🇺🇸 Monofer in United States

70 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. Flushing — 10 reports (14.29%)
  2. Dyspnoea — 8 reports (11.43%)
  3. Hypersensitivity — 8 reports (11.43%)
  4. Malaise — 7 reports (10%)
  5. Tremor — 7 reports (10%)
  6. Anaphylactic Reaction — 6 reports (8.57%)
  7. Back Pain — 6 reports (8.57%)
  8. Cardiac Arrest — 6 reports (8.57%)
  9. Foetal Exposure During Pregnancy — 6 reports (8.57%)
  10. Hypotension — 6 reports (8.57%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Monofer approved in United States?

Yes. FDA has authorised it.

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

Pharmacosmos A/S is the originator. The local marketing authorisation holder may differ — check the official source linked above.