🇺🇸 Gadoteridol (ProHance) in United States

12 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: 23 April 2025 – 23 April 2026
• Total reports: 12

Most-reported reactions

1. Nausea — 2 reports (16.67%)
2. Nephrogenic Systemic Fibrosis — 2 reports (16.67%)
3. Acute Myocardial Infarction — 1 report (8.33%)
4. Biopsy Skin Abnormal — 1 report (8.33%)
5. Coma — 1 report (8.33%)
6. Corneal Reflex Decreased — 1 report (8.33%)
7. Csf Test Abnormal — 1 report (8.33%)
8. Delayed Recovery From Anaesthesia — 1 report (8.33%)
9. Gait Disturbance — 1 report (8.33%)
10. Grip Strength Decreased — 1 report (8.33%)

Source database →

Frequently asked questions

Is Gadoteridol (ProHance) approved in United States?

Gadoteridol (ProHance) does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Gadoteridol (ProHance) in United States?

Bayer is the originator. The local marketing authorisation holder may differ — check the official source linked above.