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---
Death08.04.01.001--
Diarrhoea07.02.01.001--
Discomfort08.01.08.003---
Feeling abnormal08.01.09.014---
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal disorder07.11.01.001---
Jaundice01.06.04.004; 09.01.01.004; 23.03.03.030---
Liver disorder09.01.08.001---
Malaise08.01.01.003--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001---
Neuropathy peripheral17.09.03.003---
Pruritus23.03.12.001--
Skin disorder23.03.03.007---
Skin lesion23.03.03.010---
Urinary tract infection11.01.14.004; 20.08.02.001--
Intestinal polyp07.20.01.009; 16.05.01.002---
Transaminases increased13.03.04.036---
Ill-defined disorder08.01.03.049---
Hepatobiliary disease09.01.08.003---
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