Overview
Hydrocortisone, or cortisol, is a glucocorticoid secreted by the adrenal cortex. Hydrocortisone is used to treat immune, inflammatory, and neoplastic conditions. It was discovered in the 1930s by Edward Kendall and named Compound F, or 17-hydroxycorticosterone. Hydrocortisone was granted FDA approval on 5 August 1952.
Indication
Otic solutions are indicated for infections of the external auditory canal caused by susceptible organisms and with inflammation. Hydrocortisone tablets are indicated for certain endocrine, rheumatic, collagen, allergic, ophthalmic, respiratory, hematologic, neoplastic, edematous, gastrointestinal, and other conditions. A hydrocortisone enema is indicated for ulcerative colitis, a topical ointment with antibiotics is indicated for corticosteroid responsive dermatoses with infections, and a topical cream with acyclovir is indicated to treat cold sores. Oral granules of hydrocortisone are used as a replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age.
Associated Conditions
- Acute Gouty Arthritis
- Acute Leukemia
- Acute Otitis Externa
- Adrenal Insufficiency
- Allergic Conjunctivitis (AC)
- Allergic Rhinitis (AR)
- Allergic corneal marginal ulcers
- Ankylosing Spondylitis (AS)
- Aspiration Pneumonitis
- Asthma
- Atopic Dermatitis
- Berylliosis
- Bullous dermatitis herpetiformis
- Chorioretinitis
- Choroiditis
- Congenital Adrenal Hyperplasia (CAH)
- Congenital Hypoplastic Anemia
- Contact Dermatitis
- Crohn's Disease (CD)
- Dermatitis
- Dermatomyositis (DM)
- Dermatosis
- Drug hypersensitivity reaction
- Epicondylitis
- Erythroblastopenia
- Fissure;Anal
- Haemorrhoids
- Herpes Labialis
- Hypercalcemia of Malignancy
- Immune Thrombocytopenia (ITP)
- Infection of the Fenestration Cavity
- Infection of the Mastoidectomy Cavity
- Iridocyclitis
- Iritis
- Itching caused by Hemorrhoids
- Itching of the Anus
- Keratitis
- Leukemias
- Loeffler's syndrome
- Lymphoma
- Lymphomas NEC
- Mycosis Fungoides (MF)
- Ophthalmia, Sympathetic
- Optic Neuritis
- Pain caused by Hemorrhoids
- Pemphigus
- Posterior Uveitis
- Posttraumatic Osteoarthritis
- Primary adrenocortical insufficiency
- Proctitis
- Proteinuria
- Pruritis of the skin
- Psoriatic Arthritis
- Rectal inflammations NEC
- Rheumatic heart disease, unspecified
- Rheumatoid Arthritis
- Rheumatoid Arthritis, Juvenile
- Secondary adrenocortical insufficiency
- Secondary thrombocytopenia
- Serum Sickness
- Severe Seborrheic Dermatitis
- Skin Diseases
- Stevens-Johnson Syndrome
- Synovitis
- Systemic Lupus Erythematosus
- Trichinosis
- Tuberculous Meningitis
- Ulcerative Colitis
- Acquired immune hemolytic anemia
- Acute Bursitis
- Acute Tenosynovitis
- Acute rheumatic carditis
- Anterior eye segment inflammation
- Cryptitis
- Disseminated Pulmonary Tuberculosis (TB)
- Exfoliative erythroderma
- Fulminating Pulmonary Tuberculosis
- Non-suppurative Thyroiditis
- Severe Erythema multiforme
- Severe Psoriasis
- Subacute Bursitis
- Superficial infection of the external auditory canal with inflammation
- Symptomatic Sarcoidosis
- Systemic Dermatomyositis
- Varicella-zoster virus acute retinal necrosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/18 | Not Applicable | Not yet recruiting | |||
2025/05/21 | Phase 4 | Recruiting | Walter Reed Army Institute of Research (WRAIR) | ||
2025/04/24 | Early Phase 1 | Not yet recruiting | C17 Council | ||
2025/04/16 | Not Applicable | ENROLLING_BY_INVITATION | Nada kamel Elgamal | ||
2025/03/26 | Phase 2 | Not yet recruiting | |||
2025/03/25 | Phase 4 | Not yet recruiting | Copenhagen Respiratory Research | ||
2025/03/25 | Phase 4 | Not yet recruiting | Copenhagen Respiratory Research | ||
2024/12/09 | Not Applicable | Recruiting | Southeast University, China | ||
2024/07/23 | N/A | Active, not recruiting | |||
2024/07/16 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| MWI | 13985-608 | OPHTHALMIC | 10 mg in 1 g | 3/23/2015 | |
| Westminster Pharmaceuticals, LLC | 69367-286 | TOPICAL | 10 mg in 1 g | 5/12/2023 | |
