Trifluoperazine
Stilizan · ATC code N05AB06
Also known as: Trifluoperazin
- Key facts
- Active substance
- Trifluoperazine
- Drug class
- Antipsychotics
- ATC code
- N05AB06
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-29
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. Trifluoperazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
Key facts
Trifluoperazine is, per the US prescribing information, a phenothiazine antipsychotic used to manage schizophrenia and for short-term treatment of non-psychotic anxiety.
What it is used for
- Management of schizophrenia.
- Short-term treatment of generalized non-psychotic anxiety (not a first-choice drug); no more than 6 mg per day and not longer than 12 weeks.
- Not approved for dementia-related psychosis.
Dosing
- Use the lowest effective dosage; because of its long action usually twice daily, some patients once a day.
- Non-psychotic anxiety: 1 or 2 mg twice daily.
- Psychotic disorders (adults): start with 2 mg to 5 mg twice daily; most patients respond optimally to 15 mg or 20 mg daily, a few need 40 mg a day or more; optimum dose within two or three weeks.
- Children 6 to 12 years (hospitalized or closely supervised): start with 1 mg once or twice daily, increasing gradually; usually not above 15 mg daily.
- Elderly and debilitated patients: lower doses and more gradual increases.
Contraindications
- Known hypersensitivity to phenothiazines.
- Comatose or greatly depressed states due to CNS depressants.
- Existing blood dyscrasias, bone marrow depression and pre-existing liver damage.
Important warnings
- Boxed warning: increased mortality in elderly patients with dementia-related psychosis (about 4.5% vs. about 2.6% with placebo in 10-week trials).
- Tardive dyskinesia, potentially irreversible; risk rises with duration and cumulative dose.
- Neuroleptic malignant syndrome (potentially fatal).
- Leukopenia, neutropenia and agranulocytosis; report sore throat or signs of infection.
- May impair alertness, especially in the first few days; risk of falls from somnolence and postural hypotension.
Side effects
- No frequencies are given; reported: drowsiness, dizziness, skin reactions, dry mouth, insomnia, amenorrhea, fatigue, muscular weakness, anorexia, lactation, blurred vision.
- Extrapyramidal reactions: motor restlessness, dystonia, parkinsonism.
- Agranulocytosis and pancytopenia.
Interactions
- Sedatives, narcotics, anesthetics, tranquilizers and alcohol: additive depressant effect.
- Lithium: an encephalopathic syndrome has been reported; monitor closely.
- Propranolol raises levels of both drugs; thiazides accentuate orthostatic hypotension; effects of guanethidine and oral anticoagulants may be reduced.
- Lowers the convulsive threshold; anticonvulsant doses may need adjustment.
Pregnancy and breastfeeding
- Not recommended unless essential; neonates exposed in the third trimester may show extrapyramidal and withdrawal symptoms.
- Phenothiazines are excreted in breast milk.
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.
Turkey
- StilizanRECORDATİ İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 5 more European countries
- Cyprus
- Stelazine, Trifluoperazine Remedica
- Greece
- Stelazine
- Ireland
- Stelazine
- Italy
- Modalina
- Malta
- Trifluoperazine Remedica
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. Trifluoperazine Hydrochloride (Sandoz Inc.) – Prescribing Information, 2024-11-30. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ae43c10e-cfa9-4298-8af5-7a3e6524bbda
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- 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.