🇺🇸 Adynovate in United States

602 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 — 207 reports (34.39%)
  2. Haemarthrosis — 152 reports (25.25%)
  3. Fall — 44 reports (7.31%)
  4. Pain — 38 reports (6.31%)
  5. Arthralgia — 37 reports (6.15%)
  6. Drug Ineffective — 28 reports (4.65%)
  7. Muscle Haemorrhage — 26 reports (4.32%)
  8. Contusion — 25 reports (4.15%)
  9. Joint Injury — 23 reports (3.82%)
  10. Factor Viii Inhibition — 22 reports (3.65%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Adynovate approved in United States?

Yes. FDA has authorised it.

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

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