reactions: Hepatic Cirrhosis

Drug(s) suspected as cause:
Abilify
    Administration route: Oral

Depakote
    Administration route: Oral

Diamicron
    Administration route: Oral

Glucophage
    Administration route: Oral

Januvia
    Administration route: Oral

Mediator
    Administration route: Oral

Metformin Hydrochloride
    Administration route: Oral

Repaglinide
    Administration route: Oral

Risperidone
    Administration route: Oral



Possible Abilify side effects in 16 year old female

Reported by a physician from United States on 2012-08-23

Patient: 16 year old female, weighing 43.1 kg (94.8 pounds)

Reactions: Musculoskeletal Stiffness, Gait Disturbance

Drug(s) suspected as cause:
Abilify

Other drugs received by patient: Lithium Carbonate; Prozac; Klonopin



Possible Abilify side effects in

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

Patient:

Reactions: Portal Hypertension, Fatigue, Hypothermia, Anaemia, Epistaxis, Hepatic Cirrhosis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Abilify
    Indication: Bipolar Disorder
    Start date: 1995-01-01
    End date: 2011-01-01

Depakote
    Dosage: 500 mg, unk
    Indication: Bipolar Disorder
    End date: 2006-01-01

Diamicron
    Dosage: 60 mg, unk
    Indication: Diabetes Mellitus
    End date: 2011-01-01

Glucophage
    Dosage: unk

Glucophage
    Administration route: Oral

Glucophage
    Indication: Diabetes Mellitus
    End date: 2011-01-01

Insulin
    Dosage: unk
    Start date: 2011-05-01

Mediator
    Dosage: unk
    Indication: Diabetes Mellitus
    Start date: 2006-01-01
    End date: 2006-01-01

Metformin Hydrochloride

Metformin Hydrochloride
    Dosage: unk
    Indication: Diabetes Mellitus
    End date: 2011-05-01

Repaglinide
    Dosage: unk
    Indication: Diabetes Mellitus
    Start date: 2011-05-01
    End date: 2011-01-01

Risperidone
    Indication: Bipolar Disorder
    End date: 2011-01-01

Sitagliptin Phosphate
    Dosage: unk
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2009-04-01
    End date: 2011-01-01



Possible Abilify side effects in female

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

Patient: female, weighing 61.2 kg (134.7 pounds)

Reactions: LIP Swelling, Adverse Drug Reaction, Drug Prescribing Error, Somnolence, Fall, Cystitis Interstitial, Hypokinesia, Mental Disorder, Abnormal Loss of Weight, Depression, Gait Disturbance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abilify
    Indication: Depression
    Start date: 2012-01-01
    End date: 2012-01-01

Elmiron
    Administration route: Oral
    Indication: Cystitis Interstitial
    Start date: 2012-01-01

Lortab
    Indication: Cystitis Interstitial
    Start date: 2012-08-14

Paxil
    Indication: Depression
    Start date: 2012-01-01
    End date: 2012-01-01

Remeron
    Indication: Depression

Trazodone Hydrochloride
    Indication: Depression
    Start date: 2012-01-01
    End date: 2012-01-01

Wellbutrin
    Indication: Depression
    Start date: 2012-01-01
    End date: 2012-01-01



Possible Abilify side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient:

Reactions: Hallucination, Auditory, Suicide Attempt

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abilify
    Dosage: 400 mg, unk
    Indication: Schizophrenia
    Start date: 2009-01-29
    End date: 2009-02-24

Prinivil
    Administration route: Oral
    Indication: Hypertension

Other drugs received by patient: Hydrochlorothiazide



Possible Abilify side effects in 49 year old male

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

Patient: 49 year old male

Reactions: Cytolytic Hepatitis, Neuroleptic Malignant Syndrome, Drug Withdrawal Syndrome

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Abilify
    Dosage: until jul12
    Administration route: Oral
    Indication: Schizophrenia

Alprazolam
    Administration route: Oral
    End date: 2012-07-01

Mianserin HCL
    End date: 2012-07-01

Mirtazapine
    Dosage: formulation: tabs
    Administration route: Oral



Possible Abilify side effects in 15 year old female

Reported by a physician from United States on 2012-08-23

Patient: 15 year old female, weighing 43.1 kg (94.8 pounds)

Reactions: Musculoskeletal Stiffness, Gait Disturbance

Drug(s) suspected as cause:
Abilify

Other drugs received by patient: Lithium Carbonate



Possible Abilify side effects in 40 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-22

Patient: 40 year old male

Reactions: Depressive Symptom, Liver Function Test Abnormal, Hypothyroidism, Extrapyramidal Disorder, Metabolic Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abilify
    Dosage: 15 mg, daily
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2008-04-01

Duloxetine Hydrochloride
    Dosage: 60 mg, unk
    Indication: Bipolar Disorder

Mirtazapine
    Dosage: unk
    Indication: Depressive Symptom

Mirtazapine
    Indication: Extrapyramidal Disorder

Quetiapine
    Dosage: unk
    Indication: Mood Swings

Risperidone
    Dosage: 4 mg, daily
    Indication: Mania
    Start date: 2008-03-01

Valproate Sodium
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Lithium Carbonate



Possible Abilify side effects in female

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

Patient: female, weighing 68.0 kg (149.6 pounds)

Reactions: Weight Increased, Syncope, Skin Reaction

Drug(s) suspected as cause:
Abilify



Possible Abilify side effects in 47 year old female

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

Patient: 47 year old female, weighing 90.2 kg (198.5 pounds)

Reactions: Irritability, Weight Decreased, Panic Attack, Drug Ineffective, Depressed Mood, Haemorrhoidal Haemorrhage, Medication Residue

Drug(s) suspected as cause:
Abilify
    Dosage: unk

Lamotrigine
    Dosage: unk

Pristiq
    Dosage: 50 mg, 1x/day (qam)
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2012-04-13
    End date: 2012-06-13

Pristiq
    Indication: Major Depression

Pristiq
    Indication: Depression

Xanax
    Dosage: unk, 2x/day
    Administration route: Oral
    Indication: Anxiety
    Start date: 2011-08-01

Xanax
    Dosage: 1 mg, 3x/day
    Administration route: Oral

Other drugs received by patient: Hydrocodon



Possible Abilify side effects in 33 year old male

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

Patient: 33 year old male

Reactions: Dysphagia, Dystonia, Mastication Disorder, Tardive Dyskinesia, Dyslalia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Abilify



Possible Abilify side effects in 51 year old female

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

Patient: 51 year old female

Reactions: Vena Cava Thrombosis

Drug(s) suspected as cause:
Abilify



Possible Abilify side effects in 68 year old male

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

Patient: 68 year old male

Reactions: Haematuria, Pulmonary Embolism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abilify
    Indication: Mania
    Start date: 2011-06-01
    End date: 2011-10-01

Oxazepam
    Administration route: Oral
    Indication: Mania
    Start date: 2011-06-01

Paroxetine HCL
    Administration route: Oral
    Indication: Mania
    Start date: 2011-06-01



Possible Abilify side effects in 69 year old female

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

Patient: 69 year old female

Reactions: Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abilify

Other drugs received by patient: Trazodone HCL; Brotizolam; Nortriptyline HCL; Tandospirone Citrate; Sulpiride; Lorazepam; Milnacipran

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