Fluphenazine is a phenothiazine indicated in the management of manifestations of psychotic disorders. It is available as tablets, elixir and injection for oral and intramuscular use. MedsAcross supplies Fluphenazine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
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. 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. Fluphenazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis.
Source: US FDA prescribing information
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. 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.
Source: US FDA prescribing information
Store at 20° to 25°C (68° to 77°F). Protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
11 presentations of Fluphenazine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Fluphenazine 5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Fluphenazine 10 mg tabletOralGeneric name | — | US FDA | Available on request |
| Fluphenazine 1 mg tabletOralGeneric name | — | US FDA | Available on request |
| Fluphenazine 2.5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Fluphenazine Hydrochoride 10 mg tabletOral | Rising Pharma Holdings | US FDA | Available on request |
| Fluphenazine 0.5 mg/mL elixirOralGeneric name | — | US FDA | Available on request |
| Fluphenazine Hydrochoride 1 mg tabletOral | Rising Pharma Holdings | US FDA | Available on request |
| Fluphenazine Hydrochoride 2.5 mg tabletOral | Rising Pharma Holdings | US FDA | Available on request |
| Fluphenazine Hydrochoride 5 mg tabletOral | Rising Pharma Holdings | US FDA | Available on request |
| Fluphenazine 25 mg/10 mL injectionIntramuscularGeneric name | — | US FDA | Available on request |
| Fluphenazine 5 mg/mL oral concentrateOralGeneric name | — | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 9 September 1959 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Fluphenazine in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 11 presentations of Fluphenazine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Fluphenazine, including Fluphenazine Hydrochoride.
Yes. The US FDA first approved Fluphenazine on 9 September 1959, according to Drugs@FDA.
No listed presentation of Fluphenazine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Fluphenazine is classified under ATC code N05AB02 (Fluphenazine).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.