Chlorpromazine side effects: what 7,098 FDA adverse event reports show
Drug class
Not stated in label
Who reports
7,098 reports · 93% serious · 1,324 with death outcome · 44% female
Used for
For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups.
What it is
DESCRIPTION Chlorpromazine hydrochloride, USP, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration.
Boxed warning
Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen place.
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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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. 376 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 |
|---|---|---|---|---|---|---|
| Neuroleptic malignant syndrome | 294 | 74.9 66.8–83.9ROR 78.1 · χ² 20,831 / p <1e-300 | 72.7 EB05 66.0 · IC025 +5.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 45.2 · 94% clinician | no trial data cached |
| Schizophrenia | 176 | 43.4 37.4–50.2ROR 44.4 · χ² 7,139 / p <1e-300 | 42.6 EB05 37.5 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 27.3 · ♀ 14% (drug 44%) | no trial data cached |
| Parkinsonism | 99 | 30.3 24.9–36.9ROR 30.7 · χ² 2,747 / p <1e-300 | 29.8 EB05 25.2 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.9 | no trial data cached |
| Neutrophil count increased | 99 | 28.7 23.6–35.0ROR 29.1 · χ² 2,597 / p <1e-300 | 28.3 EB05 23.9 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 19.3 · ♀ 9% (drug 44%) | no trial data cached |
| Hallucination, auditory | 153 | 28.7 24.5–33.6ROR 29.3 · χ² 4,021 / p <1e-300 | 28.3 EB05 24.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 20.2 | no trial data cached |
| Salivary hypersecretion | 82 | 24.4 19.7–30.3ROR 24.7 · χ² 1,805 / p <1e-300 | 24.1 EB05 20.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 19.5 | no trial data cached |
| Psychotic disorder | 230 | 23.2 20.4–26.3ROR 23.9 · χ² 4,826 / p <1e-300 | 23.0 EB05 20.6 · IC025 +4.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 15.4 · ♀ 23% (drug 44%) | no trial data cached |
| Poisoning deliberate | 71 | 22.7 18.0–28.6ROR 22.9 · χ² 1,441 / p <1e-300 | 22.4 EB05 18.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.9 · ♀ 85% (drug 44%) · 94% clinician | no trial data cached |
| Sedation | 182 | 20.8 18.0–24.0ROR 21.3 · χ² 3,383 / p <1e-300 | 20.6 EB05 18.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 16.8 | no trial data cached |
| Extrapyramidal disorder | 172 | 20.4 17.6–23.6ROR 20.9 · χ² 3,134 / p <1e-300 | 20.2 EB05 17.8 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.2 · ♀ 19% (drug 44%) · 90% clinician | no trial data cached |
| Myocarditis | 77 | 20.2 16.2–25.3ROR 20.4 · χ² 1,378 / p <1e-300 | 20.0 EB05 16.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · ♀ 24% (drug 44%) | no trial data cached |
| Hepatic cytolysis | 80 | 19.5 15.6–24.2ROR 19.7 · χ² 1,374 / p <1e-300 | 19.3 EB05 16.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 · ♀ 73% (drug 44%) · 99% clinician | no trial data cached |
| Psychomotor hyperactivity | 104 | 18.5 15.3–22.4ROR 18.8 · χ² 1,699 / p <1e-300 | 18.4 EB05 15.6 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 18.7 · 93% clinician | no trial data cached |
| Sopor | 75 | 16.7 13.3–20.9ROR 16.8 · χ² 1,083 / p 8e-238 | 16.5 EB05 13.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · ♀ 82% (drug 44%) · 92% clinician | no trial data cached |
| Myoclonus | 63 | 15.7 12.3–20.1ROR 15.8 · χ² 847 / p 1e-186 | 15.5 EB05 12.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · 91% clinician | no trial data cached |
| Lymphocyte count decreased | 91 | 15.3 12.4–18.7ROR 15.5 · χ² 1,194 / p 6e-262 | 15.1 EB05 12.7 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 11.5 · ♀ 17% (drug 44%) | no trial data cached |
