Last reviewed 2026-04-20 · How we verify

FLUPHENAZINE HYDROCHLORIDE

Fluphenazine Hydrochloride is a marketed drug primarily indicated for the management of psychotic disorders. A key strength is its established presence in the market, supported by a key composition patent expiring in 2028. The primary risk is the potential increase in competition as the patent expiration approaches.

At a glance

Approved indications

• Management of psychotic disorders

Boxed warnings

• 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 Oral Solution USP (Concentrate) is not approved for the treatment of patients with dementia-related psychosis ( see WARNINGS ).

Common side effects

• Extrapyramidal symptoms
• Pseudoparkinsonism
• Dystonia
• Dyskinesia
• Akathisia
• Drowsiness
• Lethargy
• Restlessness
• Excitement
• Bizarre dreams
• Nausea
• Loss of appetite

Serious adverse events

• Neuroleptic malignant syndrome
• Tardive dyskinesia
• Acute dystonia
• Oculogyric crises
• Opisthotonos
• Hypotension
• Leukocytosis
• Elevated CPK
• Liver function abnormalities
• Acute renal failure

Key clinical trials

• Pharmacovigilance in Gerontopsychiatric Patients (PHASE3)
• Fluphenazine Hydrochloride for Psoriasis (PHASE2)
• Investigation of the Safety, Tolerability and Potential Therapeutic Effects of JNJ-40411813 in Patients With Schizophrenia (PHASE2)
• Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma (PHASE1, PHASE2)
• Study of Fluphenazine in Relapsed or Relapsed-and-Refractory Multiple Myeloma (PHASE1)

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:

• FLUPHENAZINE HYDROCHLORIDE CI brief — competitive landscape report
• FLUPHENAZINE HYDROCHLORIDE updates RSS · CI watch RSS