Prescription and over-the-counter medicine
Dexamethasone Brand names: Ozurdex, Maxidex, Hemady, Dextenza, Taperdex; first approved as Decadron
Dexamethasone (Decadron) is a prescription and over-the-counter medicine with an FDA approval on record since 1958. FDA's NDC Directory lists it from 60 generic labelers, and pharmacies paid $0.193 per dexamethasone 4 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- In shortage
Check it at the source: the dexamethasone FDA label on DailyMed (effective June 6, 2025, Hikma Pharmaceuticals USA, Inc.); the NDA 11664 record on Drugs@FDA; every dexamethasone label on DailyMed.
Highlights of the record
FDA label of June 6, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAllergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness.
Forms and strengths
- 0.25 mg
- 0.4 mg
- 0.5 mg
- 0.7 mg
- 0.75 mg
- 1 mg
- 1.5 mg
- 2 mg
- 4 mg
- 6 mg
- 20 mg
- 0.5 mg/5ml
Tablet; injection (solution); injection; elixir; solution (concentrate).
On the market
- Earliest approval on file
- October 30, 1958 Decadron, Merck; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 80 first October 20, 1971; 40 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 64 of which 60 under generic applications, 4 under brand applications, repackagers included; 1 more under the over-the-counter monograph, without an application
- Last listed patent
- April 26, 2041 Dextenza insert; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.193 per tablet Dexamethasone 4 mg tablet
- Shortage (FDA)
- 2 of 19 presentations limited or unavailable updated October 6, 2026
- Recalls by its makers (FDA)
- 8 since 2012 0 Class I among all firms' recalls; latest February 4, 2026; 23 more by firms not listed as its makers
- FAERS reports
- 304,163 through July 30, 2026
What is dexamethasone used for?
From the label: indications and usageAllergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). […]
Conditions named in the indications of dexamethasone's FDA labels, with every medicine labeled for each:
- Asthma
- Eczema (atopic dermatitis)
- Leukemia, lymphoma and myeloma
- Herpes and shingles
- Crohn's disease and ulcerative colitis
- Multiple sclerosis
- Osteoarthritis
- Rheumatoid arthritis
- Psoriasis
- Allergies
- Anemia
- Pain
From other dexamethasone labelsAsthma and Eczema (atopic dermatitis): INDICATIONS AND USAGE Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions …
Leukemia, lymphoma and myeloma: Neoplastic Diseases For the palliative management of leukemias and lymphomas.
Herpes and shingles: Herpes zoster ophthalmicus Iritis, iridocyclitis Chorioretinitis Diffuse posterior uveitis and choroiditis Optic neuritis Sympathetic ophthalmia Anterior segment inflammation Allergic conjunctivitis Allergic corneal marginal ulcers …
Crohn's disease and ulcerative colitis: Ulcerative colitis (systemic therapy) Regional enteritis (systemic therapy) 8.
Multiple sclerosis: Nervous System Acute exacerbations of multiple sclerosis 13.
Osteoarthritis: Synovitis of osteoarthritis.
FDA pharmacologic class: Corticosteroid.
Source: FDA drug label (Dexamethasone Intensol), Hikma Pharmaceuticals USA, Inc., effective June 6, 2025 (SPL set b15200fb-1826-472b-a907-e677a272513b), via openFDA; the full label on DailyMed
Is there a generic for dexamethasone (Decadron)?
The FDA approved the first generic dexamethasone on October 20, 1971. 80 generic applications are approved; 40 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists dexamethasone from 60 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Decadron tablets; a patent listed only for Dextenza insert runs to April 26, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1958 earliest approval on file
- 1971 first generic approved
- 2041 last listed patent
- 2019 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dexamethasone (Decadron)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.193 per Dexamethasone 4 mg tablet, down 26% from $0.260 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Dexamethasone 4 mg tablet (generic)
- Maxidex 0.1% eye drops (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dexamethasone 0.1% eye drop | Generic | $8.17 per mL | n/a | +9% |
| Dexamethasone 0.5 mg tablet | Generic | $0.0707 per tablet | $2.12 | -26% |
| Dexamethasone 0.5 mg/5 mL elx | Generic | $0.105 per mL | n/a | +11% |
| Dexamethasone 0.5 mg/5 mL liquid | Generic | $0.101 per mL | n/a | +14% |
| Dexamethasone 0.75 mg tablet | Generic | $0.0897 per tablet | $2.69 | -25% |
| Dexamethasone 1 mg tablet | Generic | $0.155 per tablet | $4.66 | -14% |
| Dexamethasone 1.5 mg tablet | Generic | $0.174 per tablet | $5.23 | -44% |
| Dexamethasone 10 mg/mL vial | Generic | $1.16 per mL | n/a | -5% |
| Dexamethasone 100 mg/10 mL vial | Generic | $0.510 per mL | n/a | -40% |
| Dexamethasone 120 mg/30 mL vial | Generic | $0.694 per mL | n/a | +2% |
| Dexamethasone 2 mg tablet | Generic | $0.252 per tablet | $7.56 | -25% |
| Dexamethasone 20 mg/5 mL vial | Generic | $0.238 per mL | $1.19 per vial | +49% |
| Dexamethasone 4 mg tablet | Generic | $0.193 per tablet | $5.79 | -26% |
| Dexamethasone 4 mg/mL vial | Generic | $0.674 per mL | n/a | -16% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is dexamethasone in shortage?
The FDA Drug Shortage Database lists 2 of 19 dexamethasone presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on February 8, 2019. 17 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Dexamethasone Sodium Phosphate Preservative Free, Injection, 10 mg/1 mL (NDC 63323-506-01) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Dexamethasone Sodium Phosphate Preservative Free, Injection, 10 mg/1 mL (NDC 70069-021-25) | Somerset Therapeutics, LLC | Current | September 11, 2026 |
| Dexamethasone Sodium Phosphate, Injection, 10 mg/1 mL (NDC 0641-0367-25) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Dexamethasone Sodium Phosphate, Injection, 10 mg/1 mL (NDC 55150-304-25) | Eugia US LLC | Current | October 2, 2026 |
| Dexamethasone Sodium Phosphate, Injection, 10 mg/1 mL (NDC 63323-516-10) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Dexamethasone Sodium Phosphate, Injection, 10 mg/1 mL (NDC 67457-420-10) | Mylan Institutional, a Viatris Company | Current | October 5, 2026 |
| Dexamethasone Sodium Phosphate, Injection, 10 mg/1 mL (NDC 70069-025-10) | Somerset Therapeutics, LLC | Current | September 11, 2026 |
| Dexamethasone Sodium Phosphate, Injection, 10 mg/1 mL (NDC 76045-0212-10) | Fresenius Kabi USA, LLC | Current | September 15, 2026 |
Every dexamethasone presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has dexamethasone been recalled?
The FDA's Enforcement Report lists 31 recalls naming dexamethasone since 2012: 0 Class I (the most serious), 28 Class II, 3 Class III; 3 still ongoing. 23 of them are by firms that FDA's NDC Directory does not list as a maker of dexamethasone and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 4, 2026 | Class II | SOMERSET THERAPEUTICS LLC | Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs … |
| May 23, 2024 | Class II | Eugia US LLC | Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec. |
| December 22, 2022 | Class II | Pharmacy Innovations not a listed maker | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. |
| February 21, 2022 | Class II | Morton Grove Pharmaceuticals, Inc. | Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product. |
| December 6, 2021 | Class II | Edge Pharma, LLC | Lack of Assurance of Sterility |
| January 15, 2020 | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical not a listed maker | Lack of Assurance of Sterility |
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
| April 2, 2019 | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderson … not a listed maker | Lack of sterility assurance. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dexamethasone label say about other medicines?
The dexamethasone label names 23 other medicines in its interaction, contraindication or warning sections. The labels of 41 other medicines name dexamethasone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amphotericin b | drug interactions | Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. |
| Aspirin | drug interactions | Nonsteroidal Anti-Inflammatory Agents (NSAIDS): Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents) and corticosteroids increases the risk of gastrointestinal side effects. |
| Carbamazepine | drug interactions | Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. |
| Carfilzomib | warnings and precautions | The risk for venous and arterial thromboembolism increases significantly when dexamethasone is administered with anti-myeloma products (e.g., thalidomide, lenalidomide, pomalidomide, and carfilzomib). |
| Cholestyramine | drug interactions | Cholestyramine: Cholestyramine may increase the clearance of corticosteroids. |
| Clarithromycin | drug interactions | Co-administration with other drugs which strongly inhibit CYP 3A4 (e.g., itraconazole, clarithromycin, ritonavir, cobicistat-containing products) may lead to increased plasma concentrations of corticosteroids and potentially increase the risk for systemic corticosteroid side effects. |
| Cyclosporine | drug interactions | Cyclosporine: Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. |
| Ephedrine | drug interactions | Ephedrine may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessened physiologic activity, thus requiring an increase in corticosteroid dosage. |
| Erythromycin | drug interactions | CYP 3A4 Inhibitors: Concomitant administration of dexamethasone with erythromycin, a moderate CYP 3A4 inhibitor, has the potential to result in increased plasma concentrations of dexamethasone. |
| Fluorescein | warnings and precautions | The initial prescription and renewal of the medication order of DEXTENZA should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. |
| Hydrocortisone | drug interactions | In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. |
| Indomethacin | drug interactions | Dexamethasone suppression test (DST): False-negative results in the dexamethasone suppression test (DST) in patients being treated with indomethacin have been reported. |
| Isoniazid | drug interactions | Antitubercular drugs: Serum concentrations of isoniazid may be decreased. |
