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Decadron (dexamethasone)
Dexamethasone is the most potent commonly used corticosteroid, approved in 1958. The RECOVERY trial (2020) proved it reduces COVID-19 mortality in severe cases, making it one of the most important drugs in the pandemic response. Available generically worldwide at very low cost.
At a glance
| Generic name | dexamethasone |
|---|---|
| Also known as | Decadron, DexPak |
| Sponsor | Generic (originally Merck) |
| Drug class | Corticosteroid [EPC] |
| Target | Annexin A1, Interleukin-4, Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1958-10-30 (United States) |
Approved indications
- Acquired thrombocytopenia
- Acute lymphoid leukemia
- Adrenal cortical hypofunction
- Adrenogenital disorder
- Allergic conjunctivitis
- Allergic otitis externa
- Allergic rhinitis
- Angioedema
- Ankylosing spondylitis
- Anterior uveitis
- Articular gout
- Asthma
- Atopic dermatitis
- Autoimmune hemolytic anemia
- Bacterial keratitis
- Berylliosis
- Blepharoconjunctivitis
- Branch retinal vein occlusion with macular edema
- Burkitt's lymphoma
- Bursitis
Common side effects
- Infections and infestations - Other, specify
- Neutrophil count decreased
- Febrile neutropenia
- Alanine aminotransferase increased
- Platelet count decreased
- White blood cell decreased
- Anemia
- Hyponatremia
- Hyperglycemia
- Aspartate aminotransferase increased
- Hypokalemia
- Hypocalcemia
Drug interactions
- Aminoglutethimide
- Amphotericin B injection and potassium-depleting agents
- Macrolide antibiotics
- Anticholinesterase agents
- Warfarin
- Antidiabetic agents
- Isoniazid
- Cholestyramine
- Cyclosporine
- Indomethacin
Key clinical trials
- Efficacy of Single Dose Versus Multiple Doses of Dexamethasone in Outpatients With Acute Bronchiolitis (Phase 3)
- Clinical Outcomes of Letrozole-induced Endometrial Preparation Regimens Versus Conventional Endometrial Preparation Regimens Including Natural Cycle, Hormone Replacement Regimens in FET, a Randomized (NA)
- A Randomized, Controlled, Subject- and Evaluator-Masked, Phase 2 Clinical Trial Comparing EC-104 Intravitreal Implant to Ozurdex® for the Treatment of Diabetic Macular Edema (BETTIS-1) (Phase 1)
- Phase III Double-Blind, Placebo-Controlled Study of Gabapentin for the Prevention of Delayed CINV (Chemotherapy Induced Nausea and Vomiting) in Patients Receiving Highly Emetogenic Chemotherapy (Phase 3)
- Observational Prospective Study, Evaluating the Standard of Care as Recommend by International Consensus With Zidovudine-Pegylated Interferon +/-Polychemotherapy in High Risk Adult-T-cell Lymphoma/Leu (N/A)
- Efficacy of Dengue Infection With Warning Signs Treated With Dexamethasone (NA)
- Pharmacokinetics and Safety of Dexamethasone Eye Drops in Preterm Infants With Retinopathy of Prematurity- a Feasibility Study (Phase 1)
- A Randomized Phase III Trial of Melphalan and Dexamethasone (MDex) Versus Bortezomib, Melphalan and Dexamethasone (BMDex) for Untreated Patients With Systemic Light-Chain (AL) Amyloidosis Ineligible f (Phase 3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 10028965 | 2034-05-23 | Method of Use |
| 8563027 | 2030-02-12 | Method of Use |
| 12144889 | 2041-04-26 | Method of Use |
| 12150896 | 2036-10-07 | Method of Use |
| 11097061 | 2039-06-23 | Formulation |
| 10022502 | 2034-06-22 | Method of Use |
| 11458041 | 2037-11-16 | Method of Use |
| 11304961 | 2037-12-18 | 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 |