Okedi Laboratorios Farmacéuticos Rovi, S.A. · Authorised · authorised 14 Feb 2022 · ATC N05AX08
Therapeutic indication (EMA)
Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.
Active substance
Risperidone
- SFDA 44
- US FDA 58
- EMA 1
- Health Canada 75
- US price lines 31
- NHS prices 16
- WHO EML 1
- Safety 10
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| CALMTROL 1 mg film-coated tablet | 1 mg | Film-coated tablet · Oral use | 30 Blister | SAR 58.10 | Generic · Prescription | Med City Pharma | Valid |
| CALMTROL 2 mg film-coated tablet | 2 mg | Film-coated tablet · Oral use | 30 Blister | SAR 58.10 | Generic · Prescription | Med City Pharma | Valid |
| CALMTROL 4 mg film-coated tablet | 4 mg | Film-coated tablet · Oral use | 30 Blister | SAR 142.30 | Generic · Prescription | Med City Pharma | Valid |
| PXIDONE 1MG F.C.TABLET | 1 mg | Film-coated tablet · Oral use | 20 Blister | SAR 47.40 | Generic · Prescription | Apex Pharma | Valid |
| PXIDONE 2MG F.C.TABLET | 2 mg | Film-coated tablet · Oral use | 20 Blister | SAR 60.55 | Generic · Prescription | Apex Pharma | Valid |
| PXIDONE 3MG F.C.TABLET | 3 mg | Film-coated tablet · Oral use | 30 Blister | SAR 116.80 | Generic · Prescription | Apex Pharma | Valid |
| PXIDONE 4MG F.C.TABLET | 4 mg | Film-coated tablet · Oral use | 30 Blister | SAR 148.95 | Generic · Prescription | Apex Pharma | Valid |
| RESEDRA 1MG/ML ORAL SOLUTION | 1 mg/ml | Oral solution · Oral use | 1 Bottle | SAR 170.75 | Generic · Prescription | SPIMACO ADDWAEIH | Valid |
| RESPAL 2 MG TABLETS | 2 mg | Tablet · Oral use | 20 Blister | SAR 13.25 | Generic · Prescription | Jordan Sweden Medical and Sterilization Co. | Valid |
| RESPAL 4 MG TABLETS | 4 mg | Tablet · Oral use | 20 Blister | SAR 21.50 | Generic · Prescription | Jordan Sweden Medical and Sterilization Co. | Valid |
| RESPAL ORAL SOLUTION | 1 mg/ml | Oral solution · Oral use | 1 Bottle | SAR 103.70 | Generic · Prescription | Jordan Sweden Medical and Sterilization Co. | Valid |
| RIDON 1 MG FILM COATED TABLETS | 1 mg | Film-coated tablet · Oral use | 30 Blister | SAR 58.10 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| RIDON 1 MG/ML ORAL SOLUTION | 1 mg/ml | Oral solution · Oral use | 1 Bottle | SAR 170.75 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| RIDON 2 MG FILM COATED TABLETS | 2 mg | Film-coated tablet · Oral use | 30 Blister | SAR 86.70 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| RIDON 4 MG FILM COATED TABLETS | 4 mg | Film-coated tablet · Oral use | 30 Blister | SAR 142.30 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| RISIDONE 1MG/1ML ORAL SOLUTION | 1 mg/ml | Oral solution · Oral use | 1 Bottle | SAR 170.75 | Generic · Prescription | DEEF PHARMACEUTICAL INDUSTRIES | Valid |
| RISPERDAL 1MG TAB | 1 mg | Tablet · Oral use | 6 Blister | SAR 7.75 | NCE · Prescription | JANSSEN-CILAG | Valid |
| RISPERDAL 1MG-ML SOLUTION | 1 mg/ml | Oral solution · Oral use | 1 Bottle | SAR 134.95 | NCE · Prescription | JANSSEN PHARMACEUTICA N.V | Valid |
| RISPERDAL 2MG TAB | 2 mg | Tablet · Oral use | 60 Blister | SAR 39.75 | NCE · Prescription | JANSSEN-CILAG | Valid |
| RISPERDAL 2MG TAB | 2 mg | Tablet · Oral use | 20 Blister | SAR 13.25 | NCE · Prescription | JANSSEN-CILAG | Valid |
| RISPERDAL 3MG TAB | 3 mg | Tablet · Oral use | 20 Blister | SAR 19.35 | NCE · Prescription | JANSSEN-CILAG | Valid |
| RISPERDAL 4MG TAB | 4 mg | Tablet · Oral use | 60 Blister | SAR 64.45 | NCE · Prescription | JANSSEN-CILAG | Valid |
| RISPERDAL CONSTA 25MG I.M VIAL | 25 mg | Powder and solvent for prolonged-release suspension for injection · Intramuscular use | 1 Pre-filled syringe | SAR 251.70 | NCE · Prescription | Janssen Cilag AG | Valid |
| RISPERDAL CONSTA 37.5 MG I.M VIAL | 37.5 mg | Powder and solvent for prolonged-release suspension for injection · Intramuscular use | 1 Pre-filled syringe | SAR 350.35 | NCE · Prescription | Janssen Cilag AG | Valid |
| RISPERDAL CONSTA 50MG I.M VIAL | 50 mg | Powder and solvent for prolonged-release suspension for injection · Intramuscular use | 1 Pre-filled syringe | SAR 418.40 | NCE · Prescription | Janssen Cilag AG | Valid |
19 more — full table
Indications — CHI Daman Drug Formulary
ACUTE MANIA; ALZHEIMER / DEMENTIA; ANXIETY DISORDERS; ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD); DEPRESSION; HUNTINGTON'S DISEASE-CHOREA; SCHIZOPHRENIA; TOURETTE SYNDROME
