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First-generation antipsychotic (piperazine phenothiazine) Pregnancy: §4.6 — Some animal studies indicate a teratogenic effect but results are conflicting; there is no clinical evidence (including follow-up surveys in over 800 women who had taken low-dosage trifluoperazine during pregnancy) of a teratogenic effect in man. Nevertheless, drug treatment should be avoided in pregnancy unless essential, especially during the first trimester. Neonates exposed to antipsychotics during the third trimester are at risk of extrapyramidal and/or withdrawal symptoms — monitor newborns carefully. Breast-feeding: trifluoperazine crosses the placenta and passes into the milk of lactating dogs; breast-feeding should only be allowed at the discretion of the physician.

Trifluoperazine

Brand names: Stelazine

Trifluoperazine is a piperazine phenothiazine first-generation antipsychotic used in schizophrenia and other psychoses, and at lower doses for short-term severe anxiety.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Low dosage: 2-4 mg a day in divided doses, according to the severity of the patient's condition; if necessary may be increased to 6 mg a day. High dosage (physically fit adults): 5 mg twice a day, increased after a week to 15 mg a day
Route: Oral
Frequency: In divided doses (low dosage); twice a day (high-dosage starting regimen)
Source: UK SPC (eMC) for Trifluoperazine 1 mg Tablet, §4.2 (https://www.medicines.org.uk/emc/product/101617/smpc). LOW-DOSAGE CEILING: §4.2 states that above 6 mg a day extrapyramidal symptoms are more likely to occur in some patients; §4.8 adds that extrapyramidal symptoms are rare at oral daily dosages of 6 mg or less and considerably more common at higher dosage levels. No absolute adult maximum daily dose is stated in the retrieved §4.2. HIGH-DOSAGE TITRATION: if necessary, further increases of 5 mg may be made at three-day intervals, but not more often. When satisfactory control has been achieved, dosage should be reduced gradually until an effective maintenance level has been established. Clinical improvement may not be evident for several weeks after starting treatment, and there may also be a delay before recurrence of symptoms after stopping treatment; gradual withdrawal from high-dosage treatment is advisable. ELDERLY: the starting dose for elderly or frail patients should be reduced by at least half; such patients can be especially sensitive, particularly to extrapyramidal and hypotensive effects. PAEDIATRIC (stated as fixed mg/day, NOT per kg, so not expressed as mg/kg): low dosage — for children aged 6-12 years, up to a maximum of 4 mg a day given in divided doses; high dosage — for children aged under 12 years the initial oral dosage should not exceed 5 mg a day, given in divided doses, with any subsequent increase made with caution at intervals of not less than three days and taking into account age, body weight and severity of symptoms. §4.8 notes extrapyramidal effects are likely to be particularly severe in children. Verify any under-18 use against a children's formulary. §4.4 was truncated at the source-fetch limit and §4.5 was not retrieved — the interaction entries below are taken from the §4.4 warnings text. US LABELLING DIFFERS (REMEDYREPACK, 2026-01-23): non-psychotic anxiety 1 or 2 mg twice daily, not more than 6 mg/day and not longer than 12 weeks; psychotic disorders 2 mg to 5 mg b.i.d. orally with most patients responding to 15 mg or 20 mg daily and a few requiring 40 mg a day or more.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients
  • Comatose patients, particularly where associated with other central nervous system depressants
  • Patients with existing blood dyscrasias or known liver damage
  • Patients with uncontrolled cardiac decompensation

Side effects

  • Nervous system (rare): extrapyramidal symptoms (parkinsonism; akathisia with motor restlessness; acute dystonia or dyskinesia including torticollis, facial grimacing, trismus, tongue protrusion and oculogyric crises) and neuroleptic malignant syndrome; not known — tardive dyskinesia, drowsiness, dizziness, transient restlessness, insomnia
  • Cardiac (rare): serious arrhythmias, unexplained death, cardiac arrest and Torsades de pointes; ECG changes with QT prolongation and T-wave changes (rare); tachycardia (very rare)
  • Blood (very rare): blood dyscrasias such as agranulocytosis, pancytopenia, leucopenia and thrombocytopenia
  • Endocrine (not known): hyperprolactinaemia, galactorrhoea, amenorrhoea, gynaecomastia; anorexia and weight gain
  • Vascular (not known): mild postural hypotension, venous thromboembolism, pulmonary embolism, deep vein thrombosis
  • Eye/skin: retinopathy and lenticular opacities (very rare), blurred vision; skin pigmentation (very rare), photosensitivity reactions; cholestatic jaundice (very rare)

Interactions

  • Levodopa — in patients with Parkinson's disease symptoms may be worsened and the effects of levodopa reversed (§4.4)
  • Metrizamide — should be avoided in patients with epilepsy, since phenothiazines may lower the convulsive threshold (§4.4)
  • Other neuroleptics — concomitant use should be avoided (§4.4)
  • Central nervous system depressants — use is contraindicated in comatose or greatly depressed states due to CNS depressants (§4.3). NOTE: the UK SPC §4.5 was not retrieved in this bundle and must be checked separately.

Clinical monograph

How it works

It is a potent central dopamine D2 receptor antagonist; compared with low-potency phenothiazines it has stronger antipsychotic potency and a higher propensity for extrapyramidal effects but less sedation.

Prescribing in practice

  • It has a high propensity to cause extrapyramidal symptoms, including acute dystonia, parkinsonism and tardive dyskinesia.
  • Class risks include QT-interval prolongation and neuroleptic malignant syndrome.
  • Caution is required in cardiovascular disease, epilepsy, hepatic impairment and in the elderly.

Monitoring

Monitor closely for extrapyramidal symptoms and tardive dyskinesia, along with metabolic parameters and ECG where indicated.

Counselling the patient

  • Report any abnormal movements, muscle stiffness, restlessness or tremor to your doctor.
  • Seek urgent help if you develop a high fever with muscle rigidity and confusion.
  • Do not stop the medicine suddenly without medical advice.

Evidence & guidelines

Use of trifluoperazine is supported by long-standing clinical experience and NICE guidance on antipsychotic treatment of psychosis and schizophrenia.

Reference: NICE CG178; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.