FDA — authorised 15 March 2023
- Application: ANDA217480
- Marketing authorisation holder: HAINAN POLY PHARM
- Local brand name: GADOBUTROL
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Gadovist in United States
FDA authorised Gadovist on 15 March 2023 · 813 US adverse-event reports
Marketing authorisations
FDA — authorised 8 September 2023
- Application: ANDA216081
- Marketing authorisation holder: HENGRUI PHARMA
- Local brand name: GADOBUTROL
- Indication: SOLUTION — INTRAVENOUS
- 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: 813
Most-reported reactions
- Dyspnoea — 139 reports (17.1%)
- Nausea — 126 reports (15.5%)
- Dizziness — 83 reports (10.21%)
- Headache — 76 reports (9.35%)
- Urticaria — 75 reports (9.23%)
- Erythema — 74 reports (9.1%)
- Pruritus — 68 reports (8.36%)
- Paraesthesia — 62 reports (7.63%)
- Vomiting — 56 reports (6.89%)
- Cough — 54 reports (6.64%)
Gadovist 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 Gadovist approved in United States?
Yes. FDA authorised it on 15 March 2023; FDA authorised it on 8 September 2023; FDA has authorised it.
Who is the marketing authorisation holder for Gadovist in United States?
HAINAN POLY PHARM holds the US marketing authorisation.