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.
Background
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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/06/25 | Phase 1 | UNKNOWN | |||
2015/06/16 | Phase 3 | Completed | |||
2015/06/08 | Phase 2 | Completed | |||
2015/04/24 | Phase 4 | Completed | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | ||
2015/04/17 | Phase 2 | Terminated | |||
2015/04/06 | N/A | Completed | University of Athens | ||
2015/03/30 | Not Applicable | Withdrawn | |||
2015/02/10 | Not Applicable | Terminated | |||
2014/11/13 | Not Applicable | Terminated | |||
2014/11/04 | Phase 4 | UNKNOWN | Ulla Feldt-Rasmussen |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| JEFFERS | 86010-200 | AURICULAR (OTIC) | 10 g in 1000 g | 2/21/2025 | |
| A-S Medication Solutions | 50090-0527 | TOPICAL | 25 mg in 1 g | 12/22/2016 | |
| Bryant Ranch Prepack | 71335-1989 | ORAL | 5 mg in 1 1 | 12/27/2019 | |
| Sincerus Florida, LLC | 72934-6105 | TOPICAL | 0.5 g in 100 g | 4/24/2019 | |
| A-S Medication Solutions | 50090-0350 | TOPICAL | 25 mg in 1 g | 12/22/2016 | |
| Strides Pharma Inc. | 42543-971 | ORAL | 10 mg in 1 1 | 2/16/2024 | |
| Preferred Pharmaceuticals, Inc. | 68788-7091 | TOPICAL | 25 mg in 1 g | 9/12/2023 | |
| Saptalis Pharmaceuticals, LLC | 71656-064 | AURICULAR (OTIC) | 10.375 mg in 1 mL | 1/16/2024 | |
| Rising Pharma Holdings, Inc. | 64980-324 | TOPICAL | 25 mg in 1 g | 6/23/2023 | |
| Direct_Rx | 72189-625 | TOPICAL | 25 mg in 1 g | 5/29/2025 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Hydrocortisone Injection | 国药准字H61020666 | 化学药品 | 注射剂 | 5/28/2020 | |
| Hydrocortisone Injection | 国药准字H37020731 | 化学药品 | 注射剂 | 10/17/2023 | |
| Hydrocortisone Injection | 国药准字H23021351 | 化学药品 | 注射剂 | 2/22/2023 | |
| Hydrocortisone Injection | 国药准字H37020729 | 化学药品 | 注射剂 | 10/10/2023 | |
| Hydrocortisone Injection | 国药准字H42021507 | 化学药品 | 注射剂 | 9/18/2020 | |
| Hydrocortisone Injection | 国药准字H42020220 | 化学药品 | 注射剂 | 1/3/2023 | |
| Hydrocortisone Injection | 国药准字H50021488 | 化学药品 | 注射剂 | 8/24/2020 | |
| Hydrocortisone Injection | 国药准字H51022870 | 化学药品 | 注射剂(注射液) | 11/26/2020 | |
| Hydrocortisone Injection | 国药准字H41021788 | 化学药品 | 注射剂 | 8/14/2020 | |
| Hydrocortisone Injection | 国药准字H36020038 | 化学药品 | 注射剂 | 7/17/2022 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||