Risperidone
Risperdal, Risperidon · ATC code N05AX08
Also known as: Risperidon · Brand names: Risperdal, As-Risper, Neoris, Nodirep, Perilife, Ricus, Rileptid, Ripesil, Riscolex, Rixper, Rostalept, Welris
- Key facts
- Active substance
- Risperidone
- Drug class
- Antipsychotics
- ATC code
- N05AX08
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-27
Boxed warning
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Risperidone is not approved for the treatment of patients with dementia-related psychosis. [see Warnings and Precautions (5.1)]
Key facts
Risperidone is an atypical antipsychotic. Per this US label, it is used for schizophrenia, bipolar mania and irritability associated with autistic disorder.
What it is used for
- Schizophrenia in adults and adolescents (13 to 17 years)
- Acute manic or mixed episodes of Bipolar I Disorder, as monotherapy (adults, children and adolescents 10 to 17 years) or adjunctive to lithium or valproate (adults)
- Irritability associated with autistic disorder in children and adolescents (5 to 17 years)
Dosing
- Schizophrenia, adults: start 2 mg/day, increase by 1 to 2 mg to 4 to 8 mg/day
- Schizophrenia, adolescents: start 0.5 mg once daily, target 3 mg/day
- Bipolar mania: adults start 2 to 3 mg; children/adolescents start 0.5 mg, target 1 to 2.5 mg
- Autistic disorder: start 0.25 mg (under 20 kg) or 0.5 mg (20 kg or more), weight-based titration
- Severe renal or hepatic impairment: start 0.5 mg twice daily
- Adjust dose with CYP2D6 inhibitors (e.g. fluoxetine, paroxetine) or inducers (e.g. carbamazepine)
Contraindications
- Known hypersensitivity to risperidone, paliperidone or any excipient
Important warnings
- Boxed warning: increased mortality in elderly patients with dementia-related psychosis; not approved for this use
- Cerebrovascular adverse events including stroke in elderly dementia patients
- Neuroleptic malignant syndrome, tardive dyskinesia
- Metabolic changes (hyperglycemia, dyslipidemia, weight gain), hyperprolactinemia
- Orthostatic hypotension, falls, leukopenia/neutropenia/agranulocytosis, seizures
Side effects
- Common: parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety
- Nausea, vomiting, upper abdominal pain, constipation, dry mouth, salivary hypersecretion
- Increased appetite, increased weight, fatigue, blurred vision, rash, upper respiratory tract infection
Interactions
- CYP2D6 inhibitors (fluoxetine, paroxetine): re-evaluate dosing
- Carbamazepine and other enzyme inducers lower levels; titrate dose upwards as needed
- No dose adjustment with ranitidine, cimetidine, amitriptyline or erythromycin
Pregnancy and breastfeeding
- Pregnancy: neonates exposed in the third trimester are at risk of extrapyramidal and/or withdrawal symptoms
- Lactation: present in breast milk; reports of sedation, failure to thrive and extrapyramidal symptoms in breastfed infants
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
- RisperdalJanssen-Cilag Pharma Gmbh · 2 register entries
- Risperidon1a Pharma Gmbh, Pharmathen S.A., Ratiopharm Arzneimittel Vertriebs-Gmbh, Teva B.V, Genericon Pharma Gesellschaft M.B.H., +pharma Arzneimittel Gmbh, Actavis Group Ptc Ehf., Sandoz Gmbh, Hexal Pharma Gmbh · 10 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- RisperdalJanssen-Cilag Gmbh · 2 register entries
- Risperidon1 A Pharma Gmbh, Ratiopharm Gmbh, Puren Pharma Gmbh & Co. Kg, Grindeks, Heumann Pharma Gmbh & Co. Generica Kg, Hexal Ag, Viatris Germany Gmbh, Stadapharm Gmbh, Dexcel Pharma Gmbh, Abz-Pharma Gmbh, Aliud Pharma Gmbh · 16 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- As-RisperAPOTEX İLAÇ SAN VE TİC. LTD. ŞTİ. · 1 register entry
- NeorisNEUTEC İLAÇ SAN. TİC. A.Ş · 12 register entries
- NodirepBİO-GEN İLAÇ SAN.TİC.LTD. ŞTİ. · 1 register entry
- PerilifeRECORDATİ İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
- RicusBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
- RileptidFARMA-TEK İLAÇ SAN. VE TİC. A.Ş. · 12 register entries
- RipesilALİ RAİF İLAÇ SAN. A.Ş. · 6 register entries
- RiscolexİLKO İLAÇ SAN.VE TİC. A.Ş. · 5 register entries
- RisperdalJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 8 register entries
- RixperTEVA İLAÇ SAN. VE TİC. A.Ş. · 8 register entries
- RostaleptWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
- WelrisNEUTEC İLAÇ SAN. TİC. A.Ş · 12 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 28 more European countries
