Prescription medicine
Thiothixene First approved as Navane
Thiothixene (Navane) is a prescription medicine with an FDA approval on record since 1967. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $1.72 per thiothixene 10 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the thiothixene FDA label on DailyMed (effective November 16, 2024, Amneal Pharmaceuticals NY LLC); the NDA 16584 record on Drugs@FDA; every thiothixene label on DailyMed.
Highlights of the record
FDA label of November 16, 2024; 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. Thiothixene is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).
Used for
From the label: indications and usageThiothixene capsules are effective in the management of schizophrenia.
Forms and strengths
- 1 mg
- 2 mg
- 5 mg
- 10 mg
Capsule.
On the market
- Earliest approval on file
- July 24, 1967 Navane, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first June 5, 1987; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 4 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.72 per capsule Thiothixene 10 mg capsule
- 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
- 218 through July 30, 2026
What is thiothixene used for?
From the label: indications and usageThiothixene capsules are effective in the management of schizophrenia. Thiothixene capsules have not been evaluated in the management of behavioral complications in patients with mental retardation.
Conditions named in the indications of thiothixene's FDA labels, with every medicine labeled for each:
From other thiothixene labelsSchizophrenia: INDICATIONS Thiothixene capsules are effective in the management of schizophrenia.
FDA pharmacologic class: Typical Antipsychotic.
Source: FDA drug label (thiothixene), Amneal Pharmaceuticals NY LLC, effective November 16, 2024 (SPL set 81c40311-7dc4-4332-8920-a39a8466aea6), via openFDA; the full label on DailyMed
Is there a generic for thiothixene (Navane)?
The FDA approved the first generic thiothixene on June 5, 1987. 11 generic applications are approved; 3 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 thiothixene from 4 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.
- 1967 earliest approval on file
- 1987 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 thiothixene (Navane)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.72 per Thiothixene 10 mg capsule, up 6% from $1.62 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.
- Thiothixene 1 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Thiothixene 1 mg capsule | Generic | $0.653 per capsule | $19.60 | -11% |
| Thiothixene 10 mg capsule | Generic | $1.72 per capsule | $51.50 | +6% |
| Thiothixene 2 mg capsule | Generic | $0.765 per capsule | $22.96 | -18% |
| Thiothixene 5 mg capsule | Generic | $1.39 per capsule | $41.69 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has thiothixene been recalled?
The FDA's Enforcement Report lists 1 recall naming thiothixene 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 thiothixene 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: THIOTHIXENE, Capsule, 1 mg may have potentially been mislabeled as the following drug: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the thiothixene label say about other medicines?
The thiothixene label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name thiothixene. 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 |
|---|---|---|
| Carbamazepine | drug interactions | Drug Interactions Hepatic microsomal enzyme inducing agents, such as carbamazepine, were found to significantly increase the clearance of thiothixene. |
Other labels that name thiothixene
Source: FDA drug label (thiothixene), Amneal Pharmaceuticals NY LLC, effective November 16, 2024 (SPL set 81c40311-7dc4-4332-8920-a39a8466aea6), via openFDA; the full label on DailyMed
What do FAERS reports show for thiothixene?
The FDA Adverse Event Reporting System holds 218 reports that list thiothixene among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 21 are coded as a death and 77 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 thiothixene?
16 other medicines are given the same way (oral) and in the same FDA class as thiothixene 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 |
|---|---|---|---|---|
| Haloperidol | Schizophrenia | 28 labelers | $0.181 per tablet 5 mg tablet | A presentation being discontinued |
| Molindone | Schizophrenia | 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 |
| Lurasidone | Schizophrenia | 29 labelers | $0.142 per tablet 20 mg tablet | No current entry |
| 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 |
| Paliperidone | Schizophrenia | 18 labelers | $0.972 per tablet 3 mg tablet | No current entry |
Every medicine labeled for the same conditions as thiothixene
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to thiothixene
- 16 medicines for the same use
- Other typical antipsychotics
- the pharmacologic class, with prices and generics
- Thiothixene side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other