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These highlights do not include all the information needed to use RISPERDAL ®safely and effectively. See full prescribing information for RISPERDAL ®. RISPERDAL ® (risperidone) tablets, for oral use RISPERDAL ® (risperidone) oral solution RISPERDAL ® M-TAB ®(risperidone) orally disintegrating tablets Initial U.S. Approval: 1993
Medication labelWhy this: Advisory · dailymed-prescription
RISPERDAL (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 [see Clinical Studies (14.1)] . Monotherapy RISPERDAL 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) [see Clinical Studies (14.2)] . Adjunctive Therapy RISPERDAL 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 (14.3)] . RISPERDAL 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) [see Clinical Studies (14.4)] .
- generic_name
- risperidone
- product_names
- risperidone
- ndc
- 50458-305, 50458-302, 50458-300, 50458-320, 50458-330, 50458-350, 50458-395, 50458-315, 50458-325, 50458-335, 50458-355, 50458-302-06, 50458-302-50, 50458-302-01, 50458-300-06, 50458-300-50, 50458-300-01, 50458-320-06, 50458-320-50, 50458-320-01, 50458-330-06, 50458-330-50, 50458-330-01, 50458-350-06, 50458-350-01, 50458-395-28, 50458-395-30, 50458-315-28, 50458-315-30, 50458-325-28, 50458-335-28, 50458-355-28, 50458-305-03
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en