🇺🇸 Ursodeoxycholic Acid Capsules in United States

22 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: 23 April 2025 – 23 April 2026
• Total reports: 22

Most-reported reactions

1. Neutrophil Count Decreased — 3 reports (13.64%)
2. White Blood Cell Count Decreased — 3 reports (13.64%)
3. Alanine Aminotransferase Increased — 2 reports (9.09%)
4. Anaemia — 2 reports (9.09%)
5. Death — 2 reports (9.09%)
6. Electrolyte Imbalance — 2 reports (9.09%)
7. Gastrointestinal Disorder — 2 reports (9.09%)
8. Hyperuricaemia — 2 reports (9.09%)
9. Hypokalaemia — 2 reports (9.09%)
10. Lymphocyte Count Decreased — 2 reports (9.09%)

Source database →

Frequently asked questions

Is Ursodeoxycholic Acid Capsules approved in United States?

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

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

Beijing Friendship Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.