Fluphenazine — uses, dosing, side effects & the brands that sell it · pharmaranks
Fluphenazine: uses, dosing, side effects & brands
Fluphenazine is a phenothiazine sold in the U.S. under 2 brand and generic names, for psychotic disorders and schizophrenia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
From the FDA label for Permitil (application NDA012034). Other fluphenazine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Depending on the severity and duration of symptoms, total daily dosage for adult psychotic patients may range initially from 2.5 mg to 10 mg and should be divided and given at 6 to 8 hour intervals. The smallest amount that will produce the desired results must be carefully determined for each individual, since optimal dosage levels of this potent drug vary from patient to patient. In general, the oral dose has been found to be approximately 2 to 3 times the parenteral dose of fluphenazine. Treatment is best instituted with a low initial dosage , which may be increased, if necessary, until the desired clinical effects are achieved. Therapeutic effect is often achieved with doses under 20 mg daily. Patients remaining severely disturbed or inadequately controlled may require upward titration of dosage. Daily doses up to 40 mg may be necessary; controlled clinical studies have not been performed to demonstrate safety of prolonged administration of such doses. When symptoms are controlled, dosage can generally be reduced gradually to daily maintenance doses of 1 mg to 5 mg, often given as a single daily dose. Continued treatment is needed to achieve maximum therapeutic benefits; further adjustments in dosage may be necessary during the course of therapy to meet the patient’s requirements. For psychotic patients who have been stabilized on a fixed daily dosage of orally…
Fluphenazine side effects
Central Nervous System The side effects most frequently reported with phenothiazine compounds are extrapyramidal symptoms including pseudoparkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonos, and hyperreflexia. Most often these extrapyramidal symptoms are reversible; however, they may be persistent (see below). With any given phenothiazine derivative, the incidence and severity of such reactions depend more on individual patient sensitivity than on other factors, but dosage level and patient age are also determinants. Extrapyramidal reactions may be alarming, and the patient should be forewarned and reassured. These reactions can usually be controlled by administration of antiparkinsonian drugs such as benztropine mesylate or intravenous caffeine and sodium benzoate injection, and by subsequent reduction in dosage. Extrapyramidal Symptoms Dystonia Class Effect Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic…
Every fluphenazine product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. Chemically it is 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl]propyl]-1-piperazineethanol dihydrochloride which may be represented by the following structural formula: Molecular Formula: C 22 H 26 F 3 N 3 OS.2HCl Molecular Weight: 510.44 g/mol. Fluphenazine hydrochloride, USP is a white or nearly white, crystalline powder. It is soluble in water, and practically insoluble in acetone, methylene chloride and in chloroform. Each tablet, for oral administration, contains 1 mg, 2.5 mg, 5 mg, or 10 mg of fluphenazine hydrochloride, USP per tablet. Inactive ingredients are: anhydrous lactose granulated, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, sodium lauryl sulphate and titanium dioxide. The following coloring agents are employed: 2.5 mg – iron oxide yellow 5 mg – FD&C blue No. 1, iron oxide yellow 10 mg – iron oxide red, iron oxide yellow. Meets USP Dissolution Test 2. qwerty
What kind of drug is fluphenazine?
The FDA classifies fluphenazine as a phenothiazine. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take fluphenazine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run fluphenazine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is fluphenazine sold under?
We track 2 fluphenazine-containing products in the U.S.: Permitil and Prolixin. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does fluphenazine come in?
Across the brands we track, fluphenazine is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take fluphenazine
Phenothiazines are contraindicated in patients with suspected or established subcortical brain damage, in patients receiving large doses of hypnotics, and in comatose or severely depressed states. The presence of blood dyscrasia or liver damage precludes the use of fluphenazine hydrochloride. Fluphenazine hydrochloride tablets are contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.
We do not currently list a generic-labelled fluphenazine product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has fluphenazine been recalled?
The FDA's Enforcement database lists 2 recall records whose product description mentions fluphenazine. The most recent: Fluphenazine Hydrochloride Tablets (Mar 13, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.