FDA-filed SPL labeling · retrieved through openFDA

Trifluoperazine

Trifluoperazine is an antipsychotic medication used to manage schizophrenia and, short-term, generalized non-psychotic anxiety.

Brand name Stelazine
Drug class ⓘ Phenothiazines
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 12 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJul 22, 2025
Clinical labels in scope ⓘ12
AvailabilityRx
Earliest approval/marketing year ⓘ1959
FDA-listed product records ⓘ45
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 24, 2026
⭐ Trifluoperazine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Trifluoperazine is a well-established antipsychotic used to treat schizophrenia and, on a strictly short-term basis, generalized non-psychotic anxiety. It carries important risks — including potentially permanent movement disorders and a rare but life-threatening syndrome called NMS — so it should always be taken at the lowest effective dose for the shortest time needed. Never use it in an elderly person with dementia, and keep all follow-up appointments so your doctor can monitor for early warning signs.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Trifluoperazine is not approved for use in elderly patients with dementia-related psychosis, and it should not be used for this purpose. Studies show that older adults with dementia who are treated with antipsychotic drugs — including this type — have a significantly higher risk of death compared to those given a placebo. These deaths were most often due to heart-related causes (such as heart failure or sudden death) or infections like pneumonia. If you have a loved one with dementia, talk to their doctor about safer alternatives.

Read the full warning on DailyMed →

📖 Trifluoperazine: Patient Information Guide

A plain-language walkthrough of Trifluoperazine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Trifluoperazine is used for two main purposes, and how long you can use it depends on the condition being treated.

  • Schizophrenia: Trifluoperazine Hydrochloride tablets are approved for the long-term management of schizophrenia in adults. They are also used in hospitalized or closely supervised children ages 6–12 with schizophrenia.
  • Generalized non-psychotic anxiety (short-term only): Trifluoperazine Hydrochloride tablets are approved for short-term treatment of generalized anxiety disorder that is not related to psychosis — but only when standard first-line treatments like benzodiazepines are not appropriate. Use must not exceed 12 weeks.
  • Not for dementia-related psychosis: Trifluoperazine Hydrochloride is not approved for behavioral problems related to dementia, and its use in that setting significantly raises the risk of death.
  • Not proven for: Anxiety caused by physical illness, depression, organic mental conditions, or character pathologies — the label does not support these uses.
💊How it's taken▾

Trifluoperazine Hydrochloride tablets are taken by mouth. For most patients, the drug is taken once or twice a day — your prescriber will determine the best schedule for you. The goal is always to use the lowest dose that controls your symptoms.

  • Doses are adjusted based on individual response; your doctor may start low and increase gradually.
  • Elderly patients and those who are frail should start at the lower end of the dosing range, with slow increases and careful monitoring.
  • For anxiety, use is strictly limited — no more than 12 weeks of treatment.
  • If you miss a dose, follow your prescriber's guidance; do not double up without being told to.
🤒Side effects — in detail▾

Like all medications, trifluoperazine can cause side effects — some common and manageable, others serious enough to call your doctor about right away.

  • Drowsiness or fatigue
  • Dizziness
  • Dry mouth
  • Blurred vision
  • Insomnia
  • Muscle weakness
  • Skin rash or increased sun sensitivity
  • Missed or irregular menstrual periods
  • Restlessness or agitation (especially early in treatment)
  • Parkinson's-like symptoms: tremor, shuffling gait, mask-like facial expression

Seek immediate medical attention if you develop high fever with muscle stiffness and confusion (NMS), uncontrolled repetitive movements of the face or body (tardive dyskinesia), severe neck spasms, difficulty swallowing or breathing, signs of liver problems (yellowing skin or eyes), or signs of serious blood problems (unusual bruising, fever, or infection).

