🇺🇸 Aldurazyme in United States

FDA authorised Aldurazyme on 30 April 2003 · 1,590 US adverse-event reports

Marketing authorisations

FDA — authorised 30 April 2003

  • Application: BLA125058
  • Marketing authorisation holder: BIOMARIN
  • Local brand name: ALDURAZYME
  • Indication: VIAL
  • Status: approved

Read official source →

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. Pyrexia — 379 reports (23.84%)
  2. Pneumonia — 197 reports (12.39%)
  3. Vomiting — 163 reports (10.25%)
  4. Dyspnoea — 158 reports (9.94%)
  5. Malaise — 141 reports (8.87%)
  6. Cough — 131 reports (8.24%)
  7. Death — 130 reports (8.18%)
  8. Fatigue — 98 reports (6.16%)
  9. Urticaria — 97 reports (6.1%)
  10. Headache — 96 reports (6.04%)

Source database →

Aldurazyme 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 Aldurazyme approved in United States?

Yes. FDA authorised it on 30 April 2003; FDA has authorised it.

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

BIOMARIN holds the US marketing authorisation.