| NuCare Pharmaceuticals,Inc. | 68071-1598 | TOPICAL | 25 mg in 1 g | 4/19/2023 | |
| Actavis Pharma, Inc. | 0472-0321 | TOPICAL | 10 mg in 1 g | 6/30/2017 | |
| Unipack LLC | 43749-620 | TOPICAL | 10.2 mg in 1 g | 7/13/2025 | |
| Chattem, Inc. | 41167-0039 | TOPICAL | 10 mg in 1 g | 4/10/2025 | |
| Eton Pharmaceuticals, Inc. | 71863-112 | ORAL | 5 mg in 1 1 | 2/28/2024 | |
| Akorn Operating Company LLC | 50383-901 | AURICULAR (OTIC) | 10.375 mg in 1 mL | 10/13/2022 | |
| Bryant Ranch Prepack | 63629-2396 | TOPICAL | 25 mg in 1 g | 2/15/2022 | |
| NuCare Pharmaceuticals,Inc. | 68071-4229 | AURICULAR (OTIC) | 10 mg in 1 mL | 6/16/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Neurocrine Netherlands B.V.,Van Heuven Goedhartlaan 935 A,1181 LD Amstelveen,NETHERLANDS | Authorised | 5/27/2021 | |
Neurocrine Netherlands B.V.,Van Heuven Goedhartlaan 935 A,1181 LD Amstelveen,NETHERLANDS | Authorised | 2/9/2018 | |
Authorised | 11/3/2011 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| HYDROCORTISONE CREAM 1% w/w | SIN05104P | CREAM | 1% w/w | 10/3/1990 | |
| XEPACORT CREAM 1% W/W | SIN16545P | CREAM | 1.00% W/W | 7/6/2022 | |
| AXCEL HYDROCORTISONE CREAM 1% w/w | SIN10970P | CREAM | 1% w/w | 6/5/1999 | |
| H-CORT CREAM 1% w/w | SIN12211P | CREAM | 1% w/w | 2/28/2003 | |
| CANDACORT CREAM | SIN11806P | CREAM | 1% w/w | 2/20/2002 | |
| CORTISONE CREAM 1% | SIN03897P | CREAM | 1 g/100 g | 2/23/1990 | |
| DERM-AID CREAM 0.5% | SIN07122P | CREAM | 0.5% | 8/12/1992 | |
| EGOCORT CREAM 1% | SIN04792P | CREAM | 1% w/w | 6/26/1990 | |
| H-CORT OINTMENT 1% w/w | SIN12212P | OINTMENT | 1% w/w | 2/28/2003 | |
| HYDROCORTISON TABLET 10 mg | SIN07203P | TABLET | 10.0 mg | 10/12/1992 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Hydrocortisone Tablets | 国药准字H31020777 | 化学药品 | 片剂 | 7/8/2020 | |
| Hydrocortisone Tablets | 国药准字H61021659 | 化学药品 | 片剂 | 11/11/2020 | |
| Hydrocortisone Tablets | 国药准字H37020302 | 化学药品 | 片剂 | 3/11/2020 | |
| Hydrocortisone Tablets | 国药准字H23021654 | 化学药品 | 片剂 | 12/7/2020 | |
| Hydrocortisone Tablets | 国药准字H53021390 | 化学药品 | 片剂 | 9/28/2020 | |
| Hydrocortisone Tablets | 国药准字H41020790 | 化学药品 | 片剂 | 5/18/2020 | |
| Hydrocortisone Tablets | 国药准字H20058186 | 化学药品 | 片剂 | 8/4/2020 | |
| Hydrocortisone Tablets | 国药准字H41020599 | 化学药品 | 片剂 | 7/16/2020 | |
| Hydrocortisone Tablets | 国药准字H15020177 | 化学药品 | 片剂 | 3/29/2020 | |
| Hydrocortisone Tablets | 国药准字H23021781 | 化学药品 | 片剂 | 7/26/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| HYDROCORTISONE CREAM 1% (VIDA) | N/A | N/A | N/A | 9/13/1979 | |
| UNI-CORT-N CREAM | N/A | N/A | N/A | 8/1/1995 | |
| TINACORT CREAM | N/A | N/A | N/A | 9/28/2009 | |
| UNI-CORT CREAM 1% | N/A | N/A | N/A | 8/1/1995 | |
| VIDACORTICIN CREAM | N/A | N/A | N/A | 5/19/1979 | |
| DAFRIN-H CREAM | N/A | N/A | N/A | 1/29/1983 | |
| HYDRO-FUNGA CREAM | N/A | N/A | N/A | 12/5/1991 | |
| HYDROCORTISONE CREAM 1% | N/A | N/A | N/A | 4/26/1979 | |
| NEO-CONASONE CREAM | N/A | N/A | N/A | 11/19/1999 | |
| UNI-CORT OINTMENT 1% | N/A | N/A | N/A | 8/1/1995 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DERMAID 0.5% Cream | 10605 | Medicine | A | 8/2/1991 | |
| DERMAID SOFT 0.5% CREAM hydrocortisone 5mg/g cream tube | 71683 | Medicine | A | 10/29/1999 | |
| CIPROXIN HC EAR DROPS 0.2% ciprofloxacin (as hydrochloride) and 1% hydrocortisone ear drops | 136662 | Medicine | A | 3/12/2008 | |
| DermAid 1% solution hydrocortisone 10mg/g solution bottle | 260373 | Medicine | A | 9/29/2015 | |
| DermAid 1% spray | 225475 | Medicine | A | 7/8/2014 | |
| Hydrocortisone Cream 1% (Noumed) | 397892 | Medicine | A | 10/17/2022 | |
| HYDROCORTISONE VIATRIS 4 hydrocortisone 4 mg tablet bottle | 290097 | Medicine | A | 9/21/2017 | |
| HYDROZOLE hydrocortisone / clotrimazole cream tube | 10319 | Medicine | A | 8/13/1991 | |
| Hysone '20' Tablets | 27926 | Medicine | A | 10/21/1991 | |
| ALKINDI hydrocortisone 2 mg granules (in capsule) bottle | 319410 | Medicine | A | 8/18/2020 |
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