Risperidone
Also known as: Okedi
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In short
In the European Union, risperidone is indicated for the treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone. In the United States, this atypical antipsychotic is indicated for the treatment of schizophrenia, as well as for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Additionally, in the United States, it is indicated as monotherapy or adjunctive therapy with lithium or valproate for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.
From: Source: European Medicines Agency (EMA), Okedi — EPAR, 14/10/2025. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.
AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.
Codes
- RxNorm
- 35636 risperidone
- EMA
- EMEA/H/C/005406
Official indications
Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.
EMA (EU) Okedi
Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.
Source: European Medicines Agency (EMA), Okedi — EPAR, 14/10/2025. © European Medicines Agency.
Document date: 14/10/2025 · Official document →
FDA (USA) Risperidone
1 INDICATIONS AND USAGE Risperidone is an atypical antipsychotic indicated for: • Treatment of schizophrenia ( 1.1 ) • As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) • Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia Risperidone is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies ( 14.1 )] . 1.2 Bipolar Mania Monotherapy Risperidone is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies ( 14.2 )] . Adjunctive Therapy Risperidone adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studies ( 14.3 )] . 1.3 Irritability Associated with Autistic Disorder Risperidone is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years) [see Clinical Studies ( 14.4 )] .
Data provided by the U.S. Food and Drug Administration.
Document date: 20260626 · Official document →
Related terms in the cited sources
Has an official indication for
- Schizophrenia Condition
In alphabetical order.
Other treatments A–Z
What people report
Not enough data yet. Anonymous counts appear here only for groups of at least 20 people who agreed to share them.
External resources
Questions
What is Risperidone approved for in the European Union?
Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone. (Source: European Medicines Agency (EMA), Okedi — EPAR, 14/10/2025. © European Medicines Agency.)
Sources and attribution
- Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
- Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
- Data provided by the U.S. Food and Drug Administration.
- This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
- Source: European Medicines Agency (EMA), Okedi — EPAR, 14/10/2025. © European Medicines Agency.
Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →
About this page. This page brings together public information from official sources, each cited where it is used. It is not medical advice, it is not a diagnosis, and it does not tell you which treatment to take.
Treatments. Indications are quoted unchanged from official product information (European Medicines Agency, U.S. Food and Drug Administration). They describe what a medicine is approved for, not whether it is right for you. Approved uses can differ between countries. Always read the package leaflet and follow your doctor's or pharmacist's advice.
What people report. Figures marked "reported by Anpheros users" are anonymous counts from at least 20 people who agreed to share them. They show what people report, not what works, and they are not clinical evidence.
Links between terms. "May be associated with" means the link appears in a cited source. It does not mean you have that condition.
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