FDA labeling approves risperidone for schizophrenia at ages 13–17, acute manic or mixed Bipolar I episodes at ages 10–17, and irritability associated with autistic disorder at ages 5–16. Supporting pediatric trials included 417 adolescents with schizophrenia, 169 pediatric patients with bipolar mania, and 156 patients in two autism-irritability trials.
Gynecomastia was reported in 2.3% of 1885 pediatric patients in clinical trials. Galactorrhea was reported in 0.8% of pediatric patients in clinical trials.
FDA labeling approves risperidone for schizophrenia at ages 13–17, acute manic or mixed Bipolar I episodes at ages 10–17, and irritability associated with autistic disorder at ages 5–16. Supporting pediatric trials included 417 adolescents with schizophrenia, 169 pediatric patients with bipolar mania, and 156 patients in two autism-irritability trials. Current pediatric indications limit any implication that all pediatric use remains unapproved. Label evidence does not adjudicate historical marketing allegations.