🇺🇸 Fabrazyme (agalsidase beta) in United States

14 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. Blood Pressure Decreased — 2 reports (14.29%)
  2. Cellulitis — 2 reports (14.29%)
  3. Disease Progression — 2 reports (14.29%)
  4. Fall — 2 reports (14.29%)
  5. Abscess Neck — 1 report (7.14%)
  6. Acute Abdomen — 1 report (7.14%)
  7. Altered State Of Consciousness — 1 report (7.14%)
  8. Anaemia — 1 report (7.14%)
  9. Aortic Aneurysm — 1 report (7.14%)
  10. Atrial Fibrillation — 1 report (7.14%)

Source database →

Fabrazyme (agalsidase beta) in other countries

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

Other Metabolic approved in United States

Frequently asked questions

Is Fabrazyme (agalsidase beta) approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Fabrazyme (agalsidase beta) in United States?

Genzyme, a Sanofi Company is the originator. The local marketing authorisation holder may differ — check the official source linked above.