🇺🇸 Soliris in United States

FDA authorised Soliris on 16 March 2007 · 30,869 US adverse-event reports

Marketing authorisations

FDA — authorised 16 March 2007

  • Application: BLA125166
  • Marketing authorisation holder: ALEXION PHARM
  • Status: supplemented

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 — 5,939 reports (19.24%)
  2. Off Label Use — 4,244 reports (13.75%)
  3. Haemoglobin Decreased — 4,030 reports (13.06%)
  4. Headache — 3,536 reports (11.45%)
  5. Death — 2,582 reports (8.36%)
  6. Pyrexia — 2,429 reports (7.87%)
  7. Dyspnoea — 2,174 reports (7.04%)
  8. Asthenia — 2,020 reports (6.54%)
  9. Nausea — 2,007 reports (6.5%)
  10. Haemolysis — 1,908 reports (6.18%)

Source database →

Other Neuroscience approved in United States

Frequently asked questions

Is Soliris approved in United States?

Yes. FDA authorised it on 16 March 2007; FDA has authorised it.

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

ALEXION PHARM holds the US marketing authorisation.