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hydrocortisone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
corticosteroids, except prednisolone derivatives	1388	50-23-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: hydrocortisone 17-hydroxycorticosterone acticort cetacort hydracort hydrasson hydrocortisyl cortisol	The main glucocorticoid secreted by the ADRENAL CORTEX. Its synthetic counterpart is used, either as an injection or topically, in the treatment of inflammation, allergy, collagen diseases, asthma, adrenocortical deficiency, shock, and some neoplastic conditions. Molecular weight: 362.47 Formula: C21H30O5 CLOGP: 1.89 LIPINSKI: 0 HAC: 5 HDO: 3 TPSA: 94.83 ALOGS: -3.26 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

hydrocortisone
17-hydroxycorticosterone
acticort
cetacort
hydracort
hydrasson
hydrocortisyl
cortisol

The main glucocorticoid secreted by the ADRENAL CORTEX. Its synthetic counterpart is used, either as an injection or topically, in the treatment of inflammation, allergy, collagen diseases, asthma, adrenocortical deficiency, shock, and some neoplastic conditions.

Molecular weight: 362.47
Formula: C21H30O5
CLOGP: 1.89
LIPINSKI: 0
HAC: 5
HDO: 3
TPSA: 94.83
ALOGS: -3.26
ROTB: 2

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
30	mg	O
30	mg	P

ADMET properties:

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Property	Value	Reference
CL (Clearance)	5.70 mL/min/kg	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	353.81 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
t_half (Half-life)	1.60 hours	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	0.38 L/kg	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.23 mg/mL	Bocci G, Oprea TI, Benet LZ
fu (Fraction unbound in plasma)	0.20 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Aug. 5, 1952	FDA	MERCK
May 27, 2021	EMA	Diurnal Europe B.V.

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Infusion related reaction	600.87	9.84	2010	212648	243511	63030853
Pericarditis	598.73	9.84	1353	213305	130226	63144138
Anti-cyclic citrullinated peptide antibody positive	568.20	9.84	1230	213428	114982	63159382
Rheumatoid factor positive	531.73	9.84	993	213665	83413	63190951
Wound	521.83	9.84	1468	213190	161795	63112569
Duodenal ulcer perforation	489.39	9.84	977	213681	86232	63188132
Discomfort	479.21	9.84	1447	213211	165927	63108437
Helicobacter infection	472.94	9.84	999	213659	91786	63182578
Completed suicide	456.30	9.84	7	214651	145666	63128698
Hand deformity	440.95	9.84	1362	213296	158095	63116269

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Intentional product use issue	276.87	10.17	537	92258	59279	34804857
Blood pressure fluctuation	247.61	10.17	320	92475	24929	34839207
Adrenal insufficiency	233.27	10.17	234	92561	13813	34850323
Drug abuse	224.03	10.17	9	92786	99087	34765049
Completed suicide	203.09	10.17	15	92780	98153	34765983
Toxicity to various agents	196.64	10.17	147	92648	200215	34663921
Off label use	191.35	10.17	1822	90973	417702	34446434
Death	187.24	10.17	496	92299	397553	34466583
Inappropriate schedule of product administration	177.47	10.17	461	92334	61835	34802301
Craniopharyngioma	166.29	10.17	52	92743	247	34863889

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Completed suicide	683.46	9.47	21	252810	245746	79245811
Intentional product use issue	648.06	9.47	1466	251365	150646	79340911
Toxicity to various agents	558.25	9.47	322	252509	421218	79070339
Infusion related reaction	541.48	9.47	1783	251048	228454	79263103
Pericarditis	449.72	9.47	1010	251821	103226	79388331
Drug abuse	448.25	9.47	15	252816	162676	79328881
Wound	446.79	9.47	1076	251755	115103	79376454
Anti-cyclic citrullinated peptide antibody positive	441.55	9.47	877	251954	82266	79409291
Glossodynia	433.26	9.47	990	251841	102347	79389210
Duodenal ulcer perforation	428.32	9.47	760	252071	65451	79426106

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FDA Adverse Event Reporting System (Pediatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug-induced liver injury	56.37	37.89	16	205	58	89513
Aspergillus infection	56.06	37.89	17	204	82	89489
Product use issue	41.47	37.89	16	205	175	89396
Hepatotoxicity	41.10	37.89	14	207	103	89468

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Pharmacologic Action:

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Source	Code	Description
ATC	A01AC03	ALIMENTARY TRACT AND METABOLISM STOMATOLOGICAL PREPARATIONS STOMATOLOGICAL PREPARATIONS Corticosteroids for local oral treatment
ATC	A07EA02	ALIMENTARY TRACT AND METABOLISM ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS INTESTINAL ANTIINFLAMMATORY AGENTS Corticosteroids acting locally
ATC	C05AA01	CARDIOVASCULAR SYSTEM VASOPROTECTIVES AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE Corticosteroids
ATC	D07AA02	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, weak (group I)
ATC	D07BA04	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, COMBINATIONS WITH ANTISEPTICS Corticosteroids, weak, combinations with antiseptics
ATC	D07CA01	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS Corticosteroids, weak, combinations with antibiotics
ATC	D07XA01	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, OTHER COMBINATIONS Corticosteroids, weak, other combinations
ATC	H02AB09	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CORTICOSTEROIDS FOR SYSTEMIC USE CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN Glucocorticoids
ATC	R01AD60	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids
ATC	S01BA02	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Corticosteroids, plain

