Prescription medicine
Trifluoperazine First approved as Stelazine
Trifluoperazine (Stelazine) is a prescription medicine with an FDA approval on record since 1959. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $0.579 per trifluoperazine 2 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the trifluoperazine FDA label on DailyMed (effective July 22, 2025, Mylan Institutional Inc.); the NDA 11552 record on Drugs@FDA; every trifluoperazine label on DailyMed.
Highlights of the record
FDA label of July 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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. Trifluoperazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).
Used for
From the label: indications and usageFor the management of schizophrenia.
Forms and strengths
- 1 mg
- 2 mg
- 5 mg
- 10 mg
Film-coated tablet.
On the market
- Earliest approval on file
- April 16, 1959 Stelazine, Glaxosmithkline; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first November 20, 1981; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 6 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.579 per tablet Trifluoperazine 2 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 122 through July 30, 2026
What is trifluoperazine used for?
From the label: indications and usageFor the management of schizophrenia. Trifluoperazine hydrochloride tablets, USP are effective for the short-term treatment of generalized non-psychotic anxiety. However, trifluoperazine hydrochloride tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety because certain risks associated with its use are not shared by common alternative treatments (i.e., benzodiazepines). […]
Conditions named in the indications of trifluoperazine's FDA labels, with every medicine labeled for each:
From other trifluoperazine labelsSchizophrenia: INDICATIONS AND USAGE For the management of schizophrenia.
FDA pharmacologic class: Phenothiazine.
Source: FDA drug label (Trifluoperazine Hydrochloride), Mylan Institutional Inc., effective July 22, 2025 (SPL set f742a579-411a-4140-91c4-edc735d638fa), via openFDA; the full label on DailyMed
Is there a generic for trifluoperazine (Stelazine)?
The FDA approved the first generic trifluoperazine on November 20, 1981. 16 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists trifluoperazine from 6 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1959 earliest approval on file
- 1981 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for trifluoperazine (Stelazine)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.579 per Trifluoperazine 2 mg tablet, down 14% from $0.670 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Trifluoperazine 1 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Trifluoperazine 1 mg tablet | Generic | $0.425 per tablet | $12.75 | -9% |
| Trifluoperazine 10 mg tablet | Generic | $1.24 per tablet | $37.30 | -13% |
| Trifluoperazine 2 mg tablet | Generic | $0.579 per tablet | $17.36 | -14% |
| Trifluoperazine 5 mg tablet | Generic | $0.860 per tablet | $25.80 | +21% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has trifluoperazine been recalled?
The FDA's Enforcement Report lists 1 recall naming trifluoperazine since 2013: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of trifluoperazine and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: TRIFLUOPERAZINE HCL, Tablet, 1 mg may have potentially been mislabeled as the following drug: TERBUTALINE SULFATE, Tablet, 2.5 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the trifluoperazine label say about other medicines?
The trifluoperazine label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Lithium | warnings | An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN and FBS) has occurred in a few patients treated with lithium plus an antipsychotic. |
Source: FDA drug label (Trifluoperazine Hydrochloride), Mylan Institutional Inc., effective July 22, 2025 (SPL set f742a579-411a-4140-91c4-edc735d638fa), via openFDA; the full label on DailyMed
What do FAERS reports show for trifluoperazine?
The FDA Adverse Event Reporting System holds 122 reports that list trifluoperazine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 75 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as trifluoperazine?
18 other medicines are given the same way (oral) and in the same FDA class as trifluoperazine or labeled mainly for the same use (schizophrenia), the same class first. Schizophrenia lists all 24 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Chlorpromazine | Schizophrenia | 22 labelers | $0.552 per tablet 100 mg tablet | No current entry |
| Perphenazine | Schizophrenia | 16 labelers | $0.161 per tablet 4 mg tablet | No current entry |
| Prochlorperazine | Anxiety, Schizophrenia | 29 labelers | $0.162 per tablet 10 mg tablet | No current entry |
| Amitriptyline and perphenazine | Anxiety | 1 labeler | n/a | No current entry |
| Quetiapine | Schizophrenia | 50 labelers | $0.127 per tablet 300 mg tablet | No current entry |
| Olanzapine | Schizophrenia | 33 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Haloperidol | Schizophrenia | 28 labelers | $0.181 per tablet 5 mg tablet | A presentation being discontinued |
| Lurasidone | Schizophrenia | 29 labelers | $0.142 per tablet 20 mg tablet | No current entry |
Every medicine labeled for the same conditions as trifluoperazine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does trifluoperazine compare with medicines for the same use?
1 side-by-side page set trifluoperazine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to trifluoperazine
- 18 medicines for the same use
- Other phenothiazines
- the pharmacologic class, with prices and generics
- Trifluoperazine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other