Thorazine, illustration of tablet form (not a photo of the actual pack)

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Thorazine

Chlorpromazine

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FDA 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. Chlorpromazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis

Read this with the rest of the clinical information

About Thorazine

Overview

Thorazine is a prescription tablet containing chlorpromazine, a medicine in the phenothiazine family. It is used to treat schizophrenia, manage symptoms of other psychotic disorders, and control manic symptoms in manic-depressive illness. It is also used to control nausea and vomiting and relieve persistent, hard-to-treat hiccups.

What it treats

- Schizophrenia and symptoms of other psychotic disorders. - Nausea and vomiting. - Restlessness and apprehension before surgery. - Acute intermittent porphyria. - Tetanus, alongside other treatment. - Manic symptoms of bipolar disorder. - Persistent, difficult-to-treat hiccups. - Severe behavioral problems in children aged 1–12 involving combativeness or explosive, highly excitable behavior out of proportion to the situation. - Short-term treatment of hyperactivity in children with excessive movement and associated conduct problems, such as impulsivity, difficulty sustaining attention, aggression, mood changes or poor tolerance of frustration.

Safety information

Side effects

Side effects may be more likely or more severe in people with certain medical conditions. Severely low blood pressure has been reported in people with mitral insufficiency or pheochromocytoma taking chlorpromazine as prescribed. Contact a doctor if you develop severely low blood pressure.

FDA 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. Chlorpromazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis

A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.

When to call your doctor

- Seek medical attention immediately for severely low blood pressure.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

Do not take chlorpromazine if you have a known allergy to phenothiazines. It must not be used in people who are in a coma or who have large amounts of substances that slow central nervous system activity in their system, such as alcohol, barbiturates or narcotics.

Using Thorazine

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] (DailyMed, retrieved 19 September 2026).

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