Plenadren Takeda Pharmaceuticals International AG Ireland Branch · Authorised · authorised 3 Nov 2011 · ATC H02AB09
Therapeutic indication (EMA)
Treatment of adrenal insufficiency in adults.
Active substance
Hydrocortisone
- SFDA 21
- US FDA 214
- EMA 4
- Health Canada 10
- US price lines 49
- NHS prices 33
- WHO EML 5
- Safety 11
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| ALFACORT 1% CREAM | 1 % | Cream · Topical | 1 Tube | SAR 8.20 | Generic · OTC | Gulf Pharmaceutical Industries (Julphar) | Valid |
| ALFACORT 1% OINTMENT | 1 % | Ointment · Topical | 1 Tube | SAR 8.20 | Generic · OTC | Gulf Pharmaceutical Industries (Julphar) | Valid |
| Alfacort | 1 % | Cream · Topical | 1 Tube | SAR 16.40 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Valid |
| CORTIDERM 1% CREAM | 1 % | Cream · Topical | 1 Tube | SAR 7.15 | Generic · OTC | SPIMACO ADDWAEIH | Valid |
| CORTIDERM 1% CREAM | 10 mg | Cream · Topical | 1 Tube | SAR 16.35 | Generic · OTC | SPIMACO ADDWAEIH | Valid |
| HYDROCORTISONE 100M VIAL+SOLVENT 2ML AMP | 100 mg | Solution · Parenteral use | 1 Vial | SAR 9.85 | Generic · Prescription | EIPICO | Valid |
| HYDROSONE 20MG TABLET | 20 mg | Tablet · Oral use | 100 Tablet Container | SAR 31.05 | Generic · Prescription | Hikma Pharmaceuticals PLC | Valid |
| IKOTREF 100 mg Solution For Injection | 100 mg | powder for solution for injection · Parenteral use | 1 Vial | SAR 16.80 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| IKOTREF 250 mg Solution For Injection | 250 mg | powder for solution for injection · Parenteral use | 1 Vial | SAR 17.60 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| SOLU CORTEF AOV 250 mg powder and solvent for solution for injection | 250 mg | Powder and solvent for solution for injection · Intramuscular and intravenous use | 1 Vial | SAR 16.20 | Generic · Prescription | PFIZER | Valid |
| SOLU CORTEF Act-O-Vial 100 mg powder and solvent for solution for injection | 100 mg | Powder and solvent for solution for injection · Intramuscular and intravenous use | 1 Vial | SAR 18.65 | NCE · Prescription | PFIZER | Valid |
| CORTEF ACETATE VIALS 50 MG-ML | 50 mg/ml | Injection · Intravenous use | 1 Vial | SAR 45.95 | Generic · Prescription | PHARMACIA UPJOHN | Withdrawn by MAH · Not Marketed |
| EFFICORT CREAM 0.127% (HYDROPHILIC) | 0.127 % | Cream · Topical | 1 Tube | SAR 13.65 | Generic · OTC | GALDERMA | Withdrawn by MAH · Not Marketed |
| EFFICORT LIPOCREAM 0.127% (LIPOPHILIC) | 0.127 % | Cream · Topical | 1 Tube | SAR 13.65 | Generic · OTC | GALDERMA | Withdrawn by MAH · Not Marketed |
| HYDROCORTISONE-TABUK 1% CREAM | 1 % | Cream · Topical | 1 Tube | SAR 14.70 | Generic · OTC | Tabuk Pharmaceutical Manufacturing Company | Withdrawn by MAH · Not Marketed |
| HYDROCORTISONE-TABUK 1% CREAM | 1 % | Cream · Topical | 1 Tube | SAR 8.25 | Generic · OTC | Tabuk Pharmaceutical Manufacturing Company | Withdrawn by MAH · Not Marketed |
| HYDROSONE 100 mg lyophilisate for solution for injection | 100 mg | Lyophilisate for solution for injection · Parenteral use | 1 Vial | SAR 11.60 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Withdrawn by MAH · Not Marketed |
