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Drug ReportsHydrocortisone
Cort-dome, Plenadren(hydrocortisone)
/ Hydrocortisone, / Hydrocortisone / Neomycin / Polymyxin B, Acetic Acid, Achromycin, Ala-cort, Ala-scalp, Alkindi, Alphaderm, Anusol, Calmurid, Casporyn, Cipro, Colocort, Coly-mycin, Cor-oticin, Cortef, Cortenema, Cortifoam, Cortisporin, Efmody, Epifoam, Hydrocortisone, Hydrocortisone / Neomycin / Polymyxin B, Hydrocortone, Micort-hc, Neo-cort-dome, Neo-cortef, Ophthocort, Oticair, Plenadren, Pramosone, Proctofoam, Pyocidin, Solu-cortef, Stie-cort, Terra-cortril, Texacort, Vosol, Xerese (hydrocortisone) is a small molecule pharmaceutical. Hydrocortisone was first approved as Vosol hc on 1982-01-01. It is used to treat adrenal insufficiency, congenital adrenal hyperplasia, contact dermatitis, facial dermatoses, and foot dermatoses amongst others in the USA. It has been approved in Europe to treat adrenal insufficiency and congenital adrenal hyperplasia. The pharmaceutical is active against glucocorticoid receptor. In addition, it is known to target mineralocorticoid receptor.
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
digestive system diseasesD004066
respiratory tract diseasesD012140
urogenital diseasesD000091642
cardiovascular diseasesD002318
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
endocrine system diseasesD004700
immune system diseasesD007154
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Trade Name
FDA
EMA
Ala-cort, Alkindi, Anusol, Colocort, Cortef, Cortenema, Cortifoam, Hydrocortisone, Khindivi, Micort-hc, Solu-cortef, Stie-cort, Texacort (discontinued: A-hydrocort, Aeroseb-hc, Ala-cort, Balneol-hc, Carmol, Cetacort, Cort-dome, Cortef, Cortril, Dermacort, Eldecort, Epicort, Flexicort, H-cort, Hemsol-hc, Hydrocortisone, Hydrocortone, Hytone, Micort-hc, Nogenic, Nutracort, Orabase hca, Penecort, Stie-cort, Synacort, Texacort, U-cort, Westcort)
Combinations
Bacitracin-neomycin-polymyxin w/ hydrocortisone, Casporyn, Cipro, Coly-mycin, Epifoam, Hydrocortisone acetic acid, Neomycin polymyxin b sulfates hydrocortisone, Neomycin polymyxin b sulfates, bacitracin hydrocortisone, Oticair, Pramosone, Proctofoam, Vosol, Xerese (discontinued: Acetasol, Acetic acid w/ hydrocortisone, Achromycin, Bacitracin-neomycin-polymyxin w/ hydrocortisone, Calmurid, Chloromycetin hydrocortisone, Cor-oticin, Cortisporin, Hydrocortisone acetic acid, Hydrocortisone pramoxine, Neo-cort-dome, Neo-cortef, Neomycin polymyxin b sulfates hydrocortisone, Neomycin polymyxin b sulfates, bacitracin hydrocortisone, Ophthocort, Orlex, Otobione, Otobiotic, Otocort, Pediotic, Pramosone, Pyocidin, Terra-cortril)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydrocortisone acetate
Tradename
Company
Number
Date
Products
CORTIFOAMViatrisN-017351 RX1982-02-10
1 products, RLD, RS
Show 6 discontinued
Hydrocortisone
Tradename
Company
Number
Date
Products
CORTENEMAANI PharmaceuticalsN-016199 RX1982-01-01
1 products, RLD, RS
ALKINDI SPRINKLEEton PharmaceuticalsN-213876 RX2020-09-29
4 products, RLD, RS
KHINDIVIEton PharmaceuticalsN-218980 RX2025-05-28
1 products, RLD, RS
CORTEFPharmacia & UpjohnN-008697 RX1982-01-01
3 products, RLD
Show 8 discontinued
Hydrocortisone acetate
+
Neomycin sulfate
+
Polymyxin b sulfate
Tradename
Company
Number
Date
Products
CORTISPORINMonarch PharmaceuticalsN-050218 DISCN1985-08-09
1 products, RLD
Hide discontinued
Hydrocortisone
