Risperidone

ATC code

N05AX08

Therapeutic class

Atypical antipsychotic · Dopamine and serotonin receptor antagonist

Forms

oral tablet, orally disintegrating tablet, oral solution, prolonged-release injection

Brand names

Risperdal (US) · Risperdal Consta (ES) · Risperidone Cristers (FR) · Okedi (EU)

Overall confidence

high

Regulatory sources consulted

openfda-label-5257c6b8-5d9d-1918-e063-6394a90a3cbc
aemps-ft-65213
ansm-rcp-69809723
ema-epar-EMEA/H/C/005406
CredibleMeds.org
OpenFDA · N05AX08
RxNorm rxcui 35636 ↗

Approved indications

Treatment of schizophrenia in adults and adolescents (ages 13 to 17 years).
As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults and children/adolescents (ages 10 to 17 years).
Treatment of irritability associated with autistic disorder in children and adolescents (ages 5 to 17 years), including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

Contraindications

Absolute

Known hypersensitivity to risperidone, paliperidone (an active metabolite of risperidone), or to any of the excipients.

Clinical warnings

Boxed warning · Increased mortality in elderly patients with dementia-related psychosis. Risperidone is not approved for this indication. — FDA
Major warning · Cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis. — FDA
Major warning · Neuroleptic Malignant Syndrome (NMS), a potentially fatal medical emergency. — FDA
Major warning · Tardive dyskinesia, a syndrome of potentially irreversible, involuntary movements. — FDA
Metabolic changes: Hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. — FDA
Hyperprolactinemia, which may lead to galactorrhea, amenorrhea, gynecomastia, and impotence. — FDA

Drug interactions

HighCarbamazepineN03AF01
Mechanism: Potent induction of CYP3A4 and P-gp, decreasing plasma concentrations of the active antipsychotic moiety of risperidone.
Recommendation: Increase the risperidone dose, up to double the patient's usual dose. Re-evaluate dosing when starting or stopping carbamazepine.
FDA label
HighParoxetineN06AB05
Mechanism: Potent inhibition of CYP2D6, increasing plasma concentrations of risperidone and its active moiety.
Recommendation: Reduce the risperidone dose when initiating paroxetine. Do not exceed a final dose of 8 mg/day of risperidone.
FDA label
HighFurosemideC03CA01
Mechanism: Mechanism unknown. Increased mortality was observed in elderly patients with dementia treated concomitantly.
Recommendation: Use with caution in elderly patients with dementia. Evaluate the risk/benefit balance. Avoid dehydration, which is an independent risk factor.
ANSM RCP

Adverse events

Common (≥1%)

parkinsonism · akathisia · sedation · somnolence · headache · insomnia · weight gain · anxiety · nausea · salivary hypersecretion

Rare but serious

neuroleptic malignant syndrome · tardive dyskinesia · stroke · agranulocytosis · priapism · angioedema · QT interval prolongation

Pregnancy and lactation

Exposure during the third trimester may cause extrapyramidal and/or withdrawal symptoms in the neonate. Available data have not established a risk of major birth defects. The risk of treatment should be weighed against the risk of untreated mental illness.