Drug side effects

aripiprazole Side Effects

The reactions most often reported to the FDA for aripiprazole (also sold as Abilify), with demographics, serious outcomes, and reporting trends.

Compiled by PlainMeds Editorial, Drug Information Editorial Team

Data updated 2026-05-15

118,365
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2003 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of aripiprazole come from 118,365 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 118,365 reports to the FDA Adverse Event Reporting System (FAERS) for aripiprazole (Abilify): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

118,365

Reports Mentioning Death

6,577

5.6% of reports — not proof the medicine caused the death

Hospitalizations

34,687

29.3% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

WEIGHT INCREASED

7,698

ANXIETY

4,993

FATIGUE

4,188

SUICIDAL IDEATION

3,991

DEPRESSION

3,950

NAUSEA

3,904

INSOMNIA

3,816

TREMOR

3,609

DRUG INTERACTION

3,589

SUICIDE ATTEMPT

3,504

SOMNOLENCE

3,484

HEADACHE

3,146

DIZZINESS

3,142

CONDITION AGGRAVATED

3,129

AKATHISIA

2,961

TARDIVE DYSKINESIA

2,814

PSYCHOTIC DISORDER

2,798

Who Reports Side Effects

Gender Distribution

Female 60,556 (59%)

Male 41,802 (41%)

Unknown 567

Age Distribution

0-17 11,199 (16%)

18-44 30,152 (42%)

45-64 21,738 (31%)

65-74 5,335 (8%)

75+ 2,585 (4%)

Reporting Trend by Year

2003 2025

Reactions in Death Reports

Top reactions reported in 6,577 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction	Reports
DEATH	1,749
COMPLETED SUICIDE	1,282
TOXICITY TO VARIOUS AGENTS	592
CARDIAC ARREST	384
CARDIO-RESPIRATORY ARREST	373
OVERDOSE	277
DRUG INTERACTION	239
SUDDEN DEATH	207
PNEUMONIA	203
NEUROLEPTIC MALIGNANT SYNDROME	185
DRUG ABUSE	184
MYOCARDIAL INFARCTION	168
PSYCHOTIC DISORDER	155
RESPIRATORY ARREST	153
SCHIZOPHRENIA	153
FATIGUE	144
NAUSEA	143

Reactions in Hospitalization Reports

Top reactions in 34,687 reports where hospitalization was an outcome.

Reaction	Reports
SUICIDE ATTEMPT	2,001
SUICIDAL IDEATION	1,883
DRUG INTERACTION	1,771
WEIGHT INCREASED	1,718
ANXIETY	1,676
PSYCHOTIC DISORDER	1,536
NAUSEA	1,396
HOSPITALISATION	1,353
DEPRESSION	1,317
SOMNOLENCE	1,223
CONDITION AGGRAVATED	1,221
FATIGUE	1,172
MENTAL DISORDER	1,168
NEUROLEPTIC MALIGNANT SYNDROME	1,134
VOMITING	1,114
INTENTIONAL OVERDOSE	1,112
CONFUSIONAL STATE	1,107

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What the FAERS Data Reveals About aripiprazole Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 118,365 voluntary reports linked to aripiprazole and its brand equivalents (Abilify), spanning 2003 through 2025. Of those, 6,577 (5.6%) listed death as an outcome and 34,687 (29.3%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 59% were female and 41% male; age distribution skews toward 18-44, with 30,152 reports in that bracket. The single most reported reaction is weight increased with 7,698 submissions, followed by anxiety and fatigue.

How to read these numbers

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.

Drugs With a Similar FAERS Report Volume

Other medications with a total FDA adverse-event report count closest to aripiprazole's 118,365.