Thiothixene
Thiothixene is an antipsychotic medication used to treat schizophrenia.
🧬 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 5 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 →
Thiothixene (Navane) is an older first-generation antipsychotic for schizophrenia in adults and teens 12 and up; a thioxanthene, it works much like the piperazine phenothiazines, calming dopamine signaling in the brain, and has been around since about 1967, now available as a generic. Drowsiness, restlessness, dry mouth and constipation are the side effects people most often notice. Its boxed warning is a higher risk of death in elderly people with dementia-related psychosis, so it should not be used for them. Long term, watch for tardive dyskinesia (repetitive face or tongue movements that can be permanent), and get emergency help for high fever with severe stiffness, signs of neuroleptic malignant syndrome.
Clinical pearls
- Rise slowly from sitting or lying, since it can drop blood pressure, especially alongside blood pressure medicines.
- Carbamazepine can lower thiothixene levels, so the dose may need adjusting when carbamazepine starts or stops.
- Neck spasms, trouble swallowing or a tongue that pushes out (dystonia) call for contacting your doctor right away.
- Alcohol and sleep aids deepen its drowsiness, and stopping suddenly without your prescriber’s plan can bring symptoms back.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Important safety warning: Thiothixene should NOT be used in elderly patients with dementia-related psychosis. Studies show that older adults with dementia who take antipsychotic medications — including thiothixene — have a significantly higher risk of death compared to those taking a placebo. Most of these deaths were due to heart-related causes (such as heart failure or sudden cardiac death) or infections like pneumonia. Thiothixene is not approved for this use. If you have a loved one with dementia, talk to their doctor about safer alternatives.
Patient information guide A plain-language walkthrough of Thiothixene, written from its FDA label.
What Thiothixene is used for
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Thiothixene capsules are FDA-approved for one condition:
- Schizophrenia — Thiothixene capsules are indicated for the management of schizophrenia in adults. Dosing is individualized based on symptom severity.
- Thiothixene capsules are not recommended for children under 12 years of age, as safety has not been established in this group.
- Thiothixene is not approved for treating behavioral complications in patients with dementia or intellectual disabilities.
How Thiothixene works
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Thiothixene belongs to the thioxanthene class of antipsychotics. It shares chemical and pharmacological properties with a subgroup of antipsychotics called piperazine phenothiazines, while differing from the aliphatic phenothiazine group. These properties allow it to act in the brain in ways that help reduce the symptoms of schizophrenia.
Thiothixene dosage
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Thiothixene capsules are taken by mouth. Your prescriber will start you at a low dose and increase it gradually based on how well your symptoms respond. Some people take it once a day; others divide their dose throughout the day.
- Milder conditions: typically started at a lower dose taken multiple times daily
- More severe conditions: a higher starting dose, taken twice daily, with adjustments over time
- Do not exceed the total daily amount prescribed — going higher rarely increases benefit and raises the risk of side effects
- If you miss a dose, follow your prescriber's instructions; never double up without guidance
Dosing details from the FDA-approved label
From the Thiothixene prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Schizophrenia, milder conditions
- Initial dose of 2 mg three times daily
- If indicated, a subsequent increase to 15 mg/day total daily dose is often effective
- Dosage individually adjusted; small doses initially, gradually increased to optimal effective level based on patient response
- Schizophrenia, more severe conditions
- Initial dose of 5 mg twice daily
- Usual optimal dose is 20 mg to 30 mg daily
- If indicated, an increase to 60 mg/day total daily dose is often effective
- Maximum: Exceeding a total daily dose of 60 mg rarely increases the beneficial response
- Dosage individually adjusted; small doses initially, gradually increased to optimal effective level based on patient response
- Children under 12 years of age
- Use is not recommended because safe conditions for its use have not been established
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION Dosage of thiothixene capsules should be individually adjusted depending on the chronicity and severity of the symptoms of schizophrenia. In general, small doses should be used initially and gradually increased to the optimal effective level, based on patient response. Some patients have been successfully maintained on once-a-day thiothixene capsules therapy. The use of thiothixene capsules in children under 12 years of age is not recommended because safe conditions for its use have not been established. In milder conditions, an initial dose of 2 mg three times daily is recommended. If indicated, a subsequent increase to 15 mg/day total daily dose is often effective. In more severe conditions, an initial dose of 5 mg twice daily is recommended. The usual optimal dose is 20 mg to 30 mg daily. If indicated, an increase to 60 mg/day total daily dose is often effective. Exceeding a total daily dose of 60 mg rarely increases the beneficial response.