| Respiratory depression | 62 | 15.0 11.7–19.2ROR 15.1 · χ² 793 / p 1e-174 | 14.8 EB05 11.9 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.5 · ♀ 24% (drug 44%) · 100% clinician | no trial data cached |
| Dystonia | 95 | 14.5 11.9–17.7ROR 14.7 · χ² 1,174 / p 1e-257 | 14.3 EB05 12.0 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.7 | no trial data cached |
| Muscle rigidity | 57 | 14.1 10.9–18.3ROR 14.3 · χ² 681 / p 3e-150 | 13.9 EB05 11.1 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.8 | no trial data cached |
| Delusion | 72 | 13.8 11.0–17.4ROR 13.9 · χ² 838 / p 1e-184 | 13.6 EB05 11.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Sinus tachycardia | 64 | 13.4 10.5–17.1ROR 13.5 · χ² 719 / p 1e-158 | 13.2 EB05 10.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Altered state of consciousness | 96 | 13.2 10.8–16.1ROR 13.4 · χ² 1,068 / p 2e-234 | 13.1 EB05 11.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 96% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 160 | 13.2 11.3–15.4ROR 13.5 · χ² 1,785 / p <1e-300 | 13.1 EB05 11.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Sars-cov-2 test positive | 58 | 12.9 10.0–16.7ROR 13.0 · χ² 621 / p 2e-137 | 12.6 EB05 10.0 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=58 · ♀ 0% (drug 44%) · 95% clinician | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 122 | 12.7 10.6–15.1ROR 12.9 · χ² 1,299 / p 8e-285 | 12.6 EB05 10.8 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.1 · 93% clinician | no trial data cached |
| Delirium | 148 | 12.7 10.8–14.9ROR 12.9 · χ² 1,578 / p <1e-300 | 12.6 EB05 10.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · 90% clinician | no trial data cached |
| Affect lability | 40 | 12.3 9.0–16.7ROR 12.3 · χ² 401 / p 2e-89 | 11.9 EB05 8.9 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 10.2 | no trial data cached |
| Mania | 67 | 12.1 9.5–15.3ROR 12.2 · χ² 668 / p 1e-147 | 11.8 EB05 9.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Aggression | 196 | 11.6 10.1–13.3ROR 11.9 · χ² 1,882 / p <1e-300 | 11.5 EB05 10.2 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 8.6 | no trial data cached |
| Intentional self-injury | 78 | 11.5 9.2–14.3ROR 11.6 · χ² 732 / p 2e-161 | 11.2 EB05 9.2 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 | no trial data cached |
| Pneumonia aspiration | 93 | 11.1 9.0–13.5ROR 11.2 · χ² 839 / p 1e-184 | 10.9 EB05 9.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 94% clinician | no trial data cached |
| Suicide attempt | 222 | 10.8 9.5–12.3ROR 11.1 · χ² 1,969 / p <1e-300 | 10.7 EB05 9.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Brain injury | 35 | 10.3 7.4–14.4ROR 10.4 · χ² 285 / p 3e-64 | 9.7 EB05 7.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 59 | 10.0 7.8–12.9ROR 10.1 · χ² 469 / p 3e-104 | 9.7 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Status epilepticus | 37 | 9.7 7.0–13.4ROR 9.7 · χ² 279 / p 7e-63 | 9.1 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 100% clinician | no trial data cached |
| Hypothermia | 33 | 9.6 6.9–13.6ROR 9.7 · χ² 246 / p 9e-56 | 9.0 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 100% (drug 44%) · 94% clinician | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 60 | 9.6 7.5–12.4ROR 9.7 · χ² 453 / p 6e-101 | 9.3 EB05 7.4 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 · 97% clinician | no trial data cached |
| Drug withdrawal syndrome neonatal | 47 | 9.3 7.0–12.4ROR 9.4 · χ² 339 / p 4e-76 | 8.8 EB05 6.8 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 · ♀ 18% (drug 44%) · 90% clinician | no trial data cached |
| Blood creatine phosphokinase increased | 91 | 9.2 7.5–11.3ROR 9.3 · χ² 657 / p 3e-145 | 9.0 EB05 7.5 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 6.1 | no trial data cached |
