Last reviewed 2026-04-20 · How we verify

Haldol (haloperidol)

Haloperidol (Haldol), marketed by Johnson & Johnson (Janssen), is a high-potency typical antipsychotic used primarily for the management of psychotic disorders, maintaining a significant presence in the antipsychotic market. Its key strength lies in its robust mechanism of action, effectively blocking dopamine D2 receptors, which has established it as a reliable treatment for schizophrenia, acute psychosis, and agitation. The primary risk to Haldol's market position is the key composition patent expiry in 2028, which could lead to increased competition from generic alternatives.

At a glance

Approved indications

• Management of Psychotic Disorders
• Control of Tics and Vocal Utterances in Tourette's Disorder
• Severe Behavior Problems in Children
• Short-term Treatment of Hyperactive Children

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

Common side effects

• Parkinsonism
• Oculogyric crisis

Serious adverse events

• Neuroleptic malignant syndrome
• Tardive dyskinesia
• Ventricular fibrillation
• Torsade de pointes
• Ventricular tachycardia
• Acute hepatic failure
• Pancytopenia
• Agranulocytosis
• Sudden death
• Anaphylactic reaction

Key clinical trials

• NCT00838032 (Phase 4)
• Haloperidol vs Olanzapine for the Management of ICU Delirium: A Randomized Clinical Trial (NA)
• Blood Lactate Levels in Patients Treated With Typical or Atypical Antipsychotics (N/A)
• A Randomized Double-blind Multicenter Double-dummy Non-inferiority Trial of Inhaled Loxapine and Intramuscular Haloperidol + Lorazepam for the Reduction of Agitation (Phase 4)
• Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium: A Randomized Placebo-Controlled Pilot Study (Phase 3)
• Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy With Amisulpride, Olanzapine or Haloperidol. A Study With Functional Magnetic Resonance Imaging (fMRI) and (Phase 4)
• Optimization of Post-Operative Therapy for Nausea or Vomiting (Phase 4)
• Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis (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:

• Haldol CI brief — competitive landscape report
• Haldol updates RSS · CI watch RSS
• Johnson & Johnson (Janssen) portfolio CI