Last reviewed 2026-04-20 · How we verify

Haldol (HALOPERIDOL DECANOATE)

Haldol (Haloperidol Decanoate) is a typical antipsychotic medication developed by Janssen Pharmaceutica, targeting the D(2) dopamine receptor. It is used to treat chronic schizophrenia and is available as a generic medication. As an off-patent drug, it is manufactured by multiple generic manufacturers. Key safety considerations include the risk of extrapyramidal symptoms and tardive dyskinesia. Haldol Decanoate is administered via intramuscular injection.

At a glance

Approved indications

• Chronic 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. Haloperidol decanoate is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).

Common side effects

• Extrapyramidal disorder
• Weight increased
• Neuroleptic malignant syndrome
• Akathisia
• Antipsychotic drug level below therapeutic
• Disinhibition
• Therapeutic product effect variable
• Suicide attempt
• Hospitalisation
• Euphoric mood
• Obsessive-compulsive disorder
• Treatment noncompliance

Key clinical trials

• Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer (PHASE2,PHASE3)
• Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer (PHASE2)
• Haloperidol and Lorazepam in Controlling Symptoms of Persistent Agitated Delirium in Patients With Advanced Cancer Undergoing Palliative Care (PHASE2,PHASE3)
• Comparing Haloperidol to Olanzapine in the Treatment of Suspected Cannabinoid Hyperemesis in the Emergency Department (PHASE3)
• Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy (PHASE2,PHASE3)
• Maternal And Infant Antipsychotic Study
• Do Antipsychotics Block Insulin Action in the Brain: is it a Class Effect? (PHASE4)
• Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the ED: A RCT (PHASE4)

Primary sources

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Competitive intelligence

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

• Haldol CI brief — competitive landscape report
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• Johnson & Johnson portfolio CI