Prescription medication · Typical Antipsychotic (Phenothiazine)
fluphenazine
Also sold as Prolixin. Fluphenazine is used to manage the symptoms of psychotic disorders.
Data updated 2026-05-15
- 108
- FDA reportsRarely reported
- In shortage
- FDA status
What the data shows
fluphenazine (Prolixin) is a prescription Typical Antipsychotic (Phenothiazine), among the least-reported drugs the FDA tracks (108 FDA reports).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
fluphenazine (Prolixin) is a prescription Typical Antipsychotic (Phenothiazine). Fluphenazine is used to manage the symptoms of psychotic disorders.
Fluphenazine (Prolixin) is a medicine used to treat psychotic disorders. It helps manage symptoms like hallucinations and confused thinking.
Verify with FDA → · CMS NADAC pricing →
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 →
NADAC price trail: FLUPHENAZINE 1 MG TABLET
Same CMS presentation as the headline generic unit price above (3 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: +18.6% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| December 20, 2023 | $0.3287/EA | - | 1 |
| July 17, 2024 | $0.2193/EA | -33.3% | 1 |
| December 18, 2024 | $0.2600/EA | +18.6% | 16 |
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.
The sections below are summarized in plain English from fluphenazine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 108 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for fluphenazine, by number of reports
- Sedation
Sedation
19 reports
- Anxiety
Anxiety
13 reports
- Suicide Attempt
Suicide Attempt
12 reports
- Schizophrenia
Schizophrenia
11 reports
- Blood Pressure Decreased
Blood Pressure Decreased
10 reports
- Blood Pressure Increased
Blood Pressure Increased
10 reports
- Chest Pain
Chest Pain
10 reports
- Parkinsonism
Parkinsonism
10 reports
- Dyspnoea
Dyspnoea
9 reports
- Nightmare
Nightmare
9 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for fluphenazine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where fluphenazine sits
fluphenazine has more FDA adverse-event reports than 1% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is fluphenazine; the line is the median (50th percentile).
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
Reports Mentioning Death
9
8.3% of reports — not proof of cause
Hospitalization Reports
46
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | SEDATION | 19 |
| 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 |
| 16 | SELF-INJURIOUS IDEATION | 8 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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?
What pregnancy or breastfeeding source fields are listed for fluphenazine?
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
Related Medications in Typical Antipsychotic (Phenothiazine)
Other drugs grouped near fluphenazine - same-class peers and common alternatives.
acamprosate
Campral
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alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
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amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
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amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
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aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
Compare with fluphenazine →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for fluphenazine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 108.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 8.33%.
- clindamycin Δ 0.01 pts · 27,449 reports · Lincosamide Antibiotic 8.33%death share
- metformin Δ 0.02 pts · 342,023 reports · Biguanide 8.32%death share
- methimazole Δ 0.03 pts · 7,411 reports · Anti-Thyroid Agent 8.30%death share
- acarbose Δ 0.04 pts · 3,736 reports · Alpha-Glucosidase Inhibitor 8.30%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 108 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: January 23, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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