Skip to main content

Fluphenazine Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 5, 2024.

Applies to fluphenazine: oral elixir, oral solution concentrate, oral tablets, parenteral injection.

Important warnings This medicine can cause some serious health issues

    Increased Mortality in Geriatric Patients with Dementia-related Psychosis
  • Geriatric patients with dementia-related psychosis treated with antipsychotic agents are at an increased risk of death.100 101 102 103 c f g i j k l

  • Analyses of 17 placebo-controlled trials in geriatric patients mainly receiving atypical antipsychotic agents revealed an approximate 1.6- to 1.7-fold increase in mortality compared with that in patients receiving placebo.100 c f g i j

  • Most fatalities appeared to result from cardiovascular-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).b c f g i j

  • Observational studies suggest that conventional or first-generation antipsychotic agents also may increase mortality in such patients.100 c f g i k

  • Antipsychotic agents, including fluphenazine, are not approved for the treatment of dementia-related psychosis.100 101 c f g i j

Side effects include:

Extrapyramidal reactions (e.g., pseudo-parkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonos, hyperreflexia), drowsiness, lethargy, weight gain.

For healthcare professionals

Applies to fluphenazine: injectable solution, oral concentrate, oral elixir, oral tablet.

General adverse events

The most commonly reported side effects include extrapyramidal symptoms (e.g., pseudoparkinsonism, dystonia, dyskinesia).[Ref]

Hematologic

Metabolic

Hepatic

Musculoskeletal

Acute, distressing muscle spasms usually occurred within 24 hours of injection, and required immediate administration of an anticholinergic agent.[Ref]

Immunologic

Nervous system

Parkinsonism/parkinsonian-like states tended to occur 2 to 5 days after each injection, with a decreased frequency in subsequent injections. This side effect may be reduced by using smaller, more frequent doses or adding an anti-parkinsonism agent temporarily.[Ref]

Cardiovascular

ECG changes (including QT and T-wave changes) were dose-related side effects that usually occurred at moderate to high doses. These changes may preclude serious arrhythmias.[Ref]

Genitourinary

Dermatologic

Abnormal skin pigmentation occurred in patients receiving high doses for long durations of time.[Ref]

Gastrointestinal

Ocular

Lens opacities occurred in patients receiving high doses for long durations of time.[Ref]

Other

Sudden, unexplained/unexpected death occurred in hospitalized patients with psychosis.[Ref]

Psychiatric

Respiratory

Endocrine

Hypersensitivity

Renal

Local

References

1. (2001) "Product Information. Prolixin (fluphenazine)." Bristol-Myers Squibb

2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

3. Cerner Multum, Inc. "Australian Product Information."

Frequently asked questions

Further information

Fluphenazine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.