🇺🇸 Tysabri in United States

101,994 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 — 19,099 reports (18.73%)
  2. Multiple Sclerosis Relapse — 16,638 reports (16.31%)
  3. Headache — 9,588 reports (9.4%)
  4. Multiple Sclerosis — 9,549 reports (9.36%)
  5. Gait Disturbance — 9,409 reports (9.23%)
  6. Fall — 7,913 reports (7.76%)
  7. Memory Impairment — 7,878 reports (7.72%)
  8. Asthenia — 7,838 reports (7.68%)
  9. Malaise — 7,273 reports (7.13%)
  10. Drug Ineffective — 6,809 reports (6.68%)

Source database →

Other Immunology approved in United States

Frequently asked questions

Is Tysabri approved in United States?

Yes. FDA has authorised it.

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

University of Chicago is the originator. The local marketing authorisation holder may differ — check the official source linked above.