Fluphenazine
Prolixin Decanoate · ATC code N05AB02
Also known as: Fluphenazin, Flufenazin
- Key facts
- Active substance
- Fluphenazine
- Drug class
- Antipsychotics
- ATC code
- N05AB02
- 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. Fluphenazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
Key facts
Fluphenazine is a phenothiazine antipsychotic. Per the US prescribing information, the tablets are used in the management of manifestations of psychotic disorders.
What it is used for
- Manifestations of psychotic disorders
- Not shown to be effective for behavioral complications in patients with mental retardation; not approved for dementia-related psychosis
Dosing
- Adults: initially 2.5 mg to 10 mg per day in total, divided and given at 6 to 8 hour intervals
- Start low and increase as needed; therapeutic effect is often achieved with doses under 20 mg daily; up to 40 mg daily may be necessary in severely disturbed patients
- Maintenance: usually reduced gradually to 1 mg to 5 mg per day, often as a single dose
- Elderly patients: starting dose 1 mg to 2.5 mg daily
- The oral dose is about 2 to 3 times the parenteral dose; conversion to fluphenazine decanoate – see the full text
Contraindications
- Suspected or established subcortical brain damage
- Large doses of hypnotics; comatose or severely depressed states
- Blood dyscrasia or liver damage
- Hypersensitivity to fluphenazine (cross-sensitivity with phenothiazines possible)
Important warnings
- Boxed warning: increased mortality in elderly patients with dementia-related psychosis
- Tardive dyskinesia, potentially irreversible
- Neuroleptic malignant syndrome (hyperpyrexia, muscle rigidity, altered mental status, autonomic instability), potentially fatal
- Leukopenia, neutropenia and agranulocytosis
- Somnolence, postural hypotension and instability that may lead to falls; impaired ability to drive
- Convulsions in patients with a history of seizure disorders
Side effects
- Most frequent: extrapyramidal symptoms – pseudoparkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonos, hyperreflexia
- Drowsiness or lethargy
- Serious: tardive dyskinesia, neuroleptic malignant syndrome, blood dyscrasias, severe hypotension
Interactions
- Alcohol and other CNS depressants (opiates, analgesics, antihistamines, barbiturates): increased effects
- Atropine and other anticholinergic drugs: added anticholinergic effects
- Phosphorus insecticides: use with caution
Pregnancy and breastfeeding
- Safety in pregnancy is not established; use only if the potential benefit justifies the risk
- Newborns exposed in the third trimester are at risk of extrapyramidal and/or withdrawal symptoms
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.
Germany
- Fluphenazin D NeuraxpharmNeuraxpharm Arzneimittel Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Turkey
- Prolixin DecanoateDEVA HOLDİNG A.Ş. · 4 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 5 more European countries
- Bulgaria
- Модитен Депо
- Croatia
- Moditen
- Czechia
- Afluditen
- Slovakia
- Afluditen
- Slovenia
- Moditen
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. fluphenazine hydrochloride (Amneal Pharmaceuticals NY LLC) – Prescribing Information, 2026-04-14. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b443b30-5682-4cf3-9ed0-716efddbc865
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- 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.