+
Neomycin sulfate
Tradename
Company
Number
Date
Products
NEO-CORT-DOMEBayerN-050237 DISCN1984-06-05
2 products
Hide discontinued
Hydrocortisone valerate
Tradename
Company
Number
Date
Products
WESTCORTSun Pharmaceutical IndustriesN-017950 DISCN1982-01-01
1 products, RLD
WESTCORTSun Pharmaceutical IndustriesN-018726 DISCN1983-08-08
1 products, RLD
Hide discontinued
Acyclovir
+
Hydrocortisone
Tradename
Company
Number
Date
Products
XERESEBausch Health CompaniesN-022436 RX2009-07-31
1 products, RLD, RS
Chloramphenicol
+
Hydrocortisone acetate
Tradename
Company
Number
Date
Products
CHLOROMYCETIN HYDROCORTISONEParkedale PharmaceuticalsN-050202 DISCN1982-01-01
1 products
Hide discontinued
Hydrocortisone sodium phosphate
Tradename
Company
Number
Date
Products
HYDROCORTONEMerck & CoN-012052 DISCN1982-01-01
1 products, RLD
Hide discontinued
Hydrocortisone sodium succinate
Tradename
Company
Number
Date
Products
SOLU-CORTEFPharmacia & UpjohnN-009866 RX1982-01-01
4 products, RLD, RS
Hydrocortisone
+
Tetracycline hydrochloride
Tradename
Company
Number
Date
Products
ACHROMYCINLederle LaboratoriesN-050272 DISCN1982-01-01
1 products
Hide discontinued
Bacitracin zinc
+
Hydrocortisone
+
Neomycin sulfate
+
Polymyxin b sulfate
Tradename
Company
Number
Date
Products
CORTISPORINCasper PharmaN-050416 DISCN1982-01-01
1 products, RLD
CORTISPORINMonarch PharmaceuticalsN-050168 DISCN1984-05-04
1 products, RLD
Hide discontinued
Chloramphenicol
+
Hydrocortisone acetate
+
Polymyxin b sulfate
Tradename
Company
Number
Date
Products
OPHTHOCORTParkedale PharmaceuticalsN-050201 DISCN1982-01-01
1 products
Hide discontinued
Hydrocortisone
+
Neomycin sulfate
+
Polymyxin b sulfate
Tradename
Company
Number
Date
Products
CASPORYN HCCasper PharmaN-060613 RX1982-01-01
1 products, RLD, RS
Show 2 discontinued
Acetic acid
+
glacial
+
Hydrocortisone
Tradename
Company
Number
Date
Products
VOSOL HCSaptalis PharmaceuticalsN-012770 RX1982-01-01
1 products, RLD, RS
Ciprofloxacin hydrochloride
+
Hydrocortisone
Tradename
Company
Number
Date
Products
CIPRO HCSandozN-020805 RX1998-02-10
1 products, RLD, RS
Colistin sulfate
+
Hydrocortisone acetate
+
Neomycin sulfate
+
Thonzonium bromide
Tradename
Company
Number
Date
Products
COLY-MYCIN SEndoN-050356 RX1982-01-01
1 products, RLD, RS
Acetic acid
+
glacial
+
Hydrocortisone
+
Neomycin sulfate
Tradename
Company
Number
Date
Products
NEO-CORT-DOMEBayerN-050238 DISCN1982-01-01
1 products
Hide discontinued
Hydrocortisone cypionate
Tradename
Company
Number
Date
Products
CORTEFPharmacia & UpjohnN-009900 DISCN1982-01-01
1 products
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
OTC monograph not final2012-08-24
141016 hydrocortisone 0.5% / hydroquinone 4% / tretinoin 0.025%unapproved drug other2020-07-02
141017 hydrocortisone 0.5% / hydroquinone 6% / tretinoin 0.025%unapproved drug other2020-07-02
141060 hydrocortisone 0.5% / hydroquinone 4% / tretinoin 0.025%unapproved drug other2020-07-02
141061 hydrocortisone 0.5% / hydroquinone 8% / tretinoin 0.025%unapproved drug other2020-07-02
999 itch relievingOTC monograph not final2016-11-14
advanced anti-itch therapyOTC monograph not final2016-06-14
afassco 1% hydrocortisoneOTC monograph not final2023-01-12
aftate hydrocortisone creamOTC monograph not final2016-03-31
ala-scalpANDA2025-01-08
Show 406 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Hydrocortisone, Alkindi Sprinkle, Eton
96492802034-05-12DPU-3075
