What are the most common side effects of RISPERIDONE?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for RISPERIDONE. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is RISPERIDONE the same as RISPERIDONE?

RISPERIDONE is a brand name for RISPERIDONE. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

RISPERIDONE

Q: What is RISPERIDONE used for?

RISPERIDONE (brand name RISPERIDONE) is a Atypical Antipsychotic indicated for 1 INDICATIONS AND USAGE Risperidone tablets are an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, 2 short-term trials in adolescents (ages 13 to 17 years), including symptoms of aggression towards others.

Q: How does RISPERIDONE work?

RISPERIDONE works through the following mechanism: 12.1 Mechanism of Action The mechanism of action of risperidone in schizophrenia is unclear. The drug's therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2 ) receptor antagonism. The clinical effect from risperidone results from the combined concentrations of risperidone and its major metabolite, 9-hydroxyrisperidone (paliperidone) [see Clinical Pharmacology ( 12.3 )] . Antagonism at receptors other than D 2 and 5HT 2 may explain some of the other effects of risperidone [see Clinical Pharmacology ( 12.1 )] ..

Atypical Antipsychotic

Brand names: RISPERIDONE, Risperdal

Oral

Mechanism of Action

12.1 Mechanism of Action The mechanism of action of risperidone in schizophrenia is unclear. The drug's therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2 ) receptor antagonism. The clinical effect from risperidone results from the combined concentrations of risperidone and its major metabolite, 9-hydroxyrisperidone (paliperidone) [see Clinical Pharmacology ( 12.3 )] . Antagonism at receptors other than D 2 and 5HT 2 may explain some of the other effects of risperidone [see Clinical Pharmacology ( 12.1 )] .

Indications

1 INDICATIONS AND USAGE Risperidone tablets are an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate

2 short-term trials in adolescents (ages 13 to 17 years)

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) ] .

Contraindications

• 4 CONTRAINDICATIONS Risperidone tablets are contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone
• or to any of the excipients in the risperidone tablets formulation. Hypersensitivity reactions
• including anaphylactic reactions and angioedema
• have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone. Known hypersensitivity to risperidone
• paliperidone

FDA Warnings

5 WARNINGS AND PRECAUTIONS Cerebrovascular events, including stroke, in elderly patients with dementia-related psychosis: Risperidone tablets are not approved for use in patients with dementia-related psychosis ( 5
4 ) Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular / cerebrovascular risk
Monitor glucose regularly in patients with diabetes or at risk for diabetes
6 ) Orthostatic hypotension: For patients at risk, consider a lower starting dose and slower titration

Known Side Effects

3 documented side effects by frequency

Weight Gain

1-10%

Drug Not Working

1-10%

Drowsiness

0.1-1%

Community Discussions

No community discussions found for RISPERIDONE yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → RISPERIDONE openFDA label JSON → RISPERIDONE FAERS adverse-event reports → RISPERIDONE ClinicalTrials.gov → completed Phase 2+ trials of RISPERIDONE

Compare With

19 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral