Hexadrol, Ozurdex(dexamethasone)
Ciprodex, Decadron, Dexacen, Dexacort, Dexair, Dextenza, Dexycu, Hemady, Hexadrol, Maxidex, Maxitrol, 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
Dextenza, Dexycu, Hemady, Maxidex, Ozurdex (generic drugs available since 1982-01-01, discontinued: Aeroseb-dex, Decaderm, Decadron, Decadron-la, Decaspray, Dexacen, Dexacort, Dexair, Dexone, Hexadrol, Maxidex)
CombinationsCiprodex, Maxitrol, Tobradex (generic drugs available since 1982-01-01, discontinued: Decadron w/ xylocaine, Dexacidin, Dexasporin, Neodecadron)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ciprofloxacin
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Dexamethasone
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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Neomycin sulfate
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Polymyxin b sulfate
Dexamethasone
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Tobramycin
Dexamethasone acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DECADRON-LA | Merck KGaA | N-016675 DISCN | 1982-01-01 | 1 products, RLD |
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Dexamethasone sodium phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| HEXADROL | Aspen Global | N-014694 DISCN | 1982-01-01 | 3 products |
| DECADRON | Merck KGaA | N-011977 DISCN | 1982-01-01 | 1 products |
| DECADRON | Merck KGaA | N-011983 DISCN | 1982-01-01 | 1 products |
| DECADRON | Merck KGaA | N-011984 DISCN | 1982-01-01 | 1 products, RLD |
| DECADRON | Merck KGaA | N-012071 DISCN | 1982-01-01 | 2 products, RLD |
| DEXACORT | UCB | N-013413 DISCN | 1982-01-01 | 1 products |
| DEXACORT | UCB | N-014242 DISCN | 1982-01-01 | 1 products |
Hide discontinued
Dexamethasone sodium phosphate
+
Lidocaine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DECADRON W/ XYLOCAINE | Merck KGaA | N-013334 DISCN | 1982-01-01 | 1 products |
Hide discontinued
Dexamethasone sodium phosphate
+
Neomycin sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NEODECADRON | Merck KGaA | N-050322 DISCN | 1982-01-01 | 1 products |
| NEODECADRON | Merck KGaA | N-050324 DISCN | 1982-01-01 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ciprodex | New Drug Application | 2023-06-26 |
| ciprofloxacin and dexamethasone | NDA authorized generic | 2024-01-11 |
| cortaren corticosteroid/anti-inflammatory system | ANDA | 2022-02-24 |
| 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 |
| dexabliss | ANDA | 2020-04-08 |
| dexamethasone | ANDA | 2024-01-01 |
| dexamethasone 6-day | ANDA | 2022-01-18 |
| dexamethasone dexamethasone intensol | ANDA | 2020-06-27 |
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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
4018 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 | 268 | 505 | 170 | 14 | 41 | 851 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 53 | 79 | 42 | 20 | 7 | 174 |
| Postoperative pain | D010149 | — | G89.18 | 6 | 15 | 20 | 75 | 51 | 161 |
| Macular edema | D008269 | — | — | 8 | 28 | 20 | 27 | 35 | 109 |
| Vomiting | D014839 | HP_0002013 | R11.1 | 3 | 24 | 43 | 18 | 20 | 107 |
| Neoplasms | D009369 | — | C80 | 31 | 34 | 20 | 5 | 10 | 90 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | 1 | 15 | 14 | 37 | 27 | 90 |
| Covid-19 | D000086382 | — | U07.1 | 5 | 18 | 31 | 8 | 18 | 75 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 22 | 29 | 6 | 3 | 4 | 57 |
| Cataract | D002386 | HP_0000518 | H26.9 | 2 | 6 | 14 | 18 | 15 | 54 |
Show 242 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 14 | 49 | 18 | — | 6 | 82 |
| Leukemia | D007938 | — | C95 | 8 | 38 | 27 | — | 10 | 75 |
| Plasma cell neoplasms | D054219 | — | — | 6 | 33 | 10 | — | 2 | 47 |
| Hodgkin disease | D006689 | — | C81 | 11 | 16 | 8 | — | — | 32 |
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | 11 | 16 | 6 | — | — | 29 |
| Amyloidosis | D000686 | EFO_1001875 | E85 | 8 | 14 | 4 | — | 5 | 25 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 12 | 8 | 4 | — | — | 19 |
| Extranodal nk-t-cell lymphoma | D054391 | — | C86.0 | 1 | 14 | 2 | — | 3 | 19 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 3 | 14 | 1 | — | — | 16 |
| Follicular lymphoma | D008224 | — | C82 | 4 | 9 | 2 | — | — | 13 |
Show 160 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell lymphoma | D016393 | — | — | 6 | 4 | — | — | — | 9 |
| Cholangiocarcinoma | D018281 | — | C22.1 | 2 | 6 | — | — | 1 | 9 |
| Plasma cell leukemia | D007952 | — | C90.1 | 2 | 6 | — | — | 1 | 8 |
| Recurrence | D012008 | — | — | 4 | 5 | — | — | — | 8 |
| Smoldering multiple myeloma | D000075122 | — | — | — | 8 | — | — | — | 8 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 4 | 5 | — | — | 2 | 8 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 2 | 4 | — | — | 2 | 7 |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | — | 6 | 5 | — | — | — | 7 |
| Glioblastoma | D005909 | EFO_0000515 | — | 4 | 2 | — | — | 3 | 7 |
| Post-dural puncture headache | D051299 | — | — | — | 1 | — | — | 5 | 6 |
Show 136 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 4 | — | — | — | 5 | 9 |
| Vitiligo | D014820 | EFO_0004208 | L80 | 1 | — | — | — | 3 | 4 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | 1 | — | — | — | 2 | 3 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 1 | — | — | — | 2 | 3 |
| Hairy cell leukemia | D007943 | — | C91.4 | 2 | — | — | — | — | 2 |
| Central serous chorioretinopathy | D056833 | — | H35.71 | 1 | — | — | — | 1 | 2 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | — | — | — | 1 | 2 |
| Trigeminal neuralgia | D014277 | EFO_1001219 | G50.0 | 1 | — | — | — | 1 | 2 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 1 | — | — | — | 1 | 2 |
| Glioma | D005910 | EFO_0000520 | — | 2 | — | — | — | — | 2 |
Show 45 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pituitary acth hypersecretion | D047748 | EFO_1001110 | E24.0 | — | — | — | — | 6 | 6 |
| Myopia | D009216 | EFO_0003927 | H52.1 | — | — | — | — | 5 | 5 |
| Hyperaldosteronism | D006929 | HP_0011736 | E26 | — | — | — | — | 4 | 4 |
| Male breast neoplasms | D018567 | — | — | — | — | — | — | 3 | 3 |
| Chalazion | D017043 | EFO_0007363 | H00.1 | — | — | — | — | 3 | 3 |
| Patient satisfaction | D017060 | — | — | — | — | — | — | 3 | 3 |
| Cushing syndrome | D003480 | EFO_0003099 | E24 | — | — | — | — | 3 | 3 |
| Cryptorchidism | D003456 | EFO_0004562 | Q53.1 | — | — | — | — | 3 | 3 |
| Pulpitis | D011671 | EFO_1001139 | K04.0 | — | — | — | — | 3 | 3 |
| Critical illness | D016638 | — | — | — | — | — | — | 2 | 2 |
Show 171 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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Dexamethasone
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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
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97,284 adverse events reported
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