Ursodiol: Side Effects, Uses & Monitoring
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 du
- Data source
- FDA labeling via NIH DailyMed (label ebaaa3e2…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| 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 reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
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.
Conditions associated with Ursodiol in labeling
Frequently Asked Questions
What is Ursodiol used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Ursodiol?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Ursodiol. Individual risk varies.
Does Ursodiol require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Ursodiol.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.