🇺🇸 UDCA in United States

84 US adverse-event reports

Marketing authorisation

FDA

  • Status: approved

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.

Most-reported reactions

  1. Pruritus — 21 reports (25%)
  2. Blood Bilirubin Increased — 12 reports (14.29%)
  3. Hepatic Failure — 9 reports (10.71%)
  4. Jaundice — 8 reports (9.52%)
  5. Blood Alkaline Phosphatase Increased — 7 reports (8.33%)
  6. Hepatocellular Carcinoma — 7 reports (8.33%)
  7. Ascites — 5 reports (5.95%)
  8. Asthenia — 5 reports (5.95%)
  9. Diarrhoea — 5 reports (5.95%)
  10. Fatigue — 5 reports (5.95%)

Source database →

UDCA in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is UDCA approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for UDCA in United States?

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