🇺🇸 Injectafer in United States

FDA authorised Injectafer on 25 July 2013 · 2,202 US adverse-event reports

Marketing authorisations

FDA — authorised 25 July 2013

  • Application: NDA203565
  • Marketing authorisation holder: AM REGENT
  • Local brand name: INJECTAFER
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

Read official source →

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. Nausea — 412 reports (18.71%)
  2. Hypophosphataemia — 278 reports (12.62%)
  3. Dyspnoea — 256 reports (11.63%)
  4. Headache — 221 reports (10.04%)
  5. Urticaria — 216 reports (9.81%)
  6. Pruritus — 184 reports (8.36%)
  7. Dizziness — 175 reports (7.95%)
  8. Pain — 165 reports (7.49%)
  9. Blood Phosphorus Decreased — 153 reports (6.95%)
  10. Rash — 142 reports (6.45%)

Source database →

Injectafer in other countries

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

Other Hematology approved in United States

Frequently asked questions

Is Injectafer approved in United States?

Yes. FDA authorised it on 25 July 2013; FDA has authorised it.

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

AM REGENT holds the US marketing authorisation.