Chlorpromazine Side Effects: Common, Serious & FDA Warnings
Based on 7000+ FDA adverse event reports, the most-reported chlorpromazine reactions include toxicity to various agents, overdose, and drug interaction. No active recalls are on record. The FDA-approved label carries a boxed warning.
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 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Chlorpromazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).
Common Side Effects of Chlorpromazine
The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for chlorpromazine. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.
| Reaction | Reports | % of total |
|---|---|---|
| Toxicity To Various Agents | 445 | 6.3% |
| Overdose | 356 | 5.1% |
| Drug Interaction | 324 | 4.6% |
| Neuroleptic Malignant Syndrome | 293 | 4.2% |
| Nausea | 275 | 3.9% |
| Neutropenia | 265 | 3.8% |
| Diarrhoea | 256 | 3.7% |
| Fatigue | 253 | 3.6% |
| Vomiting | 245 | 3.5% |
| Psychotic Disorder | 232 | 3.3% |
Serious Outcomes and FDA Warnings
FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.
| Outcome flag | Reports | % of total |
|---|---|---|
| Serious reports (any flag) | — | — |
| Hospitalization | — | — |
| Death reported as outcome FAERS outcome flag, not a reaction term. The patient was on the drug when the report was filed; causation is not established. | 204 | 2.9% |
Chlorpromazine Recalls
FDA enforcement actions matched to chlorpromazine via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →).
No recalls are on record for this drug in the FDA enforcement database.
Chlorpromazine Shortages
FDA-listed shortages of chlorpromazine products. Strength and dosage-form level detail.
Is Chlorpromazine Safe?
Chlorpromazine is FDA-approved.
As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.
FDA-Approved Indications
Chlorpromazine is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.
INDICATIONS AND USAGE 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. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.Show full Indications and Usage
Frequently Asked Questions
What are the most-reported side effects of chlorpromazine?
Is chlorpromazine the same as Sonazine?
Has chlorpromazine been recalled?
Does chlorpromazine have an FDA boxed warning?
Data Sources & Methodology
How each section of this page is sourced, and how often the data is refreshed.
| Source | Endpoint | Refresh |
|---|---|---|
| FAERS reactions | openFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports. | Daily |
| Recalls | openFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here. | 6 hours |
| Shortages | FDA Drug Shortages list. | Daily |
| Boxed warnings & label sections | openFDA /drug/label.json. Labels are stable; monthly cadence is sufficient. | Monthly |
| Condition categories | Synonym-mapped from drug_labels.indications. Methodology at /methodology/. | Per-drug |
What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.