Active substance
Prednisolone
- SFDA 22
- US FDA 113
- Health Canada 5
- US price lines 16
- NHS prices 23
- WHO EML 7
- Safety 13
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| APICORT 0.12% EYE DROPS | 0.12 % | Eye drops · Ophthalmic use | 1 Dropper Container | SAR 7.75 | Generic · Prescription | Amman Pharmaceutical Industries (API) | Valid |
| APICORT FORTE 10MG-ML EYE SUSP. | 1 % | Eye drops · Ophthalmic use | 1 Dropper Container | SAR 10.60 | Generic · Prescription | Amman Pharmaceutical Industries (API) | Valid |
| GUPISONE TAB 5MG | 5 mg | Tablet · Oral use | 20 Blister | SAR 8.45 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Valid |
| Gupisone | 20 mg | Tablet · Oral use | 20 Blister | SAR 28.20 | Generic · Prescription | GULF PHARMACEUTICAL INDUSTIRES- JULPHAR | Valid |
| Isolone | 5 mg | Effervescent tablet · Oral use | 30 Vial | SAR 11.70 | NCE · Prescription | Laboratories SOTHEMA | Valid |
| Isolone | 20 mg | Effervescent tablet · Oral use | 20 Vial | SAR 26.45 | NCE · Prescription | Laboratories SOTHEMA | Valid |
| OPTIPRED 1% OPTHALMIC SUSP. | 1 % | Eye drops, suspension · Ophthalmic use | 1 Dropper Container | SAR 14.45 | Generic · Prescription | Jamjoom Pharmaceuticals Factory Company | Valid |
| PRED FORTE OPTH. SUSP | 1 % | Eye drops, suspension · Ophthalmic use | 1 Dropper Container | SAR 16.05 | NCE · Prescription | ABBVIE LIMITED | Valid |
| PREDNISOLONE | 5 mg | Tablet · Oral use | 30 Blister | SAR 17.10 | NCE · Prescription | ACINO PHARMA AG | Valid |
| PREDO 15MG-5ML SYRUP | 3 mg/ml | Syrup · Oral use | 1 Bottle | SAR 42.00 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| PREDO 25MG TABLETS | 25 mg | Tablet · Oral use | 30 Blister | SAR 52.85 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| PREDO 5MG TABLETS | 5 mg | Tablet · Oral use | 30 Blister | SAR 15.90 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| PREDO 5MG-5ML SYRUP | 1 mg/ml | Syrup · Oral use | 1 Bottle | SAR 20.00 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| PRENA 15MG/5ML SYRUP | 3 mg/ml | Syrup · Oral use | 1 Bottle | SAR 34.00 | Generic · Prescription | SPIMACO ADDWAEIH | Valid |
| Resliva | 3 mg/ml | Syrup · Oral use | 1 Bottle | SAR 37.80 | Generic · Prescription | SAUDI PHARMACEUTICAL INDUSTRIES | Valid |
| Resliva 5 mg/5 ml syrup | 1 mg/ml | Syrup · Oral use | 1 Bottle | SAR 16.70 | Generic · Prescription | SAUDI PHARMACEUTICAL INDUSTRIES | Valid |
| Zylone | 0.3 % | Syrup · Oral use | 1 Bottle | SAR 34.00 | Generic · Prescription | BATTERJEE PHARMACETICAL FACTORY | Valid |
| Zylone | 0.1 % | Syrup · Oral use | 1 Bottle | SAR 15.00 | Generic · Prescription | BATTERJEE PHARMACETICAL FACTORY | Valid |
| DELTACORTRIL 5MG TAB | 5 mg | Tablet · Oral use | 20 Blister | SAR 6.95 | Generic · Prescription | PFIZER | Withdrawn by MAH · Not Marketed |
| ECONOPRED PLUS 1% OPHTHALMIC DROP | 1 % | Eye drops · Ocular use | 1 Dropper Container | SAR 9.55 | Generic · Prescription | ALCON LABORATORIES | Withdrawn by MAH · Not Marketed |
