FDA label
What is Rexulti used for?
Rexulti contains brexpiprazole. 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: “REXULTI is indicated for: Adjunctive treatment to antidepressants for major depressive disorder (MDD) in adults; Treatment of schizophrenia in adults and pediatric patients ages 13 years and older; Treatment of agitation associated with dementia due to Alzheimer's disease.”
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Rexulti, tablet
Indications and Usage, quoted from the label by Otsuka America Pharmaceutical, Inc. (NDA205422). Cross-references to other label sections are left out.
REXULTI is indicated for:
- Adjunctive treatment to antidepressants for major depressive disorder (MDD) in adults
- Treatment of schizophrenia in adults and pediatric patients ages 13 years and older
- Treatment of agitation associated with dementia due to Alzheimer's disease
Limitations of Use:
REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease.
Source: DailyMed label, set id 2d301358-6291-4ec1-bd87-37b4ad9bd850, version 26, effective May 6, 2026. NDC 59148-035, one of 8 listings for this product.
Questions
What is Rexulti used for?
The FDA label says: “REXULTI is indicated for: Adjunctive treatment to antidepressants for major depressive disorder (MDD) in adults; Treatment of schizophrenia in adults and pediatric patients ages 13 years and older; Treatment of agitation associated with dementia due to Alzheimer's disease.”
What drug class is Rexulti?
FDA lists brexpiprazole 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.