Cariprazine
Also known as: Reagila · Vraylar
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In short
In the European Union, cariprazine is indicated for the treatment of schizophrenia in adult patients. In the United States, it is indicated for the treatment of schizophrenia in adults and pediatric patients 13 years of age and older, and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and pediatric patients 10 years of age and older. Additionally, in the United States, it is indicated for the treatment of depressive episodes associated with bipolar I disorder in adults, and as an adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults.
From: Source: European Medicines Agency (EMA), Reagila — EPAR, 08/01/2026. © 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
- 1667655 cariprazine
- EMA
- EMEA/H/C/002770
Official indications
Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.
EMA (EU) Reagila
Reagila is indicated for the treatment of schizophrenia in adult patients.
Source: European Medicines Agency (EMA), Reagila — EPAR, 08/01/2026. © European Medicines Agency.
Document date: 08/01/2026 · Official document →
FDA (USA) Vraylar
1 . INDICATIONS AND USAGE VRAYLAR ® is indicated for: • Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies ( 14.1 )] • Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies ( 14.2 )] • Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies ( 14.3 )] • Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies ( 14.4 )] VRAYLAR is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults and pediatric patients 13 years of age and older ( 1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and pediatric patients 10 years of age and older ( 1 ) Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults ( 1 ) Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults ( 1 )
Data provided by the U.S. Food and Drug Administration.
Document date: 20251218 · 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 Cariprazine approved for in the European Union?
Reagila is indicated for the treatment of schizophrenia in adult patients. (Source: European Medicines Agency (EMA), Reagila — EPAR, 08/01/2026. © European Medicines Agency.)
Sources and attribution
- Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
- Data provided by the U.S. Food and Drug Administration.
- 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.
- 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), Reagila — EPAR, 08/01/2026. © 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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