Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Ursodiol
Drug ID BADD_D02321
Description Ursodeoxycholic acid is 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.
Indications and Usage The drug decreases the absorption of cholesterol and is used to dissolve (cholesterol) gallstones in patients as an alternative to a surgical procedure to remove the gallstones.
Marketing Status approved; investigational
ATC Code A05AA02
DrugBank ID DB01586
KEGG ID D00734
MeSH ID D014580
PubChem ID 31401
TTD Drug ID D0G3SH
NDC Product Code 72789-205; 46438-0653; 50268-797; 60687-527; 63629-2286; 63629-2287; 0527-1326; 0591-2998; 72162-1500; 0591-3159; 46438-0089; 49345-2612; 42806-503; 64380-844; 70710-1128; 70771-1407; 0591-3005; 22365-012; 49452-8085; 49884-412; 51407-754; 60687-100; 62135-430; 64380-919; 69238-1540; 71930-015; 64980-483; 68462-474; 70710-1127; 70771-1408; 80056-144; 0904-6221; 60592-998; 63629-8353; 46438-0090; 46438-0654; 24658-780; 49884-413; 63629-1048; 63629-1173; 70710-1483; 70771-1524; 72887-144; 51552-0906; 58914-790; 68001-378; 72887-143; 42291-923; 42385-946; 58914-785; 72162-1501; 72664-217; 80056-143; 38779-1987; 52544-930; 51224-151; 59651-421; 64380-918; 68001-377; 68462-473; 62991-2185; 0904-6890; 0904-7168; 51927-2909; 61200-001; 66039-936; 24658-999
UNII 724L30Y2QR
Synonyms Ursodeoxycholic Acid | Acid, Ursodeoxycholic | Ursacholic Acid | Acid, Ursacholic | 3 alpha,7 beta-Dihydroxy-5 beta-cholan-24-oic Acid | 3 alpha,7 beta Dihydroxy 5 beta cholan 24 oic Acid | Ursodiol | Deoxyursocholic Acid | Acid, Deoxyursocholic | Ursolvan | Delursan | Destolit | Sodium Ursodeoxycholate | Ursodeoxycholate, Sodium | Urdox | Urso | Urso Heumann | Ursobilane | Ursochol | Ursofalk | Ursogal | Ursolite | Cholit-Ursan | Cholofalk
Chemical Information
Molecular Formula C24H40O4
CAS Registry Number 128-13-2
SMILES CC(CCC(=O)O)C1CCC2C1(CCC3C2C(CC4C3(CCC(C4)O)C)O)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Drug hypersensitivity10.01.01.001--Not Available
Drug ineffective08.06.01.006--Not Available
Drug interaction08.06.03.001--Not Available
Dry mouth07.06.01.002--
Duodenal ulcer07.04.02.002--
Dysmenorrhoea21.01.01.002--
Dyspepsia07.01.02.001--
Dysphagia07.01.06.003--
Dyspnoea02.11.05.003; 22.02.01.004--
Dysuria20.02.02.002--
Ear disorder04.03.01.001--Not Available
Ecchymosis24.07.06.002; 23.06.01.001; 01.01.03.001--Not Available
Epistaxis24.07.01.005; 22.04.03.001--
Eructation07.01.02.003--
Eye disorder06.08.03.001--Not Available
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.003--
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Flatulence07.01.04.002--
Fluid retention20.01.02.003; 14.05.06.002--Not Available
Gamma-glutamyltransferase increased13.03.04.024--
Gastric ulcer07.04.03.002--
Gastritis07.08.02.001--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal pain07.01.05.005--
Generalised oedema14.05.06.007; 08.01.07.004--
Granuloma23.03.15.001; 08.01.05.001--Not Available
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.006--
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