| Itraconazole | drug interactions | Co-administration with other drugs which strongly inhibit CYP 3A4 (e.g., itraconazole, clarithromycin, ritonavir, cobicistat-containing products) may lead to increased plasma concentrations of corticosteroids and potentially increase the risk for systemic corticosteroid side effects. |
Every other medicine the dexamethasone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Ketoconazole | drug interactions | Ketoconazole, a strong CYP3A4 inhibitor, has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. |
| Lenalidomide | warnings and precautions | The risk for venous and arterial thromboembolism increases significantly when dexamethasone is administered with anti-myeloma products (e.g., thalidomide, lenalidomide, pomalidomide, and carfilzomib). |
| Levothyroxine | warnings and precautions | When concomitant administration of corticosteroids and levothyroxine is required, administration of corticosteroid should precede the initiation of levothyroxine therapy to avoid adrenal crisis. |
| Phenytoin | drug interactions | Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin) may enhance the metabolism of corticosteroids and require that the dosage of … |
| Pomalidomide | warnings and precautions | The risk for venous and arterial thromboembolism increases significantly when dexamethasone is administered with anti-myeloma products (e.g., thalidomide, lenalidomide, pomalidomide, and carfilzomib). |
| Rifampin | drug interactions | Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin) may enhance the metabolism of corticosteroids and require that the dosage of … |
| Ritonavir | drug interactions | Co-administration with other drugs which strongly inhibit CYP 3A4 (e.g., itraconazole, clarithromycin, ritonavir, cobicistat-containing products) may lead to increased plasma concentrations of … |
| Thalidomide | drug interactions | Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. |
| Warfarin | drug interactions | Anticoagulants, oral: Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. |
Other labels that name dexamethasone
- Arsenic trioxide
- Atazanavir
- Blinatumomab
- Buspirone
- Cobicistat
- Dabrafenib
- Daratumumab and hyaluronidase
- Darunavir
- Diazepam
- Donepezil and memantine
- Enasidenib
- Etravirine
- Everolimus
- Fosamprenavir
- Fosaprepitant
- Gilteritinib
- Iberdomide
- Ivosidenib
- Ixazomib
- Lenacapavir
- Liothyronine
- Nivolumab
- Pegaspargase
- Pembrolizumab
- Rilpivirine
- Temsirolimus
- Venetoclax
- Ziftomenib
Source: FDA drug label (Dexamethasone Intensol), Hikma Pharmaceuticals USA, Inc., effective June 6, 2025 (SPL set b15200fb-1826-472b-a907-e677a272513b), via openFDA; the full label on DailyMed
What do FAERS reports show for dexamethasone?
The FDA Adverse Event Reporting System holds 304,163 reports that list dexamethasone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 49,353 are coded as a death and 117,148 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as dexamethasone?
14 other medicines are given the same way (oral) and in the same FDA class as dexamethasone or labeled mainly for the same use (asthma), the same class first. Asthma lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Prednisone | Osteoarthritis, Asthma, Allergies, Crohn's disease and ulcerative colitis, Herpes and shingles, Eczema (atopic dermatitis), Leukemia, lymphoma and myeloma, Anemia | 46 labelers | $0.0643 per tablet 20 mg tablet | No current entry |
| Hydrocortisone | Osteoarthritis, Asthma, Allergies, Crohn's disease and ulcerative colitis, Herpes and shingles, Leukemia, lymphoma and myeloma | 16 labelers | $0.180 per tablet 10 mg tablet | A presentation being discontinued |
| Methylprednisolone | Osteoarthritis, Allergies, Crohn's disease and ulcerative colitis, Herpes and shingles, Leukemia, lymphoma and myeloma, Anemia | 24 labelers | $0.121 per tablet 4 mg tablet | In shortage |
| Prednisolone | Osteoarthritis, Asthma, Allergies, Crohn's disease and ulcerative colitis, Herpes and shingles, Eczema (atopic dermatitis), Leukemia, lymphoma and myeloma, Anemia | 23 labelers | $0.568 per mL 15 mg/5 mL solution | No current entry |
| Budesonide | Asthma, Crohn's disease and ulcerative colitis | 14 labelers | $0.498 per capsule 3 mg capsule | No current entry |
| Cortisone | Osteoarthritis, Asthma, Allergies, Crohn's disease and ulcerative colitis, Herpes and shingles, Leukemia, lymphoma and myeloma | 1 labeler | n/a | No current entry |
| Montelukast | Asthma, Allergies | 36 labelers | $0.0419 per tablet 10 mg tablet | A presentation being discontinued |
| Theophylline | Asthma | 26 labelers | $0.330 per tablet 300 mg tablet | No current entry |
Every medicine labeled for the same conditions as dexamethasone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does dexamethasone compare with medicines for the same use?
18 side-by-side pages set dexamethasone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to dexamethasone
- 14 medicines for the same use
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Dexamethasone side effects
- the label's list beside FAERS reports
- Dexamethasone shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other