Read the full Dosage and Administration section on DailyMed →
Thiothixene side effects
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Thiothixene can cause a range of side effects. Common ones include:
Common side effects
- Drowsiness or sedation
- Restlessness or agitation
- Dry mouth
- Blurred vision
- Constipation
- Lightheadedness or low blood pressure
- Fast heart rate (tachycardia)
- Increased sweating
- Restlessness, agitation, or trouble sleeping
- Lightheadedness or low blood pressure, especially when standing up
- Increased sweating or nasal congestion
- Menstrual changes or breast changes in women
- Nausea, loss of appetite, or weight changes
When to get medical help
- Call your doctor right away if you develop uncontrolled or unusual muscle movements, especially of the face, tongue, or limbs — this may be tardive dyskinesia
- Seek emergency help if you have a very high fever, severe muscle stiffness, confusion, or irregular heartbeat — these can be signs of neuroleptic malignant syndrome (NMS), a rare but life-threatening reaction
- Tell your doctor if you have muscle spasms in the neck, trouble swallowing, difficulty breathing, or your tongue protrudes — these are signs of dystonia
- Contact your doctor if you feel faint, have a sudden drop in blood pressure, or lose consciousness
- Tell your doctor about any signs of infection such as fever or difficulty breathing
- Tell your doctor if you notice yellowing of the skin or eyes, or unusual changes in mood or behavior
More serious reactions — including uncontrolled muscle movements (tardive dyskinesia), very high fever with muscle stiffness (neuroleptic malignant syndrome), or severe muscle spasms (dystonia) — require immediate medical attention. Contact your doctor or go to an emergency room if these occur.
Thiothixene warnings and precautions
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- Increased mortality in elderly patients with dementia: Thiothixene is not approved for dementia-related psychosis. Elderly patients with dementia who take antipsychotics have a significantly higher risk of death — mostly from heart-related causes or infections. Do not use thiothixene for this purpose.
- Tardive dyskinesia: Long-term use can cause involuntary, repetitive movements — often of the tongue, face, or mouth — that may be permanent. Risk increases with dose and duration. Report any unusual movements to your doctor promptly.
- Neuroleptic malignant syndrome (NMS): A rare, potentially fatal reaction with symptoms including high fever, severe muscle rigidity, confusion, and unstable heart rate or blood pressure. Stop the medication and seek emergency care immediately if this occurs.
- Dystonia: Muscle spasms — especially in the neck, throat, or tongue — can occur, particularly in the first few days of treatment and more often in younger males or at higher doses.
- Drowsiness and driving: Thiothixene may impair your ability to drive or operate machinery, especially early in treatment.
- Pregnancy: Newborns exposed in the third trimester may experience muscle problems or withdrawal symptoms after delivery. Use only if clearly necessary.
Thiothixene interactions
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Thiothixene can interact with several medications and substances. Key ones to know about:
- Carbamazepine and other enzyme-inducing drugs: These speed up how quickly the body clears thiothixene, which can make it less effective. Your doctor may need to monitor and adjust your dose.
- Blood pressure-lowering medications: Combining these with thiothixene can cause excessive drops in blood pressure. Close monitoring is needed.
- Alcohol and CNS depressants (sedatives, sleep aids, anxiety medications): These add to thiothixene's sedating effects and can increase the risk of low blood pressure and drowsiness. Avoid or use with extreme caution.
- Epinephrine: Should not be used to treat low blood pressure caused by thiothixene — it can paradoxically lower blood pressure further.
Interactions listed in the FDA-approved label
From the Thiothixene prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Hepatic microsomal enzyme inducing agents, such as carbamazepine: Were found to significantly increase the clearance of thiothixene. Observe patients for signs of reduced thiothixene effectiveness.
- Hypotensive agents: Possible additive effect with hypotensive agents. Observe patients closely for signs of excessive hypotension when thiothixene is added to their drug regimen.
Read the label’s full interactions text
DRUG INTERACTIONS Hepatic microsomal enzyme inducing agents, such as carbamazepine, were found to significantly increase the clearance of thiothixene. Patients receiving these drugs should be observed for signs of reduced thiothixene effectiveness 4,5 . Due to a possible additive effect with hypotensive agents, patients receiving these drugs should be observed closely for signs of excessive hypotension when thiothixene is added to their drug regimen 6 .
