Prescription medicine
Thioridazine First approved as Mellaril
Thioridazine (Mellaril) is a prescription medicine with an FDA approval on record since 1962. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $0.571 per thioridazine 25 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the thioridazine FDA label on DailyMed (effective November 11, 2025, Mylan Institutional Inc.); the NDA 11808 record on Drugs@FDA; every thioridazine label on DailyMed.
Highlights of the record
FDA label of November 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Thioridazine has been shown to prolong the QTc interval in a dose related manner, and drugs with this potential, including thioridazine, have been associated with Torsades de pointes type arrhythmias and sudden death. Due to its potential for significant, possibly life threatening, proarrhythmic effects, thioridazine should be reserved for use in the treatment of schizophrenic patients who fail to show an acceptable response to adequate courses of treatment with other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs (see WARNINGS , CONTRAINDICATIONS , and INDICATIONS ). 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. […]
Used for
From the label: indications and usageThioridazine hydrochloride tablets are indicated for the management of schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs.
Forms and strengths
- 10 mg
- 25 mg
- 50 mg
- 100 mg
Film-coated tablet.
On the market
- Earliest approval on file
- March 15, 1962 Mellaril, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 51 first April 14, 1983; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 5 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.571 per tablet Thioridazine 25 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
- 54 through July 30, 2026
What is thioridazine used for?
From the label: indications and usageThioridazine hydrochloride tablets are indicated for the management of schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. Due to the risk of significant, potentially life threatening, proarrhythmic effects with thioridazine treatment, thioridazine hydrochloride tablets should be used only in patients who have failed to respond adequately to treatment with appropriate courses of other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs. […]
FDA pharmacologic class: Phenothiazine.
Source: FDA drug label (Thioridazine Hydrochloride), Mylan Institutional Inc., effective November 11, 2025 (SPL set 52fea941-0b47-41c1-b00d-f88150e8ab93), via openFDA; the full label on DailyMed
Is there a generic for thioridazine (Mellaril)?
The FDA approved the first generic thioridazine on April 14, 1983. 51 generic applications are approved; 1 of them carries 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 thioridazine from 5 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.
- 1962 earliest approval on file
- 1983 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 thioridazine (Mellaril)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.571 per Thioridazine 25 mg tablet, about the same as a year earlier. 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.
- Thioridazine 25 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Thioridazine 10 mg tablet | Generic | $0.394 per tablet | $11.82 | -10% |
| Thioridazine 100 mg tablet | Generic | $0.830 per tablet | $24.91 | -1% |
| Thioridazine 25 mg tablet | Generic | $0.571 per tablet | $17.14 | -0.7% |
| Thioridazine 50 mg tablet | Generic | $0.722 per tablet | $21.66 | -1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has thioridazine been recalled?
The FDA's Enforcement Report lists 1 recall naming thioridazine 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 thioridazine 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: THIORIDAZINE HCL, Tablet, 50 mg may have potentially been mislabeled as the following drug: guanFACINE HCl, Tablet, 1 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the thioridazine label say about other medicines?
The thioridazine label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 35 other medicines name thioridazine. 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 |
|---|---|---|
| Atropine | warnings | Attention should be paid to the fact that phenothiazines are capable of potentiating central nervous system depressants (e.g., anesthetics, opiates, alcohol, etc.) as well as atropine and phosphorus insecticides. |
| Fluoxetine | contraindications | Reduced cytochrome P450 2D6 isozyme activity drugs that inhibit this isozyme (e.g., fluoxetine and paroxetine) and certain other drugs (e.g., fluvoxamine, propranolol, and pindolol) appear to appreciably inhibit the metabolism of thioridazine. |
| Fluvoxamine | contraindications | Reduced cytochrome P450 2D6 isozyme activity drugs that inhibit this isozyme (e.g., fluoxetine and paroxetine) and certain other drugs (e.g., fluvoxamine, propranolol, and pindolol) appear to appreciably inhibit the metabolism of thioridazine. |
| Paroxetine | contraindications | Reduced cytochrome P450 2D6 isozyme activity drugs that inhibit this isozyme (e.g., fluoxetine and paroxetine) and certain other drugs (e.g., fluvoxamine, propranolol, and pindolol) appear to appreciably inhibit the metabolism of thioridazine. |
| Pindolol | contraindications | Reduced cytochrome P450 2D6 isozyme activity drugs that inhibit this isozyme (e.g., fluoxetine and paroxetine) and certain other drugs (e.g., fluvoxamine, propranolol, and pindolol) appear to appreciably inhibit the metabolism of thioridazine. |
| Propranolol | contraindications | Reduced cytochrome P450 2D6 isozyme activity drugs that inhibit this isozyme (e.g., fluoxetine and paroxetine) and certain other drugs (e.g., fluvoxamine, propranolol, and pindolol) appear to appreciably inhibit the metabolism of thioridazine. |
Other labels that name thioridazine
Source: FDA drug label (Thioridazine Hydrochloride), Mylan Institutional Inc., effective November 11, 2025 (SPL set 52fea941-0b47-41c1-b00d-f88150e8ab93), via openFDA; the full label on DailyMed
What do FAERS reports show for thioridazine?
The FDA Adverse Event Reporting System holds 54 reports that list thioridazine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 19 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 next?
- Alternatives to thioridazine
- medicines labeled for the same conditions
- Other phenothiazines
- the pharmacologic class, with prices and generics
- Thioridazine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other