Ursodiol: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Ursodiol. Educational only — not medical advice.

Reported adverse reactions

ReactionHighest frequency reported*
Abdominal pain44%
Diarrhea27.1%
Infection viral25.8%
Headache21.4%
Nausea17%
Dyspepsia16.8%
Dizziness16.5%
Upper respiratory tract infection15.5%
Arthralgia15.1%
Back pain11.3%
Sinusitis11.3%
Constipation9.7%
Vomiting9.7%
Pharyngitis8.4%
Flatulence7.7%
Coughing7.1%
Rhinitis6.9%
Bronchitis6.5%
Urinary tract infection6.5%
Influenza-like symptoms6.5%

*Highest percentage across placebo-controlled trial tables summarized in current labeling.

Labeled uses

Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

Source: FDA labeling via NIH DailyMed (set a061bb07…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.

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