Last reviewed 2026-04-20 · How we verify

CHLORPROMAZINE HYDROCHLORIDE

At a glance

Approved indications

No approved indications tracked.

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

Common side effects

• Drowsiness
• Postural hypotension
• Dizziness
• Tachycardia
• Fainting

Serious adverse events

• Agranulocytosis
• Jaundice
• Aplastic anemia
• Hemolytic anemia
• Thrombocytopenic purpura
• Pancytopenia
• Leukopenia
• Eosinophilia
• EKG changes
• Sudden cardiac death

Key clinical trials

• Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer (PHASE2, PHASE3)
• Safety and Preliminary Efficacy of Hibernation-Like Therapy (Chlorpromazine and Promethazine) in Patients With Acute Ischemic Stroke (AIS) Eligible for Reperfusion Therapy. (NA)
• Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy (PHASE2, PHASE3)
• Chlorpromazine and Standard of Care in Glioblastoma (PHASE1)
• A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group
• Explorations of the Normal Neural Behavioral and Pathological Bases of Metacognition
• Study on Hibernation-like Therapy Based on Mechanical Thrombectomy (PHASE1)
• A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia (NA)

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:

• CHLORPROMAZINE HYDROCHLORIDE CI brief — competitive landscape report
• CHLORPROMAZINE HYDROCHLORIDE updates RSS · CI watch RSS