Maxitrol, Ozurdex(dexamethasone)
/ Dexamethasone, Ciprodex, Decadron-la, Dexamethasone, Dexamethasone /, Dexamethasone / /, Dexasporin, Dextenza, Dexycu, Hemady, Maxidex, Maxitrol, Neodecadron, Neofordex, Ozurdex, Tobradex (dexamethasone) is a small molecule pharmaceutical. Dexamethasone was first approved as Hexadrol on 1982-01-01. It is used to treat addison disease, allergic rhinitis perennial, ankylosing spondylitis, brain edema, and bursitis amongst others in the USA. It has been approved in Europe to treat macular edema, multiple myeloma, and uveitis.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Dexamethasone, Dextenza, Dexycu, Hemady, Maxidex, Ozurdex (discontinued: Aeroseb-dex, Decaderm, Decadron, Decadron-la, Decaspray, Dexacen, Dexacort, Dexamethasone, Dexone, Hexadrol, Maxidex)
CombinationsCiprodex, Ciprofloxacin dexamethasone, Dexasporin, Maxitrol, Neomycin polymyxin b sulfates dexamethasone, Tobradex, Tobramycin dexamethasone (discontinued: Decadron w/ xylocaine, Dexacidin, Neodecadron, Neomycin dexamethasone, Neomycin polymyxin b sulfates dexamethasone, Neomycin sulfate-dexamethasone, Tobramycin dexamethasone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dexamethasone
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Neomycin sulfate
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Polymyxin b sulfate
Dexamethasone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OZURDEX | AbbVie | N-022315 RX | 2009-06-17 | 1 products, RLD, RS |
| HEMADY | Dexcel Pharma | N-211379 RX | 2019-10-03 | 1 products, RLD, RS |
| DEXYCU KIT | Eyepoint Pharmaceuticals | N-208912 RX | 2018-02-09 | 1 products, RLD, RS |
| MAXIDEX | Harrow | N-013422 RX | 1982-01-01 | 1 products, RLD, RS |
| DEXTENZA | Ocular Therapeutix | N-208742 RX | 2018-11-30 | 1 products, RLD, RS |
Show 6 discontinued
Dexamethasone
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Tobramycin
Dexamethasone acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DECADRON-LA | Merck & Co | N-016675 DISCN | 1982-01-01 | 1 products, RLD |
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Ciprofloxacin
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Dexamethasone
Dexamethasone sodium phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| HEXADROL | Aspen Global | N-014694 DISCN | 1982-01-01 | 3 products |
| DECADRON | Merck & Co | N-011983 DISCN | 1982-01-01 | 1 products |
| DECADRON | Merck & Co | N-012071 DISCN | 1982-01-01 | 2 products, RLD |
| DECADRON | Merck & Co | N-011977 DISCN | 1982-01-01 | 1 products |
| DECADRON | Merck & Co | N-011984 DISCN | 1982-01-01 | 1 products, RLD |
| DEXACORT | UCB | N-013413 DISCN | 1982-01-01 | 1 products |
| DEXACORT | UCB | N-014242 DISCN | 1982-01-01 | 1 products |
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Dexamethasone sodium phosphate
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Lidocaine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DECADRON W/ XYLOCAINE | Merck & Co | N-013334 DISCN | 1982-01-01 | 1 products |
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Dexamethasone sodium phosphate
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Neomycin sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NEODECADRON | Merck & Co | N-050324 DISCN | 1982-01-01 | 1 products |
| NEODECADRON | Merck & Co | N-050322 DISCN | 1982-01-01 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| baycadron | ANDA | 2009-07-15 |
| ciprodex | New Drug Application | 2011-08-23 |
| ciprofloxacin and dexamethasone | ANDA | 2026-03-19 |
| cortaren corticosteroid/anti-inflammatory system | ANDA | 2022-02-24 |