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Thiothixene
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- Do not take thiothixene if you are in a comatose state or have significant CNS (central nervous system) depression from any cause
- Do not take thiothixene if you have circulatory collapse or a blood disorder (blood dyscrasia)
- Do not take thiothixene if you have ever had a serious allergic reaction (hypersensitivity) to it
- Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding — this medication carries risks for the fetus, especially if taken in the third trimester
- Thiothixene is not recommended for children under 12 years of age
- Elderly patients with dementia should not take thiothixene — it is not approved for this use and increases the risk of death
- Tell your doctor about all other medications you take, especially carbamazepine, blood pressure drugs, or any sedatives
- Use caution driving or doing anything that requires full alertness until you know how thiothixene affects you
Thiothixene overdose
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Taking too much thiothixene can cause muscle twitching, drowsiness, and dizziness at lower excess amounts. A serious overdose can lead to severe CNS depression, muscle rigidity, tremor, difficulty swallowing, very low blood pressure, and coma. If an overdose is suspected, seek emergency medical help immediately — treatment focuses on supportive care, monitoring, and keeping the airway open.
How to store Thiothixene
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Store at 20° to 25°C (68° to 77°F). Protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Thiothixene
51 supplements and herbal products have documented interactions with Thiothixene in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 37
- Minor · 11
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.
Thiothixene: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Thiothixene — the kind of thing our pharmacy team would talk through with you at the counter.
What is thiothixene actually used for?
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How long does it take before I notice it working?
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What side effects should I watch out for?
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Can I drink alcohol while taking this medication?
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Is it safe to take thiothixene during pregnancy?
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Can an elderly family member with dementia take this medication?
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Is Thiothixene available over the counter?
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When was Thiothixene first available?
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Who makes Thiothixene?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Thiothixene on HelloPharmacist
Thiothixene forms and strengths (how it comes)
Thiothixene 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Thiothixene inactive ingredients by manufacturer.
Capsule
How this form is used
- Thiothixene capsules are used for the management of schizophrenia in adults
- Thiothixene capsules are not recommended for children under 12 years of age
- Thiothixene capsules are not approved for dementia-related psychosis
- Thiothixene capsules are taken by mouth, with frequency (once daily or divided doses) determined by your prescriber based on symptom severity
- Start at the lowest effective dose and increase gradually only as directed by your prescriber
- Some patients on Thiothixene capsules are successfully maintained on a once-daily schedule
- Do not exceed the total daily dose your prescriber has prescribed; going beyond the recommended maximum rarely adds benefit and increases risk
Thiothixene on the U.S. market: products, makers and brands
How Thiothixene 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.
4 companies list 13 Thiothixene product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 1967. Brand names on the directory include Navane; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Thiothixene is used (Medicaid data)
A general measure of how commonly Thiothixene 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 Thiothixene 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.
How commonly is Thiothixene prescribed? Of the 1,601 medications we measure, Thiothixene ranks #1,106 by Medicaid prescriptions — more than 31% of them.
Utilization by Thiothixene 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.
thiothixene 5 MG Oral Capsule Most dispensed
Summed across the 2 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313366
thiothixene 10 MG Oral Capsule
Summed across the 2 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313361
thiothixene 2 MG Oral Capsule
Summed across the 2 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313364
thiothixene 1 MG Oral Capsule
Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313362
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 Thiothixene, 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 8 of 42 listed Thiothixene NDCs with Medicaid activity.
Compare Thiothixene products
A representative set of FDA-listed product records for Thiothixene — 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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 1 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 2 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 5 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 10 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 1 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 2 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 5 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 1 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 2 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
Showing 13 of 13 products — FDA National Drug Code Directory. See every product, package size and price: browse all 13 Thiothixene NDCs →
Thiothixene side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Thiothixene — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Thiothixene in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Thiothixene FDA approval history
How Thiothixene went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Thiothixene recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Thiothixene recalls since July 2021.
✅No Thiothixene recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
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.
RxCUI 10510 2 dose forms · 5 strengths
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Dose form (SCDF) Oral Capsule RxCUI 374110In current FDA listings -
Dose form (SCDF) Oral Solution RxCUI 374111No current FDA listingClinical drug / strength (SCD) 5 MG/MLRxCUI 313368
Look up RxCUI 10510 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.
Thiothixene supply and shortage status
Whether Thiothixene is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Thiothixene brand names
Thiothixene is sold under one brand name in the FDA directory — Navane. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Thiothixene: manufacturers and labelers
4 companies list Thiothixene products with the FDA. By number of product records, the largest are ANI Pharmaceuticals, Inc., Amneal Pharmaceuticals NY LLC, Golden State Medical Supply, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Thiothixene drug class (RxNorm)
Thiothixene belongs to the Typical Antipsychotic class.
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.
Sources for this Thiothixene page
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.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Novitium Pharma LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →