🇺🇸 Ursoplus in United States

30 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. Hepatic Enzyme Increased — 6 reports (20%)
  2. Blood Creatinine Increased — 3 reports (10%)
  3. Blood Urea Increased — 3 reports (10%)
  4. Bone Pain — 3 reports (10%)
  5. Drug Ineffective — 3 reports (10%)
  6. Fatigue — 3 reports (10%)
  7. Renal Impairment — 3 reports (10%)
  8. Anaemia — 2 reports (6.67%)
  9. Angina Pectoris — 2 reports (6.67%)
  10. Back Pain — 2 reports (6.67%)

Source database →

Ursoplus in other countries

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

Other Other approved in United States

Frequently asked questions

Is Ursoplus approved in United States?

Yes. FDA has authorised it.

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

MinaPharm Pharmaceuticals is the originator. The local marketing authorisation holder may differ — check the official source linked above.