🇺🇸 Replagal (agalsidase alfa) in United States

13 US adverse-event reports

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 Related Reaction — 2 reports (15.38%)
  2. Nausea — 2 reports (15.38%)
  3. Pyrexia — 2 reports (15.38%)
  4. Anaphylactic Reaction — 1 report (7.69%)
  5. Angiokeratoma — 1 report (7.69%)
  6. Arthralgia — 1 report (7.69%)
  7. Body Temperature Increased — 1 report (7.69%)
  8. C-Reactive Protein Increased — 1 report (7.69%)
  9. Cardiac Disorder — 1 report (7.69%)
  10. Chills — 1 report (7.69%)

Source database →

Other Rare genetic disease / Lysosomal storage disorder approved in United States

Frequently asked questions

Is Replagal (agalsidase alfa) approved in United States?

Replagal (agalsidase alfa) does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Replagal (agalsidase alfa) in United States?

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