Ursodiol: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Ursodiol. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| Abdominal pain | 70% |
| Dizziness | 53% |
| Diarrhea | 42% |
| Infection viral | 41% |
| Headache | 34% |
| Nausea | 27% |
| Dyspepsia | 26% |
| Arthralgia | 24% |
| Tract infection | 24% |
| Influenza-like symptoms | 21% |
| Musculoskeletal pain | 19% |
| Dysmenorrhea | 19% |
| Back pain | 18% |
| Sinusitis | 18% |
| Alopecia | 17% |
| Constipation | 15% |
| Vomiting | 15% |
| Pharyngitis | 13% |
| Flatulence | 12% |
| Coughing | 11% |
*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.
Medical disclaimer: Always consult a qualified healthcare professional about any medication.