96755592033-01-10U-3075
97177402032-11-19U-3075
ATC Codes
A: Alimentary tract and metabolism drugs
A01: Stomatological preparations
A01A: Stomatological preparations
A01AC: Corticosteroids for local oral treatment
A01AC03: Hydrocortisone
A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
A07E: Intestinal antiinflammatory agents
A07EA: Corticosteroids acting locally
A07EA02: Hydrocortisone
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
C05AA01: Hydrocortisone
D: Dermatologicals
D07: Corticosteroids, dermatological preparations
D07A: Corticosteroid dermatological preparations, plain
D07AA: Corticosteroids, weak (group i)
D07AA02: Hydrocortisone
D07AB: Corticosteroids, moderately potent (group ii)
D07AB02: Hydrocortisone butyrate
D07AB11: Hydrocortisone buteprate
D07AC: Corticosteroids, potent (group iii)
D07AC16: Hydrocortisone aceponate
D07B: Corticosteroids, combinations with antiseptics
D07BA: Corticosteroids, weak, combinations with antiseptics
D07BA04: Hydrocortisone and antiseptics
D07BB: Corticosteroids, moderately potent, combinations with antiseptics
D07BB04: Hydrocortisone butyrate and antiseptics
D07C: Corticosteroids, combinations with antibiotics
D07CA: Corticosteroids, weak, combinations with antibiotics
D07CA01: Hydrocortisone and antibiotics
D07X: Corticosteroids, other combinations
D07XA: Corticosteroids, weak, other combinations
D07XA01: Hydrocortisone
H: Systemic hormonal preparations, excl. sex hormones and insulins
H02: Corticosteroids for systemic use
H02A: Corticosteroids for systemic use, plain
H02AB: Glucocorticoids, systemic
H02AB09: Hydrocortisone
R: Respiratory system drugs
R01: Nasal preparations
R01A: Decongestants and other nasal preparations for topical use
R01AD: Corticosteroid nasal preparations for topical use
R01AD60: Hydrocortisone, combinations
S: Sensory organ drugs
S01: Ophthalmologicals
S01B: Antiinflammatory agents, ophthalmologic
S01BA: Corticosteroid ophthalmologic antiinflammatory agents, plain
S01BA02: Hydrocortisone
S01BB: Corticosteroids and mydriatics in combination
S01BB01: Hydrocortisone and mydriatics
S01C: Antiinflammatory agents and antiinfectives in combination
S01CA: Corticosteroids and antiinfectives in combination, opthalmologic
S01CA03: Hydrocortisone and antiinfectives
S01CB: Corticosteroids/antiinfectives/mydriatics in combination
S01CB03: Hydrocortisone
S02: Otologicals
S02B: Corticosteroid otologicals
S02BA: Corticosteroids
S02BA01: Hydrocortisone
S02C: Corticosteroids and antiinfectives in combination, otologic
S02CA: Corticosteroids and antiinfectives in combination
S02CA03: Hydrocortisone and antiinfectives
S03: Ophthalmological and otological preparations
S03C: Corticosteroids and antiinfectives in combination, opthalmologic and otologic
S03CA: Corticosteroids and antiinfectives in combination
S03CA04: Hydrocortisone and antiinfectives
HCPCS
Code
Description
J1700
Injection, hydrocortisone acetate, up to 25 mg
J1710
Injection, hydrocortisone sodium phosphate, up to 50 mg
J1720
Injection, hydrocortisone sodium succinate, up to 100 mg
Clinical
Clinical Trials
3743 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atrial fibrillationD001281EFO_0000275I48.011
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AsthmaD001249EFO_0000270J4511
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic kidney failureD007676EFO_0003884N18.611
Renal insufficiencyD051437N1911
Kidney transplantationD01603011
