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

Stem definition	Drug id	CAS RN
	2797	128-13-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: urosiol ursodiol ursocol ursodeoxycholic acid ursodesoxycholic acid ursolvan ursacholic acid deoxyursocholic acid	An epimer of chenodeoxycholic acid. It is a mammalian bile acid found first in the bear and is apparently either a precursor or a product of chenodeoxycholate. Its administration changes the composition of bile and may dissolve gallstones. It is used as a cholagogue and choleretic. Molecular weight: 392.58 Formula: C24H40O4 CLOGP: 4.51 LIPINSKI: 0 HAC: 4 HDO: 3 TPSA: 77.76 ALOGS: -4.30 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

urosiol
ursodiol
ursocol
ursodeoxycholic acid
ursodesoxycholic acid
ursolvan
ursacholic acid
deoxyursocholic acid

An epimer of chenodeoxycholic acid. It is a mammalian bile acid found first in the bear and is apparently either a precursor or a product of chenodeoxycholate. Its administration changes the composition of bile and may dissolve gallstones. It is used as a cholagogue and choleretic.

Molecular weight: 392.58
Formula: C24H40O4
CLOGP: 4.51
LIPINSKI: 0
HAC: 4
HDO: 3
TPSA: 77.76
ALOGS: -4.30
ROTB: 4

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.75	g	O

ADMET properties:

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Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	38.21 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
Dec. 31, 1987	FDA	ACTAVIS LABS UT INC

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
Hepatic function abnormal	334.39	11.99	224	34533	36918	63417347
Ascites	224.89	11.99	183	34574	40545	63413720
Blood bilirubin increased	222.38	11.99	175	34582	36965	63417300
Hepatic failure	207.02	11.99	165	34592	35491	63418774
Hepatic encephalopathy	204.50	11.99	107	34650	11175	63443090
Aspartate aminotransferase increased	165.90	11.99	225	34532	90052	63364213
Pruritus	158.96	11.99	496	34261	360957	63093308
Platelet count decreased	157.78	11.99	251	34506	115871	63338394
Infective pulmonary exacerbation of cystic fibrosis	152.35	11.99	81	34676	8736	63445529
Hepatic cirrhosis	136.20	11.99	111	34646	24623	63429642

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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
Hepatic function abnormal	348.24	11.96	304	31867	44059	34880701
Hepatic encephalopathy	249.27	11.96	160	32011	14525	34910235
Hepatic failure	205.68	11.96	203	31968	34328	34890432
Venoocclusive liver disease	190.01	11.96	108	32063	7858	34916902
Blood bilirubin increased	182.87	11.96	200	31971	38096	34886664
Infective pulmonary exacerbation of cystic fibrosis	180.74	11.96	99	32072	6702	34918058
Hepatic cancer	162.67	11.96	99	32072	8176	34916584
Hepatocellular carcinoma	158.39	11.96	94	32077	7415	34917345
Cholangitis	153.20	11.96	97	32074	8592	34916168
Ascites	152.87	11.96	201	31970	46370	34878390

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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
Hepatic function abnormal	549.96	10.59	443	57661	72664	79613620
Hepatic encephalopathy	431.35	10.59	250	57854	23916	79662368
Venoocclusive liver disease	398.20	10.59	187	57917	11584	79674700
Hepatic failure	373.74	10.59	329	57775	60883	79625401
Blood bilirubin increased	351.45	10.59	329	57775	65903	79620381
Ascites	340.25	10.59	343	57761	75219	79611065
Infective pulmonary exacerbation of cystic fibrosis	259.07	10.59	144	57960	12707	79673577
Platelet count decreased	241.90	10.59	475	57629	194189	79492095
Hepatocellular carcinoma	235.23	10.59	120	57984	8901	79677383
Liver disorder	232.20	10.59	275	57829	72142	79614142

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A05AA02	ALIMENTARY TRACT AND METABOLISM BILE AND LIVER THERAPY BILE THERAPY Bile acids and derivatives
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
FDA CS	M0002475	Bile Acids and Salts
FDA EPC	N0000175802	Bile Acid
MeSH PA	D002756	Cholagogues and Choleretics
MeSH PA	D005765	Gastrointestinal Agents

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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
Primary biliary cirrhosis	indication	31712002	DOID:12236
Calculus in biliary tract	indication	266474003
Cholelithiasis Prevention	indication

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.92	acidic

Orange Book patent data (new drug applications)

None

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
Bile acid receptor	Nuclear hormone receptor	Q96RI1	NR1H4_HUMAN	AGONIST			CHEMBL	CHEMBL
Phospholipase A2	Enzyme	P04054	PA21B_HUMAN		Kd	5	CHEMBL
G-protein coupled bile acid receptor 1	GPCR	Q8TDU6	GPBAR_HUMAN		EC50	5.62	CHEMBL
Ectonucleotide pyrophosphatase/phosphodiesterase family member 2	Enzyme	Q13822	ENPP2_HUMAN		IC50	4.99	CHEMBL
Sodium/bile acid cotransporter	Transporter	Q14973	NTCP_HUMAN	INHIBITOR	IC50	5.44	IUPHAR
CDGSH iron-sulfur domain-containing protein 1	Unclassified	Q9NZ45	CISD1_HUMAN		Ki	5.95	CHEMBL
Aldo-keto reductase family 1 member C2	Enzyme	P52895	AK1C2_HUMAN				WOMBAT-PK
Sodium/bile acid cotransporter	Transporter	Q14973	NTCP_HUMAN	INHIBITOR	IC50	5.44	IUPHAR
M1-family alanyl aminopeptidase	Enzyme		Q8IEK1_PLAF7		IC50	5.59	CHEMBL

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External reference:

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ID	Source
001212	NDDF
108669000	SNOMEDCT_US
11065	RXNORM
31401	PUBCHEM_CID
31954	MMSL
4019318	VUID
4019318	VANDF
41143004	SNOMEDCT_US
4920	INN_ID
5659	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1730	CAPSULE	300 mg	ORAL	ANDA	18 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1326	CAPSULE	300 mg	ORAL	ANDA	19 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1326	CAPSULE	300 mg	ORAL	ANDA	19 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1326	CAPSULE	300 mg	ORAL	ANDA	19 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2998	TABLET	250 mg	ORAL	NDA authorized generic	25 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2998	TABLET	250 mg	ORAL	NDA authorized generic	25 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3005	TABLET	500 mg	ORAL	NDA authorized generic	25 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3005	TABLET	500 mg	ORAL	NDA authorized generic	25 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3159	CAPSULE	300 mg	ORAL	NDA authorized generic	20 sections
Ursodiol	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3159	CAPSULE	300 mg	ORAL	NDA authorized generic	20 sections

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