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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/10/08 | Not Applicable | Recruiting | |||
2025/10/06 | Not Applicable | Not yet recruiting | Nishtar Medical University | ||
2025/10/02 | Not Applicable | Active, not recruiting | |||
2025/09/22 | Not Applicable | Not yet recruiting | Konya City Hospital | ||
2025/09/22 | Not Applicable | Not yet recruiting | |||
2025/09/22 | Not Applicable | Recruiting | |||
2025/09/18 | Not Applicable | Recruiting | Poznan University of Medical Sciences | ||
2025/09/18 | Not Applicable | Recruiting | Poznan University of Medical Sciences | ||
2025/09/16 | Not Applicable | Recruiting | Konya City Hospital | ||
2025/09/08 | Not Applicable | Recruiting | The First Affiliated Hospital of Soochow University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aidarex Pharmaceuticals LLC | 53217-310 | ORAL | 0.5 mg in 5 mL | 5/21/2018 | |
| Quality Care Products, LLC | 55700-854 | ORAL | 1.5 mg in 1 1 | 3/31/2020 | |
| Imprimis NJOF, LLC | 71384-513 | OPHTHALMIC | 1 mg in 1 mL | 2/10/2020 | |
| RedPharm Drug | 67296-0326 | ORAL | 4 mg in 1 1 | 1/19/2022 | |
| Aidarex Pharmaceuticals LLC | 33261-551 | OPHTHALMIC | 1 mg in 1 mL | 8/14/2018 | |
| Eugia US LLC | 55150-304 | INTRAVENOUS, INTRAMUSCULAR | 10 mg in 1 mL | 2/17/2024 | |
| Amneal Pharmaceuticals NY LLC | 60219-2044 | ORAL | 6 mg in 1 1 | 12/28/2023 | |
| Mylan Institutional LLC | 67457-421 | INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE | 4 mg in 1 mL | 3/5/2024 | |
| Medical Purchasing Solutions, LLC | 71872-7164 | INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE | 4 mg in 1 mL | 5/15/2023 | |
| DIRECT RX | 61919-113 | OPHTHALMIC | 1 mg in 1 g | 1/21/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/26/2010 | ||
N/A | N/A | N/A |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DEXAMETHASONE TABLET 0.5 mg | SIN04238P | TABLET | 0.5 mg | 4/12/1990 | |
| DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP | SIN04295P | INJECTION | 4 mg/ml | 4/23/1990 | |
| ROXIMETH TABLET 0.5 mg | SIN03936P | TABLET | 0.5 mg | 3/1/1990 | |
| MAXITROL STERILE OPHTHALMIC SUSPENSION | SIN04358P | SOLUTION | 1.0 mg/ml | 5/2/1990 | |
| DEXA-GENTAMICIN EYE OINTMENT | SIN09755P | OINTMENT | 0.3 mg/g | 5/14/1998 | |
| DBL DEXAMETHASONE SODIUM PHOSPHATE INJECTION 4 mg/ml | SIN04162P | INJECTION | 4mg/mL | 4/20/1990 | |
| DEXALTIN ORAL PASTE 1 mg/g | SIN05232P | PASTE | 1 mg/g | 11/30/1990 | |
| DEXAMETHASONE TABLET 4 mg | SIN07155P | TABLET | 4 mg | 10/12/1992 | |
| DEXASONE TABLET 0.5 mg | ATLANTIC LABORATORIES CORPN LTD | SIN04860P | TABLET | 0.5 mg | 6/29/1990 |
| CILODEX OTIC SUSPENSION | SIN13199P | SOLUTION | 0.1% | 4/18/2006 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| DEXA-GENTAMICIN EYE OINTMENT | N/A | N/A | N/A | 4/12/2011 | |
| MEVODEX EYE OINTMENT | N/A | N/A | N/A | 10/22/2024 | |
| DEXMETHA TAB 0.5MG | N/A | synco (h.k.) limited | N/A | N/A | 4/18/1979 |