| ULTRACORTENOL 0.5% OPTH.DROPS | 0.5 % | Eye drops · Ocular use | 1 Bottle | SAR 12.50 | NCE · Prescription | NOVARTIS | Withdrawn by MAH · Not Marketed |
| ULTRACORTENOL OINTMENT 0.5% 5GM | 0.5 % | Eye ointment · Ocular use | 1 Tube | SAR 12.95 | NCE · Prescription | NOVARTIS | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL)-ADVERSE REACTIONS MANAGEMENT; ADULT ACUTE MYELOID LEUKAEMIA (AML); ALLERGIC RHINITIS-ALLERGIC RHINO-CONJUNCTIVITIS; BURKITT`S LYMPHOMA; CYSTOID MACULAR EDEMA; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; HERPESVIRAL KERATITIS, KERATITIS, OTHER CYTOMEGALOVIRAL DISEASES, ADENOVIRAL KERATOCONJUNCTIVITIS; HODGKIN'S LYMPHOMA; MANTLE CELL LYMPHOMA; PEDIATRIC ACUTE LYMPHOBLASTIC LEUKAEMIA (ALL)-ADVERSE REACTIONS MANAGEMENT; PEDIATRIC B-CELL LYMPHOMA; SJOGREN'S SYNDROME; T-CELL LYMPHOMA-RENAL TOXICITY
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PREDNISOLONE | 5MG | tablet · oral | WATSON LABS | Prescription | 17 Jan 1972 |
| PRED MILD | 0.12% | suspension/drops · ophthalmic | ABBVIE | Prescription | 10 Nov 1972 |
| PRED FORTE | 1% | suspension/drops · ophthalmic | ABBVIE | Prescription | 30 May 1973 |
| OMNIPRED | 1% | suspension/drops · ophthalmic | SANDOZ | Prescription | 10 Jul 1973 |
| PREDNISOLONE | 5MG | tablet · oral | CHARTWELL MOLECULAR | Prescription | 31 May 1974 |
| PRELONE | 15MG/5ML | solution · oral | TEVA | Prescription | 4 Feb 1986 |
| PEDIAPRED | EQ 5MG BASE/5ML | solution · oral | PAI HOLDINGS | Prescription | 28 May 1986 |
| PREDNISOLONE SODIUM PHOSPHATE | EQ 0.9% PHOSPHATE | solution/drops · ophthalmic | BAUSCH AND LOMB INC | Prescription | 29 Jul 1994 |
| PREDNISOLONE | 15MG/5ML | solution · oral | CHARTWELL RX | Prescription | 13 May 1999 |
| PREDNISOLONE SODIUM PHOSPHATE | EQ 5MG BASE/5ML | solution · oral | CHARTWELL RX | Prescription | 25 May 2004 |
| PREDNISOLONE SODIUM PHOSPHATE | EQ 15MG BASE/5ML | solution · oral | PHARM ASSOC | Prescription | 25 Apr 2005 |
| PREDNISOLONE | 15MG/5ML | solution · oral | PHARM ASSOC | Prescription | 25 Aug 2005 |
| ORAPRED ODT | EQ 10MG BASE; EQ 15MG BASE; EQ 30MG BASE | tablet, orally disintegrating · oral | ADVANZ PHARMA | Prescription | 1 Jun 2006 |
| PREDNISOLONE | 15MG/5ML | solution · oral | LANNETT CO INC | Prescription | 21 Sep 2007 |
| PREDNISOLONE SODIUM PHOSPHATE | EQ 10MG BASE/5ML | solution · oral | PHARM ASSOC | Prescription | 7 Mar 2008 |
| PREDNISOLONE SODIUM PHOSPHATE | EQ 20MG BASE/5ML | solution · oral | PHARM ASSOC | Prescription | 9 Jun 2008 |
| PREDNISOLONE SODIUM PHOSPHATE | EQ 25MG BASE/5ML | solution · oral | MISSION PHARMA | Prescription | 13 Sep 2010 |
| PREDNISOLONE SODIUM PHOSPHATE | EQ 10MG BASE/5ML; EQ 20MG BASE/5ML; EQ 15MG BASE/5ML; EQ 25MG BASE/5ML | solution · oral | EDENBRIDGE PHARMS | Prescription | 20 Dec 2016 |
| PREDNISOLONE SODIUM PHOSPHATE | EQ 15MG BASE/5ML | solution · oral | AMNEAL | Prescription | 25 Oct 2022 |
| PREDNISOLONE | 5MG | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 17 Mar 2023 |
| PREDNISOLONE | 5MG | tablet · oral | ZHEJIANG XIANJU | Prescription | 2 May 2024 |
| PREDNISOLONE ACETATE | 1% | suspension/drops · ophthalmic | LUPIN | Prescription | 2 Aug 2024 |
| PREDNISOLONE ACETATE | 1% | suspension/drops · ophthalmic | AMNEAL | Prescription | 11 Jun 2025 |
| PREDNISOLONE | 15MG/5ML | solution · oral | TP ANDA HOLDINGS | Prescription | 23 Jun 2025 |
| PREDNISOLONE ACETATE | 1% | suspension/drops · ophthalmic | UPSHER SMITH LABS | Prescription | 28 Sep 2026 |
88 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| MINIMS PREDNISOLONE SODIUM PHOSPHATE | 02148498 | 0.5 % / W/V | DROPS · OPHTHALMIC | BAUSCH & LOMB INC |
| PMS-PREDNISOLONE | 02245532 | 5 MG / 5 ML | SOLUTION · ORAL | PHARMASCIENCE INC |
| PRED FORTE | 00301175 | 1 % / W/V | SUSPENSION · OPHTHALMIC | ABBVIE CORPORATION |
| SANDOZ PREDNISOLONE | 01916203 | 1 % | SUSPENSION · OPHTHALMIC | SANDOZ CANADA INCORPORATED |
| TEVA-PREDNISOLONE | 00700401 | 1 % | SUSPENSION · OPHTHALMIC | TEVA CANADA LIMITED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | PRED FORTE 1% EYE DROPS | $30.7132 | per ML | 17 Dec 2025 |
| US NADAC | PRED FORTE 1% EYE DROPS | $30.83057 | per ML | 17 Dec 2025 |
| US NADAC | PRED MILD 0.12% EYE DROPS | $30.64983 | per ML | 23 Sep 2026 |
| US NADAC | PRED MILD 0.12% EYE DROPS | $30.67471 | per ML | 23 Sep 2026 |
| US NADAC | PREDNISOLONE 10 MG/5 ML SOLN | $2.43026 | per ML | 22 Apr 2026 |
| US NADAC | PREDNISOLONE 15 MG/5 ML SOLN | $0.10345 | per ML | 23 Sep 2026 |
| US NADAC | PREDNISOLONE 15 MG/5 ML SOLN | $0.5676 | per ML | 30 Sep 2026 |
| US NADAC | PREDNISOLONE 15 MG/5 ML SOLN | $0.61529 | per ML | 30 Sep 2026 |
| US NADAC | PREDNISOLONE 15 MG/5 ML SYRUP | $0.5676 | per ML | 23 Sep 2026 |
| US NADAC | PREDNISOLONE 15 MG/5 ML SYRUP | $0.61529 | per ML | 23 Sep 2026 |
| US NADAC | PREDNISOLONE 5 MG TABLET | $8.48393 | per EA | 23 Sep 2026 |
| US NADAC | PREDNISOLONE 5 MG/5 ML SOLN | $0.54905 | per ML | 23 Sep 2026 |
| NHS Drug Tariff | Prednisolone 10mg tablets | £9.70 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Prednisolone 10mg/ml oral solution sugar free | £55.50 | 30 ml | 1 Oct 2026 |
| NHS Drug Tariff | Prednisolone 1mg gastro-resistant tablets | £32.49 | 100 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Prednisolone 1mg tablets | £0.71 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Prednisolone 2.5mg gastro-resistant tablets | £0.99 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Prednisolone 2.5mg tablets | £3.94 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Prednisolone 20mg tablets | £19.46 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Prednisolone 20mg/100ml rectal solution | £29.95 | 7 enema | 1 Oct 2026 |
| NHS Drug Tariff | Prednisolone 20mg/application foam enema | £332.04 | 14 dose | 1 Oct 2026 |
| NHS Drug Tariff | Prednisolone 25mg tablets | £49.50 | 56 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Prednisolone 2mg tablets | £5.00 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Prednisolone 30mg tablets | £29.12 | 28 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)