| decadron | ANDA | 2017-10-01 |
| dex-moxi | unapproved drug other | 2020-02-10 |
| dex-moxi pf | unapproved drug other | 2018-05-08 |
| dex-moxi-ketor | unapproved drug other | 2020-02-10 |
| dexamethasone | ANDA | 2026-02-10 |
| dexamethasone 6-day | ANDA | 2022-01-18 |
Show 38 more
Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DEXAMETHASONE, HEMADY, DEXCEL | |||
| 2026-10-03 | ODE-271 | ||
DEXAMETHASONE, DEXTENZA, OCULAR THERAPEUTIX | |||
| 2024-10-07 | I-876 | ||
DEXAMETHASONE, DEXAMETHASONE, AMNEAL | |||
| 2023-03-08 | CGT | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Dexamethasone, Dexycu Kit, Eyepoint Pharms | |||
| 11097061 | 2039-06-23 | DP | U-3418 |
| 10022502 | 2034-06-22 | U-2340 | |
| 10028965 | 2034-05-23 | U-2340 | |
| 10159683 | 2034-05-23 | DP | |
| 10799642 | 2032-05-11 | DP | |
| 6960346 | 2023-07-03 | DP | |
| Dexamethasone, Hemady, Dexcel | |||
| 10537585 | 2037-12-18 | DP | |
| 11304961 | 2037-12-18 | DP | U-3344 |
| Dexamethasone, Dextenza, Ocular Therapeutix | |||
| 11458041 | 2037-11-16 | U-1680, U-3455 | |
| 8409606 | 2030-05-14 | DP | |
| 8563027 | 2030-02-12 | U-2487 | |
| 9254267 | 2024-09-11 | DP | |
| Dexamethasone / Tobramycin, Tobradex St, Eyevance | |||
| 7795316 | 2028-08-03 | DP | U-1082 |
| 8101582 | 2027-12-19 | DP | U-1082 |
| 8450287 | 2027-12-19 | DP | |
| Ciprofloxacin / Dexamethasone, Ciprodex, Novartis | |||
| 8846650 | 2025-06-04 | DP | U-1578 |
| Dexamethasone, Ozurdex, Abbvie | |||
| 6899717 | 2023-11-01 | U-1206 | |
| 8034366 | 2023-01-09 | DP | U-1204, U-1205 |
| 8034370 | 2023-01-09 | DP | |
| 8506987 | 2023-01-09 | U-1204, U-1205 | |
| 9192511 | 2023-01-09 | DP | |
| 10076526 | 2023-01-09 | DP | |
| 10702539 | 2023-01-09 | U-985, U-1597, U-2868 | |
ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AC: Corticosteroids for local oral treatment
— A01AC02: Dexamethasone
C: Cardiovascular system drugs
— C05: Vasoprotectives
— C05A: Agents for treatment of hemorrhoids and anal fissures for topical use
— C05AA: Corticosteroids, topical for treatment of hemorrhoids and anal fissures
— C05AA09: Dexamethasone
D: Dermatologicals
— D07: Corticosteroids, dermatological preparations
— D07A: Corticosteroid dermatological preparations, plain
— D07AB: Corticosteroids, moderately potent (group ii)
— D07AB19: Dexamethasone
— D07C: Corticosteroids, combinations with antibiotics
— D07CB: Corticosteroids, moderately potent, combinations with antibiotics
— D07CB04: Dexamethasone and antibiotics
— D07X: Corticosteroids, other combinations
— D07XB: Corticosteroids, moderately potent, other combinations
— D07XB05: Dexamethasone
— D10: Anti-acne preparations
— D10A: Anti-acne preparations for topical use
— D10AA: Corticosteroids, combinations for treatment of acne
— D10AA03: Dexamethasone
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H02: Corticosteroids for systemic use
— H02A: Corticosteroids for systemic use, plain
— H02AB: Glucocorticoids, systemic
— H02AB02: Dexamethasone
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AD: Corticosteroid nasal preparations for topical use
— R01AD03: Dexamethasone
— R01AD53: Dexamethasone, combinations
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01B: Antiinflammatory agents, ophthalmologic
— S01BA: Corticosteroid ophthalmologic antiinflammatory agents, plain
— S01BA01: Dexamethasone
— S01C: Antiinflammatory agents and antiinfectives in combination
— S01CA: Corticosteroids and antiinfectives in combination, opthalmologic
— S01CA01: Dexamethasone and antiinfectives
— S01CB: Corticosteroids/antiinfectives/mydriatics in combination
— S01CB01: Dexamethasone
— S02: Otologicals
— S02B: Corticosteroid otologicals
— S02BA: Corticosteroids
— S02BA06: Dexamethasone
— S02C: Corticosteroids and antiinfectives in combination, otologic
— S02CA: Corticosteroids and antiinfectives in combination
— S02CA06: Dexamethasone and antiinfectives
— S03: Ophthalmological and otological preparations
— S03B: Corticosteroid ophthalmologic and otologic preparations
— S03BA: Corticosteroids
— S03BA01: Dexamethasone
— S03C: Corticosteroids and antiinfectives in combination, opthalmologic and otologic
— S03CA: Corticosteroids and antiinfectives in combination
— S03CA01: Dexamethasone and antiinfectives
HCPCS
Code | Description |
|---|---|
| J1094 | Injection, dexamethasone acetate, 1 mg |
| J1095 | Injection, dexamethasone 9 percent, intraocular, 1 microgram |
| J1096 | Dexamethasone, lacrimal ophthalmic insert, 0.1 mg |
| J1100 | Injection, dexamethasone sodium phosphate, 1 mg |
| J7312 | Injection, dexamethasone, intravitreal implant, 0.1 mg |
| J7637 | Dexamethasone, inhalation solution, compounded product, administered through dme, concentrated form, per milligram |
| J7638 | Dexamethasone, inhalation solution, compounded product, administered through dme, unit dose form, per milligram |
| J8540 | Dexamethasone, oral, 0.25 mg |
Clinical
Clinical Trials
4587 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 319 | 601 | 210 | 18 | 60 | 1039 |
| Plasma cell neoplasms | D054219 | — | — | 196 | 390 | 135 | 14 | 50 | 675 |
| Postoperative pain | D010149 | — | G89.18 | 13 | 19 | 28 | 100 | 108 | 260 |
| Lymphoma | D008223 | — | C85.9 | 48 | 167 | 46 | 11 | 13 | 255 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 63 | 131 | 65 | 21 | 16 | 255 |
| Vomiting | D014839 | — | R11.1 | 8 | 43 | 83 | 54 | 54 | 239 |
| Leukemia | D007938 | — | C95 | 53 | 121 | 56 | 15 | 13 | 222 |
| Nausea | D009325 | — | R11.0 | 5 | 33 | 57 | 46 | 38 | 177 |
| Neoplasms | D009369 | — | C80 | 53 | 60 | 25 | 9 | 17 | 144 |
| Lymphoid leukemia | D007945 | — | C91 | 29 | 70 | 31 | 14 | 7 | 132 |
Show 412 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Amyloidosis | D000686 | EFO_1001875 | E85 | 15 | 41 | 11 | — | 8 | 66 |
| Plasmacytoma | D010954 | — | C90.3 | 5 | 33 | 14 | — | 2 | 53 |
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | 15 | 29 | 10 | — | 4 | 53 |
| Hodgkin disease | D006689 | — | C81 | 11 | 23 | 10 | — | 1 | 41 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 17 | 19 | 6 | — | 3 | 39 |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | — | 14 | 22 | 6 | — | — | 30 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 15 | 10 | 5 | — | 1 | 26 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 7 | 19 | 1 | — | 1 | 25 |
| Follicular lymphoma | D008224 | — | C82 | 6 | 16 | 4 | — | 2 | 25 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 7 | 13 | 5 | — | 2 | 25 |
Show 246 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 3 | 12 | — | — | 1 | 14 |
| Plasma cell leukemia | D007952 | — | C90.1 | 3 | 9 | — | — | 1 | 12 |
| Cholangiocarcinoma | D018281 | — | C22.1 | 2 | 7 | — | — | 2 | 11 |
| Blast crisis | D001752 | — | — | 2 | 7 | — | — | 1 | 9 |
| Hyperaldosteronism | D006929 | — | E26 | 2 | 1 | — | — | 7 | 9 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 3 | 7 | — | — | — | 9 |
| Meningeal carcinomatosis | D055756 | EFO_1001012 | — | 3 | 6 | — | — | 2 | 9 |
| Cushing syndrome | D003480 | EFO_0003099 | E24 | — | 1 | — | — | 8 | 9 |
| Glioblastoma | D005909 | EFO_0000515 | — | 4 | 3 | — | — | 3 | 8 |
| Pituitary acth hypersecretion | D047748 | EFO_1001110 | E24.0 | — | 1 | — | — | 7 | 8 |