| DEXAMETHASONE TABLET 0.5MG | N/A | synco (h.k.) limited | N/A | N/A | 12/28/1998 |
| TOBESON OPHTHALMIC SOLUTION 0.3/0.1% W/V | N/A | N/A | N/A | 9/2/2016 | |
| MAXITROL OPHTH SUSP | N/A | N/A | N/A | 2/5/1982 | |
| MAXITROL OPHTH OINT | N/A | N/A | N/A | 3/10/1982 | |
| MAXIDEX OPHTH SUSP 0.1% | N/A | N/A | N/A | 2/5/1982 | |
| TOBRADEX OPHTHALMIC SUSP | N/A | N/A | N/A | 4/2/1990 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| TOBRADEX | novartis pharmaceuticals canada inc | 00778907 | Suspension - Ophthalmic | 0.1 % / W/V | 12/31/1990 |
| HEXADROL PHOSPHATE INJ 10MG/ML | organon teknika canada inc. | 00732893 | Liquid - Intramuscular
,
Intravenous | 10 MG / ML | 12/31/1987 |
| MAXIDEX | novartis pharmaceuticals canada inc | 00042560 | Suspension - Ophthalmic | 0.1 % / W/V | 12/31/1977 |
| HEXADROL PHOSPHATE INJ 4MG/ML | organon teknika canada inc. | 00732885 | Liquid - Intramuscular
,
Intravenous | 4 MG / ML | 12/31/1987 |
| DECADRON TAB 0.5MG | merck frosst canada & cie, merck frosst canada & co. | 00016462 | Tablet - Oral | .5 MG | 12/31/1958 |
| APO-DEXAMETHASONE | 02250055 | Tablet - Oral | 4 MG | 3/8/2004 | |
| ODAN-DEXAMETHASONE | odan laboratories ltd | 00627763 | Solution - Ophthalmic
,
Otic | 0.1 % | 12/31/1985 |
| ENCOR DEC MODEL 033-443 IMP 0.5MG/IMP | telectronics pacing systems inc. | 02095122 | Implant - Refer (See Dosage Form) | .5 MG / UNIT | 12/31/1994 |
| APO-DEXAMETHASONE | 02261081 | Tablet - Oral | 0.5 MG | 11/17/2004 | |
| ODAN-DEXAMETHASONE ELIXIR | odan laboratories ltd | 02528584 | Elixir - Oral | 0.5 MG / 5 ML | 11/25/2022 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| MAXIDEX 1 MG/ML COLIRIO EN SUSPENSIÓN | Novartis Farmaceutica S.A. | 42666 | COLIRIO EN SUSPENSIÓN | Medicamento Sujeto A Prescripción Médica | Commercialized |
| FORTECORTIN 1 mg COMPRIMIDOS | Laboratorios Ern S.A. | 32224 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| MAXITROL colirio | Alcon Laboratories Ltd (Uk) | PL 00649-5915R | COLIRIO EN SUSPENSIÓN | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| DEXAMETASONA ABDRUG 4 MG COMPRIMIDOS | Mabo Farma S.A. | 86124 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| OZURDEX 700 microgramos IMPLANTE INTRAVITREO EN APLICADOR | 10638001 | IMPLANTE INTRAVÍTREO EN APLICADOR | Uso Hospitalario | Commercialized | |
| DEXAMETASONA TAD 4 MG COMPRIMIDOS | 81414 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| DEXAMETASONA TAD 20 MG COMPRIMIDOS | 81417 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| FORTECORTIN 8 mg COMPRIMIDOS | Laboratorios Ern S.A. | 70078 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| TOBRADEX 1 MG/ML + 3 MG/ML COLIRIO EN SUSPENSIÓN | Novartis Farmaceutica S.A. | 61575 | COLIRIO EN SUSPENSIÓN | Medicamento Sujeto A Prescripción Médica | Commercialized |
| DEXAMETASONA ABDRUG 8 MG COMPRIMIDOS | Mabo Farma S.A. | 86123 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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