🇺🇸 Iron isomaltoside in United States
191 US adverse-event reports
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.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 191
Most-reported reactions
- Dyspnoea — 36 reports (18.85%)
- Maternal Exposure During Pregnancy — 25 reports (13.09%)
- Bradycardia — 23 reports (12.04%)
- Hypotension — 20 reports (10.47%)
- Nausea — 20 reports (10.47%)
- Chest Discomfort — 14 reports (7.33%)
- Dizziness — 14 reports (7.33%)
- Chest Pain — 13 reports (6.81%)
- Off Label Use — 13 reports (6.81%)
- Pyrexia — 13 reports (6.81%)
Other Hematology approved in United States
Frequently asked questions
Is Iron isomaltoside approved in United States?
Iron isomaltoside does not currently have US marketing authorisation in our dataset.
Who is the marketing authorisation holder for Iron isomaltoside in United States?
Thomas Jefferson University is the originator. The local marketing authorisation holder may differ — check the official source linked above.