Droperidol side effects: what 1,613 FDA adverse event reports show
Drug class
Dopamine-2 Receptor Antagonist
Who reports
1,613 reports · 92% serious · 189 with death outcome · 64% female
Used for
Droperidol Injection, USP is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures.
What it is
DESCRIPTION Droperidol Injection, USP is a neuroleptic (tranquilizer) agent. Droperidol Injection, USP is available in vials. Each milliliter contains 2.5 mg of droperidol in an aqueous solution adjusted to pH 3.4 ± 0.4 with lactic acid.
Boxed warning
Cases of QT prolongation and/or torsade de pointes have been reported in patients receiving droperidol at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 45 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Anaphylactic shock | 92 | 46.8 38.4–57.1ROR 49.6 · χ² 4,071 / p <1e-300 | 46.2 EB05 38.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 29.4 · 100% clinician | no trial data cached |
| Brain oedema | 43 | 44.4 33.1–59.7ROR 45.6 · χ² 1,777 / p <1e-300 | 43.5 EB05 33.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 28.7 · ♀ 97% (drug 64%) | no trial data cached |
| Metastases to central nervous system | 38 | 38.7 28.2–53.0ROR 39.6 · χ² 1,354 / p 1e-296 | 37.9 EB05 28.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 24.5 · ♀ 100% (drug 64%) | no trial data cached |
| Candida infection (yeast infection) | 44 | 34.4 25.7–46.0ROR 35.3 · χ² 1,390 / p <1e-300 | 33.8 EB05 26.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 28.8 · ♀ 100% (drug 64%) | no trial data cached |
| Restlessness | 77 | 27.4 22.0–34.0ROR 28.7 · χ² 1,929 / p <1e-300 | 27.2 EB05 22.4 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.4 · ♀ 85% (drug 64%) | no trial data cached |
| Hepatic cytolysis | 23 | 24.5 16.3–36.8ROR 24.9 · χ² 495 / p 6e-110 | 24.0 EB05 16.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 · 100% clinician | no trial data cached |
| Akathisia (inner restlessness) | 25 | 23.9 16.2–35.2ROR 24.2 · χ² 524 / p 3e-116 | 23.4 EB05 16.7 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.5 | no trial data cached |
| Neuroleptic malignant syndrome | 20 | 21.9 14.2–33.9ROR 22.2 · χ² 378 / p 2e-84 | 21.4 EB05 14.6 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.8 · 90% clinician | no trial data cached |
| Dystonia | 31 | 20.7 14.6–29.4ROR 21.1 · χ² 562 / p 1e-124 | 20.5 EB05 15.1 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.0 | no trial data cached |
| Ventricular fibrillation | 16 | 18.7 11.5–30.5ROR 18.9 · χ² 250 / p 1e-56 | 18.1 EB05 11.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Skin fissures | 27 | 18.6 12.8–27.1ROR 18.9 · χ² 432 / p 3e-96 | 18.3 EB05 13.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 100% (drug 64%) | no trial data cached |
| Ventricular tachycardia | 21 | 16.5 10.8–25.2ROR 16.7 · χ² 290 / p 2e-65 | 16.0 EB05 10.8 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.9 · 100% clinician | no trial data cached |
| C-reactive protein increased | 46 | 16.5 12.4–21.9ROR 16.9 · χ² 653 / p 3e-144 | 16.3 EB05 12.6 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 10.1 · ♀ 97% (drug 64%) | no trial data cached |
| Toxic skin eruption | 12 | 15.5 8.8–27.2ROR 15.6 · χ² 148 / p 2e-34 | 14.2 EB05 7.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Lymphopenia | 16 | 14.8 9.1–24.1ROR 14.9 · χ² 192 / p 5e-44 | 14.0 EB05 8.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Electrocardiogram qt prolonged | 39 | 14.1 10.3–19.2ROR 14.4 · χ² 462 / p 9e-103 | 13.8 EB05 10.4 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.5 · 100% clinician | no trial data cached |
