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:

PropertyValueReference
S (Water solubility) 0.23 mg/mL Bocci G, Oprea TI, Benet LZ

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
Facet joint syndrome 92.91 26.91 40 7811 12098 63469073
Lip dry 89.75 26.91 42 7809 15428 63465743
Rheumatoid factor positive 81.64 26.91 74 7777 84332 63396839
Peripheral venous disease 65.81 26.91 34 7817 15443 63465728
Anti-cyclic citrullinated peptide antibody positive 65.20 26.91 76 7775 116136 63365035
Duodenal ulcer perforation 64.54 26.91 66 7785 87143 63394028
Pericarditis 62.35 26.91 79 7772 131500 63349671
C-reactive protein 61.36 26.91 23 7828 4859 63476312
Helicobacter infection 59.39 26.91 65 7786 92720 63388451
Hand deformity 56.27 26.91 83 7768 159374 63321797
Joint range of motion decreased 56.10 26.91 40 7811 32388 63448783
Wound 54.78 26.91 83 7768 163180 63317991
Swollen joint count increased 54.51 26.91 41 7810 36013 63445158
Rheumatic fever 52.19 26.91 43 7808 43068 63438103
Glossodynia 51.80 26.91 85 7766 178791 63302380
Folliculitis 51.62 26.91 53 7798 70264 63410907
Stomatitis 50.07 26.91 73 7778 138652 63342519
Deep vein thrombosis postoperative 48.40 26.91 25 7826 11344 63469827
Obesity 45.14 26.91 34 7817 29918 63451253
Type 2 diabetes mellitus 44.82 26.91 47 7804 63821 63417350
Bursitis 42.87 26.91 36 7815 37005 63444166
Synovitis 42.65 26.91 80 7771 186838 63294333
Systemic lupus erythematosus 42.29 26.91 85 7766 208833 63272338
Blood cholesterol 42.08 26.91 11 7840 709 63480462
Hepatic enzyme increased 41.77 26.91 83 7768 202245 63278926
Autoimmune disorder 41.28 26.91 26 7825 17151 63464020
Pemphigus 41.13 26.91 78 7773 183648 63297523
Lung disorder 38.74 26.91 43 7808 62218 63418953
Liver injury 38.01 26.91 42 7809 60478 63420693
Infusion related reaction 37.30 26.91 89 7762 245432 63235739
Irritable bowel syndrome 36.67 26.91 48 7803 82364 63398807
Night sweats 36.18 26.91 37 7814 48777 63432394
Dry mouth 35.65 26.91 46 7805 77817 63403354
Road traffic accident 35.14 26.91 32 7819 36600 63444571
Fibromyalgia 34.48 26.91 46 7805 80374 63400797
Impaired healing 34.16 26.91 52 7799 102490 63378681
Muscle injury 33.74 26.91 41 7810 65304 63415867
Blood cholesterol increased 33.20 26.91 49 7802 93983 63387188
Psoriatic arthropathy 32.76 26.91 48 7803 91472 63389699
General physical health deterioration 32.75 26.91 75 7776 201327 63279844
Discomfort 32.54 26.91 67 7784 167307 63313864
Sciatica 29.11 26.91 28 7823 34296 63446875
Fall 28.07 26.91 7 7844 392327 63088844
Prescribed overdose 27.35 26.91 27 7824 34126 63447045

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 54.93 22.56 16 1967 3389 34951559
Dermatitis acneiform 53.30 22.56 18 1965 6171 34948777
Hepatic function abnormal 37.37 22.56 26 1957 44337 34910611
Device dislocation 27.17 22.56 11 1972 6238 34948710
Cerebellar stroke 24.94 22.56 5 1978 217 34954731