- Belgium
- Risperdal, Risperidon Sandoz, Risperidone Eg, Risperidone Grindeks, Risperidone Teva
- Bulgaria
- Медориспер, Рисар, Сперидан, Торендо
- Croatia
- Prospera, Risdonal, Risperidon Grindeks, Rispolept, Risset, Torendo
- Cyprus
- Eperon, Risperdal, Risperidone Aurobindo, Risperidone Remedica, Risperidone Synto
- Czechia
- Medorisper, Rileptid, Rispen, Risperdal, Risperidon Actavis, Risperidon Farmax, Risperidon Orion, Risperidon Vipharm, Risperidone Grindeks, Rorendo Oro Tab
- Denmark
- Rispemyl, Risperanne, Risperdal, Risperidon Actavis, Risperidon Krka, Risperidon Sandoz, Risperidon Stada, Risperidon Teva, Risperidone Teva Gmbh
- Estonia
- Medorisper, Risperidon Actavis, Rispolept
- Finland
- Rismyl, Risperdal, Risperidon Krka, Risperidon Orion, Risperidon Ratiopharm, Risperidon Sandoz, Risperidone Grindeks, Risperidone Ratiopharm, Risperidone Stada
- France
- Risperdal, Risperdalconsta L.P., Risperidone
- Greece
- Adovia, Axelabron, Belasperdal-S, Depolan, Depredon, Evitrat, Helposper, Isipredon, Linipon, Natibo, Novoris, Orotral, Psychordal, Ribex, Ridoron, Ridrozal, Ripepral, Risgal, Rispefar, Rispelen, Rispelen®, Rispenet, Risperdal, Risperidone Grindeks, Risperidone Teva, Risperoprol, Rubrum, Shixofren, Zafitral
- Hungary
- Perdox, Rileptid, Ripedon, Risperdal Consta, Risperidone Accord, Risperidone Teva, Rispons
- Iceland
- Okedi, Risperdal, Risperidon Krka, Risperidone Teva, Risperidón Alvogen, Ríson
- Ireland
- Perdamel, Risperdal, Risperidone Grindeks, Risperidone Wockhardt Uk, Rispeva, Rispone, Sperizak
- Italy
- Risperdal, Risperidone Aurobindo, Risperidone Grindeks, Risperidone Mylan Generics, Risperidone Mylan Pharma, Risperidone Ratiopharm, Risperidone Sandoz, Risperidone Teva Group
- Latvia
- Medorisper, Rispaxol, Risperidone Grindeks, Rispolept
- Liechtenstein
- Okedi, Risperdal Consta
- Lithuania
- Medorisper, Risperidon Actavis, Risperidone Grindeks, Risperidone Teva, Rispolept
- Luxembourg
- Risperdal, Risperidon Ratiopharm, Risperidone Eg
- Malta
- Eperon, Evitrat, Risperdal, Risperidone Aurobindo, Risperidone Mylan, Risperidone Remedica, Risperidone Syri Pharma, Rispone
- Netherlands
- Risperdal, Risperidon Accord, Risperidon Cf, Risperidon Disper Stada, Risperidon G.L., Risperidon Grindeks, Risperidon Pch, Risperidon Sandoz, Risperidon Stada, Risperidon Teva, Risperidon Viatris, Risperidone Aurobindo
- Norway
- Okedi, Risperdal, Risperidon Sandoz, Risperidone Grindeks, Risperidone Teva
- Poland
- Orizon, Risperidon Vipharm, Risperidone, Risperon, Rispolept, Ryspolit, Torendo Q-Tab
- Portugal
- Risperdal, Risperidon Ratiopharm, Risperidona Alter, Risperidona Anova, Risperidona Aurobindo, Risperidona Basi, Risperidona Bluepharma, Risperidona Genedec, Risperidona Generis, Risperidona Krka, Risperidona Mylan, Risperidona Pentafarma, Risperidona Pharmakern, Risperidona Ratiopharm, Risperidona Sandoz, Risperidona Teva, Risperidona Tolife, Risperidone Grindeks
- Romania
- Rispen, Risperidona Grindeks, Risperidonă Arena, Risperidonă Grindeks, Risperidonă Teva, Rispolept, Torendo
- Slovakia
- Medorisper, Rispen, Risperdal Consta, Risperidon Farmax, Risperidon Orion, Torendo
- Slovenia
- Risperdal, Risperidon Grindeks, Rispolux, Risset, Torendo
- Spain
- Arketin, Risperdal, Risperidona Alter, Risperidona Aurovitas, Risperidona Benel, Risperidona Cinfa, Risperidona Cinfamed, Risperidona Codramol Farmalider, Risperidona Farmalid, Risperidona Farmalider, Risperidona Flas Krka, Risperidona Flas Teva-Ratiopharm, Risperidona Grindeks, Risperidona Kern Pharma, Risperidona Krka, Risperidona Normon, Risperidona Qualigen, Risperidona Sandoz, Risperidona Stada, Risperidona Tarbis, Risperidona Teva, Risperidona Viatris, Risperidona Winadol
- Sweden
- Medorisper, Rispemyl, Risperdal, Risperidon Actavis, Risperidon Krka, Risperidon Orion, Risperidon Sandoz, Risperidon Stada, Risperidone Grindeks, Risperidone Teva
EMA – Article 57 product data (EU/EEA), 2026-10-28
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Sources
- U.S. Food and Drug Administration. Risperidone (Janssen Pharmaceuticals, Inc.) – Prescribing Information, 2026-08-20. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=701e1cd8-2868-4d29-85a9-a2212c88165f
- 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 N05AX.
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.