cariprazine Side Effects
Also known as: Vraylar
Analysis of 8,574 adverse event reports submitted to the FDA from 2011 to 2025.
Total Reports
8,574
Death-Related
225
2.6% of reports
Hospitalizations
1,156
13.5% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 225 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 95 |
| COMPLETED SUICIDE | 70 |
| TOXICITY TO VARIOUS AGENTS | 13 |
| OFF LABEL USE | 9 |
| CARDIO-RESPIRATORY ARREST | 8 |
| FALL | 6 |
| CARDIAC ARREST | 5 |
| DRUG INEFFECTIVE | 5 |
| MYOCARDIAL INFARCTION | 5 |
| CEREBROVASCULAR ACCIDENT | 4 |
| PNEUMONIA ASPIRATION | 4 |
| AKATHISIA | 3 |
| FEELING ABNORMAL | 3 |
| HOSPITALISATION | 3 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 3 |
| NEOPLASM MALIGNANT | 3 |
| OVERDOSE | 3 |
| PRODUCT USE IN UNAPPROVED INDICATION | 3 |
| THERAPY CESSATION | 3 |
| ACCIDENTAL OVERDOSE | 2 |
Reactions in Hospitalization Reports
Top reactions in 1,156 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INEFFECTIVE | 92 |
| SUICIDAL IDEATION | 85 |
| DRUG INTERACTION | 83 |
| OFF LABEL USE | 78 |
| HOSPITALISATION | 70 |
| INSOMNIA | 56 |
| SUICIDE ATTEMPT | 56 |
| TREMOR | 56 |
| AKATHISIA | 55 |
| WEIGHT INCREASED | 55 |
| ANXIETY | 51 |
| FALL | 50 |
| FATIGUE | 49 |
| INTENTIONAL OVERDOSE | 49 |
| TREATMENT NONCOMPLIANCE | 48 |
| CONDITION AGGRAVATED | 47 |
| DEPRESSION | 47 |
| EXTRAPYRAMIDAL DISORDER | 46 |
| MANIA | 45 |
| NAUSEA | 43 |
Nearby — Related Medications
What the FAERS Data Reveals About cariprazine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 8,574 voluntary reports linked to cariprazine and its brand equivalents (Vraylar), spanning 2011 through 2025. Of those, 225 (2.6%) listed death as an outcome and 1,156 (13.5%) 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, 67% were female and 33% male; age distribution skews toward 18-44, with 1,655 reports in that bracket. The single most reported reaction is off label use with 1,017 submissions, followed by drug ineffective and weight increased.
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.
Read our methodology — how this data is sourced, computed, and verified.