🇺🇸 Xembify in United States

997 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. Infusion Site Erythema — 193 reports (19.36%)
  2. Infusion Site Pruritus — 173 reports (17.35%)
  3. Infusion Site Swelling — 130 reports (13.04%)
  4. Infusion Site Pain — 103 reports (10.33%)
  5. Pruritus — 87 reports (8.73%)
  6. Headache — 80 reports (8.02%)
  7. Infusion Site Rash — 65 reports (6.52%)
  8. Fatigue — 60 reports (6.02%)
  9. Swelling — 54 reports (5.42%)
  10. Erythema — 52 reports (5.22%)

Source database →

Xembify in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Xembify approved in United States?

Yes. FDA has authorised it.

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

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