🇺🇸 agalsidase in United States

755 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. Fatigue — 111 reports (14.7%)
  2. Pain — 105 reports (13.91%)
  3. Malaise — 104 reports (13.77%)
  4. Pain In Extremity — 70 reports (9.27%)
  5. Pyrexia — 64 reports (8.48%)
  6. Headache — 63 reports (8.34%)
  7. Nausea — 61 reports (8.08%)
  8. Dizziness — 60 reports (7.95%)
  9. Dyspnoea — 59 reports (7.81%)
  10. Vomiting — 58 reports (7.68%)

Source database →

Other Rare Disease approved in United States

Frequently asked questions

Is agalsidase approved in United States?

Yes. FDA has authorised it.

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

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