Last reviewed 2026-04-20 · How we verify

Stelazine (TRIFLUOPERAZINE)

Stelazine (Trifluoperazine) is a phenothiazine antipsychotic medication originally developed by a pharmaceutical company, now owned by Glaxosmithkline. It targets the D(3) dopamine receptor, a key component in the treatment of anxiety and schizophrenia. Stelazine is a small molecule modality that has been FDA-approved since 1959 and is available as a generic medication. With eight generic manufacturers and no active Orange Book patents, it is considered off-patent. As a result, it is widely available and used to treat various psychiatric conditions.

At a glance

Approved indications

• Anxiety
• Schizophrenia

Boxed warnings

• 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. Trifluoperazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).

Common side effects

• Dystonia
• Tardive Dyskinesia
• Pseudo-parkinsonism
• Motor Restlessness
• Grand mal convulsions
• Petit mal convulsions
• Cardiac arrest
• Blood dyscrasias
• Liver damage
• Endocrine disturbances
• Skin disorders
• Hypotension

Drug interactions

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

Key clinical trials

• Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia (PHASE2,PHASE3)
• A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group
• The Use of Trifluoperazine in Transfusion Dependent DBA (PHASE1,PHASE2)
• Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)
• Reducing Antipsychotic-Induced Weight Gain in Children With Metformin (PHASE1)
• Olanzapine vs. Low-dose Olanzapine Plus Trifluoperazine (PHASE4)
• Antipsychotics and Risk of Hyperglycemic Emergencies
• Clinical Trial to Evaluate the Efficacy of Treatment vs Discontinuation in a First Episode of Non-affective Psychosis (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Stelazine CI brief — competitive landscape report
• Stelazine updates RSS · CI watch RSS