risperidone Side Effects
Also known as: Risperdal
Analysis of 129,958 adverse event reports submitted to the FDA from 2003 to 2025.
Total Reports
129,958
Death-Related
9,958
7.7% of reports
Hospitalizations
39,145
30.1% 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 9,958 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 2,327 |
| COMPLETED SUICIDE | 1,683 |
| TOXICITY TO VARIOUS AGENTS | 961 |
| CARDIAC ARREST | 490 |
| CARDIO-RESPIRATORY ARREST | 478 |
| PNEUMONIA | 451 |
| OVERDOSE | 404 |
| DRUG INTERACTION | 401 |
| OFF LABEL USE | 384 |
| FALL | 339 |
| SUDDEN DEATH | 320 |
| NEUROLEPTIC MALIGNANT SYNDROME | 281 |
| HYPOTENSION | 268 |
| MYOCARDIAL INFARCTION | 268 |
| DYSPNOEA | 264 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 258 |
| SOMNOLENCE | 256 |
| PULMONARY EMBOLISM | 252 |
| RENAL FAILURE | 235 |
| DRUG ABUSE | 227 |
Reactions in Hospitalization Reports
Top reactions in 39,145 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INEFFECTIVE | 2,673 |
| DRUG INTERACTION | 2,528 |
| OFF LABEL USE | 2,384 |
| SOMNOLENCE | 1,892 |
| FALL | 1,800 |
| PSYCHOTIC DISORDER | 1,797 |
| HOSPITALISATION | 1,630 |
| NEUROLEPTIC MALIGNANT SYNDROME | 1,562 |
| CONFUSIONAL STATE | 1,555 |
| SUICIDE ATTEMPT | 1,551 |
| CONDITION AGGRAVATED | 1,541 |
| WEIGHT INCREASED | 1,530 |
| ANXIETY | 1,481 |
| TOXICITY TO VARIOUS AGENTS | 1,463 |
| AGGRESSION | 1,430 |
| SUICIDAL IDEATION | 1,380 |
| HYPOTENSION | 1,355 |
| EXTRAPYRAMIDAL DISORDER | 1,347 |
| OVERDOSE | 1,314 |
| PYREXIA | 1,301 |
Nearby — Related Medications
What the FAERS Data Reveals About risperidone Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 129,958 voluntary reports linked to risperidone and its brand equivalents (Risperdal), spanning 2003 through 2025. Of those, 9,958 (7.7%) listed death as an outcome and 39,145 (30.1%) 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, 36% were female and 64% male; age distribution skews toward 18-44, with 26,227 reports in that bracket. The single most reported reaction is gynaecomastia with 24,608 submissions, followed by off label use and abnormal weight gain.
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.