| Respiratory depression | 13 | 13.8 8.0–23.7ROR 13.9 · χ² 142 / p 6e-33 | 12.5 EB05 7.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 58 | 13.7 10.7–17.7ROR 14.2 · χ² 674 / p 9e-149 | 13.6 EB05 10.8 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.8 · 95% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 25 | 12.7 8.6–18.8ROR 12.9 · χ² 259 / p 2e-58 | 12.1 EB05 8.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · ♀ 87% (drug 64%) · 100% clinician | no trial data cached |
| Bronchospasm (airway tightening) | 14 | 12.7 7.6–21.4ROR 12.8 · χ² 140 / p 2e-32 | 11.4 EB05 6.6 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 | no trial data cached |
| Renal failure acute | 42 | 12.7 9.4–17.1ROR 13.0 · χ² 441 / p 3e-98 | 12.4 EB05 9.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Ileus | 12 | 12.7 7.2–22.3ROR 12.8 · χ² 118 / p 1e-27 | 11.1 EB05 6.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Altered state of consciousness | 21 | 12.7 8.3–19.4ROR 12.8 · χ² 214 / p 8e-49 | 11.9 EB05 7.8 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 · ♀ 90% (drug 64%) · 90% clinician | no trial data cached |
| Mydriasis | 12 | 12.2 6.9–21.4ROR 12.3 · χ² 112 / p 2e-26 | 10.5 EB05 5.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Lactic acidosis | 29 | 11.8 8.2–16.9ROR 12.0 · χ² 275 / p 5e-62 | 11.2 EB05 7.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · 100% clinician | no trial data cached |
| Rash maculo-papular | 20 | 11.7 7.6–18.2ROR 11.9 · χ² 186 / p 1e-42 | 10.8 EB05 7.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Respiratory arrest | 24 | 11.2 7.5–16.7ROR 11.4 · χ² 214 / p 1e-48 | 10.5 EB05 7.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Cardio-respiratory arrest | 36 | 11.1 8.1–15.4ROR 11.4 · χ² 322 / p 2e-72 | 10.6 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · 94% clinician | no trial data cached |
| Serotonin syndrome | 16 | 10.9 6.7–17.7ROR 11.0 · χ² 134 / p 3e-31 | 9.6 EB05 5.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Gingival bleeding | 11 | 10.5 5.8–18.9ROR 10.5 · χ² 85 / p 2e-20 | 8.6 EB05 4.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Extrapyramidal disorder | 20 | 10.4 6.7–16.0ROR 10.5 · χ² 160 / p 5e-37 | 9.3 EB05 6.1 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 | no trial data cached |
| Haematuria (blood in urine) | 25 | 9.5 6.4–14.0ROR 9.6 · χ² 181 / p 1e-41 | 8.6 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · ♀ 92% (drug 64%) | no trial data cached |
| Cardiac arrest (heart stopping) | 60 | 9.4 7.3–12.1ROR 9.7 · χ² 445 / p 5e-99 | 9.1 EB05 7.2 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 · 95% clinician | no trial data cached |
| Pleural effusion | 44 | 9.4 7.0–12.6ROR 9.6 · χ² 322 / p 2e-72 | 8.9 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · ♀ 89% (drug 64%) | no trial data cached |
| Sinus tachycardia | 10 | 9.2 4.9–17.0ROR 9.2 · χ² 65 / p 4e-16 | 7.2 EB05 3.9 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Delirium | 24 | 9.0 6.1–13.4ROR 9.1 · χ² 164 / p 9e-38 | 8.2 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 91% clinician | no trial data cached |
| Post procedural complication | 12 | 8.1 4.6–14.3ROR 8.2 · χ² 68 / p 9e-17 | 6.6 EB05 3.9 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 | no trial data cached |
| Bradycardia (slow heart rate) | 33 | 8.1 5.8–11.3ROR 8.2 · χ² 198 / p 3e-45 | 7.5 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.8 · 100% clinician | no trial data cached |
| Urinary retention | 20 | 7.8 5.1–12.1ROR 7.9 · χ² 112 / p 2e-26 | 6.9 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · 90% clinician | no trial data cached |
| Eczema | 29 | 7.5 5.2–10.8ROR 7.6 · χ² 157 / p 2e-36 | 6.8 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 · ♀ 96% (drug 64%) | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Anaphylactic shock | 92 | 46.8 38.4–57.1ROR 49.6 · χ² 4,071 / p <1e-300 | 46.2 EB05 38.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 29.4 · 100% clinician | no trial data cached |
