🇺🇸 Ursodeoxycholic acid in United States

2,442 US adverse-event reports

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

• Window: 22 April 2025 – 22 April 2026
• Total reports: 2,442

Most-reported reactions

1. Off Label Use — 419 reports (17.16%)
2. Pyrexia — 353 reports (14.46%)
3. Diarrhoea — 269 reports (11.02%)
4. Drug Ineffective — 225 reports (9.21%)
5. Hepatic Function Abnormal — 215 reports (8.8%)
6. Anaemia — 203 reports (8.31%)
7. Pneumonia — 203 reports (8.31%)
8. Nausea — 190 reports (7.78%)
9. Platelet Count Decreased — 183 reports (7.49%)
10. Decreased Appetite — 182 reports (7.45%)

Source database →

Frequently asked questions

Is Ursodeoxycholic acid approved in United States?

Ursodeoxycholic acid does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Ursodeoxycholic acid in United States?

University of Oxford is the originator. The local marketing authorisation holder may differ — check the official source linked above.