| OFTALMOLOSA CUSI HYDROCORTISONE 1% | 1 % | Eye ointment · Ocular use | 1 Tube | SAR 6.80 | Generic · Prescription | ALCON CUSI | Withdrawn by MAH · Not Marketed |
| RIACORT | 1 % | Ointment · Topical | 1 Tube | SAR 7.45 | Generic · OTC | RIYADH PHARMA | Withdrawn by MAH · Not Marketed |
| RIACORT 1% cream | 1 % | Cream · Topical | 1 Tube | SAR 7.45 | Generic · OTC | RIYADH PHARMA | Withdrawn by MAH · Not Marketed |
| TOPICORT | 1 % | Cream · Topical | 1 Tube | SAR 5.55 | Generic · OTC | HAYAT PHARMACEUTICAL INDUSTRIES | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ANAL FISSURE; BEHCET DISEASE; ECZEMA; GRAFT VERSUS HOST DISEASE; PSORIASIS; VITILIGO
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| CORTEF | 10MG; 20MG; 5MG | tablet · oral | PHARMACIA AND UPJOHN | Prescription | 15 Dec 1952 |
| SOLU-CORTEF | EQ 100MG BASE/VIAL; EQ 250MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL | injectable · injection | PHARMACIA AND UPJOHN | Prescription | 27 Apr 1955 |
| CORTENEMA | 100MG/60ML | enema · rectal | ANI PHARMS | Prescription | 12 Jan 1966 |
| ALA-SCALP | 2% | lotion · topical | LEGACY | Prescription | 28 Feb 1973 |
| ALA-CORT | 1%; 2.5% | cream · topical | CROWN LABS | Prescription | 9 Mar 1973 |
| HYDROCORTISONE | 1% | ointment · topical | FOUGERA PHARMS | Prescription | 16 Apr 1975 |
| HYDROCORTISONE | 1% | cream · topical | FOUGERA PHARMS INC | Prescription | 30 Apr 1976 |
| HYDROCORTISONE | 2.5% | ointment · topical | PADAGIS US | Prescription | 30 Nov 1977 |
| CORTIFOAM | 10% | aerosol, metered · rectal | VIATRIS | Prescription | 12 Feb 1982 |
| HYDROCORTISONE | 2.5% | cream · topical | PADAGIS US | Prescription | 21 Apr 1983 |
| HYDROCORTISONE | 1% | cream · topical | ACTAVIS MID ATLANTIC | Prescription | 3 May 1983 |
| HYDROCORTISONE | 2.5% | cream · topical | TARO | Prescription | 9 Nov 1984 |
| HYDROCORTISONE IN ABSORBASE | 1% | ointment · topical | CMP PHARMA INC | Prescription | 6 Sep 1985 |
| STIE-CORT | 2.5% | lotion · topical | PADAGIS US | Prescription | 26 Nov 1985 |
| HYDROCORTISONE | 2.5% | cream · topical | FOUGERA PHARMS INC | Prescription | 16 Dec 1986 |
| TEXACORT | 2.5% | solution · topical | MISSION PHARMA | Prescription | 17 Apr 1992 |
| HYDROCORTISONE | 2.5% | ointment · topical | FOUGERA PHARMS INC | Prescription | 28 May 1993 |
| HYDROCORTISONE VALERATE | 0.2% | cream · topical | SUN PHARMA CANADA | Prescription | 25 Aug 1998 |
| HYDROCORTISONE VALERATE | 0.2% | ointment · topical | SUN PHARMA CANADA | Prescription | 25 Aug 1998 |
| COLOCORT | 100MG/60ML | enema · rectal | CHARTWELL | Prescription | 3 Dec 1999 |
| MICORT-HC | 2.5% | cream · topical | LEGACY | Prescription | 27 Feb 2001 |
| HYDROCORTISONE | 5MG; 10MG; 20MG | tablet · oral | IMPAX LABS INC | Prescription | 30 Mar 2007 |
| HYDROCORTISONE | 2.5% | cream · topical | RISING | Prescription | 20 Aug 2010 |
| HYDROCORTISONE | 5MG; 10MG; 20MG | tablet · oral | STRIDES PHARMA | Prescription | 27 Apr 2017 |
| HYDROCORTISONE | 2.5% | cream · topical | ENCUBE | Prescription | 23 Jul 2018 |
189 more — full table
EMA European Union — centrally authorised medicines
Alkindi Immedica Pharma AB · Authorised · authorised 9 Feb 2018 · ATC H02AB09
Therapeutic indication (EMA)
Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).
