Overview
Dexamethasone, or MK-125, is a corticosteroid fluorinated at position 9 used to treat endocrine, rheumatic, collagen, dermatologic, allergic, ophthalmic, gastrointestinal, respiratory, hematologic, neoplastic, edematous, and other conditions. Developed in 1957, it is structurally similar to other corticosteroids like hydrocortisone and prednisolone. Dexamethasone was granted FDA approval on 30 October 1958. In a press release for the Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial on 16 June 2020, dexamethasone was recommended for use in COVID-19 patients with severe respiratory symptoms. Dexamethasone reduced deaths by approximately one third in patients requiring ventilation and by one fifth in those requiring oxygen.
Indication
Dexamethasone and ciprofloxacin otic suspension is indicated for bacterial infections with inflammation in acute otitis media and acute otitis externa. Intramuscular and intravenous injections are indicated for a number of endocrine, rheumatic, collagen, dermatologic, allergic, ophthalmic, gastrointestinal, respiratory, hematologic, neoplastic, edematous, and other conditions. Oral tablets are indicated for the treatment of multiple myeloma. An intravitreal implant is indicated for some forms of macular edema and non-infectious posterior uveitis affecting the posterior of the eye. Various ophthalmic formulations are indicated for inflammatory conditions of the eye.
Associated Conditions
- Acute Gouty Arthritis
- Acute Leukemia
- Acute Otitis Externa
- Acute Otitis Media (AOM)
- Adrenocortical Hyperfunction
- Adrenocortical Insufficiency
- Allergic Conjunctivitis (AC)
- Alopecia Areata (AA)
- Ankylosing Spondylitis (AS)
- Aspiration Pneumonitis
- Asthma
- Atopic Dermatitis
- Berylliosis
- Bullous dermatitis herpetiformis
- Bursitis
- Chorioretinitis
- Choroiditis
- Congenital Adrenal Hyperplasia (CAH)
- Congenital Hypoplastic Anemia
- Conjunctivitis
- Contact Dermatitis
- Cushing's Syndrome
- Dermatitis
- Diabetic Macular Edema (DME)
- Discoid Lupus Erythematosus (DLE)
- Drug hypersensitivity reaction
- Edema of the cerebrum
- Epicondylitis
- Episcleritis
- Erythroblastopenia
- Eye Infections
- Eye allergy
- Glaucoma
- Hypercalcemia
- Immune Thrombocytopenia (ITP)
- Infection
- Inflammation
- Inflammation of the External Auditory Canal
- Intraocular Inflammation
- Iridocyclitis
- Iritis
- Keloids Scars
- Keratitis
- Lichen Planus (LP)
- Lichen simplex chronicus
- Loeffler's syndrome
- Lymphoma
- Macular Edema
- Meningitis caused by Mycobacterium Tuberculosis
- Middle ear inflammation
- Mucosal Inflammation of the eye
- Multiple Myeloma (MM)
- Muscle Inflammation caused by Cataract Surgery of the eye
- Mycosis Fungoides (MF)
- Necrobiosis lipoidica diabeticorum
- Non-infectious Posterior Uveitis
- Ocular Infections, Irritations and Inflammations
- Ocular Inflammation
- Ocular Inflammation and Pain
- Ocular Irritation
- Ocular Itching
- Ophthalmia, Sympathetic
- Optic Neuritis
- Otitis Externa
- Pemphigus
- Perennial Allergic Rhinitis (PAR)
- Phlyctenular keratoconjunctivitis
- Postoperative Infections of the eyes caused by susceptible bacteria
- Posttraumatic Osteoarthritis
- Regional Enteritis
- Rheumatoid Arthritis
- Rheumatoid Arthritis, Juvenile
- Rosacea
- Sarcoidosis
- Scleritis
- Seasonal Allergic Rhinitis
- Secondary thrombocytopenia
- Serum Sickness
- Severe Seborrheic Dermatitis
- Stevens-Johnson Syndrome
- Synovitis
- Systemic Lupus Erythematosus
- Tenosynovitis
- Trichinosis
- Tuberculosis (TB)
- Ulcerative Colitis
- Uveitis
- Vernal Keratoconjunctivitis
- Acquired immune hemolytic anemia
- Acute rheumatic carditis
- Anterior eye segment inflammation
- Corticosteroid-responsive dermatoses
- Ear infection-not otherwise specified caused by susceptible bacteria
- Exfoliative erythroderma
- Granuloma annulare lesions
- Non-suppurative Thyroiditis
- Ocular bacterial infections
- Severe Psoriasis
- Steroid-responsive inflammation of the eye
- Swelling of the eyes
- Varicella-zoster virus acute retinal necrosis
- Watery itchy eyes
Research Report
Dexamethasone (DB01234): A Comprehensive Pharmacological and Clinical Monograph
Executive Summary
Dexamethasone is a potent, long-acting synthetic glucocorticoid that has been a cornerstone of medical therapy for over six decades. First granted regulatory approval in 1958 [1], this small molecule drug (DrugBank ID: DB01234; CAS: 50-02-2) has demonstrated remarkable therapeutic longevity and versatility. Its clinical utility is rooted in powerful anti-inflammatory and immunosuppressive actions, which are mediated primarily through agonism of the intracellular glucocorticoid receptor.[2] This interaction modulates the expression of a vast network of genes, leading to the suppression of pro-inflammatory pathways and the enhancement of anti-inflammatory signals.
