fluphenazine
Brand names: Prolixin
Fluphenazine (Prolixin) is a medicine used to treat psychotic disorders. It helps manage symptoms like hallucinations and confused thinking.
Drug Shortage Alert
fluphenazine is currently listed as to be discontinued by the FDA. Affected manufacturer: Upsher-Smith Laboratories, LLC.
View all drug shortages →Drug Pricing (NADAC)
Generic Price
$0.26/unit
Generic Available
Yes (26 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Fluphenazine is used to manage the symptoms of psychotic disorders.
Common side effects
Extrapyramidal symptoms (muscle stiffness, tremors, slow movement), Drowsiness, Restlessness
Key warnings
Fluphenazine may increase the risk of death in elderly patients with dementia-related psychosis.
How It Works
Fluphenazine belongs to a class of drugs called typical antipsychotics. It works by changing the way certain chemicals in your brain work. This helps to reduce psychotic symptoms.
How to Take It
Take fluphenazine exactly as your doctor tells you. The usual starting dose for adults is 2.5 to 10 mg per day, divided into doses every 6 to 8 hours. Your doctor may adjust your dose to find what works best for you. You can take the oral concentrate with tomato juice, fruit juice, milk, or uncaffeinated soft drinks.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if fluphenazine will harm your unborn baby. Talk to your doctor about the risks and benefits of taking fluphenazine during pregnancy.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store fluphenazine at room temperature (68° to 77° F). Protect from light and keep tightly closed. Do not freeze.
Side Effects (from patient reports)
Based on 119 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 108 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2007–2025.
Total Reports
108
Death-Related Reports
9
Hospitalization Reports
46
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | SEDATION | 19 |
| 2 | DRUG INEFFECTIVE | 15 |
| 3 | ANXIETY | 13 |
| 4 | SUICIDE ATTEMPT | 12 |
| 5 | SCHIZOPHRENIA | 11 |
| 6 | BLOOD PRESSURE DECREASED | 10 |
| 7 | BLOOD PRESSURE INCREASED | 10 |
| 8 | CHEST PAIN | 10 |
| 9 | PARKINSONISM | 10 |
| 10 | DYSPNOEA | 9 |
| 11 | NIGHTMARE | 9 |
| 12 | OEDEMA PERIPHERAL | 9 |
| 13 | THINKING ABNORMAL | 9 |
| 14 | ADVERSE DRUG REACTION | 8 |
| 15 | AKATHISIA | 8 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Fluphenazine may increase the risk of death in elderly patients with dementia-related psychosis. Fluphenazine is not approved for treating dementia-related psychosis. Tell your doctor right away if you have Neuroleptic Malignant Syndrome (NMS) symptoms like high fever, stiff muscles, confusion, sweating, fast or irregular heartbeat.
Common Questions
What should I avoid while taking fluphenazine?
Can I drive while taking this medicine?
How long will it take for fluphenazine to work?
What if I experience muscle stiffness or tremors?
Can I stop taking fluphenazine suddenly?
Will this medicine cure my condition?
Does fluphenazine interact with other medications?
What should I do if I think I'm experiencing a serious side effect?
Can I drink alcohol while taking fluphenazine?
How often will I need to see my doctor while taking this medicine?
What are the common side effects of fluphenazine?
What drug class is fluphenazine?
Is fluphenazine safe during pregnancy?
Has fluphenazine been recalled?
Is fluphenazine currently in shortage?
Active Recalls
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
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What the FDA Data Shows for fluphenazine
The FDA label for fluphenazine (sold under brand names such as Prolixin) classifies it as a prescription-only medication in the Typical Antipsychotic (Phenothiazine) class. Fluphenazine is used to manage the symptoms of psychotic disorders. Official labeling lists 3 commonly reported side effects, including Extrapyramidal symptoms (muscle stiffness, tremors, slow movement), Drowsiness, Restlessness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 119 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.26.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: January 23, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages