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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
Show 1 more
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 416 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
shock—D012769R57.1
ulcerative colitisEFO_0000729D003093K51
pruritus ani—D011538L29.0
inflammationMP_0001845D007249—
adrenal insufficiency—D000309—
rheumatic diseases—D012216M79.0
status asthmaticus—D013224—
contact dermatitis—D003877L25
facial dermatoses—D005148—
hemorrhoidsEFO_0009552D006484K64
Show 74 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
3818 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple sclerosisD009103EFO_0003885G35—1——12
Lupus nephritisD008181EFO_0005761——1———1
Systemic lupus erythematosusD008180EFO_0002690M32—1———1
NeoplasmsD009369—C80—1———1
Hodgkin diseaseD006689—C81—1———1
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InflammationD007249MP_0001845—————11
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
4306
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
Q96KQ9
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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Neomycin
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Polymyxin b
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Oxytetracycline
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Polymyxin b
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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 124,921 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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35,186 adverse events reported
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