🇺🇸 contrast agent, Gadolinium in United States

12 US adverse-event reports

Marketing authorisation

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.

Most-reported reactions

  1. Arthralgia — 2 reports (16.67%)
  2. Nephrogenic Systemic Fibrosis — 2 reports (16.67%)
  3. Abdominal Pain — 1 report (8.33%)
  4. Back Pain — 1 report (8.33%)
  5. Burning Sensation — 1 report (8.33%)
  6. Contrast Media Deposition — 1 report (8.33%)
  7. Contrast Media Toxicity — 1 report (8.33%)
  8. Drug Level Increased — 1 report (8.33%)
  9. Eczema — 1 report (8.33%)
  10. Feeling Abnormal — 1 report (8.33%)

Source database →

contrast agent, Gadolinium in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is contrast agent, Gadolinium approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for contrast agent, Gadolinium in United States?

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