Quetiapine vs Haloperidol: side effects in FDA adverse event reports
At a glance
| Quetiapine | Haloperidol | |
|---|---|---|
| Drug class | – | Typical Antipsychotic |
| Brand names | Quetiapine Extended Release | – |
| FAERS reports | 191,471 | 24,153 |
| Serious | 79% | 93% |
| Death outcome | 28,195 | 3,987 |
| 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 WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drug |
Signals both drugs share
| Reaction | Quetiapine | Haloperidol | Label screen (A / B) |
|---|---|---|---|
| Neuroleptic malignant syndrome | 2,768 · PRR 33.0 | 1,630 · PRR 138.0 | Labeled — boxed warning / Labeled adverse reaction |
| Anticholinergic syndrome | 349 · PRR 30.5 | 105 · PRR 61.2 | Labeled (related wording) / Labeled (related wording) |
| Cogwheel rigidity | 226 · PRR 29.7 | 104 · PRR 95.1 | Labeled adverse reaction / Not in label — unassessed |
| Schizoaffective disorder | 362 · PRR 27.5 | 85 · PRR 43.2 | Likely indication confounding / Not in label — unassessed |
Labeled signals distinctive to Quetiapine
- Type 2 diabetes mellitus — n=5,970, PRR 23.4 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)
- Bezoar — n=335, PRR 35.0 Labeled adverse reaction
Labeled signals distinctive to Haloperidol
- Extrapyramidal disorder — n=1,237, PRR 45.0 Labeled (related wording)
- Akathisia — n=623, PRR 41.5 Labeled adverse reaction
- Psychotic symptom — n=113, PRR 50.9 Labeled adverse reaction
- Oculogyric crisis — n=103, PRR 44.6 Labeled adverse reaction
- Protrusion tongue — n=30, PRR 47.5 Labeled (related wording)
- Foetal arrhythmia — n=15, PRR 50.7 Labeled (related wording)
Common questions
Which has more reported side effects, Quetiapine or Haloperidol?
Quetiapine has 191,471 FAERS reports and Haloperidol 24,153. 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 93%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Quetiapine and Haloperidol share?
Both drugs carry disproportionality signals for neuroleptic malignant syndrome, anticholinergic syndrome, cogwheel rigidity, schizoaffective disorder. Shared signals often reflect a shared drug class or the condition both are used for.
Is Quetiapine or Haloperidol 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.