Aripiprazole vs Olanzapine: side effects in FDA adverse event reports
At a glance
| Aripiprazole | Olanzapine | |
|---|---|---|
| Drug class | Atypical Antipsychotic | Atypical Antipsychotic |
| Brand names | – | – |
| FAERS reports | 121,713 | 106,808 |
| Serious | 67% | 86% |
| Death outcome | 6,758 | 13,180 |
| Boxed warning | Yes INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS Elderly patients with dem | Yes INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at |
Signals both drugs share
| Reaction | Aripiprazole | Olanzapine | Label screen (A / B) |
|---|---|---|---|
| Akathisia | 3,031 · PRR 49.1 | 1,619 · PRR 26.3 | Labeled adverse reaction / Labeled adverse reaction |
| Schizophrenia | 2,056 · PRR 34.9 | 2,234 · PRR 44.1 | Likely indication confounding / Labeled — boxed warning |
| Schizoaffective disorder | 575 · PRR 81.3 | 531 · PRR 82.6 | Likely indication confounding / Labeled adverse reaction |
| Psychotic symptom | 491 · PRR 54.5 | 371 · PRR 43.5 | Labeled (related wording) / Likely indication confounding |
| Oculogyric crisis | 490 · PRR 52.1 | 347 · PRR 38.6 | Labeled adverse reaction / Labeled adverse reaction |
| Cogwheel rigidity | 175 · PRR 34.2 | 154 · PRR 33.5 | Labeled adverse reaction / Labeled adverse reaction |
| Orthostatic hypertension | 123 · PRR 45.7 | 113 · PRR 46.8 | Labeled (related wording) / Labeled (related wording) |
| Anosognosia | 468 · PRR 269.0 | 476 · PRR 320.7 | Not in label — unassessed / Not in label — unassessed |
| Psychiatric decompensation | 364 · PRR 39.4 | 260 · PRR 30.1 | Not in label — unassessed / Not in label — unassessed |
| Disinhibition | 280 · PRR 36.1 | 271 · PRR 39.6 | Not in label — unassessed / Not in label — unassessed |
| Delusion of grandeur | 89 · PRR 42.6 | 122 · PRR 73.5 | Not in label — unassessed / Not in label — unassessed |
| Delusional disorder, persecutory type | 96 · PRR 50.4 | 101 · PRR 61.4 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Aripiprazole
- 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
Labeled signals distinctive to Olanzapine
- Neuroleptic malignant syndrome — n=2,718, PRR 58.1 Labeled — boxed warning
- Metabolic disorder — n=1,229, PRR 52.6 Labeled (related wording)
- Parkinsonism — n=1,188, PRR 27.1 Labeled adverse reaction
- Diabetic coma — n=616, PRR 54.6 Labeled adverse reaction
- Diabetes mellitus non-insulin-dependent — n=594, PRR 133.1 Labeled (related wording)
- Metabolic syndrome — n=407, PRR 64.6 Labeled (related wording)
- Anticholinergic syndrome — n=236, PRR 34.0 Labeled (related wording)
- Diabetes mellitus insulin-dependent — n=159, PRR 89.3 Labeled (related wording)
Common questions
Which has more reported side effects, Aripiprazole or Olanzapine?
Aripiprazole has 121,713 FAERS reports and Olanzapine 106,808. 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 86%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Aripiprazole and Olanzapine share?
Both drugs carry disproportionality signals for akathisia, schizophrenia, schizoaffective disorder, psychotic symptom, oculogyric crisis. Shared signals often reflect a shared drug class or the condition both are used for.
Is Aripiprazole or Olanzapine 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.