🇺🇸 Novoseven in United States

1,504 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. Haemorrhage — 276 reports (18.35%)
  2. Death — 247 reports (16.42%)
  3. Drug Ineffective — 242 reports (16.09%)
  4. Off Label Use — 203 reports (13.5%)
  5. Multi-Organ Failure — 111 reports (7.38%)
  6. Haemarthrosis — 90 reports (5.98%)
  7. Concomitant Disease Progression — 88 reports (5.85%)
  8. Thrombosis — 86 reports (5.72%)
  9. Pulmonary Embolism — 83 reports (5.52%)
  10. Sepsis — 78 reports (5.19%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Novoseven approved in United States?

Yes. FDA has authorised it.

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

AryoGen Pharmed Co. is the originator. The local marketing authorisation holder may differ — check the official source linked above.