| Drug interaction | 90 | 7.4 6.0–9.0ROR 7.8 · χ² 493 / p 1e-109 | 7.2 EB05 6.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 | no trial data cached |
| Restlessness | 77 | 27.4 22.0–34.0ROR 28.7 · χ² 1,929 / p <1e-300 | 27.2 EB05 22.4 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.4 · ♀ 85% (drug 64%) | no trial data cached |
| Cardiac arrest (heart stopping) | 60 | 9.4 7.3–12.1ROR 9.7 · χ² 445 / p 5e-99 | 9.1 EB05 7.2 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 · 95% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 58 | 13.7 10.7–17.7ROR 14.2 · χ² 674 / p 9e-149 | 13.6 EB05 10.8 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.8 · 95% clinician | no trial data cached |
| C-reactive protein increased | 46 | 16.5 12.4–21.9ROR 16.9 · χ² 653 / p 3e-144 | 16.3 EB05 12.6 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 10.1 · ♀ 97% (drug 64%) | no trial data cached |
| Pleural effusion | 44 | 9.4 7.0–12.6ROR 9.6 · χ² 322 / p 2e-72 | 8.9 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · ♀ 89% (drug 64%) | no trial data cached |
| Candida infection (yeast infection) | 44 | 34.4 25.7–46.0ROR 35.3 · χ² 1,390 / p <1e-300 | 33.8 EB05 26.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 28.8 · ♀ 100% (drug 64%) | no trial data cached |
| Brain oedema | 43 | 44.4 33.1–59.7ROR 45.6 · χ² 1,777 / p <1e-300 | 43.5 EB05 33.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 28.7 · ♀ 97% (drug 64%) | no trial data cached |
| Renal failure acute | 42 | 12.7 9.4–17.1ROR 13.0 · χ² 441 / p 3e-98 | 12.4 EB05 9.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Agitation | 40 | 7.1 5.2–9.6ROR 7.2 · χ² 203 / p 3e-46 | 6.6 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Electrocardiogram qt prolonged | 39 | 14.1 10.3–19.2ROR 14.4 · χ² 462 / p 9e-103 | 13.8 EB05 10.4 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.5 · 100% clinician | no trial data cached |
| Metastases to central nervous system | 38 | 38.7 28.2–53.0ROR 39.6 · χ² 1,354 / p 1e-296 | 37.9 EB05 28.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 24.5 · ♀ 100% (drug 64%) | no trial data cached |
| Cardio-respiratory arrest | 36 | 11.1 8.1–15.4ROR 11.4 · χ² 322 / p 2e-72 | 10.6 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · 94% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 33 | 8.1 5.8–11.3ROR 8.2 · χ² 198 / p 3e-45 | 7.5 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.8 · 100% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Anaphylactic shock — n=92, PRR 46.8
- Brain oedema — n=43, PRR 44.4
- Metastases to central nervous system — n=38, PRR 38.7
- Candida infection — n=44, PRR 34.4
- Hepatic cytolysis — n=23, PRR 24.5
- Skin fissures — n=27, PRR 18.6
- Drug reaction with eosinophilia and systemic symptoms — n=25, PRR 12.7
- Renal failure acute — n=42, PRR 12.7
- Lactic acidosis — n=29, PRR 11.8
- Rash maculo-papular — n=20, PRR 11.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Droperidol ↔ QT prolongation.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Droperidol?
In FDA FAERS, the most frequently co-reported reaction terms for Droperidol are anaphylactic shock, restlessness, cardiac arrest, anaphylactic reaction, c-reactive protein increased, pleural effusion. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Droperidol have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Cases of QT prolongation and/or torsade de pointes have been reported in patients receiving droperidol at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal.
Do FAERS signals prove that Droperidol causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID d89f33ac-8a6e-49e7-94fb-84e58aad65a8, effective 20220608; matched on
openfda.generic_name.exact:"DROPERIDOL") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 85 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.