The most commonly reported side effects of ursodiol include off label use, pruritus, and fatigue, based on 22,036 FDA adverse event reports from 2004 to 2025. 3.9% of reports found the drug to be ineffective.
Percentages show how often each reaction appears relative to total reports for ursodiol.
These are voluntary reports and do not establish that ursodiol caused these reactions.
Report severity
Seriousness is determined by the reporter, not by OpenClaim.
Other drugs that appear in adverse event reports alongside ursodiol. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.
Also suspected
Taken alongside
Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.
50.1% of ursodiol adverse event reports involve female patients and 38.9% involve male patients. The largest age group is adult at 54%. These figures reflect who reports side effects, not underlying risk.
Sex
Age group
Conditions and purposes for which patients were taking ursodiol when the adverse event was reported.
Showing 15 of 582 indications
Ursodiol is sold under the brand name Urso Forte.
An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.
Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.