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
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/09/17 | Not Applicable | Completed | |||
2015/08/14 | Not Applicable | Completed | |||
2015/08/07 | Phase 3 | Completed | |||
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 |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sincerus Florida, LLC | 72934-6225 | TOPICAL | 0.5 g in 100 g | 7/2/2020 | |
| STAT RX USA LLC | 16590-990 | ORAL | 20 mg in 1 1 | 8/30/2011 | |
| Blenheim Pharmacal, Inc | 10544-912 | AURICULAR (OTIC) | 10 mg in 1 mL | 5/21/2015 | |
| Chartwell RX LLC | 62135-020 | RECTAL | 100 mg in 60 mL | 12/20/2022 | |
| Sun Pharmaceutical Industries, Inc. | 10631-407 | TOPICAL | 25 mg in 1 g | 1/11/2021 | |
| RPK Pharmaceuticals, Inc. | 53002-9662 | TOPICAL | 25 mg in 1 g | 12/22/2016 | |
| Major Pharmaceuticals | 0904-7188 | ORAL | 10 mg in 1 1 | 2/8/2022 | |
| Bausch Health US LLC | 0187-5104 | TOPICAL | 10 mg in 1 g | 8/3/2020 | |
| Sincerus Florida, LLC | 72934-6107 | TOPICAL | 0.5 g in 100 g | 4/24/2019 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-3003 | TOPICAL | 25 mg in 1 g | 12/18/2023 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
View More Health Canada Approvals
Sign in to access additional Health Canada approved drug information with detailed regulatory data.
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
View More CIMA AEMPS Approvals
Sign in to access additional CIMA AEMPS approved drug information with detailed regulatory data.
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
View More Philippines FDA Approvals
Sign in to access additional Philippines FDA approved drug information with detailed regulatory data.
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
View More Saudi SFDA Approvals
Sign in to access additional Saudi SFDA approved drug information with detailed regulatory data.
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
View More Malaysia NPRA Approvals
Sign in to access additional Malaysia NPRA approved drug information with detailed regulatory data.
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
View More UK EMC Drug Information
Sign in to access additional UK EMC drug information with detailed pharmaceutical data.
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.