Overview
Risperidone is a second-generation antipsychotic (SGA) medication used in the treatment of a number of mood and mental health conditions including schizophrenia and bipolar disorder. It is one of the most widely used SGAs. Paliperidone, another commonly used SGA, is the primary active metabolite of risperidone (i.e. 9-hydroxyrisperidone). Schizophrenia and various mood disorders are thought to be caused by an excess of dopaminergic D2 and serotonergic 5-HT2A activity, resulting in overactivity of central mesolimbic pathways and mesocortical pathways, respectively. Risperidone is thought to reduce this overactivity through inhibition of dopaminergic D2 receptors and serotonergic 5-HT2A receptors in the brain. Risperidone binds with a very high affinity to 5-HT2A receptors, approximately 10-20 fold greater than the drug's binding affinity to D2 receptors, and carries lesser activity at several off-targets which may responsible for some of its undesirable effects.
Indication
Risperidone is indicated for the treatment of schizophrenia and irritability associated with autistic disorder. It is also indicated as monotherapy, or adjunctly with lithium or valproic acid, for the treatment of acute mania or mixed episodes associated with bipolar I disorder. Risperidone is additionally indicated in Canada for the short-term symptomatic management of aggression or psychotic symptoms in patients with severe dementia of the Alzheimer type unresponsive to nonpharmacological approaches. Risperidone is also used off-label for a number of conditions including as an adjunct to antidepressants in treatment-resistant depression.
Associated Conditions
- Acute Mania
- Irritability
- Mixed manic depressive episode
- Psychosis
- Schizophrenia
- Acute Manic episode
- Agitated psychotic state
Research Report
A Comprehensive Monograph on Risperidone: Pharmacology, Clinical Efficacy, and Safety
Executive Summary
Risperidone (DrugBank ID: DB00734) is a foundational second-generation, or atypical, antipsychotic agent that has played a pivotal role in psychiatric pharmacotherapy since its initial approval. As a small molecule benzisoxazole derivative, its pharmacological signature is defined by a potent, high-affinity antagonism of serotonin type 2A (5−HT2A) receptors combined with a moderate-affinity antagonism of dopamine type 2 (D2) receptors. This distinct receptor binding profile differentiates it from first-generation antipsychotics and is believed to underpin its efficacy against both the positive and negative symptoms of schizophrenia while carrying a reduced, though not eliminated, risk of extrapyramidal symptoms at therapeutic doses.
The clinical utility of risperidone is well-established across a range of psychiatric disorders. It holds regulatory approval for the treatment of schizophrenia in adults and adolescents, as monotherapy or adjunctive therapy for acute manic or mixed episodes associated with Bipolar I Disorder in adults and children, and for the management of irritability associated with autistic disorder in pediatric patients. Its application has also extended to numerous off-label uses, including as an adjunctive therapy in treatment-resistant depression.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/12 | Not Applicable | Completed | |||
2025/07/11 | Not Applicable | Not yet recruiting | |||
2025/05/14 | Phase 4 | Not yet recruiting | |||
2024/07/22 | Phase 2 | Recruiting | |||
2024/07/01 | Phase 3 | Recruiting | Louisiana State University Health Sciences Center Shreveport | ||
2024/04/16 | Phase 1 | ENROLLING_BY_INVITATION | Spanish Foundation for Neurometrics Development | ||
2024/02/01 | Phase 4 | Recruiting | All India Institute of Medical Sciences, Bhubaneswar | ||
2024/01/23 | Phase 1 | Completed | |||
2024/01/11 | Not Applicable | Completed | Dr Rabia Arshad | ||
2023/06/06 | Phase 4 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Janssen Pharmaceutical, Inc. | 50458-602 | ORAL | 1 mg in 1 1 | 7/31/2025 | |
| Major Pharmaceuticals | 0904-7363 | ORAL | 2 mg in 1 1 | 10/29/2023 | |
| State of Florida DOH Central Pharmacy | 53808-1022 | ORAL | 3 mg in 1 1 | 1/18/2015 | |
| MSM Repackaging | 42495-004 | ORAL | 2 mg in 1 1 | 10/13/2015 | |
| NuCare Pharmaceuticals,Inc. | 68071-4618 | ORAL | 2 mg in 1 1 | 2/22/2021 | |
| Teva Pharmaceuticals USA, Inc. | 51759-960 | SUBCUTANEOUS | 250 mg in 0.7 mL | 5/8/2023 | |
| Teva Pharmaceuticals USA, Inc. | 51759-630 | SUBCUTANEOUS | 125 mg in 0.35 mL | 5/8/2023 | |
| REMEDYREPACK INC. | 70518-2130 | ORAL | 1 mg in 1 1 | 2/27/2024 | |
| Ajanta Pharma USA Inc. | 27241-005 | ORAL | 3 mg in 1 1 | 3/18/2024 | |
| TYA Pharmaceuticals | 64725-0321 | ORAL | 4 mg in 1 1 | 8/14/2012 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/14/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| RISPERDAL CONSTA FOR INJECTION 37.5 mg/vial | SIN12354P | INJECTION, POWDER, FOR SOLUTION | 37.5 mg/vial | 7/21/2003 | |
