Risperidone vs Aripiprazole: side effects in FDA adverse event reports
At a glance
| Risperidone | Aripiprazole | |
|---|---|---|
| Drug class | Atypical Antipsychotic | Atypical Antipsychotic |
| Brand names | – | – |
| FAERS reports | 131,005 | 121,713 |
| Serious | 67% | 67% |
| Death outcome | 10,143 | 6,758 |
| Boxed warning | Yes INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at | Yes INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS Elderly patients with dem |
Signals both drugs share
| Reaction | Risperidone | Aripiprazole | Label screen (A / B) |
|---|---|---|---|
| Oculogyric crisis | 434 · PRR 41.1 | 490 · PRR 52.1 | Not in label — unassessed / Labeled adverse reaction |
| Psychotic symptom | 310 · PRR 28.3 | 491 · PRR 54.5 | Likely indication confounding / Labeled (related wording) |
| Cogwheel rigidity | 245 · PRR 47.9 | 175 · PRR 34.2 | Labeled adverse reaction / Labeled adverse reaction |
| Schizophrenia | 2,145 · PRR 33.8 | 2,056 · PRR 34.9 | Likely indication confounding / Likely indication confounding |
| Anosognosia | 446 · PRR 219.5 | 468 · PRR 269.0 | Not in label — unassessed / Not in label — unassessed |
| Schizoaffective disorder | 292 · PRR 30.7 | 575 · PRR 81.3 | Likely indication confounding / Likely indication confounding |
| Psychiatric decompensation | 329 · PRR 32.0 | 364 · PRR 39.4 | Not in label — unassessed / Not in label — unassessed |
| Disinhibition | 225 · PRR 25.6 | 280 · PRR 36.1 | Not in label — unassessed / Not in label — unassessed |
| Delusion of grandeur | 106 · PRR 49.1 | 89 · PRR 42.6 | Not in label — unassessed / Not in label — unassessed |
| Delusional disorder, persecutory type | 92 · PRR 43.9 | 96 · PRR 50.4 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Risperidone
- Gynaecomastia — n=24,650, PRR 614.0 Labeled adverse reaction
- Abnormal weight gain — n=9,452, PRR 513.3 Labeled (related wording)
- Hyperprolactinaemia — n=4,483, PRR 360.6 Labeled — boxed warning
- Obesity — n=3,717, PRR 48.1 Labeled adverse reaction
- Extrapyramidal disorder — n=3,471, PRR 25.4 Labeled adverse reaction
- Neuroleptic malignant syndrome — n=2,246, PRR 36.8 Labeled — boxed warning
- Catatonia — n=829, PRR 29.9 Labeled adverse reaction
- Metabolic disorder — n=732, PRR 22.8 Labeled (related wording)
Labeled signals distinctive to Aripiprazole
- Akathisia — n=3,031, PRR 49.1 Labeled adverse reaction
- Gambling disorder — n=2,053, PRR 553.3 Labeled (related wording)
- Compulsive shopping — n=1,166, PRR 224.7 Labeled adverse reaction
- Gambling — n=528, PRR 140.3 Labeled — boxed warning
- Impulse-control disorder — n=356, PRR 35.9 Labeled (related wording)
- Binge eating — n=171, PRR 32.5 Labeled adverse reaction
- Orthostatic hypertension — n=123, PRR 45.7 Labeled (related wording)
Common questions
Which has more reported side effects, Risperidone or Aripiprazole?
Risperidone has 131,005 FAERS reports and Aripiprazole 121,713. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (67% vs 67%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Risperidone and Aripiprazole share?
Both drugs carry disproportionality signals for oculogyric crisis, psychotic symptom, cogwheel rigidity, schizophrenia, anosognosia. Shared signals often reflect a shared drug class or the condition both are used for.
Is Risperidone or Aripiprazole safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.