FDA label
What is Vraylar used for?
Vraylar contains cariprazine. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “VRAYLAR® is indicated for: Treatment of schizophrenia in adult and pediatric patients 13 years of age and older; Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older; Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients; Adjunctive therapy to antidepressants f...”
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Vraylar, capsule, gelatin coated
Indications and Usage, quoted from the label by Allergan, Inc. (NDA204370). Cross-references to other label sections are left out.
VRAYLAR® is indicated for:
- Treatment of schizophrenia in adult and pediatric patients 13 years of age and older
- Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older
- Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients
- Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients
Source: DailyMed label, set id 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f, version 32, effective December 18, 2025. NDC 61874-115, one of 6 listings for this product.
Questions
What is Vraylar used for?
The FDA label says: “VRAYLAR® is indicated for: Treatment of schizophrenia in adult and pediatric patients 13 years of age and older; Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older; Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients; Adjunctive therapy to antidepressants f...”
What drug class is Vraylar?
FDA lists cariprazine in the Atypical Antipsychotic established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.