Show 182 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperandrogenism | D017588 | — | — | 4 | — | — | — | 3 | 7 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | 2 | — | — | — | 3 | 5 |
| Overweight | D050177 | — | E66.3 | 3 | — | — | — | 1 | 4 |
| Hairy cell leukemia | D007943 | — | C91.4 | 2 | — | — | — | 1 | 3 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | — | — | — | 2 | 3 |
| Trigeminal neuralgia | D014277 | EFO_1001219 | G50.0 | 1 | — | — | — | 2 | 3 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 1 | — | — | — | 2 | 3 |
| Female infertility | D007247 | EFO_0008560 | N97 | 1 | — | — | — | 2 | 3 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 1 | — | — | — | 2 | 3 |
| Endometrioid carcinoma | D018269 | — | — | 1 | — | — | — | 1 | 2 |
Show 68 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myopia | D009216 | EFO_0003927 | H52.1 | — | — | — | — | 5 | 5 |
| Rib fractures | D012253 | — | — | — | — | — | — | 4 | 4 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | — | — | 3 | 3 |
| Intraoperative complications | D007431 | — | — | — | — | — | — | 3 | 3 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | — | 3 | 3 |
| Bilateral hearing loss | D006312 | — | — | — | — | — | — | 3 | 3 |
| Chalazion | D017043 | EFO_0007363 | H00.1 | — | — | — | — | 3 | 3 |
| Cryptorchidism | D003456 | EFO_0004562 | Q53.1 | — | — | — | — | 3 | 3 |
| Gallstones | D042882 | EFO_0004210 | — | — | — | — | — | 3 | 3 |
| Thoracic surgical procedures | D019616 | — | — | — | — | — | — | 3 | 3 |
Show 250 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dexamethasone |
| INN | dexamethasone |
| Description | Dexamethasone is a fluorinated steroid that is 9-fluoropregna-1,4-diene substituted by hydroxy groups at positions 11, 17 and 21, a methyl group at position 16 and oxo groups at positions 3 and 20. It is a synthetic member of the class of glucocorticoids. It has a role as an adrenergic agent, an antiemetic, an antineoplastic agent, an environmental contaminant, a xenobiotic, an immunosuppressive agent and an anti-inflammatory drug. It is a fluorinated steroid, a 3-oxo-Delta(1),Delta(4)-steroid, a glucocorticoid, a 20-oxo steroid, an 11beta-hydroxy steroid, a 17alpha-hydroxy steroid and a 21-hydroxy steroid. It derives from a hydride of a pregnane. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@@H]1C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@]2(C)[C@@]1(O)C(=O)CO |
Identifiers
| PDB | — |
| CAS-ID | 50-02-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL384467 |
| ChEBI ID | 41879 |
| PubChem CID | 5743 |
| DrugBank | DB01234 |
| UNII ID | 7S5I7G3JQL (ChemIDplus, GSRS) |
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Ozurdex – Allergan
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Ozurdex – AbbVie
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Dexamethasone
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Ciprofloxacin
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Dexamethasone
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Dexamethasone
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Dexamethasone
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Polymyxin b
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Dexamethasone
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Tobramycin
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Trends
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Safety
Black-box Warning
Black-box warning for: Dexlido-m kit, Mardex 25 kit
Adverse Events
Top Adverse Reactions
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155,492 adverse events reported
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