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Risperidone: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Risperidone. Educational only — not medical advice.

Reported adverse reactions

ReactionHighest frequency reported*
Eps incidence35%
Insomnia32%
Parkinsonism*28%
Nervous system disorders parkinsonism*17%
Anxiety16%
Abdominal pain upper16%
Pyrexia16%
Enuresis16%
Drooling12%
Headache12%
Rhinorrhea12%
Tremor11%
Akathisia*10%
Sedation10%
Vomiting10%
Nausea9%
Constipation9%
Rhinitis9%
Dyspepsia8%
Weight increased8%

*Highest percentage across placebo-controlled trial tables summarized in current labeling.

Labeled uses

1.1 Schizophrenia RISPERIDONE (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 )]. 1.2 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) [see Clinical Studies ( 14.2 )]. 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 ( 14.3 )]. 1.3 Irritability Associated with Autistic Disorder Pediatrics 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 chi…

Source: FDA labeling via NIH DailyMed (set 89595dbd…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.