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)
Pruritus23.03.12.001--
Psoriasis23.03.14.002; 10.02.01.036--Not Available
Pulmonary fibrosis22.01.02.006--
Pulmonary hypertension24.08.03.002; 22.06.01.001--
Rash23.03.13.001--Not Available
Renal failure20.01.03.005--Not Available
Retinal disorder06.08.03.005--Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Salivary gland enlargement07.06.03.002--Not Available
Seizure17.12.03.001--
Shock24.06.02.002--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Skin discolouration23.03.03.005--Not Available
Skin disorder23.03.03.007--Not Available
Skin hypertrophy23.01.04.002--Not Available
Skin papilloma23.10.01.002; 16.26.01.002; 11.05.07.001--
Skin ulcer24.04.03.007; 23.07.03.003--
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008--
Tachycardia02.03.02.007--Not Available
Tension19.06.02.005--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombosis24.01.01.006--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Type I hypersensitivity10.01.03.006--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urethral disorder20.07.01.002--Not Available
Urinary incontinence20.02.02.010; 17.05.01.008--
Urinary tract disorder20.08.01.001--Not Available
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