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
Facet joint syndrome 100.08 21.07 40 8754 11262 79724332
Lip dry 94.48 21.07 42 8752 15376 79720218
Rheumatoid factor positive 74.82 21.07 58 8736 59781 79675813
Stomatitis 74.11 21.07 86 8708 146671 79588923
Duodenal ulcer perforation 69.65 21.07 58 8736 66153 79669441
Peripheral venous disease 68.60 21.07 34 8760 15875 79719719
Glossodynia 66.85 21.07 69 8725 103268 79632326
Folliculitis 65.60 21.07 52 8742 55328 79680266
Helicobacter infection 65.03 21.07 57 8737 69647 79665947
Hand deformity 64.73 21.07 68 8726 103851 79631743
Anti-cyclic citrullinated peptide antibody positive 63.92 21.07 61 8733 83082 79652512
Dermatitis acneiform 63.73 21.07 28 8766 9965 79725629
C-reactive protein 63.48 21.07 23 8771 4956 79730638
Systemic lupus erythematosus 59.48 21.07 70 8724 121079 79614515
Wound 58.49 21.07 68 8726 116111 79619483
Pemphigus 58.19 21.07 63 8731 99519 79636075
Joint range of motion decreased 56.91 21.07 39 8755 33243 79702351
Pericarditis 55.82 21.07 63 8731 104173 79631421
Paronychia 53.45 21.07 23 8771 7785 79727809
Rheumatic fever 50.13 21.07 34 8760 28491 79707103
Deep vein thrombosis postoperative 49.40 21.07 24 8770 10728 79724866
Swollen joint count increased 49.27 21.07 31 8763 22896 79712698
Irritable bowel syndrome 48.46 21.07 46 8748 62195 79673399
Obesity 45.97 21.07 35 8759 35090 79700504
Muscle injury 45.86 21.07 40 8754 48521 79687073
Bursitis 45.34 21.07 35 8759 35809 79699785
Fibromyalgia 45.30 21.07 45 8749 64295 79671299
Liver injury 44.38 21.07 42 8752 56572 79679022
Autoimmune disorder 42.20 21.07 25 8769 16587 79719007
Lung disorder 41.95 21.07 48 8746 80509 79655085
Impaired healing 41.93 21.07 50 8744 87605 79647989
Psoriatic arthropathy 41.50 21.07 47 8747 77952 79657642
Road traffic accident 41.29 21.07 36 8758 43628 79691966
Synovitis 40.39 21.07 65 8729 150669 79584925
Type 2 diabetes mellitus 40.30 21.07 40 8754 57082 79678512
Infusion related reaction 39.71 21.07 82 8712 230155 79505439
Night sweats 37.72 21.07 37 8757 52058 79683536
Hepatic enzyme increased 36.25 21.07 69 8725 182541 79553053
Dry mouth 35.35 21.07 46 8748 87973 79647621
Maternal exposure during pregnancy 32.71 21.07 56 8738 136482 79599112
Blood cholesterol increased 30.92 21.07 42 8752 83678 79651916
Discomfort 30.72 21.07 52 8742 125565 79610029
Sciatica 30.62 21.07 27 8767 33195 79702399
Alopecia 30.45 21.07 74 8720 231281 79504313
Inflammation 30.13 21.07 44 8750 93709 79641885
Acute kidney injury 29.95 21.07 10 8784 519394 79216200
Swelling 28.18 21.07 69 8725 216642 79518952
Arthropathy 28.10 21.07 61 8733 177050 79558544
Sleep disorder due to general medical condition, insomnia type 27.98 21.07 29 8765 43527 79692067
Prescribed overdose 27.59 21.07 27 8767 37856 79697738
Oedema 27.27 21.07 48 8746 119532 79616062
Rash 26.60 21.07 130 8664 578228 79157366
Blister 26.02 21.07 47 8747 119429 79616165
Lower limb fracture 25.77 21.07 21 8773 23194 79712400
Osteoarthritis 25.23 21.07 39 8755 87270 79648324
Hepatic function abnormal 24.49 21.07 35 8759 73072 79662522
Hypotension 24.48 21.07 9 8785 440308 79295286
Wheezing 24.27 21.07 45 8749 116619 79618975
Drug intolerance 24.24 21.07 74 8720 264045 79471549
Fall 23.88 21.07 12 8782 487617 79247977
C-reactive protein abnormal 23.79 21.07 28 8766 48339 79687255
Death 23.47 21.07 17 8777 566497 79169097
Liver disorder 23.28 21.07 34 8760 72383 79663211
Live birth 23.04 21.07 18 8776 18726 79716868
Injury 22.93 21.07 35 8759 77461 79658133
Toxicity to various agents 22.79 21.07 9 8785 421531 79314063
Urticaria 22.00 21.07 57 8737 185144 79550450
Hip arthroplasty 21.53 21.07 23 8771 35733 79699861

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
5754 PUBCHEM_CID
D006854 MESH_DESCRIPTOR_UI

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
Aquax-H HUMAN PRESCRIPTION DRUG LABEL 1 82160-127 CREAM 30 mg TOPICAL unapproved drug other 17 sections