🇺🇸 IV Iron in United States

FDA authorised IV Iron on 6 November 2000 · 13 US adverse-event reports

Marketing authorisations

FDA — authorised 6 November 2000

  • Application: NDA021135
  • Marketing authorisation holder: AM REGENT
  • Local brand name: VENOFER
  • Indication: INJECTABLE — 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. Blood Creatinine Increased — 2 reports (15.38%)
  2. Drug Hypersensitivity — 2 reports (15.38%)
  3. Drug Ineffective — 2 reports (15.38%)
  4. Abdominal Pain — 1 report (7.69%)
  5. Aphasia — 1 report (7.69%)
  6. Arthralgia — 1 report (7.69%)
  7. Blood Calcium Decreased — 1 report (7.69%)
  8. Blood Glucose Decreased — 1 report (7.69%)
  9. Cerebrovascular Accident — 1 report (7.69%)
  10. Chest Pain — 1 report (7.69%)

Source database →

IV Iron 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 IV Iron approved in United States?

Yes. FDA authorised it on 6 November 2000; FDA has authorised it.

Who is the marketing authorisation holder for IV Iron in United States?

AM REGENT holds the US marketing authorisation.