What is risperidone used for?

Indications and Usage, quoted from the label by Solco Healthcare US, LLC (ANDA077493). Cross-references to other label sections are left out.

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.

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).

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.

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).

Source: DailyMed label, set id 43aa2a4f-1123-4f86-800b-9218882f7bcd, version 14, effective March 31, 2026. NDC 43547-339, one of 75 listings for this product.

Indications and Usage, quoted from the label by Westminster Pharmaceuticals, LLC (ANDA078707). Cross-references to other label sections are left out.

Schizophrenia

Risperidone tablets are 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].

Bipolar Mania

Monotherapy

Risperidone tablets are 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].

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].

Irritability Associated with Autistic Disorder

Risperidone tablets are 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].

Source: DailyMed label, set id 07d43bf6-a695-453a-a5c7-9581effe585c, version 6, effective December 7, 2025. NDC 69367-368, one of 45 listings for this product.