Risperidone is an atypical antipsychotic indicated for treatment of schizophrenia, among other approved uses. It is available as tablets, orally disintegrating tablets and oral solution for subcutaneous use. MedsAcross supplies Risperidone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
RISPERDAL is an atypical antipsychotic indicated for: Treatment of schizophrenia. As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Treatment of irritability associated with autistic disorder
Source: US FDA prescribing information
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). Antagonism at receptors other than D 2 and 5HT 2 may explain some of the other effects of risperidone.
Source: US FDA prescribing information
Table 1. Recommended Daily Dosage by Indication Initial Dose Titration (Increments) Target Dose Effective Dose Range Schizophrenia: adults 2 mg 1 to 2 mg 4 to 8 mg 4 to 16 mg Schizophrenia: adolescents 0.5 mg 0.5 to 1 mg 3 mg 1 to 6 mg Bipolar mania: adults 2 to 3 mg 1 mg 1 to 6 mg 1 to 6 mg Bipolar mania: children and adolescents 0.5 mg 0.5 to 1 mg 1 to 2.5 mg 1 to 6 mg Irritability in autistic disorder 0.25 mg Can increase to 0.5 mg by Day 4: (body weight less than 20 kg) 0.5 mg Can increase to 1 mg by Day 4: (body weight greater than or equal to 20 kg) After Day 4, at intervals of > 2 weeks: 0.25 mg (body weight less than 20 kg) 0.5 mg (body weight greater than or equal to 20 kg) 0.5 mg: (body weight less than 20 kg) 1 mg: (body weight greater than or equal to 20 kg) 0.5 to 3 mg Severe Renal and Hepatic Impairment in Adults: use a lower starting dose of 0.5 mg twice daily.
Source: US FDA prescribing information
RISPERDAL is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the RISPERDAL 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, or to any excipients in RISPERDAL.
Source: US FDA prescribing information
Boxed warning (increased mortality in elderly patients with dementia-related psychosis): Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. RISPERDAL is not approved for the treatment of patients with dementia-related psychosis. RISPERDAL is not approved for use in patients with dementia-related psychosis. Cerebrovascular events, including stroke, in elderly patients with dementia-related psychosis: RISPERDAL is not approved for use in patients with dementia-related psychosis. Neuroleptic Malignant Syndrome: Manage with immediate discontinuation of RISPERDAL and close monitoring. Tardive dyskinesia: Consider discontinuing RISPERDAL if clinically indicated. Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/ cerebrovascular risk.
Source: US FDA prescribing information
The following are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis Cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis Neuroleptic malignant syndrome Tardive dyskinesia Metabolic Changes (Hyperglycemia and diabetes mellitus, Dyslipidemia, and Weight Gain) Hyperprolactinemia Orthostatic hypotension Falls Leukopenia, neutropenia, and agranulocytosis Potential for cognitive and motor impairment Seizures Dysphagia Priapism Disruption of body temperature regulation Patients with Phenylketonuria.
Source: US FDA prescribing information
Carbamazepine and other enzyme inducers decrease plasma concentrations of risperidone. Increase the RISPERDAL dose up to double the patient's usual dose. Titrate slowly. Fluoxetine, paroxetine, and other CYP 2D6 enzyme inhibitors increase plasma concentrations of risperidone. Reduce the initial dose. Do not exceed a final dose of 8 mg per day of RISPERDAL.
Source: US FDA prescribing information
RISPERDAL Tablets should be stored at controlled room temperature 15 °C to 25 °C (59 °F to 77 °F). RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15 °C to 25 °C (59 °F to 77 °F). Protect from light and freezing. RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15 °C to 25 °C (59 °F to 77 °F). Protect from light and moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
33 presentations of Risperidone, sorted by availability.
5 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Risperidone in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 33 presentations of Risperidone and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 5 brand names for Risperidone, including Risperdal, Risperdal Consta, Risperdal M-tab, Rykindo extended-release microspheres, Uzedy.
Yes. The US FDA first approved Risperidone on 29 December 1993, according to Drugs@FDA.
Yes. Risperidone has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Risperidone must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Risperidone is classified under ATC code N05AX08 (Risperidone).
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