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

Stem definition	Drug id	CAS RN
corticosteroids, except prednisolone derivatives	3959	13609-67-1

Description:

Molecule	Description
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

Molecule

Description

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:

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

Approvals:

Date	Agency	Company	Orphan
March 31, 1982	FDA	PRECISION DERMAT

FDA Adverse Event Reporting System (Female)

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
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 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
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 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
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:

Source	Code	Description
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 level	Dissociation constant	Type (acidic/basic)
pKa1	11.48	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN	AGONIST				CHEMBL	CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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