🇺🇸 Bivalirudin Injection in United States

60 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. Hypotension — 9 reports (15%)
  2. Thrombosis In Device — 9 reports (15%)
  3. Cardio-Respiratory Arrest — 7 reports (11.67%)
  4. Coronary Artery Perforation — 5 reports (8.33%)
  5. Coronary Artery Thrombosis — 5 reports (8.33%)
  6. Drug Ineffective — 5 reports (8.33%)
  7. Gastrointestinal Haemorrhage — 5 reports (8.33%)
  8. Haemoglobin Decreased — 5 reports (8.33%)
  9. Off Label Use — 5 reports (8.33%)
  10. Post Procedural Complication — 5 reports (8.33%)

Source database →

Bivalirudin Injection 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 Bivalirudin Injection approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Bivalirudin Injection in United States?

Hamad Medical Corporation is the originator. The local marketing authorisation holder may differ — check the official source linked above.