| Leukocytosis | 56 | 9.2 7.1–11.9ROR 9.2 · χ² 399 / p 5e-89 | 8.8 EB05 6.9 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 · ♀ 17% (drug 44%) | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 544 | 1.2 1.1–1.3ROR 1.2 · χ² 23 / p 9e-7 | 1.2 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 2.0 | no trial data cached |
| Toxicity to various agents | 458 | 8.1 7.4–8.8ROR 8.6 · χ² 2,849 / p <1e-300 | 8.0 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 93% clinician | no trial data cached |
| Off label use (used outside approved label) | 449 | 1.5 1.4–1.7ROR 1.6 · χ² 85 / p 1e-20 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Overdose | 354 | 4.8 4.4–5.4ROR 5.0 · χ² 1,082 / p 1e-237 | 4.8 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · 92% clinician | no trial data cached |
| Drug interaction | 326 | 6.1 5.5–6.8ROR 6.3 · χ² 1,386 / p <1e-300 | 6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | no trial data cached |
| Neuroleptic malignant syndrome | 294 | 74.9 66.8–83.9ROR 78.1 · χ² 20,831 / p <1e-300 | 72.7 EB05 66.0 · IC025 +5.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 45.2 · 94% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 271 | 5.9 5.3–6.7ROR 6.1 · χ² 1,108 / p 4e-243 | 5.9 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · ♀ 21% (drug 44%) | no trial data cached |
| Somnolence (drowsiness) | 241 | 3.5 3.1–4.0ROR 3.6 · χ² 441 / p 3e-98 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Psychotic disorder | 230 | 23.2 20.4–26.3ROR 23.9 · χ² 4,826 / p <1e-300 | 23.0 EB05 20.6 · IC025 +4.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 15.4 · ♀ 23% (drug 44%) | no trial data cached |
| Suicide attempt | 222 | 10.8 9.5–12.3ROR 11.1 · χ² 1,969 / p <1e-300 | 10.7 EB05 9.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Hypotension (low blood pressure) | 206 | 3.0 2.7–3.5ROR 3.1 · χ² 282 / p 1e-63 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Condition aggravated | 205 | 2.0 1.8–2.3ROR 2.0 · χ² 104 / p 1e-24 | 2.0 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 1.8 | no trial data cached |
| Seizure | 203 | 5.2 4.6–6.0ROR 5.4 · χ² 693 / p 4e-153 | 5.2 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Completed suicide (death by suicide) | 198 | 7.0 6.1–8.0ROR 7.1 · χ² 1,007 / p 3e-221 | 6.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 4.3 · 97% clinician | no trial data cached |
| Drug abuse | 198 | 7.0 6.1–8.0ROR 7.2 · χ² 1,015 / p 5e-223 | 6.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 96% 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.
- Hallucination, auditory — n=153, PRR 28.7
- Salivary hypersecretion — n=82, PRR 24.4
- Poisoning deliberate — n=71, PRR 22.7
- Sedation — n=182, PRR 20.8
- Myocarditis — n=77, PRR 20.2
- Hepatic cytolysis — n=80, PRR 19.5
- Sopor — n=75, PRR 16.7
- Myoclonus — n=63, PRR 15.7
- Delusion — n=72, PRR 13.8
- Sinus tachycardia — n=64, PRR 13.4
✓ A hand-written Bradford Hill causality assessment exists for this drug: Chlorpromazine ↔ Neuroleptic malignant syndrome.
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 Chlorpromazine?
In FDA FAERS, the most frequently co-reported reaction terms for Chlorpromazine are toxicity to various agents, neuroleptic malignant syndrome, neutropenia, somnolence, psychotic disorder, suicide attempt. 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 Chlorpromazine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen place.
Do FAERS signals prove that Chlorpromazine 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 0dc38655-01b1-413e-9139-2466014cb4d0, effective 20260819; matched on
openfda.generic_name.exact:"CHLORPROMAZINE") - 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, 416 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.