Risperidone: Side Effects, Uses & Monitoring
1.1 Schizophrenia RISPERIDONE (risperidone) is indicated for the treatment of schizophrenia.
- Data source
- FDA labeling via NIH DailyMed (label 89595dbd…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Eps incidence | 35% |
| Insomnia | 32% |
| Parkinsonism* | 28% |
| Nervous system disorders parkinsonism* | 17% |
| Anxiety | 16% |
| Abdominal pain upper | 16% |
| Pyrexia | 16% |
| Enuresis | 16% |
| Drooling | 12% |
| Headache | 12% |
| Rhinorrhea | 12% |
| Tremor | 11% |
| Akathisia* | 10% |
| Sedation | 10% |
| Vomiting | 10% |
| Nausea | 9% |
| Constipation | 9% |
| Rhinitis | 9% |
| Dyspepsia | 8% |
| Weight increased | 8% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
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…
Frequently Asked Questions
What is Risperidone used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Risperidone?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Risperidone. Individual risk varies.
Does Risperidone require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Risperidone.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.