🇺🇸 Monoferric in United States

FDA authorised Monoferric on 16 January 2020 · 1,035 US adverse-event reports

Marketing authorisations

FDA — authorised 16 January 2020

  • Application: NDA208171
  • Marketing authorisation holder: PHARMACOSMOS
  • Status: approved

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. Dyspnoea — 220 reports (21.26%)
  2. Flushing — 125 reports (12.08%)
  3. Nausea — 117 reports (11.3%)
  4. Chest Discomfort — 115 reports (11.11%)
  5. Back Pain — 100 reports (9.66%)
  6. Dizziness — 83 reports (8.02%)
  7. Infusion Related Reaction — 77 reports (7.44%)
  8. Pruritus — 72 reports (6.96%)
  9. Chest Pain — 64 reports (6.18%)
  10. Vomiting — 62 reports (5.99%)

Source database →

Other Hematology approved in United States

Frequently asked questions

Is Monoferric approved in United States?

Yes. FDA authorised it on 16 January 2020; FDA has authorised it.

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

PHARMACOSMOS holds the US marketing authorisation.