FDA — authorised 2 June 1988
- Application: NDA019596
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: MAGNEVIST
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Magnevist in United States
FDA authorised Magnevist on 2 June 1988 · 7,287 US adverse-event reports
Marketing authorisations
FDA — authorised 10 March 2000
- Application: NDA021037
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: MAGNEVIST
- Indication: INJECTABLE — INJECTION
- 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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 7,287
Most-reported reactions
- Nephrogenic Systemic Fibrosis — 1,407 reports (19.31%)
- Urticaria — 964 reports (13.23%)
- Pain — 876 reports (12.02%)
- Nausea — 741 reports (10.17%)
- Vomiting — 672 reports (9.22%)
- Pruritus — 651 reports (8.93%)
- Anxiety — 537 reports (7.37%)
- Dyspnoea — 531 reports (7.29%)
- Injury — 455 reports (6.24%)
- Emotional Distress — 453 reports (6.22%)
Magnevist in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Magnevist approved in United States?
Yes. FDA authorised it on 2 June 1988; FDA authorised it on 10 March 2000; FDA has authorised it.
Who is the marketing authorisation holder for Magnevist in United States?
BAYER HLTHCARE holds the US marketing authorisation.