Haloperidol
Haldol, Haloperidol Hikma · ATC code N05AD01
Brand names: Haldol, Haloperidol Hikma, Haloperidol Decanoat Neuraxpharm, Haloperidol Forte Neuraxpharm, Haloperidol Neuraxpharm, Haloperidol Ratiopharm, Leptol, Norodol, Sedaperidol
- Key facts
- Active substance
- Haloperidol
- Drug class
- Antipsychotics
- ATC code
- N05AD01
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-27
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).
Key facts
Haloperidol is a conventional (butyrophenone) antipsychotic. Per the US label, it is used for psychotic disorders, Tourette's disorder and certain severe behavior problems in children.
What it is used for
- Management of manifestations of psychotic disorders
- Control of tics and vocal utterances of Tourette's Disorder in children and adults
- Severe behavior problems and hyperactivity in children, only after failure of psychotherapy or non-antipsychotic medications
Dosing
- Adults, moderate symptoms: 0.5 mg to 2 mg b.i.d. or t.i.d.
- Adults, severe symptoms or chronic/resistant patients: 3 mg to 5 mg b.i.d. or t.i.d.; daily dosages up to 100 mg may be necessary in some cases
- Geriatric or debilitated patients: 0.5 mg to 2 mg b.i.d. or t.i.d.
- Children 3 to 12 years: start at 0.5 mg per day, increase in 0.5 mg increments; not for children under 3 years
- Individualize dosage; maintenance dosing is in the full prescribing information
Contraindications
- Severe toxic CNS depression or comatose states from any cause
- Hypersensitivity to haloperidol
- Parkinson's disease
Important warnings
- Boxed warning: increased mortality in elderly patients with dementia-related psychosis; not approved for this use
- Sudden death, QT prolongation and torsades de pointes, especially at higher doses; caution with hypokalemia, hypomagnesemia, QT-prolonging drugs
- Tardive dyskinesia, potentially irreversible
- Extrapyramidal symptoms
Side effects
- Cardiovascular: tachycardia, hypotension, hypertension, QT prolongation, ventricular arrhythmias
- CNS: extrapyramidal symptoms, tardive dyskinesia
- Cases of sudden and unexpected death have been reported
Interactions
- Drugs known to prolong QT: increased risk of torsades de pointes
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Patient information (US)
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
Austria
- HaldolEssential Pharma Limited · 3 register entries
- Haloperidol HikmaHikma Farmacêutica (Portugal), S.A. · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- HaldolEssential Pharma Limited · 5 register entries
- Haloperidol Decanoat NeuraxpharmNeuraxpharm Arzneimittel Gmbh · 1 register entry
- Haloperidol Forte NeuraxpharmNeuraxpharm Arzneimittel Gmbh · 1 register entry
- Haloperidol NeuraxpharmNeuraxpharm Arzneimittel Gmbh · 4 register entries
- Haloperidol RatiopharmRatiopharm Gmbh · 3 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- LeptolMENARİNİ SAĞLIK VE İLAÇ SAN. TİC. A.Ş. · 6 register entries
- NorodolALİ RAİF İLAÇ SAN. A.Ş. · 15 register entries
- SedaperidolOSEL İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 28 more European countries
- Belgium
- Haldol
- Bulgaria
- Халоперидол
- Croatia
- Haloperidol Depo Krka, Haloperidol Krka
- Cyprus
- Haldol, Haloxen
- Czechia
- Haloperidol Decanoat Richter, Haloperidol Richter
- Denmark
- Serenase
- Estonia
- Haloperidol Richter
- Finland
- Serenase
- France
- Haldol, Haloperidol Lp Hikma
- Greece
- Aloperidin
- Hungary
- Haloperidol Decanoat Richter, Haloperidol Richter
- Iceland
- Haldol
- Ireland
- Haldol Decanoate, Haloperidol Mercury Pharmaceuticals (Ireland)
- Italy
- Aloperidolo Galenica Senese, Aloperidolo Hikma, Aloperidolo Pensa, Aloperidolo S.A.L.F, Haldol, Serenase
- Latvia
- Haloperidol Grindeks, Haloperidol Richter
- Liechtenstein
- Haldol
- Lithuania
- Haloperidol Decanoate Richter, Haloperidol Richter
- Luxembourg
- Haldol
- Malta
- Haldol Decanoate, Haloperidol, Haloxen
- Netherlands
- Haldol, Haloperidol Cf, Haloperidol Hikma, Haloperidol Teva
- Norway
- Haldol
- Poland
- Decaldol, Haloperidol Unia, Haloperidol Wzf
- Portugal
- Haldol, Haloperidol Hikma, Haloperidol Teva
- Romania
- Haloperidol Arena, Haloperidol Laropharm, Haloperidol Richter, Haloperidol Rompharm
- Slovakia
- Haloperidol Richter
- Slovenia
- Haloperidol Depo Krka, Haloperidol Krka
- Spain
- Haloperidol Esteve, Haloperidol Prodes
- Sweden
- Haldol
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Sources
- U.S. Food and Drug Administration. Haloperidol (AiPing Pharmaceutical, Inc) – Prescribing Information, 2026-04-08. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=bacc68ed-717b-477a-afa4-c45c182c617b
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC N05AD.
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.