⚠️Warnings & precautions▾
  • Increased death risk in elderly patients with dementia-related psychosis: This is the most critical warning. Trifluoperazine is not approved for this use, and studies show a significantly higher risk of death — often from heart or infectious causes — in this group.
  • Tardive dyskinesia (TD): Long-term or high-dose use can cause involuntary, repetitive muscle movements that may become permanent. Older adults — especially older women — are at greatest risk. Report any unusual facial or body movements to your doctor immediately.
  • Neuroleptic Malignant Syndrome (NMS): A rare but potentially fatal reaction involving high fever, severe muscle rigidity, confusion, and unstable heart rate or blood pressure. Stop the drug and get emergency help if these occur.
  • Falls: Trifluoperazine can cause dizziness, low blood pressure upon standing, and impaired coordination — raising fall and fracture risk, especially in older adults.
  • Impaired alertness: Avoid driving or operating machinery — especially early in treatment — until you know how the medication affects you.
  • Pregnancy and newborns: Babies born to mothers taking trifluoperazine near delivery may experience movement problems, muscle tone changes, tremor, or breathing difficulties.
  • Encephalopathic syndrome with lithium: Combining trifluoperazine with lithium has caused a serious brain syndrome in some patients, sometimes with lasting damage — this combination requires very close medical supervision.
🔀What it interacts with▾

Trifluoperazine can interact with several medications and substances — always give your prescriber and pharmacist a full list of everything you take.

  • Alcohol: Greatly increases sedation and CNS depression — avoid drinking while on this medication.
  • Sedatives, narcotics, antihistamines, barbiturates, and tranquilizers: Combining these with trifluoperazine multiplies drowsiness and breathing-related risks.
  • Anesthetics: Can have additive depressant effects — always tell your surgical or dental team you take this medication.
  • Lithium: Combined use has caused a serious brain syndrome with potential for permanent damage; close monitoring is essential.
  • Epinephrine (adrenaline): Trifluoperazine reverses the normal blood-pressure-raising effect of epinephrine — it should not be used as an emergency treatment for low blood pressure in patients on this drug.
  • Organophosphorus insecticides (certain pesticides): Effects of trifluoperazine can be intensified with exposure to these chemicals.
  • Heat: Phenothiazines like trifluoperazine can impair the body's ability to regulate temperature — use extra caution in hot environments.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Allergy to phenothiazines: Do not take trifluoperazine if you have had a serious allergic or sensitivity reaction to any phenothiazine drug. Do not re-expose yourself to this drug class after a prior reaction such as blood problems or jaundice.
  • Coma or severe CNS depression: Trifluoperazine is contraindicated if you are in a coma or severely sedated.
  • Blood disorders or bone marrow depression: Tell your doctor if you have any history of blood cell problems before starting this medication.
  • Liver disease: Pre-existing liver damage is a contraindication — discuss your liver health with your doctor.
  • Pregnancy: Safety has not been established. Use only if the benefit clearly outweighs the risk. Babies exposed in the third trimester may have movement problems or withdrawal symptoms after birth.
  • Breastfeeding: Trifluoperazine passes into breast milk. Talk to your doctor about whether to stop nursing or stop the medication.
  • Older adults: More susceptible to low blood pressure, movement problems, and falls — lower doses and close monitoring are standard.
  • Children: Oral use is established only for hospitalized or closely supervised children ages 6–12. Safety in younger children has not been established.
  • Dementia: Do not use in elderly patients with dementia-related psychosis — this drug is not approved for that condition and significantly increases mortality risk.
🚑If you take too much▾

Taking too much trifluoperazine can cause severe drowsiness, agitation, stiff or spasming muscles, difficulty breathing, seizures, heart rhythm changes, low blood pressure, dry mouth, and high fever. In serious overdose, the person may lose consciousness. If overdose is suspected, call emergency services (911) or Poison Control (1-800-222-1222) immediately — do not try to make the person vomit, as throat or neck muscle spasms from the drug can cause inhaled vomit to enter the lungs.

📦How to store it▾

Store at 20° to 25°C (68° to 77°F) . Protect from moisture. Dispense in a tight, light-resistant container.

