Risperidone

The label describes risperidone for treating schizophrenia, and for acute manic or mixed episodes of bipolar I disorder, alone or with lithium or valproate.

It is also described for irritability associated with autistic disorder. Studies covered adults, adolescents, and children for different uses.

• Schizophrenia in adults and adolescents
• Manic or mixed episodes of bipolar I disorder
• Irritability associated with autistic disorder

The label says how risperidone works in schizophrenia is unclear. Its effect may come from blocking dopamine type 2 and serotonin type 2 receptors.

Its main active metabolite is 9-hydroxyrisperidone (paliperidone). Blocking other receptors may explain some other effects.

This page covers the US label for risperidone tablets taken by mouth, with the dosing the label gives for adults and, where the label says so, children.

This is label-level information, not personal advice. Indian pack labels may differ, and your prescriber's instruction always comes first.

For adults with schizophrenia, the label describes a starting dose of 2 mg a day, a target of 4 to 8 mg, and an effective range of 4 to 16 mg. For adolescents, it describes starting at 0.5 mg with a target of 3 mg.

For bipolar mania in adults, it describes a starting dose of 2 to 3 mg and a range of 1 to 6 mg. For irritability in autistic disorder, starting doses of 0.25 mg or 0.5 mg depend on body weight.

In severe kidney or liver impairment in adults, the label describes a lower starting dose of 0.5 mg twice daily.

• Adult schizophrenia: start 2 mg, target 4 to 8 mg a day
• Adolescent schizophrenia: start 0.5 mg
• Bipolar mania in adults: start 2 to 3 mg
• Autism irritability: weight-based start of 0.25 or 0.5 mg
• Lower start in severe kidney or liver impairment

The boxed warning says elderly patients with dementia-related psychosis treated with antipsychotic drugs have a higher risk of death. Risperidone is not approved for dementia-related psychosis. Strokes have also been reported in this group.

It must not be used in people with known hypersensitivity to risperidone or paliperidone. The label advises monitoring blood sugar, weight, and blood counts, and using a lower starting dose in people prone to low blood pressure.

Newborns exposed in the third trimester may have movement or withdrawal symptoms. Use caution with machinery because thinking and movement can be affected.

• Boxed warning: higher death risk in elderly with dementia-related psychosis
• Do not use if allergic to risperidone or paliperidone
• Blood sugar, weight and blood count monitoring
• Tardive dyskinesia and neuroleptic malignant syndrome
• Caution with machinery and in the third trimester of pregnancy

• Carbamazepine and other enzyme inducers
• Fluoxetine and paroxetine
• Other CYP 2D6 inhibitors
• Carbamazepine and other enzyme inducers lower risperidone levels, so the label describes raising the dose, up to double the usual, with slow titration.
• Fluoxetine, paroxetine, and other CYP 2D6 inhibitors raise risperidone levels.
• The label describes a lower starting dose and a final dose not exceeding 8 mg a day.

No match in this label text. Ask your pharmacist about any medicine you take.

The label gives a storage range of 15 to 25 degrees C.

The label also says to protect it from light, keep it away from moisture.

Follow the storage line on your own pack, and keep medicines out of the reach of children.

In the Drugs Rules schedules we checked, risperidone is listed under Schedule H (serial and rule: Schedule H, serial 434 (rules 65 and 97)). Schedule H medicines are sold only on a registered doctor's prescription.

Risperidone is on the National List of Essential Medicines 2022. Listed forms include: Oral liquid 1 mg/mL (page 102); Injection (Long acting) 25 mg (page 102); Injection (Long acting) 37.5 mg (page 102).

NPPA lists ceiling prices for scheduled risperidone formulations. The table shows the rows we found. Check NPPA directly for the current list.

The Jan Aushadhi (PMBJP) list we checked has 7 product rows that mention risperidone. We did not capture prices for them.

NPPA ceiling prices set the most a seller can charge per unit for the listed formulations, before local taxes. They are ceilings, not the price you will always pay.

Jan Aushadhi lists risperidone products including Risperidone 4mg and Trihexiphenidyl 2mg Tablets 4mg; Risperidone Tablets IP 4mg 4mg; Risperidone Tablets IP 1mg 1mg; Risperidone Tablets IP 2 mg 2 mg. We have not shown a price for them. Check the pack and the seller for the actual price.