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Disorder of musculoskeletal system	indication	928000	DOID:17
Cerebral edema	indication	2032001
Otitis externa	indication	3135009
Proctitis	indication	3951002	DOID:3127
Keratitis	indication	5888003	DOID:4677
Tinea pedis	indication	6020002	DOID:12403
Berylliosis	indication	8247009	DOID:10322
Psoriasis	indication	9014002	DOID:8893
Ankylosing spondylitis	indication	9631008	DOID:7147
Cyclitis	indication	17657000

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🐶 Veterinary Drug Use

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Species	Use	Relation
Cats	Acute otitis externa	Indication
Cats	Chronic otitis externa	Indication
Cats	Ear canker	Indication
Cats	Inflammatory conditions of the external ear canal	Indication
Cats	Allergy	Indication
Cats	Infectious skin conditions	Indication
Cats	Traumatic skin conditions	Indication
Cats	Prevention of bacterial infections in superficial wounds	Indication
Cats	Prevention of bacterial infections in cuts	Indication
Cats	Prevention of bacterial infections in abrasions	Indication

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🐶 Veterinary products

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Product	Applicant	Ingredients
Cortisporin Veterinary Ophthalmic Ointment	Intervet Inc.	4
Liqua-Cortril Spray, Terra-Cortril Spray	Zoetis Inc.	2

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Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.31	acidic
pKa2	13.65	acidic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.5MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9717740	Nov. 19, 2032	TREATMENT OF ADRENAL INSUFFICIENCY
0.5MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9675559	Jan. 10, 2033	TREATMENT OF ADRENAL INSUFFICIENCY
0.5MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9649280	May 12, 2034	TREATMENT OF ADRENAL INSUFFICIENCY
1MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9717740	Nov. 19, 2032	TREATMENT OF ADRENAL INSUFFICIENCY
1MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9675559	Jan. 10, 2033	TREATMENT OF ADRENAL INSUFFICIENCY
1MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9649280	May 12, 2034	TREATMENT OF ADRENAL INSUFFICIENCY
2MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9717740	Nov. 19, 2032	TREATMENT OF ADRENAL INSUFFICIENCY
2MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9675559	Jan. 10, 2033	TREATMENT OF ADRENAL INSUFFICIENCY
2MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9649280	May 12, 2034	TREATMENT OF ADRENAL INSUFFICIENCY
5MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9717740	Nov. 19, 2032	TREATMENT OF ADRENAL INSUFFICIENCY

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN	AGONIST	EC50	8.50	WOMBAT-PK	CHEMBL
Annexin A1	Cytosolic other	P04083	ANXA1_HUMAN				WOMBAT-PK
Mineralocorticoid receptor	Nuclear hormone receptor	P08235	MCR_HUMAN	AGONIST	IC50	9.95	IUPHAR
Nitric oxide synthase, inducible	Enzyme	P35228	NOS2_HUMAN		IC50	8	WOMBAT-PK
Corticosteroid-binding globulin	Secreted	P08185	CBG_HUMAN		Ki	7.88	WOMBAT-PK
Sex hormone-binding globulin	Secreted	P04278	SHBG_HUMAN		Kd	6.20	CHEMBL
Glucocorticoid receptor	Transcription factor		GCR_RAT		IC50	7.60	CHEMBL
Glucocorticoid receptor	Transcription factor		GCR_MOUSE		Kd	7.37	CHEMBL

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External reference:

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ID	Source
HCY	PDB_CHEM_ID
002147	NDDF
16602005	SNOMEDCT_US
174	MMSL
202643	RXNORM
2500	MMSL
2868	IUPHAR_LIGAND_ID
38	INN_ID
396458002	SNOMEDCT_US
4017941	VUID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Aquanil HC	HUMAN OTC DRUG LABEL	1	0096-0732	LOTION	0.01 g	TOPICAL	OTC monograph not final	10 sections
Aquanil HC	HUMAN OTC DRUG LABEL	1	0096-0732	LOTION	0.01 g	TOPICAL	OTC monograph not final	10 sections
basic care hydrocortisone	HUMAN OTC DRUG LABEL	1	0113-0793	CREAM	1 g	TOPICAL	OTC monograph not final	13 sections
basic care hydrocortisone	HUMAN OTC DRUG LABEL	1	0113-7369	CREAM	1 g	TOPICAL	OTC monograph not final	13 sections
Basic Case Hydrocortisone Anti-Itch	HUMAN OTC DRUG LABEL	1	0113-7006	CREAM	1 g	TOPICAL	OTC monograph not final	13 sections
CIPROHC	HUMAN PRESCRIPTION DRUG LABEL	2	0065-8531	SUSPENSION	10 mg	AURICULAR (OTIC)	NDA	16 sections
CIPROHC	HUMAN PRESCRIPTION DRUG LABEL	2	0065-8531	SUSPENSION	10 mg	AURICULAR (OTIC)	NDA	16 sections
CIPROHC	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0855	SUSPENSION/ DROPS	10 mg	AURICULAR (OTIC)	NDA	16 sections
CIPROHC	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0855	SUSPENSION/ DROPS	10 mg	AURICULAR (OTIC)	NDA	16 sections
CORTEF	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0012	TABLET	5 mg	ORAL	NDA	15 sections

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