🇺🇸 DOTAREM in United States

FDA authorised DOTAREM on 20 March 2013 · 3,462 US adverse-event reports

Marketing authorisation

FDA — authorised 20 March 2013

  • Application: NDA204781
  • Marketing authorisation holder: GUERBET
  • Status: supplemented

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. Urticaria — 580 reports (16.75%)
  2. Dyspnoea — 463 reports (13.37%)
  3. Nausea — 436 reports (12.59%)
  4. Pruritus — 418 reports (12.07%)
  5. Vomiting — 367 reports (10.6%)
  6. Erythema — 351 reports (10.14%)
  7. Cough — 248 reports (7.16%)
  8. Rash — 234 reports (6.76%)
  9. Product Use In Unapproved Indication — 186 reports (5.37%)
  10. Headache — 179 reports (5.17%)

Source database →

Other Diagnostic Imaging approved in United States

Frequently asked questions

Is DOTAREM approved in United States?

Yes. FDA authorised it on 20 March 2013.

Who is the marketing authorisation holder for DOTAREM in United States?

GUERBET holds the US marketing authorisation.