🇺🇸 Pradax in United States

264 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. Gastrointestinal Haemorrhage — 42 reports (15.91%)
  2. Cerebrovascular Accident — 38 reports (14.39%)
  3. Dyspnoea — 35 reports (13.26%)
  4. Haemoglobin Decreased — 33 reports (12.5%)
  5. Asthenia — 21 reports (7.95%)
  6. Fall — 21 reports (7.95%)
  7. Fatigue — 21 reports (7.95%)
  8. Haemorrhage — 21 reports (7.95%)
  9. Dizziness — 16 reports (6.06%)
  10. Ischaemic Stroke — 16 reports (6.06%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Pradax approved in United States?

Yes. FDA has authorised it.

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

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