- 17.3. Anti-inflammatory medicines · complementary
Therapeutic equivalent to hydrocortisone for Crohn disease site; Crohn disease site; Ulcerative colitis
Local > Rectal > Retention enema: 20 mg per 100 mL (as sodium phosphate) - 8.2.4. Hormones and antihormones · complementary
Lymphoid leukaemia, not elsewhere classified; Diffuse large B-cell lymphoma, not otherwise specified; Chronic lymphocytic leukaemia or small lymphocytic lymphoma; Plasma cell myeloma; Burkitt lymphoma including Burkitt leukaemia; Anaplastic large cell lymphoma, ALK-negative; Anaplastic large cell lymphoma, ALK-positive; Langerhans cell histiocytosis; Hodgkin lymphoma; Malignant neoplasms of prostate; Follicular lymphoma
Oral > Liquid: 5 mg per mL (EMLc) | Oral > Solid: 5 mg; 25 mg - 3. Antiallergics and medicines used in anaphylaxis · core
Allergic or hypersensitivity conditions of unspecified type
Oral > Liquid: 5 mg per mL (EMLc) | Oral > Solid: 5 mg; 25 mg - 21.2. Ophthalmological preparations > Anti-inflammatory agents · core
Scleritis; Anterior uveitis
Local > Ophthalmological > Solution (eye drops): 0.5% (sodium phosphate) - 18.1. Adrenal hormones and synthetic substitutes · core
Adrenocortical insufficiency
Oral > Solid > tablet: 1 mg - 5.1.5.3. Medicines for cluster headache · core
Trigeminal autonomic cephalalgias
Oral > Solid > tablet: 5 mg; 25 mg - 5.1.1. Antiseizure medicines · core
Infantile spasms
Oral > Liquid: 1 mg per mL (EMLc) | Oral > Solid > tablet: 1 mg (EMLc); 5 mg (EMLc); 10 mg (EMLc)
Safety signals and safety-related labeling changes
- US FDA 5 Jun 2024 FLO-PRED — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 5 Jun 2024 ORAPRED ODT — 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 5 Jun 2024 PEDIAPRED — safety-related labeling change
Labeling sections changed: Warnings and Precautions - US FDA 4 Mar 2022 OMNIPRED — safety-related labeling change
Labeling sections changed: Contraindications; Adverse Reactions - EMA PRAC 11 Feb 2021 PRAC signal: Bradycardia
Action for MAH: update of the product information: Yes - EMA PRAC 1 Oct 2020 PRAC signal: Bradycardia
Action for MAH: update of the product information: No - US FDA 7 Jun 2018 PRED-G — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 7 Jun 2018 PRED-G — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 6 Jun 2018 PRED FORTE — 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 6 Jun 2018 PRED MILD — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 18 Jul 2017 BLEPHAMIDE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions - EMA PRAC 6 Jul 2017 PRAC signal: Induced scleroderma renal crisis
Action for MAH: update of the product information: Yes - EMA PRAC 9 Jun 2017 PRAC signal: Induced scleroderma renal crisis
Action for MAH: update of the product information: No
Combinations containing Prednisolone
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.