🇺🇸 Ulunar in United States

63 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. Nausea — 11 reports (17.46%)
  2. Melaena — 10 reports (15.87%)
  3. Abdominal Pain — 7 reports (11.11%)
  4. Atrial Fibrillation — 6 reports (9.52%)
  5. General Physical Health Deterioration — 6 reports (9.52%)
  6. Tachycardia — 6 reports (9.52%)
  7. Dyspnoea — 5 reports (7.94%)
  8. Abdominal Pain Upper — 4 reports (6.35%)
  9. Haematemesis — 4 reports (6.35%)
  10. Pallor — 4 reports (6.35%)

Source database →

Ulunar 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 Ulunar approved in United States?

Yes. FDA has authorised it.

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

Fundacio Privada Mon Clinic Barcelona is the originator. The local marketing authorisation holder may differ — check the official source linked above.