Last reviewed · How we verify
Cortef (hydrocortisone)
Hydrocortisone is synthetic cortisol, first isolated by Nobel laureates Edward Kendall and Tadeus Reichstein. Available since the 1950s in oral, topical, and injectable forms, it is essential for adrenal replacement therapy and widely available OTC as a 1% topical cream for dermatitis and itching.
At a glance
| Generic name | hydrocortisone |
|---|---|
| Also known as | Cortef, Solu-Cortef, Cortizone-10 |
| Sponsor | Generic (originally Merck/Upjohn) |
| Drug class | Corticosteroid [EPC] |
| Target | Annexin A1, Corticosteroid-binding globulin, Nitric oxide synthase, inducible |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1952-01-01 (United States) |
Approved indications
- Acne vulgaris
- Acquired thrombocytopenia
- Acute lymphoid leukemia
- Adrenal cortical hypofunction
- Adrenogenital disorder
- Allergic conjunctivitis
- Allergic rhinitis
- Angioedema
- Ankylosing spondylitis
- Aphthous ulcer of mouth
- Articular gout
- Aspiration pneumonitis
- Asthma
- Atopic dermatitis
- Autoimmune disease
- Autoimmune hemolytic anemia
- Bacterial keratitis
- Berylliosis
- Blepharoconjunctivitis
- Bursitis
Common side effects
- Burning
- Itching
- Irritation
- Dryness
- Folliculitis
- Hypopigmentation
- Allergic contact dermatitis
- Secondary infection
Key clinical trials
- A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015) (Phase 2)
- An Open Label, Partially Randomised, Single Dose, Crossover Study to Evaluate the PK, Oral Bioavailability and Relationship to Metabolic Parameters of Hydrocortisone and Infacort® in Healthy Adult Mal (Phase 1)
- Investigating the Central and Peripheral Mechanisms by Which Glucocorticoids Affect Hunger (Phase 1)
- Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer Who Have Relapse in Biochemistry Whilst Androgenic Blockage (Phase 3)
- Metabolic, Pressor and Neuropsychological Effects of Metyrapone Treatment in Patients With Hypercortisolism (N/A)
- Effect of A Single Dose of Lorazepam on Salivary Cortisol Response in Children Undergoing Digestive Endoscopy: a Randomized Double Blinded Study (Phase 2)
- Acute Consequences of Glucocorticoid Secretion in Overweight and Obese Individuals During Maximum Calorie Intake: a Double-blind, Randomized, Placebo-controlled, Cross-over Study (NA)
- Learning, Neural Signaling of Cortisol, and Early Adversity in Depression (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 12133914 | 2043-02-23 | Method of Use |
| 11904046 | 2043-02-23 | Formulation |
| 9717740 | 2032-11-19 | Method of Use |
| 9675559 | 2033-01-10 | Method of Use |
| 9649280 | 2034-05-12 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cortef CI brief — competitive landscape report
- Cortef updates RSS · CI watch RSS
- Generic (originally Merck/Upjohn) portfolio CI