Efmody Immedica Pharma AB · Authorised · authorised 27 May 2021 · ATC H02AB09
Therapeutic indication (EMA)
Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.
Hydrocortisone Aguettant Laboratoire Aguettant · Application withdrawn
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| AURO-HYDROCORTISONE | 02524465 | 10 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-HYDROCORTISONE | 02524473 | 20 MG | TABLET · ORAL | AURO PHARMA INC |
| CORTEF | 00030910 | 10 MG | TABLET · ORAL | PFIZER CANADA ULC |
| CORTEF | 00030929 | 20 MG | TABLET · ORAL | PFIZER CANADA ULC |
| HYDROVAL CREAM 0.2% | 02242984 | 0.2 % | CREAM · TOPICAL | TAROPHARMA, A DIVISION OF TARO PHARMACEUTICALS INC. |
| HYDROVAL OINTMENT 0.2% | 02242985 | 0.2 % | OINTMENT · TOPICAL | TAROPHARMA, A DIVISION OF TARO PHARMACEUTICALS INC. |
| SOLU-CORTEF | 00030600 | 100 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS; INTRAMUSCULAR | PFIZER CANADA ULC |
| SOLU-CORTEF | 00030619 | 250 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS; INTRAMUSCULAR | PFIZER CANADA ULC |
| SOLU-CORTEF | 00030627 | 500 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS; INTRAMUSCULAR | PFIZER CANADA ULC |
| SOLU-CORTEF | 00030635 | 1 G / VIAL | POWDER FOR SOLUTION · INTRAVENOUS; INTRAMUSCULAR | PFIZER CANADA ULC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | CORTEF 10 MG TABLET | $1.63356 | per EA | 23 Sep 2026 |
| US NADAC | CORTEF 5 MG TABLET | $0.9751 | per EA | 23 Sep 2026 |
| US NADAC | CORTIFOAM 10% AEROSOL | $30.66807 | per GM | 23 Sep 2026 |
| US NADAC | HYDROCORTISONE 0.5% CREAM | $0.05051 | per GM | 23 Sep 2026 |
| US NADAC | HYDROCORTISONE 0.5% CREAM | $0.11264 | per GM | 23 Sep 2026 |
| US NADAC | HYDROCORTISONE 1% CREAM | $0.10855 | per GM | 23 Sep 2026 |
| US NADAC | HYDROCORTISONE 1% CREAM | $0.11455 | per GM | 23 Sep 2026 |
| US NADAC | HYDROCORTISONE 1% CREAM | $0.11245 | per GM | 21 Jan 2026 |
| US NADAC | HYDROCORTISONE 1% CREAM | $0.06129 | per GM | 23 Sep 2026 |
| US NADAC | HYDROCORTISONE 1% CREAM | $0.0588 | per GM | 23 Sep 2026 |
| US NADAC | HYDROCORTISONE 1% CREAM | $0.60009 | per GM | 23 Sep 2026 |
| US NADAC | HYDROCORTISONE 1% CREAM | $0.04078 | per GM | 23 Sep 2026 |
| NHS Drug Tariff | Hydrocortisone 0.1% topical emulsion | £5.91 | 100 gram | 1 Oct 2026 |
| NHS Drug Tariff | Hydrocortisone 0.5% ointment | £108.03 | 15 gram | 1 Oct 2026 |
| NHS Drug Tariff | Hydrocortisone 1% cream | £1.93 | 15 gram | 1 Oct 2026 |
| NHS Drug Tariff | Hydrocortisone 1% cream | £3.26 | 30 gram | 1 Oct 2026 |
| NHS Drug Tariff | Hydrocortisone 1% cream | £5.23 | 50 gram | 1 Oct 2026 |
| NHS Drug Tariff | Hydrocortisone 1% ointment | £1.45 | 15 gram | 1 Oct 2026 |
| NHS Drug Tariff | Hydrocortisone 1% ointment | £3.54 | 30 gram | 1 Oct 2026 |
| NHS Drug Tariff | Hydrocortisone 1% ointment | £7.49 | 50 gram | 1 Oct 2026 |
