Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cholic acid
Drug ID BADD_D00453
Description A major primary bile acid produced in the liver and usually conjugated with glycine or taurine. It facilitates fat absorption and cholesterol excretion. [PubChem] Cholic acid, formulated as Cholbam capsules, is approved by the United States Food and Drug Administration as a treatment for children and adults with bile acid synthesis disorders due to single enzyme defects, and for peroxisomal disorders (such as Zellweger syndrome).
Indications and Usage Oral cholic acid is indicated for: treatment of bile acid synthesis disorders due to single enzyme defects; and as adjunctive treatment of peroxisomal disorders including Zellweger spectrum disorders in patients who exhibit manifestations of liver disease, steatorrhea or complications from decreased fat soluble vitamin absorption.
Marketing Status approved
ATC Code A05AA03
DrugBank ID DB02659
KEGG ID D10699
MeSH ID D019826
PubChem ID 221493
TTD Drug ID D0OR2L
NDC Product Code 45043-002; 45043-001; 47049-002; 47049-001
UNII G1JO7801AE
Synonyms Cholic Acid | Cholbam
Chemical Information
Molecular Formula C24H40O5
CAS Registry Number 81-25-4
SMILES CC(CCC(=O)O)C1CCC2C1(C(CC3C2C(CC4C3(CCC(C4)O)C)O)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)
Abdominal pain07.01.05.002--
Blood bilirubin increased13.03.04.018--
Cholestasis09.01.01.001--Not Available
Death08.04.01.001--
Diarrhoea07.02.01.001--
Discomfort08.01.08.003--Not Available
Feeling abnormal08.01.09.014--Not Available
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal disorder07.11.01.001--Not Available
Jaundice09.01.01.004; 01.06.04.004; 23.03.03.030--Not Available
Liver disorder09.01.08.001--Not Available
Malaise08.01.01.003--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Neuropathy peripheral17.09.03.003--Not Available
Pruritus23.03.12.001--
Skin disorder23.03.03.007--Not Available
Skin lesion23.03.03.010--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Intestinal polyp16.05.01.002; 07.20.01.009--Not Available
Transaminases increased13.03.04.036--Not Available
Ill-defined disorder08.01.03.049--Not Available
Hepatobiliary disease09.01.08.003--Not Available
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