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Navane Side Effects

Generic name: thiothixene

Medically reviewed by Last updated on Nov 26, 2023.

Note: This document contains side effect information about thiothixene. Some dosage forms listed on this page may not apply to the brand name Navane.

Applies to thiothixene: oral capsule.


Oral route (Capsule)

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Thiothixene hydrochloride is not approved for the treatment of patients with dementia-related psychosis.

Serious side effects of Navane

Along with its needed effects, thiothixene (the active ingredient contained in Navane) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking thiothixene:


Incidence not known

Get emergency help immediately if any of the following symptoms of overdose occur while taking thiothixene:

Symptoms of overdose

Other side effects of Navane

Some side effects of thiothixene may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

For Healthcare Professionals

Applies to thiothixene: intramuscular powder for injection, oral capsule, oral concentrate.

Nervous system

Frequency not reported: Tardive dyskinesia, extrapyramidal symptoms (e.g., pseudoparkinsonism, akathisia, dystonia), drowsiness, sedation, restlessness, agitation, insomnia, seizures, paradoxical exacerbation of psychotic symptoms[Ref]


Frequency not reported: Hyperprolactinemia, lactation, menstrual irregularities, moderate breast enlargement, galactorrhea, amenorrhea, gynecomastia, impotence[Ref]


Frequency not reported: Tachycardia, hypotension, lightheadedness, syncope, nonspecific ECG changes[Ref]


-As this drug has certain chemical and pharmacological similarities to the phenothiazines, all the side effects and toxicity associated with phenothiazines should be considered when this drug is used.

-Side effects of phenothiazines (not reported in this drug) include: cerebral edema, cerebrospinal fluid abnormalities, liver damage (jaundice, biliary stasis), eosinophilia, hemolytic anemia, pancytopenia, thrombocytopenic purpura, neutropenia, agranulocytosis, hyperreflexia (in infants whose mothers received phenothiazines), hypoglycemia, hyperglycemia, glycosuria, exfoliative dermatitis, contact dermatitis (in nursing personnel), miosis, mydriasis, adynamic ileus, and systemic lupus erythematosus-like syndrome.[Ref]


Rare (less than 0.1%): Anaphylaxis

Frequency not reported: Allergic reactions (rash, pruritus, urticaria, photosensitivity)[Ref]


Frequency not reported: Leukopenia and leukocytosis (usually transient)[Ref]


Frequency not reported: Elevated serum transaminase and elevated alkaline phosphatase (usually transient)[Ref]


Frequency not reported: Anorexia, increased appetite, increased weight, polydipsia[Ref]


Frequency not reported: Hyperpyrexia, weakness/fatigue, peripheral edema[Ref]


Frequency not reported: Dry mouth, constipation, increased salivation[Ref]


Frequency not reported: Blurred vision[Ref]


Frequency not reported: Increased sweating[Ref]


Frequency not reported: Nasal congestion[Ref]


1. (2001) "Product Information. Navane (thiothixene)." Roerig Division

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.