📄 Written from Trifluoperazine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

76

Supplements & herbs that interact with Trifluoperazine

76 supplements and herbal products have documented interactions with Trifluoperazine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 48
  • Minor · 23
Every supplement checked against Trifluoperazine — ranked by severity The full interaction hub: 5 major · 48 moderate · 23 minor · every one linked to its full report. Check Trifluoperazine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Trifluoperazine — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is trifluoperazine used for? ▾
Trifluoperazine is mainly used to treat schizophrenia. It's also approved for short-term relief of generalized anxiety — meaning anxiety that isn't part of a psychotic condition — but only when other medications like benzodiazepines aren't the right fit for you, and only for up to 12 weeks. It's not a first-choice anxiety medication, so your doctor had specific reasons for choosing it in your case.
How do I take trifluoperazine tablets, and does it matter if I take them with food? ▾
You take trifluoperazine by mouth, usually once or twice a day depending on what it's being used for. The label doesn't restrict it to with or without food, so you can take it whichever way you find easiest — just try to be consistent. The most important thing is to stick to the schedule your doctor set and not change your dose on your own.
What side effects should I watch out for? ▾
The most common ones are drowsiness, dizziness, dry mouth, blurred vision, and restlessness — especially in the first few days. More serious ones to act on right away include uncontrolled repetitive movements of your face or body (called tardive dyskinesia), high fever with severe muscle stiffness and confusion (a rare reaction called NMS), neck muscle spasms, or trouble swallowing or breathing. Don't wait on those — call your doctor or get emergency help.
Can I drink alcohol while taking this medication? ▾
No — it's best to avoid alcohol completely while taking trifluoperazine. Alcohol adds to the drug's sedating effects, and together they can cause dangerous levels of drowsiness and slow your breathing. The same caution applies to sleep aids, antihistamines, and other sedating medicines — always check with your pharmacist before combining anything.
I'm older — are there extra things I need to know? ▾
Yes, and it's good that you're asking. Older adults tend to be more sensitive to trifluoperazine's effects, especially dizziness when standing up (which can lead to falls) and movement-related side effects. Your doctor should start you at a lower dose and monitor you closely. Also, this drug is absolutely not to be used for dementia-related behavioral problems — studies show it significantly raises the risk of death in that situation, so it should only be used if you have a separate, appropriate reason for it.
Is it safe to take during pregnancy or while breastfeeding? ▾
It's not considered safe to use during pregnancy unless your doctor has determined the benefit clearly outweighs the risk — and there's no established proof of safety. Babies born to mothers who took it close to delivery can have movement problems, tremor, or breathing difficulties for a period after birth. As for breastfeeding, trifluoperazine does pass into breast milk, so you and your doctor will need to decide together whether to stop the medication or stop nursing.
Is Trifluoperazine available over the counter? ▾
Trifluoperazine is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Trifluoperazine first available? ▾
Trifluoperazine has been available in the United States since at least 1959, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Trifluoperazine? ▾
Trifluoperazine is supplied by 7 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, Mylan Institutional Inc., Mylan Pharmaceuticals Inc..

💬 Answers drafted from Trifluoperazine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Trifluoperazine comes

Trifluoperazine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
How this form is used
What it may be used for
  • Trifluoperazine Hydrochloride tablets are used to manage schizophrenia in adults and children ages 6–12
  • Trifluoperazine Hydrochloride tablets are used for short-term treatment of generalized non-psychotic anxiety in adults (no longer than 12 weeks)
  • Trifluoperazine Hydrochloride tablets have not been shown effective for anxiety caused by physical illness, depression, or other non-psychotic conditions
Important instructions
  • Trifluoperazine Hydrochloride tablets are taken by mouth, typically once or twice daily as directed by your prescriber
  • Trifluoperazine Hydrochloride tablets for anxiety must not be used for more than 12 weeks
  • Trifluoperazine Hydrochloride tablets should be started at the lowest effective dose; your doctor will adjust based on your response
  • Elderly patients taking Trifluoperazine Hydrochloride tablets should start on lower doses and be monitored closely for dizziness and movement-related side effects
Available strengths 4 strengths
44 FDA-listed product records ⓘ

📊 Trifluoperazine across the U.S. market

How Trifluoperazine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
7
Manufacturers
1
Brand names
45
FDA-listed product records ⓘ
1959
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack18%
Mylan Institutional Inc.18%
Mylan Pharmaceuticals Inc.18%
Remedyrepack Inc.18%
Sandoz Inc.18%
Safecor Health LLC9%
Other makers2%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Trifluoperazine is used

A general measure of how commonly Trifluoperazine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Trifluoperazine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

7,503
Medicaid prescriptions filled (Q1–Q4 2025)
$313,491 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Trifluoperazine prescribed? Of the 1,597 medications we measure, Trifluoperazine ranks #980 by Medicaid prescriptions — more than 39% of them.

Where Trifluoperazine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Trifluoperazine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1 mg oral tablet is the most-dispensed Trifluoperazine product — about 39% of these Medicaid prescriptions.

trifluoperazine 1 MG Oral Tablet Most dispensed

2,926 Medicaid prescriptions (Q1–Q4 2025) 39% of Trifluoperazine prescriptions shown $69,749 gross reimbursement (before rebates) ≈ $24 per prescription (gross)

Summed across the 3 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198322

trifluoperazine 5 MG Oral Tablet

1,979 Medicaid prescriptions (Q1–Q4 2025) 26% of Trifluoperazine prescriptions shown $105,090 gross reimbursement (before rebates) ≈ $53 per prescription (gross)

Summed across the 2 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198325

trifluoperazine 2 MG Oral Tablet

1,871 Medicaid prescriptions (Q1–Q4 2025) 25% of Trifluoperazine prescriptions shown $81,385 gross reimbursement (before rebates) ≈ $43 per prescription (gross)

Summed across the 2 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198324

trifluoperazine 10 MG Oral Tablet

727 Medicaid prescriptions (Q1–Q4 2025) 10% of Trifluoperazine prescriptions shown $57,266 gross reimbursement (before rebates) ≈ $79 per prescription (gross)

Summed across the 2 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198323

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Trifluoperazine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 9 of 38 listed Trifluoperazine NDCs with Medicaid activity.

🔍 Compare Trifluoperazine products

A representative set of FDA-listed product records for Trifluoperazine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 45 of 45 products — FDA National Drug Code Directory. See every product, package size and price: browse all 45 Trifluoperazine NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Trifluoperazine RxCUI 10800 4 dose forms · 11 strengths
  1. Dose form (SCDF) Extended Release Oral Capsule RxCUI 385488 No current FDA listing
    Clinical drug / strength (SCD) 2 MG RxCUI 104762 10 MG RxCUI 104763 15 MG RxCUI 104764
  2. Dose form (SCDF) Oral Solution RxCUI 374207 No current FDA listing
    Clinical drug / strength (SCD) 0.2 MG/ML RxCUI 756203 1 MG/ML RxCUI 245380 10 MG/ML RxCUI 313473
  3. Dose form (SCDF) Oral Suspension RxCUI 483997 No current FDA listing
    Clinical drug / strength (SCD) 1 MG/ML RxCUI 483998
  4. Dose form (SCDF) Oral Tablet RxCUI 374208 In current FDA listings
    Clinical drug / strength (SCD) 1 MG RxCUI 198322 2 MG RxCUI 198324 5 MG RxCUI 198325 10 MG RxCUI 198323

Look up RxCUI 10800 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Stelazine

🏭 Manufacturers & labelers

Bryant Ranch Prepack 8 Mylan Institutional Inc. 8 Mylan Pharmaceuticals Inc. 8 Remedyrepack Inc. 8 Sandoz Inc. 8 Safecor Health LLC 4 Trifluoperazine Hydrochloride 1

RxNorm drug class

Trifluoperazine belongs to the Phenothiazine class.

Pharmacologic class Phenothiazine
Drug family (ATC) Phenothiazines with piperazine structure

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 22, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Trifluoperazine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Trifluoperazine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
12
NDC products indexed
45
Distinct labelers/manufacturers represented
7
Linked representative label ⓘ
Mylan Institutional Inc.
Linked label effective
Jul 22, 2025
Composite sections available
12
Linked SPL Set ID
f742a579-411a-4140-91c4-edc735d638fa
Linked SPL Document ID
3a877366-459b-cfac-e063-6294a90a6453
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 12 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Mylan Institutional Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.