| RISPERIDONE-CHANELLE ORAL SOLUTION 1 MG/ML | SIN15227P | SOLUTION | 1mg/ml | 4/26/2017 | |
| Apo-Risperidone 2mg Tablet | SIN13577P | TABLET, FILM COATED | 2mg | 12/1/2008 | |
| RISPERIDEX TABLET 4MG | SIN14416P | TABLET, FILM COATED | 4.0MG | 10/22/2013 | |
| RISPERDAL TABLET 1 mg | SIN08061P | TABLET, FILM COATED | 1 mg | 3/9/1995 | |
| RISPERIDEX TABLET 1MG | SIN14418P | TABLET, FILM COATED | 1.0MG | 10/22/2013 | |
| Apo-Risperidone 1mg Tablet | SIN13578P | TABLET, FILM COATED | 1mg | 12/1/2008 | |
| RISPERDAL ORAL SOLUTION 1 mg/ml | SIN09905P | SOLUTION | 1 mg/ml | 7/27/1998 | |
| EPERON FILM COATED TABLETS 2MG | SIN14774P | TABLET, FILM COATED | 2.0 mg | 4/10/2015 | |
| EPERON FILM COATED TABLETS 1MG | SIN14773P | TABLET, FILM COATED | 1.0 mg | 4/10/2015 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| RISPONS TAB 1MG | N/A | N/A | N/A | 6/28/2010 | |
| RISPONS TAB 4MG | N/A | N/A | N/A | 6/28/2010 | |
| JMP-RISPERIDONE TABLET 3MG | N/A | N/A | N/A | 7/14/2014 | |
| RISPER TAB 4MG | N/A | N/A | N/A | 2/29/2012 | |
| PMS-RISPERIDONE TAB 2MG | N/A | N/A | N/A | 9/11/2006 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| GENRX RISPERIDONE risperidone 3mg tablets blister pack | 127574 | Medicine | A | 8/3/2007 | |
| RISPERNIA risperidone 0.5mg tablets bottle | 127918 | Medicine | A | 6/26/2006 | |
| RISPERNIA risperidone 1mg tablets bottle | 127920 | Medicine | A | 6/26/2006 | |
| RIXADONE risperidone 2 mg film coated tablet blister pack | 199180 | Medicine | A | 9/3/2013 | |
| NOUMED RISPERIDONE risperidone 2 mg film-coated tablet blister pack | 284371 | Medicine | A | 6/6/2017 | |
| RISPERIDONE RBX risperidone 3mg tablet blister pack | 191540 | Medicine | A | 6/14/2012 | |
| RISPERIDONE KXP risperidone 0.5 mg film-coated tablet blister pack | 303376 | Medicine | A | 8/21/2018 | |
| RISPERIDONE LAPL risperidone 1 mg/mL oral liquid solution bottle | 389692 | Medicine | A | 9/26/2023 | |
| RISPERIDONE RBX risperidone 1mg tablet blister pack | 191538 | Medicine | A | 6/14/2012 | |
| RISPERIDONE RAN risperidone 4mg tablet blister pack | 191529 | Medicine | A | 6/14/2012 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| RAN-RISPERIDONE | ranbaxy pharmaceuticals canada inc. | 02280949 | Tablet - Oral | 3 MG | 6/30/2006 |
| RAN-RISPERIDONE | ranbaxy pharmaceuticals canada inc. | 02280922 | Tablet - Oral | 1 MG | 6/30/2006 |
| DOM-RISPERIDONE | dominion pharmacal | 02278472 | Tablet - Oral | 3.0 MG | 8/8/2006 |
| AG-RISPERIDONE | angita pharma inc. | 02369087 | Tablet - Oral | 0.5 MG | 9/6/2018 |
| IPG-RISPERIDONE | marcan pharmaceuticals inc | 02359065 | Tablet - Oral | 0.5 MG | N/A |
| MYLAN-RISPERIDONE ODT | Mylan Pharmaceuticals ULC | 02413485 | Tablet (Orally Disintegrating) - Oral | 0.5 MG | 10/24/2013 |
| TEVA-RISPERIDONE | teva canada limited | 02264226 | Tablet - Oral | 3 MG | 7/5/2006 |
| RATIO-RISPERIDONE | ratiopharm inc division of teva canada limited | 02264781 | Tablet - Oral | 2.0 MG | 7/5/2006 |
| RAN-RISPERIDONE | ranbaxy pharmaceuticals canada inc. | 02280957 | Tablet - Oral | 4 MG | 6/30/2006 |
| RISPERDAL CONSTA | 02298465 | Powder For Suspension, Sustained-Release
,
Kit - Intramuscular | 12.5 MG / VIAL | 10/24/2007 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| RISPERIDONA AUROVITAS 1 MG/ML SOLUCION ORAL EFG | Aurovitas Spain, S.A.U. | 81426 | SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ARKETIN 1 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Neuraxpharm Spain S.L. | 66588 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| RISPERIDONA CINFAMED 3 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Cinfa S.A. | 66776 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| RISPERIDONA VIATRIS 1 MG/ML SOLUCION ORAL EFG | 69553 | SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| RISPERIDONA FLAS KRKA 2 mg COMPRIMIDOS BUCODISPERSABLES EFG | Krka D.D. Novo Mesto | 71096 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| RISPERIDONA AUROVITAS SPAIN 1 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Aurovitas Spain, S.A.U. | 69623 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| RISPERIDONA CINFA 6 mg COMPRIMIDOS EFG | Laboratorios Cinfa S.A. | 66931 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| RISPERIDONA TEVA 1 mg/ml SOLUCION ORAL EFG | Teva Pharma S.L.U. | 69514 | SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| RISPERIDONA STADA 0,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Laboratorio Stada S.L. | 67484 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| RISPERDAL CONSTA, 37,5 mg POLVO Y DISOLVENTE PARA SUSPENSION DE LIBERACION PROLONGADA PARA INYECCION INTRAMUSCULAR | Janssen Cilag S.A. | 65215 | POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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