🇺🇸 Rivaroxaban 10 mg in United States

20 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. Pulmonary Embolism — 5 reports (25%)
  2. Haemoglobin Decreased — 3 reports (15%)
  3. Deep Vein Thrombosis — 2 reports (10%)
  4. Gastrointestinal Haemorrhage — 2 reports (10%)
  5. Haematoma — 2 reports (10%)
  6. Post Procedural Pulmonary Embolism — 2 reports (10%)
  7. Acute Kidney Injury — 1 report (5%)
  8. Acute Respiratory Failure — 1 report (5%)
  9. Anaemia — 1 report (5%)
  10. Atrial Fibrillation — 1 report (5%)

Source database →

Rivaroxaban 10 mg 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 Rivaroxaban 10 mg approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Rivaroxaban 10 mg in United States?

Hospital Alemão Oswaldo Cruz is the originator. The local marketing authorisation holder may differ — check the official source linked above.