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| RISPERDAL | 1MG; 2MG; 3MG; 4MG; 0.5MG; 0.25MG | tablet · oral | JANSSEN PHARMS | Prescription | 29 Dec 1993 |
| RISPERDAL | 1MG/ML | solution · oral | JANSSEN PHARMS | Prescription | 10 Jun 1996 |
| RISPERDAL CONSTA | 25MG/VIAL; 37.5MG/VIAL; 50MG/VIAL; 12.5MG/VIAL | powder · intramuscular | JANSSEN PHARMS | Prescription | 29 Oct 2003 |
| RISPERIDONE | 0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG | tablet · oral | RISING | Prescription | 8 Oct 2008 |
| RISPERIDONE | 0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG | tablet · oral | NOVITIUM PHARMA | Prescription | 9 Oct 2008 |
| RISPERIDONE | 0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG | tablet · oral | ZYDUS PHARMS USA INC | Prescription | 16 Oct 2008 |
| RISPERIDONE | 0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG | tablet · oral | DR REDDYS LABS LTD | Prescription | 24 Oct 2008 |
| RISPERIDONE | 0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG | tablet · oral | TORRENT PHARMS | Prescription | 30 Oct 2008 |
| RISPERIDONE | 0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG | tablet · oral | RENATA | Prescription | 29 Dec 2008 |
| RISPERIDONE | 1MG/ML | solution · oral | ANI PHARMS | Prescription | 30 Jan 2009 |
| RISPERIDONE | 0.5MG; 1MG; 2MG; 3MG; 4MG; 0.25MG | tablet, orally disintegrating · oral | SENORES PHARMS | Prescription | 24 Feb 2009 |
| RISPERIDONE | 0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG | tablet · oral | JUBILANT CADISTA | Prescription | 23 Mar 2009 |
| RISPERIDONE | 0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG | tablet, orally disintegrating · oral | PH HEALTH | Prescription | 30 Apr 2009 |
| RISPERIDONE | 0.5MG; 2MG | tablet, orally disintegrating · oral | ZYDUS PHARMS USA | Prescription | 1 May 2009 |
| RISPERIDONE | 1MG/ML | solution · oral | APOZEAL PHARMS | Prescription | 29 Jul 2009 |
| RISPERIDONE | 1MG/ML | solution · oral | AUROBINDO PHARMA LTD | Prescription | 4 Sep 2009 |
| RISPERIDONE | 0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG | tablet · oral | SANDOZ | Prescription | 16 Oct 2009 |
| RISPERIDONE | 0.5MG; 1MG; 2MG; 3MG; 4MG | tablet, orally disintegrating · oral | SANDOZ | Prescription | 22 Dec 2009 |
| RISPERIDONE | 0.5MG; 1MG; 2MG | tablet, orally disintegrating · oral | SUN PHARM INDS LTD | Prescription | 6 Aug 2010 |
| RISPERIDONE | 3MG; 4MG | tablet, orally disintegrating · oral | SUN PHARM INDS LTD | Prescription | 6 Aug 2010 |
| RISPERIDONE | 0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG | tablet · oral | CHARTWELL MOLECULAR | Prescription | 18 May 2011 |
| RISPERIDONE | 1MG/ML | solution · oral | AMNEAL PHARMS | Prescription | 25 May 2011 |
| RISPERIDONE | 0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG | tablet · oral | AJANTA PHARMA LTD | Prescription | 24 Aug 2011 |
| RISPERIDONE | 0.5MG; 1MG; 2MG; 3MG; 4MG | tablet, orally disintegrating · oral | JUBILANT GENERICS | Prescription | 4 Nov 2011 |
| RISPERIDONE | 0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG | tablet · oral | PRINSTON INC | Prescription | 29 Nov 2011 |
33 more — full table
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-RISPERIDONE | 02282119 | 0.25 MG | TABLET · ORAL | APOTEX INC |
| APO-RISPERIDONE | 02282127 | 0.50 MG | TABLET · ORAL | APOTEX INC |
| APO-RISPERIDONE | 02282135 | 1.0 MG | TABLET · ORAL | APOTEX INC |
| APO-RISPERIDONE | 02282143 | 2.0 MG | TABLET · ORAL | APOTEX INC |
| APO-RISPERIDONE | 02282151 | 3.0 MG | TABLET · ORAL | APOTEX INC |
| APO-RISPERIDONE | 02282178 | 4.0 MG | TABLET · ORAL | APOTEX INC |
| JAMP RISPERIDONE TABLETS | 02563320 | 0.25 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP RISPERIDONE TABLETS | 02563339 | 0.5 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP RISPERIDONE TABLETS | 02563347 | 1 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP RISPERIDONE TABLETS | 02563363 | 3 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-RISPERIDONE | 02359529 | 0.25 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-RISPERIDONE | 02359537 | 0.50 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-RISPERIDONE | 02359545 | 1.0 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-RISPERIDONE | 02359553 | 2.0 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-RISPERIDONE | 02359561 | 3.0 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-RISPERIDONE | 02359588 | 4.0 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| MAR-RISPERIDONE | 02371766 | 0.25 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-RISPERIDONE | 02371774 | 0.50 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-RISPERIDONE | 02371782 | 1.0 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-RISPERIDONE | 02371790 | 2.0 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-RISPERIDONE | 02371804 | 3.0 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-RISPERIDONE | 02371812 | 4 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| MINT-RISPERIDON | 02359790 | 0.25 MG | TABLET · ORAL | MINT PHARMACEUTICALS INC |
| MINT-RISPERIDON | 02359804 | 0.50 MG | TABLET · ORAL | MINT PHARMACEUTICALS INC |
| MINT-RISPERIDON | 02359812 | 1.0 MG | TABLET · ORAL | MINT PHARMACEUTICALS INC |
50 more — full table
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | RISPERDAL 0.5 MG TABLET | $4.38113 | per EA | 23 Sep 2026 |
| US NADAC | RISPERDAL 1 MG TABLET | $4.69073 | per EA | 23 Sep 2026 |
| US NADAC | RISPERDAL 1 MG/ML SOLUTION | $5.28293 | per ML | 23 Sep 2026 |
| US NADAC | RISPERDAL 2 MG TABLET | $7.86404 | per EA | 23 Sep 2026 |
| US NADAC | RISPERDAL 3 MG TABLET | $9.20606 | per EA | 23 Sep 2026 |
| US NADAC | RISPERDAL 4 MG TABLET | $12.35264 | per EA | 23 Sep 2026 |
| US NADAC | RISPERDAL CONSTA 12.5 MG VIAL | $317.93143 | per EA | 23 Sep 2026 |
| US NADAC | RISPERDAL CONSTA 25 MG VIAL | $636.878 | per EA | 23 Sep 2026 |
| US NADAC | RISPERDAL CONSTA 37.5 MG VIAL | $949.93769 | per EA | 23 Sep 2026 |
| US NADAC | RISPERDAL CONSTA 50 MG VIAL | $1273.39195 | per EA | 23 Sep 2026 |
| US NADAC | RISPERIDONE 0.25 MG ODT | $2.55281 | per EA | 23 Sep 2026 |
| US NADAC | RISPERIDONE 0.25 MG TABLET | $0.03684 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Risperidone 1mg orodispersible tablets sugar free | £9.42 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Risperidone 1mg tablets | £0.88 | 20 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Risperidone 1mg/ml oral solution sugar free | £3.80 | 100 ml | 1 Oct 2026 |
| NHS Drug Tariff | Risperidone 250microgram tablets | £38.00 | 20 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Risperidone 25mg powder and solvent for prolonged-release suspension for injection vials | £79.69 | 1 vial | 1 Oct 2026 |
| NHS Drug Tariff | Risperidone 2mg orodispersible tablets sugar free | £10.14 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Risperidone 2mg tablets | £1.56 | 60 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Risperidone 37.5mg powder and solvent for prolonged-release suspension for injection vials | £111.32 | 1 vial | 1 Oct 2026 |
| NHS Drug Tariff | Risperidone 3mg orodispersible tablets sugar free | £43.48 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Risperidone 3mg tablets | £1.87 | 60 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Risperidone 4mg orodispersible tablets sugar free | £56.02 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Risperidone 4mg tablets | £1.91 | 60 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 24.1. Medicines for psychotic disorders · core
Schizophrenia or other primary psychotic disorders; Therapeutic equivalent to paliperidone for Schizophrenia or other primary psychotic disorders
Oral > Solid: 0.25 mg; 0.5 mg; 1 mg; 2 mg; 3 mg; 4 mg; 6 mg
Safety signals and safety-related labeling changes
- US FDA 16 Jan 2026 RYKINDO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions - US FDA 10 Oct 2025 UZEDY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations - US FDA 24 Jan 2025 PERSERIS KIT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Jan 2025 RISPERDAL — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Jan 2025 RISPERDAL — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Jan 2025 RISPERDAL — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Jan 2025 RISPERDAL CONSTA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Jan 2025 RISVAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions - EMA PRAC 11 Jun 2015 PRAC signal: Acute renal failure
Action for MAH: update of the product information: No - EMA PRAC 6 Nov 2014 PRAC signal: Acute renal failure
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.