Prochlorperazine
ATC code N05AB04
Also known as: Prochlorperazin, Proklorperazin
- Key facts
- Active substance
- Prochlorperazine
- Drug class
- Antipsychotics
- ATC code
- N05AB04
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-29
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 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. Prochlorperazine maleate is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).
Key facts
Prochlorperazine is, per the US prescribing information, a phenothiazine antipsychotic used for severe nausea and vomiting, schizophrenia and short-term non-psychotic anxiety.
What it is used for
- Control of severe nausea and vomiting.
- Treatment of schizophrenia.
- Short-term treatment of generalized non-psychotic anxiety (not a first-choice drug); no more than 20 mg per day and not longer than 12 weeks.
- Not approved for dementia-related psychosis.
Dosing
- Severe nausea and vomiting (adults): usually 5 mg or 10 mg 3 or 4 times daily; above 40 mg daily only in resistant cases.
- Non-psychotic anxiety: 5 mg 3 or 4 times daily.
- Psychotic disorders: mild cases 5 or 10 mg 3 or 4 times daily; moderate to severe cases start with 10 mg 3 or 4 times daily, increasing gradually; severe disturbances usually 100 to 150 mg daily.
- Elderly and debilitated patients: lower doses and more gradual increases.
- Children from 2 years or 20 lbs: weight-based dosing – see the full text; children are more prone to extrapyramidal reactions.
Contraindications
- Known hypersensitivity to phenothiazines.
- Comatose states or large amounts of CNS depressants (alcohol, barbiturates, narcotics).
- Pediatric surgery; children under 2 years of age or under 20 lbs.
Important warnings
- Boxed warning: increased mortality in elderly patients with dementia-related psychosis (death rate about 4.5% vs. about 2.6% with placebo in 10-week trials).
- Tardive dyskinesia, potentially irreversible; risk rises with treatment duration and cumulative dose.
- Neuroleptic malignant syndrome (potentially fatal): hyperpyrexia, muscle rigidity, altered mental status.
- Leukopenia, neutropenia and agranulocytosis; check blood counts if sore throat or signs of infection appear.
- Extrapyramidal symptoms may mask signs of Reye's syndrome or other encephalopathy; impaired alertness, risk of falls.
Side effects
- No frequencies are given; reported: drowsiness, dizziness, amenorrhea, blurred vision, skin reactions, hypotension.
- Extrapyramidal reactions: motor restlessness, dystonia, parkinsonism.
- Cholestatic jaundice; leukopenia and agranulocytosis.
Interactions
- Intensifies or prolongs the action of CNS depressants (e.g. alcohol, anesthetics, narcotics).
- Lithium: an encephalopathic syndrome has been reported; monitor closely.
- Thiazides accentuate orthostatic hypotension; guanethidine's effect may be counteracted; with propranolol, levels of both drugs rise.
- Lowers the convulsive threshold; anticonvulsant doses may need adjustment.
Pregnancy and breastfeeding
- Not recommended except for severe, intractable nausea and vomiting; neonates exposed in the third trimester may show extrapyramidal and withdrawal symptoms.
- Phenothiazines are excreted in breast milk; use caution in nursing women.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Patient information (US)
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
USA
- ComproPadagis US LLC · 2 register entries
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29
Brand names in 7 more European countries
- Cyprus
- Nautisol
- Finland
- Stemetil
- Ireland
- Stemetil
- Italy
- Stemetil
- Norway
- Stemetil
- Poland
- Chloropernazinum
- Romania
- Emetiral, Proclorperazina Sintofarm
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Sources
- U.S. Food and Drug Administration. PROCHLORPERAZINE MALEATE (GLENMARK PHARMACEUTICALS INC., USA) – Prescribing Information, 2026-01-27. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c806152-70d0-43eb-b183-b51b12b82b31
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
- Wikidata (CC0): ATC N05AB.
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.