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)
Haemoglobin13.01.05.018--Not Available
Haemolytic anaemia01.06.03.002--Not Available
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.001--Not Available
Hepatic function abnormal09.01.02.001--Not Available
Herpes simplex23.11.05.004; 11.05.02.001--Not Available
Hip fracture15.08.03.001; 12.04.01.001--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hypotension24.06.03.002--
Immune system disorder10.02.01.001--Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Influenza like illness08.01.03.010--
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Interstitial lung disease22.01.02.003; 10.02.01.033--Not Available
Intestinal obstruction07.13.01.002--Not Available
Jaundice09.01.01.004; 01.06.04.004; 23.03.03.030--Not Available
Laboratory test abnormal13.18.01.001--Not Available
Laryngeal oedema23.04.01.005; 22.04.02.001; 10.01.05.003--
Leukopenia01.02.02.001--Not Available
Liver disorder09.01.08.001--Not Available
Liver function test abnormal13.03.04.030--Not Available
Loss of consciousness17.02.04.004--Not Available
Lung disorder22.02.07.001--Not Available
Lung infiltration22.01.02.004--Not Available
Lymphadenopathy01.09.01.002--Not Available
Malaise08.01.01.003--
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