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Drug ReportsDexamethasone
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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Novartis Pharmaceuticals
Case Study: COVID-19
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
neoplasmsD009369
musculoskeletal diseasesD009140
digestive system diseasesD004066
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
nervous system diseasesD009422
eye diseasesD005128
cardiovascular diseasesD002318
hemic and lymphatic diseasesD006425
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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)
Combinations
Ciprodex, Ciprofloxacin dexamethasone, 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
+
Neomycin sulfate
+
Polymyxin b sulfate
Tradename
Company
Number
Date
Products
MAXITROLHarrowN-050023 RX1982-01-01
1 products, RLD, RS
MAXITROLSandozN-050065 RX1982-01-01
1 products, RLD, RS
Dexamethasone
Tradename
Company
Number
Date
Products
OZURDEXAbbVieN-022315 RX2009-06-17
1 products, RLD, RS
HEMADYDexcel PharmaN-211379 RX2019-10-03
1 products, RLD, RS
DEXYCU KITEyepoint PharmaceuticalsN-208912 RX2018-02-09
1 products, RLD, RS
MAXIDEXHarrowN-013422 RX1982-01-01
1 products, RLD, RS
DEXTENZAOcular TherapeutixN-208742 RX2018-11-30
1 products, RLD, RS
Show 6 discontinued
Dexamethasone
+
Tobramycin
Tradename
Company
Number
Date
Products
TOBRADEX STHarrowN-050818 RX2009-02-13
1 products, RLD, RS
TOBRADEXNovartisN-050616 RX1988-09-28
1 products, RLD, RS
TOBRADEXSandozN-050592 RX1988-08-18
1 products, RLD, RS
Dexamethasone sodium phosphate
Tradename
Company
Number
Date
Products
HEXADROLAspen GlobalN-014694 DISCN1982-01-01
3 products
DECADRONMerck & CoN-011977 DISCN1982-01-01
1 products
DECADRONMerck & CoN-011983 DISCN1982-01-01
1 products
DECADRONMerck & CoN-011984 DISCN1982-01-01
1 products, RLD
DECADRONMerck & CoN-012071 DISCN1982-01-01
2 products, RLD
DEXACORTUCBN-013413 DISCN1982-01-01
1 products
DEXACORTUCBN-014242 DISCN1982-01-01
1 products
Hide discontinued
Dexamethasone sodium phosphate
+
Lidocaine hydrochloride
Tradename
Company
Number
Date
Products
DECADRON W/ XYLOCAINEMerck & CoN-013334 DISCN1982-01-01
1 products
Hide discontinued
Dexamethasone acetate
Tradename
Company
Number
Date
Products
DECADRON-LAMerck & CoN-016675 DISCN1982-01-01
1 products, RLD
Hide discontinued
Dexamethasone sodium phosphate
+
Neomycin sulfate
Tradename
Company
Number
Date
Products
NEODECADRONMerck & CoN-050322 DISCN1982-01-01
1 products
NEODECADRONMerck & CoN-050324 DISCN1982-01-01
1 products
Hide discontinued
Ciprofloxacin
+
Dexamethasone
Tradename
Company
Number
Date
Products
CIPRODEXSandozN-021537 RX2003-07-18
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
baycadronANDA2009-07-15
ciprodexNew Drug Application2023-06-26
ciprofloxacin and dexamethasoneANDA2024-11-01
cortaren corticosteroid/anti-inflammatory systemANDA2022-02-24
decadronANDA2017-10-01
dex-moxiunapproved drug other2020-02-10
dex-moxi pfunapproved drug other2018-05-08
dex-moxi-ketorunapproved drug other2020-02-10
dexablissANDA2020-04-08
dexamethasoneANDA2025-01-02
Show 39 more
Agency Specific
FDA
EMA
Expiration
Code
DEXAMETHASONE, HEMADY, DEXCEL
2026-10-03ODE-271
DEXAMETHASONE, DEXTENZA, OCULAR THERAPEUTIX
2024-10-07I-876
DEXAMETHASONE, DEXAMETHASONE, AMNEAL
2023-03-08CGT
Patent Expiration
Patent
Expires
Flag
FDA Information
Dexamethasone, Dexycu Kit, Eyepoint Pharms
110970612039-06-23DPU-3418
100225022034-06-22U-2340
100289652034-05-23U-2340
101596832034-05-23DP
107996422032-05-11DP
69603462023-07-03DP
Dexamethasone, Hemady, Dexcel
105375852037-12-18DP
113049612037-12-18DPU-3344
Dexamethasone, Dextenza, Ocular Therapeutix
114580412037-11-16U-1680, U-3455
84096062030-05-14DP
85630272030-02-12U-2487
92542672024-09-11DP
Dexamethasone / Tobramycin, Tobradex St, Eyevance
77953162028-08-03DPU-1082
81015822027-12-19DPU-1082
84502872027-12-19DP
Ciprofloxacin / Dexamethasone, Ciprodex, Novartis
88466502025-06-04DPU-1578
Dexamethasone, Ozurdex, Abbvie
68997172023-11-01U-1206
80343662023-01-09DPU-1204, U-1205
80343702023-01-09DP
85069872023-01-09U-1204, U-1205
91925112023-01-09DP
100765262023-01-09DP
107025392023-01-09U-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
4202 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AdenomaD00023611
Adrenocortical adenomaD01824611
Cushing syndromeD003480EFO_0003099E2411
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101C90.09116125
Plasma cell neoplasmsD0542199106124
LymphomaD008223C85.94216
Macular edemaD008269134
EdemaD004487HP_0000969R60.9134
Lung neoplasmsD008175HP_0100526C34.9033
Small cell lung carcinomaD05575233
Disease progressionD01845011
Covid-19D00008638211
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C95526
Precursor cell lymphoblastic leukemia-lymphomaD054198526
Lymphoid leukemiaD007945C91425
Non-hodgkin lymphomaD008228C85.9414
NeoplasmsD009369C80223
B-cell lymphomaD016393313
Acute diseaseD000208112
Precursor t-cell lymphoblastic leukemia-lymphomaD054218112
Prostatic neoplasmsD011471C61111
CarcinomaD002277C80.0111
Show 12 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470C92.022
NeuroblastomaD009447EFO_000062111
Myelodysplastic syndromesD009190D4611
Hematologic neoplasmsD01933711
RecurrenceD01200811
PreleukemiaD01128911
SyndromeD01357711
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Diabetes mellitusD003920HP_0000819E08-E1311
Retinal vein occlusionD012170EFO_1001157H34.8111
Vascular diseasesD014652EFO_0004264I7711
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDexamethasone
INNdexamethasone
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)Loading
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-ID50-02-2
RxCUI
ChEMBL IDCHEMBL384467
ChEBI ID41879
PubChem CID5743
DrugBankDB01234
UNII ID7S5I7G3JQL (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Ozurdex Allergan
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Ozurdex Warner Chilcott
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Ozurdex AbbVie
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Tabular view
Estimated US medical usage
Dexamethasone
+
Ciprofloxacin
Total medical expenditures per year (USD, in millions)
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Dexamethasone
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Dexamethasone
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Moxifloxacin
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Dexamethasone
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Neomycin
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Dexamethasone
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Neomycin
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Polymyxin b
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Number of persons purchased
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Dexamethasone
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Tobramycin
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 106,013 documents
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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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143,564 adverse events reported
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