FDA — authorised 20 March 2013
- Application: NDA204781
- Marketing authorisation holder: GUERBET
- Local brand name: DOTAREM
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Gadoterate in United States
FDA authorised Gadoterate on 20 March 2013 · 163 US adverse-event reports
Marketing authorisations
FDA — authorised 1 November 2019
- Application: ANDA210016
- Marketing authorisation holder: GE HEALTHCARE
- Status: approved
FDA — authorised 11 April 2022
- Application: ANDA215304
- Marketing authorisation holder: HENGRUI PHARMA
- Status: approved
FDA — authorised 17 June 2024
- Application: ANDA218073
- Marketing authorisation holder: HAINAN POLY
- 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: 163
Most-reported reactions
- Nausea — 24 reports (14.72%)
- Vomiting — 20 reports (12.27%)
- Dyspnoea — 18 reports (11.04%)
- Hypotension — 17 reports (10.43%)
- Rash — 16 reports (9.82%)
- Erythema — 14 reports (8.59%)
- Loss Of Consciousness — 14 reports (8.59%)
- Oedema Peripheral — 14 reports (8.59%)
- Nephrogenic Systemic Fibrosis — 13 reports (7.98%)
- Pruritus — 13 reports (7.98%)
Gadoterate 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 Gadoterate approved in United States?
Yes. FDA authorised it on 20 March 2013; FDA authorised it on 1 November 2019; FDA authorised it on 11 April 2022.
Who is the marketing authorisation holder for Gadoterate in United States?
GUERBET holds the US marketing authorisation.