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

Stem definitionDrug idCAS RN
corticosteroids, except prednisolone derivatives 3959 13609-67-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • hydrocortisone butyrate
  • Hydrocortisone 17-butyrate
  • laticort
  • Hydrocortisone 17alpha-butyrate
  • Molecular weight: 432.56
  • Formula: C25H36O6
  • CLOGP: 3.48
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 2
  • TPSA: 100.90
  • ALOGS: -4.50
  • ROTB: 6

  • Status: OFP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
March 31, 1982 FDA PRECISION DERMAT

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Rheumatoid factor positive 58.60 22.49 46 4306 69014 56218701
Anti-cyclic citrullinated peptide antibody positive 44.48 22.49 46 4306 98554 56189161
Blood cholesterol 43.15 22.49 10 4342 630 56287085
Pericarditis 42.41 22.49 47 4305 108876 56178839
Dermatitis acneiform 38.58 22.49 14 4338 4330 56283385
Hand deformity 32.95 22.49 46 4306 134446 56153269
Wound 31.83 22.49 46 4306 138758 56148957
Discomfort 31.09 22.49 46 4306 141715 56146000
Glossodynia 29.94 22.49 47 4305 152411 56135304
Rash 27.52 22.49 92 4260 492955 55794760
Pemphigus 27.51 22.49 46 4306 157166 56130549
Duodenal ulcer perforation 27.45 22.49 30 4322 68312 56219403
Vaginal flatulence 27.17 22.49 7 4345 686 56287029
Systemic lupus erythematosus 26.72 22.49 49 4303 180029 56107686
Synovitis 26.64 22.49 46 4306 161259 56126456
Hepatic enzyme increased 25.89 22.49 47 4305 171337 56116378
Infusion related reaction 23.93 22.49 51 4301 208880 56078835
Stomatitis 23.36 22.49 37 4315 120773 56166942

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Paronychia 56.94 22.96 16 1660 3202 31692466
Dermatitis acneiform 55.80 22.96 18 1658 5749 31689919
Hepatic function abnormal 38.33 22.96 25 1651 41197 31654471
Cerebellar stroke 25.96 22.96 5 1671 189 31695479
Stomatitis 22.96 22.96 18 1658 39420 31656248

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Dermatitis acneiform 94.15 20.50 32 5006 8913 70914493
Paronychia 65.50 20.50 23 5015 7051 70916355
Stomatitis 44.33 20.50 50 4988 128461 70794945
Rash 43.37 20.50 105 4933 510457 70412949
Rheumatoid factor positive 40.69 20.50 31 5007 48369 70875037
Hepatic function abnormal 37.27 20.50 34 5004 67962 70855444
Anti-cyclic citrullinated peptide antibody positive 32.55 20.50 32 5006 70153 70853253
Dry skin 28.77 20.50 27 5011 55904 70867502
Pemphigus 28.08 20.50 32 5006 83004 70840402
Pericarditis 27.56 20.50 32 5006 84673 70838733
Systemic lupus erythematosus 27.48 20.50 35 5003 101867 70821539
Hand deformity 27.02 20.50 32 5006 86450 70836956
Glossodynia 27.02 20.50 32 5006 86455 70836951
Eczema 26.99 20.50 21 5017 33760 70889646
Drug eruption 26.15 20.50 22 5016 39474 70883932
Wound 23.65 20.50 32 5006 98700 70824706
Neutrophil count decreased 23.00 20.50 29 5009 83527 70839879
Lip dry 22.89 20.50 12 5026 9773 70913633
Discomfort 22.02 20.50 32 5006 105404 70818002
Colorectal cancer 21.58 20.50 11 5027 8459 70914947
Duodenal ulcer perforation 21.30 20.50 22 5016 51090 70872316

