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U.S. Department of Health and Human Services

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Drug Approved to Treat Two Psychiatric Conditions in Children and Adolescents

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Risperdal (risperidone) has been approved for the treatment of schizophrenia in adolescents, ages 13 to 17, and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents ages 10 to 17.

Until now, there has been no FDA-approved drug to treat schizophrenia in adolescents and only lithium has been approved to treat bipolar disorder in adolescents ages 12 and up.

Drug Effectiveness

Risperdal's effectiveness in treating schizophrenia in adolescents was shown in two short-term (six to eight weeks) clinical trials. All participants were experiencing an acute episode of schizophrenia at the time of enrollment in the clinical trials. Treated participants generally had fewer symptoms, including a decrease in hallucinations, delusional thinking, and other symptoms of their illness.

The effectiveness of Risperdal to treat manic or mixed episodes in children or adolescents with bipolar I disorder was shown in a three-week clinical trial in people who were experiencing a manic or mixed episode. Treated participants generally had fewer symptoms, including a decrease in their elevated mood and hyperactivity, and other symptoms of their illness.

Side Effects

The most common side effects reported in clinical trials were

  • drowsiness
  • fatigue
  • increase in appetite
  • anxiety
  • nausea
  • dizziness
  • dry mouth
  • tremor
  • rash

Schizophrenia is a serious and disabling psychiatric disorder. Symptoms may include hallucinations, delusions, and disorganized thinking.

Bipolar Disorder

Bipolar disorder, also known as manic-depressive illness, is a serious psychiatric disorder that causes wide shifts in a person's mood, energy, and ability to function. Bipolar I disorder, for which Risperdal is approved, involves recurrent episodes of mania and depression. Bipolar II disorder involves milder episodes of hypomania that alternate with depression.

History of Risperdal

FDA first approved Risperdal in 1993 to treat schizophrenia in adults. The drug later was approved for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults and the treatment of irritability associated with autistic disorder in children and adolescents 5 to 16 years old.

Risperdal is manufactured by Janssen L.P. of Titusville, N.J.


This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.

Date Posted: Aug. 22, 2007