🇺🇸 Replagal in United States

262 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 — 35 reports (13.36%)
  2. Inappropriate Schedule Of Product Administration — 31 reports (11.83%)
  3. Malaise — 29 reports (11.07%)
  4. Pyrexia — 26 reports (9.92%)
  5. Cough — 25 reports (9.54%)
  6. Dizziness — 24 reports (9.16%)
  7. Nasopharyngitis — 24 reports (9.16%)
  8. Headache — 23 reports (8.78%)
  9. Pain — 23 reports (8.78%)
  10. Blood Pressure Decreased — 22 reports (8.4%)

Source database →

Replagal in other countries

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

Other Rare Disease approved in United States

Frequently asked questions

Is Replagal approved in United States?

Yes. FDA has authorised it.

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

National Institute of Neurological Disorders and Stroke (NINDS) is the originator. The local marketing authorisation holder may differ — check the official source linked above.