Chlorpromazine
Largactil, Largasel · ATC code N05AA01
Also known as: Chlorpromazin, Klorpromazin
- Key facts
- Active substance
- Chlorpromazine
- Drug class
- Antipsychotics
- ATC code
- N05AA01
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-27
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. Chlorpromazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
Key facts
Chlorpromazine is a phenothiazine antipsychotic. Per the US label it is used for psychotic disorders, nausea and vomiting, intractable hiccups and other indications.
What it is used for
- Psychotic disorders and schizophrenia
- Manic type of manic-depressive illness
- Nausea and vomiting
- Restlessness and apprehension before surgery
- Acute intermittent porphyria; adjunct in tetanus
- Intractable hiccups
- Severe behavioural problems in children (1 to 12 years) and short-term treatment of hyperactive children with conduct disorders
Dosing
- Individualise to severity; increase until symptoms are controlled, then reduce gradually to the lowest effective maintenance dose
- Psychotic disorders: 200 mg daily is not unusual; in hospitalised patients 500 mg a day is generally sufficient
- Outpatients: 10 mg t.i.d. or q.i.d., or 25 mg b.i.d. or t.i.d.
- Nausea and vomiting: 10 mg to 25 mg every 4 to 6 hours as needed
- Hiccups and porphyria: 25 mg to 50 mg t.i.d. or q.i.d.
- Elderly, debilitated or emaciated patients: lower doses and slower increases; further schemes in the full text
Contraindications
- Known hypersensitivity to phenothiazines
- Comatose states or presence of large amounts of CNS depressants (alcohol, barbiturates, narcotics)
Important warnings
- Boxed warning: increased mortality in elderly patients with dementia-related psychosis; not approved for this use
- Tardive dyskinesia, potentially irreversible
- Extrapyramidal symptoms may mask signs of Reye's syndrome or encephalopathy; avoid in children with suspected Reye's syndrome
- Caution in liver disease; severe hypotension reported in mitral insufficiency or pheochromocytoma
Side effects
- Drowsiness, usually mild to moderate, mainly in the first weeks
- Jaundice (sensitivity reaction), usually reversible on withdrawal
- Hypotension and neuromuscular (extrapyramidal) reactions, especially in the elderly
- Tardive dyskinesia
Interactions
- Additive effect with CNS depressants (alcohol, barbiturates, narcotics); contraindicated with large amounts
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. 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.
Turkey
- LargactilLİLYUM İLAÇ VE KİMYA SAN. TİC. A.Ş. · 2 register entries
- LargaselHAVER FARMA İLAÇ A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 9 more European countries
- Cyprus
- Chlorpromazine Remedica
- France
- Largactil
- Greece
- Solidon, Zuledine
- Ireland
- Chloropromazine Pinewood Laboratories, Clonactil
- Italy
- Largactil
- Malta
- Chlorpromazine Remedica
- Poland
- Fenactil
- Portugal
- Largactil
- Spain
- Largactil
EMA – Article 57 product data (EU/EEA), 2026-10-28
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. Chlorpromazine hydrochloride (Northstar Rx LLC) – Prescribing Information, 2026-08-26. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2bd42d3a-bf89-4d74-a252-9b914106a570
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC N05AA.
Editorial: Medelix editorial team · last updated 2026-10-27 · 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.