Last reviewed 2026-05-13 · How we verify

Prolixin Decanoate (FLUPHENAZINE DECANOATE)

Prolixin Decanoate, also known as Fluphenazine Decanoate, is a phenothiazine antipsychotic medication originally developed by Bristol Myers Squibb. It is a small molecule that targets the D(2) dopamine receptor, and was FDA approved in 1972 for the treatment of psychotic disorders and schizophrenia. The medication is now off-patent and has multiple generic manufacturers. As a long-acting injectable, it is administered via intramuscular injection to provide sustained therapeutic effects. Key safety considerations include the risk of extrapyramidal symptoms and tardive dyskinesia.

At a glance

Approved indications

• Psychotic disorder
• Schizophrenia

Boxed warnings

• 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 Decanoate Injection, USP is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).

Common side effects

• Extrapyramidal symptoms
• Tardive Dyskinesia
• Neuroleptic malignant syndrome (NMS)
• Drowsiness or lethargy
• Hypertension
• Hypotension
• Nausea
• Loss of appetite
• Salivation
• Polyuria
• Perspiration
• Dry mouth

Key clinical trials

• Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum
• CATIE- Schizophrenia Trial (PHASE4)
• Investigation of the Safety, Tolerability and Potential Therapeutic Effects of JNJ-40411813 in Patients With Schizophrenia (PHASE2)
• Fluphenazine Decanoate for Psoriasis (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Prolixin Decanoate CI brief — competitive landscape report
• Prolixin Decanoate updates RSS · CI watch RSS
• Bristol-Myers Squibb portfolio CI