Quetiapine vs Aripiprazole: side effects in FDA adverse event reports
At a glance
| Quetiapine | Aripiprazole | |
|---|---|---|
| Drug class | – | Atypical Antipsychotic |
| Brand names | Quetiapine Extended Release | – |
| FAERS reports | 191,471 | 121,713 |
| Serious | 79% | 67% |
| Death outcome | 28,195 | 6,758 |
| Boxed warning | Yes INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dement | 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 | Quetiapine | Aripiprazole | Label screen (A / B) |
|---|---|---|---|
| Cogwheel rigidity | 226 · PRR 29.7 | 175 · PRR 34.2 | Labeled adverse reaction / Labeled adverse reaction |
| Schizoaffective disorder | 362 · PRR 27.5 | 575 · PRR 81.3 | Likely indication confounding / Likely indication confounding |
| Anosognosia | 459 · PRR 162.2 | 468 · PRR 269.0 | Not in label — unassessed / Not in label — unassessed |
| Psychiatric decompensation | 357 · PRR 24.4 | 364 · PRR 39.4 | Not in label — unassessed / Not in label — unassessed |
| Stubbornness | 174 · PRR 73.1 | 174 · PRR 115.3 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Quetiapine
- Type 2 diabetes mellitus — n=5,970, PRR 23.4 Labeled — boxed warning
- Neuroleptic malignant syndrome — n=2,768, PRR 33.0 Labeled — boxed warning
- Diabetic coma — n=886, PRR 49.8 Labeled (related wording)
- Peripheral venous disease — n=834, PRR 28.7 Labeled (related wording)
- Temperature regulation disorder — n=373, PRR 22.4 Labeled (related wording)
- Metabolic syndrome — n=364, PRR 31.0 Labeled (related wording)
- Anticholinergic syndrome — n=349, PRR 30.5 Labeled (related wording)
- Bezoar — n=335, PRR 35.0 Labeled adverse reaction
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
- Psychotic symptom — n=491, PRR 54.5 Labeled (related wording)
- Oculogyric crisis — n=490, PRR 52.1 Labeled adverse reaction
- Impulse-control disorder — n=356, PRR 35.9 Labeled (related wording)
- Binge eating — n=171, PRR 32.5 Labeled adverse reaction
Common questions
Which has more reported side effects, Quetiapine or Aripiprazole?
Quetiapine has 191,471 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 (79% vs 67%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Quetiapine and Aripiprazole share?
Both drugs carry disproportionality signals for cogwheel rigidity, schizoaffective disorder, anosognosia, psychiatric decompensation, stubbornness. Shared signals often reflect a shared drug class or the condition both are used for.
Is Quetiapine 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.