🇺🇸 Ultomiris in United States

5,998 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 — 1,526 reports (25.44%)
  2. Asthenia — 750 reports (12.5%)
  3. Headache — 672 reports (11.2%)
  4. Drug Ineffective — 599 reports (9.99%)
  5. Off Label Use — 473 reports (7.89%)
  6. Muscular Weakness — 430 reports (7.17%)
  7. Dyspnoea — 427 reports (7.12%)
  8. Myasthenia Gravis — 379 reports (6.32%)
  9. Malaise — 377 reports (6.29%)
  10. Death — 365 reports (6.09%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Ultomiris approved in United States?

Yes. FDA has authorised it.

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

Alexion Pharmaceuticals, Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.