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Risperidone (Risperdal), an antipsychotic drug widely used for adults, has gained FDA approval to treat schizophrenia in adolescents ages 13 to 17 and for the short-term treatment of mania associated with manic or mixed episodes of bipolar I disorder in children and adolescents ages 10 to 17. Risperdal was previously approved to treat irritability in pediatric patients with autism ages 5 to 16.


Until now, no drug had been approved to treat schizophrenia in children, and lithium was the only drug previously approved to treat bipolar disorder in adolescents.


The approved dose for risperidone is slightly lower for children than for adults. Common adverse reactions include drowsiness, fatigue, increased appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash. For more information, visit the FDA's Web site at http://www.fda.gov.