🇺🇸 Fumaric acid esters in United States

10 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. Acute Myocardial Infarction — 1 report (10%)
  2. Bowen^S Disease — 1 report (10%)
  3. Chest Pain — 1 report (10%)
  4. Drug Dose Omission — 1 report (10%)
  5. Drug Ineffective — 1 report (10%)
  6. Dyspnoea Exertional — 1 report (10%)
  7. Erectile Dysfunction — 1 report (10%)
  8. Fall — 1 report (10%)
  9. Head Injury — 1 report (10%)
  10. Inappropriate Schedule Of Drug Administration — 1 report (10%)

Source database →

Fumaric acid esters in other countries

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

Frequently asked questions

Is Fumaric acid esters approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Fumaric acid esters in United States?

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