Last reviewed 2026-04-20 · How we verify

Navane (THIOTHIXENE)

At a glance

Approved indications

• Schizophrenia

Boxed warnings

• BOXED WARNING WARNING 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 ).

Common side effects

• Dystonia
• Tardive Dyskinesia
• Leukopenia
• Leucocytosis
• Agranulocytosis
• Eosinophilia
• Hemolytic anemia
• Thrombocytopenia
• Pancytopenia
• Hyperpyrexia
• Anorexia
• Nausea

Drug interactions

• cabergoline
• entacapone
• levodopa
• pergolide
• pramipexole
• ropinirole

Key clinical trials

• A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group
• Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)
• Reducing Antipsychotic-Induced Weight Gain in Children With Metformin (PHASE1)
• Antipsychotics and Risk of Hyperglycemic Emergencies
• Atypical Antipsychotic Treatment Effect On Brain Function In Schizophrenia Measured By FMRI (NA)

Primary sources

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