| NHS Drug Tariff | Hydrocortisone 10mg dispersible tablets sugar free | £35.00 | 30 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Hydrocortisone 10mg modified-release capsules | £270.00 | 50 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Hydrocortisone 10mg soluble tablets sugar free | £37.50 | 30 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Hydrocortisone 10mg tablets | £1.41 | 30 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)
- 8.2.4. Hormones and antihormones · complementary
Lymphoid leukaemia, not elsewhere classified; Burkitt lymphoma including Burkitt leukaemia
Parenteral > General injections > unspecified: 100 mg in vial (as sodium succinate) - 3. Antiallergics and medicines used in anaphylaxis · core
Anaphylaxis
Parenteral > General injections > unspecified: 100 mg in vial powder for injection (as sodium succinate) - 17.3. Anti-inflammatory medicines · complementary
Crohn disease site; Ulcerative colitis
Local > Rectal > Suppository: 25 mg (acetate) | Local > Rectal > Retention enema: 100 mg per 60 mL - 13.3. Dermatological medicines > Anti-inflammatory and antipruritic medicines · core
Dermatitis or eczema; Pruritus due to skin disorder; Psoriasis of unspecified type; Lichen planus
Local > Topical > Cream: 1% (acetate) | Local > Topical > Ointment: 1% (acetate) - 18.1. Adrenal hormones and synthetic substitutes · core
Adrenocortical insufficiency
Oral > Solid > tablet: 5 mg; 10 mg; 20 mg | Oral > Solid > granules: 0.5 mg in capsule (EMLc); 1 mg in capsule (EMLc); 2 mg in capsule (EMLc); 5 mg in capsule (EMLc)
Safety signals and safety-related labeling changes
- US FDA 8 Aug 2025 CORTISPORIN — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 8 Aug 2025 CORTISPORIN — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 8 Aug 2025 CORTISPORIN — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 5 Jun 2024 ALKINDI SPRINKLE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 5 Jun 2024 CORTEF — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions - US FDA 5 Jun 2024 SOLU-CORTEF — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations - US FDA 1 Mar 2024 CORTIFOAM — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions - EMA PRAC 14 Jan 2021 PRAC signal: Adrenal crisis
Action for MAH: update of the product information: Yes - US FDA 11 Dec 2019 XERESE — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 5 Jan 2019 COLY-MYCIN S — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 20 Mar 2017 CIPRO HC — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations
Combinations containing Hydrocortisone
- Aciclovir + hydrocortisone
- Chloramphenicol + hydrocortisone
- Clioquinol + hydrocortisone
- Fusidic acid + hydrocortisone
- Hydrocortisone + miconazole
- Hydrocortisone + neomycin
- Hydrocortisone + pramoxine
- Hydrocortisone + quinoline
- Centella extract + hydrocortisone + neomycin
- Hydrocortisone + hydroquinone + tretinoin
- Hydrocortisone + natamycin + neomycin
- Hydrocortisone + neomycin + polymyxin b
- Hydrocortisone + oxytetracycline + polymyxin b
- Aluminuium + hydrocortisone + lidocaine + zinc oxide
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.