Uses
Haloperidol injection is indicated for the treatment of patients with schizophrenia.
Source: US FDA prescribing information
- Presentations
- 10
- Brands
- 0
- Manufacturers
- 0
- Available from stock
- 0
Haloperidol is a typical antipsychotic indicated for the treatment of patients with schizophrenia. It is available as tablets, injection and oral solution for intramuscular use. MedsAcross supplies Haloperidol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Typical Antipsychotic
- ATC classification
- N05AD01 Haloperidol · Antipsychotics, subgroup N05AD
- US FDA first approval
- 12 April 1967
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral, Intramuscular
- Dosage forms
- Tablet, Injection, Oral solution, Oral concentrate
- Identifiers
- UNII J6292F8L3DRxCUI 5093CAS 52-86-8DrugBank DB00502Q251347
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
of haloperidol for the treatment of schizophrenia is unclear. However, its efficacy could be mediated through its activity as an antagonist at central dopamine type 2 receptors. Haloperidol also binds to alpha-1 adrenergic receptors, but with lower affinity, and displays minimal binding to muscarinic cholinergic and histaminergic (H 1 ) receptors.
Source: US FDA prescribing information
Dosing overview
There is considerable variation from patient to patient in the amount of medication required for treatment. As with all drugs used to treat schizophrenia, dosage should be individualized according to the needs and response of each patient. Dosage adjustments, either upward or downward, should be carried out as rapidly as practicable to achieve optimum therapeutic control. To determine the initial dosage, consideration should be given to the patient's age, severity of illness, previous response to other antipsychotic drugs, and any concomitant medication or disease state. Debilitated or geriatric patients, as well as those with a history of adverse reactions to antipsychotic drugs, may require less haloperidol injection. The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels.
Source: US FDA prescribing information
Contraindications
Haloperidol injection is contraindicated in patients with: • Severe toxic central nervous system depression or comatose states from any cause. • Hypersensitivity to this drug – hypersensitivity reactions have included anaphylactic reaction and angioedema. • Parkinson's disease. • Dementia with Lewy bodies.
Source: US FDA prescribing information
Warnings and precautions
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. 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. Haloperidol injection is not approved for the treatment of patients with dementia-related psychosis. Cardiovascular Effects Cases of sudden death, QTc interval-prolongation, and Torsades de Pointes have been reported in patients receiving haloperidol injection.
Source: US FDA prescribing information
Side effects
The following adverse reactions are discussed in more detail in other sections of the labeling: • WARNINGS, Increased mortality in Elderly Patients with Dementia-Related Psychosis • WARNINGS, Cardiovascular Effects • WARNINGS, Tardive Dyskinesia • WARNINGS, Neuroleptic Malignant Syndrome • WARNINGS, Hypersensitivity Reactions • WARNINGS, Falls • WARNINGS, Usage in Pregnancy • WARNINGS, Combined Use of Haloperidol injection and Lithium • WARNINGS, General • PRECAUTIONS, Leukopenia, Neutropenia, and Agranulocytosis • PRECAUTIONS, Withdrawal Emergent Dyskinesia • PRECAUTIONS, Other Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice.
Source: US FDA prescribing information
Interactions
Drug-drug interactions can be pharmacodynamic (combined pharmacologic effects) or pharmacokinetic (alteration of plasma levels). The risks of using haloperidol in combination with other drugs have been evaluated as described below. Pharmacodynamic Interactions Since QTc interval-prolongation has been observed during haloperidol treatment, caution is advised when prescribing to a patient with QT-prolongation conditions or to patients receiving medications known to prolong the QTc-interval. Examples include (but are not limited to): Class 1A antiarrhythmics (e.g., procainamide, quinidine, disopyramide), Class 3 antiarrhythmics (e.g., amiodarone, sotalol), and other drugs such as citalopram, erythromycin, levofloxacin, methadone, and ziprasidone.
Source: US FDA prescribing information
Storage
Store at 20°C to 25°C (68°F to 77°F). Do not freeze. PROTECT FROM LIGHT.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
10 presentations of Haloperidol, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Haloperidol 5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Haloperidol 2 mg tabletOralGeneric name | — | US FDA | Available on request |
| Haloperidol 1 mg tabletOralGeneric name | — | US FDA | Available on request |
| Haloperidol 0.5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Haloperidol 10 mg tabletOralGeneric name | — | US FDA | Available on request |
| Haloperidol 20 mg tabletOralGeneric name | — | US FDA | Available on request |
| Haloperidol 5 mg/1 mL injectionIntramuscularGeneric name | — | US FDA | Available on request |
| Haloperidol 2 mg/mL oral solutionOralGeneric name | — | US FDA | Available on request |
| Haloperidol 50 mg/10 mL injectionIntramuscularGeneric name | — | US FDA | Available on request |
| Haloperidol 2 mg/mL oral concentrateOralGeneric name | — | US FDA | Available on request |
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 12 April 1967 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions
Conditions linked to Haloperidol in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Haloperidol available for export from India?
Yes, on request. MedsAcross lists 10 presentations of Haloperidol and sources them for licensed hospitals, importers and physicians against valid import documents.
Is Haloperidol approved by the US FDA?
Yes. The US FDA first approved Haloperidol on 12 April 1967, according to Drugs@FDA.
Does Haloperidol need cold chain shipping?
No listed presentation of Haloperidol is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Haloperidol in?
Haloperidol is classified under ATC code N05AD01 (Haloperidol).
References
- Haloperidol prescribing information (Fresenius Kabi). U.S. National Library of Medicine, DailyMed. Retrieved 22 September 2026
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