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D07AB02 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, PLAIN
Corticosteroids, moderately potent (group II)
ATC D07BB04 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, COMBINATIONS WITH ANTISEPTICS
Corticosteroids, moderately potent, combinations with antiseptics
FDA MoA N0000175450 Corticosteroid Hormone Receptor Agonists
FDA EPC N0000175576 Corticosteroid
MeSH PA D003879 Dermatologic Agents
MeSH PA D000893 Anti-Inflammatory Agents
CHEBI has role CHEBI:35472 anti-inflammatory drugs
CHEBI has role CHEBI:49167 anti-asthmatic drugs
CHEBI has role CHEBI:50857 anti-allergic drugs
CHEBI has role CHEBI:75771 Mus musculus metabolites
CHEBI has role CHEBI:77746 Homo sapiens metabolite
CHEBI has role CHEBI:88188 allergenic drug
CHEBI has role CHEBI:50177 dermatologic agent

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

None




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.48 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST CHEMBL CHEMBL

External reference:

IDSource
4017947 VUID
N0000146297 NUI
D01619 KEGG_DRUG
4017941 VANDF
4017947 VANDF
C0352536 UMLSCUI
CHEBI:31674 CHEBI
CHEBI:17650 CHEBI
CHEMBL1683 ChEMBL_ID
DB14540 DRUGBANK_ID
C007975 MESH_SUPPLEMENTAL_RECORD_UI
05RMF7YPWN UNII
26133 PUBCHEM_CID
DB00741 DRUGBANK_ID
103468 RXNORM
2500 MMSL
4837 MMSL
4840 MMSL
72408 MMSL
d00254 MMSL
002147 NDDF
002149 NDDF
16602005 SNOMEDCT_US
396458002 SNOMEDCT_US
50665003 SNOMEDCT_US
C0020268 UMLSCUI
38 INN_ID
D006854 MESH_DESCRIPTOR_UI
5754 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Locoid Lipocream HUMAN PRESCRIPTION DRUG LABEL 1 16781-384 CREAM 1 mg TOPICAL NDA 21 sections
Locoid HUMAN PRESCRIPTION DRUG LABEL 1 16781-392 LOTION 1 mg TOPICAL NDA 22 sections
Hydrocortisone Butyrate HUMAN PRESCRIPTION DRUG LABEL 1 21695-971 CREAM 1 mg TOPICAL NDA 18 sections
Hydrocortisone Butyrate HUMAN PRESCRIPTION DRUG LABEL 1 51672-4061 SOLUTION 1 mg TOPICAL ANDA 18 sections
Hydrocortisone Butyrate HUMAN PRESCRIPTION DRUG LABEL 1 51672-4074 CREAM 1 mg TOPICAL ANDA 18 sections
Hydrocortisone Butyrate HUMAN PRESCRIPTION DRUG LABEL 1 51672-4083 OINTMENT 1 mg TOPICAL ANDA 18 sections
HYDROCORTISONE BUTYRATE HUMAN PRESCRIPTION DRUG LABEL 1 51862-159 LOTION 1 mg TOPICAL ANDA 26 sections
Hydrocortisone Butyrate HUMAN PRESCRIPTION DRUG LABEL 1 52565-087 LOTION 1 mg TOPICAL ANDA 22 sections
HYDROCORTISONE BUTYRATE HUMAN PRESCRIPTION DRUG LABEL 1 54868-6248 CREAM 1 mg TOPICAL NDA 18 sections
Hydrocortisone Butyrate HUMAN PRESCRIPTION DRUG LABEL 1 68180-951 LOTION 1 mg TOPICAL ANDA 14 sections
Hydrocortisone Butyrate HUMAN PRESCRIPTION DRUG LABEL 1 68682-271 OINTMENT 1 mg TOPICAL NDA 17 sections
Hydrocortisone Butyrate HUMAN PRESCRIPTION DRUG LABEL 1 68682-384 CREAM 1 mg TOPICAL NDA authorized generic 21 sections
HYDROCORTISONE BUTYRATE HUMAN PRESCRIPTION DRUG LABEL 1 68682-392 LOTION 1 mg TOPICAL NDA authorized generic 22 sections
Hydrocortisone Butyrate HUMAN PRESCRIPTION DRUG LABEL 1 70512-032 LOTION 1 mg TOPICAL ANDA 14 sections
Aquax-H HUMAN PRESCRIPTION DRUG LABEL 1 82160-127 CREAM 30 mg TOPICAL unapproved drug other 17 sections