HyperparathyroidismD006961EFO_0008506E21.311
Secondary hyperparathyroidismD006962EFO_100117311
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameHydrocortisone
INNhydrocortisone
Description
Cortisol is a 17alpha-hydroxy-C21-steroid that is pregn-4-ene substituted by oxo groups at positions 3 and 20 and hydroxy groups at positions 11, 17 and 21. Cortisol is a corticosteroid hormone or glucocorticoid produced by zona fasciculata of the adrenal cortex, which is a part of the adrenal gland. It is usually referred to as the "stress hormone" as it is involved in response to stress and anxiety, controlled by corticotropin-releasing hormone (CRH). It increases blood pressure and blood sugar, and reduces immune responses. It has a role as an anti-inflammatory drug, an anti-allergic agent, an anti-asthmatic drug, a human metabolite, a mouse metabolite and a drug allergen. It is a 21-hydroxy steroid, an 11beta-hydroxy steroid, a 20-oxo steroid, a 3-oxo-Delta(4) steroid, a primary alpha-hydroxy ketone, a tertiary alpha-hydroxy ketone, a 17alpha-hydroxy-C21-steroid and a glucocorticoid. It derives from a hydride of a pregnane.
Classification
Small molecule
Drug classcortisone derivatives
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C[C@]12C[C@H](O)[C@H]3[C@@H](CCC4=CC(=O)CC[C@@]43C)[C@@H]1CC[C@]2(O)C(=O)CO
Identifiers
PDB
CAS-ID50-23-7
RxCUI
ChEMBL IDCHEMBL389621
ChEBI ID17650
PubChem CID5754
DrugBankDB00741
UNII IDWI4X0X7BPJ (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
NR3C2
NR3C2
Organism
Homo sapiens
Gene name
NR3C2
Gene synonyms
MCR, MLR
NCBI Gene ID
Protein name
mineralocorticoid receptor
Protein synonyms
aldosterone receptor, mineralocorticoid receptor 1, mineralocorticoid receptor 2, mineralocorticoid receptor delta, Nuclear receptor subfamily 3 group C member 2
Uniprot ID
Mouse ortholog
Nr3c2 (110784)
mineralocorticoid receptor (Q8VII8)
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Hydrocortisone
+
Benzoyl peroxide
Total medical expenditures per year (USD, in millions)
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Hydrocortisone
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Ciprofloxacin
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Hydrocortisone
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Clioquinol
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Hydrocortisone
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Hydrocortisone
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Lidocaine
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Hydrocortisone
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Neomycin
+
Polymyxin b
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Hydrocortisone
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Oxytetracycline
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Polymyxin b
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Hydrocortisone
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Pramoxine
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 115,475 documents
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Safety
Black-box Warning
Black-box warning for: Ciprofloxacin, Ciprofloxacin hcl, Ciprofloxacin in dextrose, Proquin, Proquin xr
Adverse Events
Top Adverse Reactions
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33,949 adverse events reported
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