The therapeutic scope of dexamethasone is exceptionally broad, spanning numerous medical disciplines. It is an established treatment for a wide array of endocrine, rheumatic, allergic, dermatologic, and hematologic disorders.[3] In oncology, it serves a dual role as both a direct cytotoxic agent in hematological malignancies, most notably multiple myeloma, and as an indispensable supportive care medication for managing treatment-related complications such as cerebral edema and chemotherapy-induced nausea and vomiting.[5] Its enduring relevance was dramatically highlighted during the COVID-19 pandemic, where it was identified as a life-saving intervention for patients with severe respiratory disease, capable of mitigating the hyperinflammatory response that drives acute respiratory distress syndrome.[1]
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 |
|---|---|---|---|---|---|
2023/03/30 | Phase 4 | Completed | |||
2023/03/29 | Phase 2 | Recruiting | |||
2023/03/17 | Phase 1 | Not yet recruiting | City of Hope Medical Center | ||
2023/03/09 | Phase 1 | Recruiting | May Samaha | ||
2023/03/02 | Phase 2 | Recruiting | |||
2023/03/02 | Phase 2 | Completed | |||
2023/03/02 | Phase 1 | Not yet recruiting | Princess Maxima Center for Pediatric Oncology | ||
2023/02/27 | Phase 1 | Not yet recruiting | Princess Maxima Center for Pediatric Oncology | ||
2023/02/22 | Phase 3 | Active, not recruiting | |||
2023/02/21 | Phase 4 | Completed | Asociación para Evitar la Ceguera en México |
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 |
|---|---|---|---|---|---|
| NuCare Pharmaceuticals,Inc. | 68071-3359 | OPHTHALMIC | 1 mg in 1 mL | 9/26/2019 | |
| Mylan Institutional LLC | 67457-418 | INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE | 4 mg in 1 mL | 11/4/2019 | |
| Physicians Total Care, Inc | 54868-1744 | ORAL | 1.5 mg in 1 1 | 1/21/2010 | |
| Physicians Total Care, Inc | 54868-5903 | ORAL | 6 mg in 1 1 | 1/21/2010 | |
| NorthStar Rx LLC | 72603-187 | ORAL | 1.5 mg in 1 1 | 3/8/2024 | |
| REMEDYREPACK INC. | 70518-3019 | INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE | 4 mg in 1 mL | 3/8/2024 | |
| PD-Rx Pharmaceuticals, Inc. | 55289-903 | ORAL | 0.75 mg in 1 1 | 3/13/2024 | |
| Gland Pharma Limited | 68083-473 | INTRAVENOUS, INTRAMUSCULAR, INTRA-ARTICULAR, SOFT TISSUE, INTRALESIONAL | 4 mg in 1 mL | 10/4/2023 | |
| Chartwell RX, LLC | 62135-114 | ORAL | 0.5 mg in 5 mL | 3/14/2024 | |
| Alvogen Inc. | 47781-914 | ORAL | 4 mg in 1 1 | 5/31/2021 |
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.