ursodiol Indications/Contra | FAERs | Orange Book | BioActivity |

Stem definitionDrug idCAS RN
2797 128-13-2

Description:

MoleculeDescription

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

Drug dosage:

DoseUnitRoute
0.75 g O

Approvals:

DateAgencyCompanyOrphan
Dec. 31, 1987 FDA ACTAVIS LABS UT INC

FDA Adverse Event Reporting System

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
Maternal exposure during pregnancy 100.61 55.33 26 432 10245 3375156
Bile duct stone 100.58 55.33 17 441 836 3384565
Premature baby 99.20 55.33 24 434 7229 3378172
Foetal exposure during pregnancy 94.42 55.33 27 431 15524 3369877
Caesarean section 93.80 55.33 21 437 4505 3380896
Cholestasis 69.49 55.33 17 441 5320 3380081
Cholangitis 65.14 55.33 13 445 1596 3383805
Interstitial lung disease 61.63 55.33 19 439 13997 3371404
Jaundice 58.73 55.33 17 441 10090 3375311

Pharmacologic Action:

SourceCodeDescription
ATC A05AA02 ALIMENTARY TRACT AND METABOLISM
BILE AND LIVER THERAPY
BILE THERAPY
Bile acids and derivatives
MeSH PA D002756 Cholagogues and Choleretics
MeSH PA D005765 Gastrointestinal Agents
FDA EPC N0000175802 Bile Acid
FDA Chemical/Ingredient N0000006801 Bile Acids and Salts

Drug Use (View source of the data)

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

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.92 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
Bile acid receptor Nuclear hormone receptor AGONIST CHEMBL CHEMBL
Aldo-keto reductase family 1 member C2 Enzyme WOMBAT-PK
G-protein coupled bile acid receptor 1 GPCR EC50 5.62 CHEMBL
M1-family alanyl aminopeptidase Unclassified IC50 5.59 CHEMBL

External reference:

IDSource
4019318 VUID
N0000147507 NUI
C0042105 UMLSCUI
D00734 KEGG_DRUG
724L30Y2QR UNII
4920 INN_ID
11065 RXNORM
N0000007189 NDFRT
N0000147507 NDFRT
41143004 SNOMEDCT_US
31954 MMSL
108669000 SNOMEDCT_US
5659 MMSL
d01005 MMSL
4019318 VANDF
001212 NDDF
CHEMBL1551 ChEMBL_ID
31401 PUBCHEM_CID
DB01586 DRUGBANK_ID
D014580 MESH_DESCRIPTOR_UI
CHEBI:9907 CHEBI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Actigall HUMAN PRESCRIPTION DRUG LABEL 1 0023-6145 CAPSULE 300 mg ORAL NDA 11 sections
URSODIOL HUMAN PRESCRIPTION DRUG LABEL 1 0115-1524 TABLET, FILM COATED 250 mg ORAL ANDA 17 sections
URSODIOL HUMAN PRESCRIPTION DRUG LABEL 1 0115-1525 TABLET, FILM COATED 500 mg ORAL ANDA 17 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-1730 CAPSULE 300 mg ORAL ANDA 11 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0527-1326 CAPSULE 300 mg ORAL ANDA 11 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0591-2368 TABLET, FILM COATED 250 mg ORAL ANDA 16 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0591-2369 TABLET, FILM COATED 500 mg ORAL ANDA 16 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0591-2998 TABLET 250 mg ORAL NDA AUTHORIZED GENERIC 16 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0591-3005 TABLET 500 mg ORAL NDA AUTHORIZED GENERIC 16 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0591-3159 CAPSULE 300 mg ORAL NDA AUTHORIZED GENERIC 11 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0615-1374 CAPSULE 300 mg ORAL NDA 11 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6221 CAPSULE 300 mg ORAL ANDA 12 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6483 CAPSULE 300 mg ORAL ANDA 11 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 10135-543 CAPSULE 300 mg ORAL ANDA 11 sections
URSODIOL HUMAN PRESCRIPTION DRUG LABEL 1 16590-349 CAPSULE 300 mg ORAL NDA 11 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 24658-780 CAPSULE 300 mg ORAL ANDA 12 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 42291-850 CAPSULE 300 mg ORAL ANDA 12 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 42806-503 CAPSULE 300 mg ORAL ANDA 12 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 49884-412 TABLET, FILM COATED 250 mg ORAL ANDA 16 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 49884-413 TABLET, FILM COATED 500 mg ORAL ANDA 16 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 50268-796 CAPSULE 300 mg ORAL ANDA 12 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 51079-383 CAPSULE 300 mg ORAL ANDA 11 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 51224-151 CAPSULE 300 mg ORAL ANDA 11 sections
Actigall HUMAN PRESCRIPTION DRUG LABEL 1 52544-930 CAPSULE 300 mg ORAL NDA 11 sections
BAMBOO SALT Eunganggo Jook Yeom Toothpaste HUMAN OTC DRUG LABEL 5 53208-459 PASTE 0.02 g DENTAL OTC monograph not final 4 sections
BAMBOO SALT Eunganggo Jook Yeom HUMAN OTC DRUG LABEL 5 53208-505 PASTE 0.02 g DENTAL OTC monograph not final 8 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 54868-5033 CAPSULE 300 mg ORAL NDA AUTHORIZED GENERIC 11 sections
URSO HUMAN PRESCRIPTION DRUG LABEL 1 55154-1855 TABLET, FILM COATED 250 mg ORAL NDA 16 sections
Ursodiol HUMAN PRESCRIPTION DRUG LABEL 1 55154-6642 CAPSULE 300 mg ORAL NDA 11 sections
URSODIOL HUMAN PRESCRIPTION DRUG LABEL 1 55700-273 TABLET, FILM COATED 500 mg ORAL ANDA 16 sections