🇺🇸 Tecfidera in United States

FDA authorised Tecfidera on 27 March 2013 · 76,038 US adverse-event reports

Marketing authorisations

FDA — authorised 27 March 2013

  • Application: NDA204063
  • Marketing authorisation holder: BIOGEN INC
  • 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. Flushing — 16,802 reports (22.1%)
  2. Nausea — 8,848 reports (11.64%)
  3. Diarrhoea — 8,145 reports (10.71%)
  4. Multiple Sclerosis Relapse — 7,878 reports (10.36%)
  5. Fatigue — 6,816 reports (8.96%)
  6. Vomiting — 5,595 reports (7.36%)
  7. Multiple Sclerosis — 5,570 reports (7.33%)
  8. Gastric Disorder — 5,543 reports (7.29%)
  9. Memory Impairment — 5,511 reports (7.25%)
  10. Abdominal Pain Upper — 5,330 reports (7.01%)

Source database →

Tecfidera in other countries

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

Other Immunology approved in United States

Frequently asked questions

Is Tecfidera approved in United States?

Yes. FDA authorised it on 27 March 2013; FDA has authorised it.

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

BIOGEN INC holds the US marketing authorisation.