brexpiprazole Side Effects
Also known as: Rexulti
Analysis of 15,755 adverse event reports submitted to the FDA from 2012 to 2025.
Total Reports
15,755
Death-Related
856
5.4% of reports
Hospitalizations
1,926
12.2% 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 856 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 427 |
| COMPLETED SUICIDE | 120 |
| PRODUCT USE IN UNAPPROVED INDICATION | 71 |
| FALL | 50 |
| DISCOLOURED VOMIT | 43 |
| DRUG INEFFECTIVE | 37 |
| UNDERDOSE | 37 |
| PRODUCT USE ISSUE | 35 |
| CARDIAC FAILURE | 32 |
| RESPIRATORY ARREST | 31 |
| TREMOR | 28 |
| OFF LABEL USE | 26 |
| HALLUCINATION, AUDITORY | 25 |
| PNEUMONIA ASPIRATION | 25 |
| INTERNAL HAEMORRHAGE | 24 |
| CARDIAC ARREST | 18 |
| CARDIO-RESPIRATORY ARREST | 16 |
| DYSPHAGIA | 15 |
| MARASMUS | 15 |
| PNEUMONIA | 15 |
Reactions in Hospitalization Reports
Top reactions in 1,926 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INEFFECTIVE | 217 |
| SUICIDAL IDEATION | 217 |
| PRODUCT USE IN UNAPPROVED INDICATION | 166 |
| SUICIDE ATTEMPT | 163 |
| CONDITION AGGRAVATED | 161 |
| OFF LABEL USE | 149 |
| DEPRESSION | 126 |
| HOSPITALISATION | 116 |
| FALL | 101 |
| ANXIETY | 93 |
| FATIGUE | 83 |
| TREMOR | 80 |
| AKATHISIA | 77 |
| NAUSEA | 71 |
| TREATMENT NONCOMPLIANCE | 71 |
| ADVERSE DRUG REACTION | 70 |
| DIZZINESS | 70 |
| SOMNOLENCE | 70 |
| WEIGHT INCREASED | 69 |
| DRUG INTERACTION | 68 |
Nearby — Related Medications
What the FAERS Data Reveals About brexpiprazole Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 15,755 voluntary reports linked to brexpiprazole and its brand equivalents (Rexulti), spanning 2012 through 2025. Of those, 856 (5.4%) listed death as an outcome and 1,926 (12.2%) 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, 69% were female and 31% male; age distribution skews toward 18-44, with 2,243 reports in that bracket. The single most reported reaction is weight increased with 1,673 submissions, followed by product use in unapproved indication and off label use.
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.