🇺🇸 Ioxaglate in United States

FDA authorised Ioxaglate on 26 July 1985 · 16 US adverse-event reports

Marketing authorisations

FDA — authorised 26 July 1985

  • Application: NDA018905
  • Marketing authorisation holder: GUERBET
  • Local brand name: HEXABRIX
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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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. Anaphylactic Reaction — 2 reports (12.5%)
  2. Anxiety — 2 reports (12.5%)
  3. Dyspnoea — 2 reports (12.5%)
  4. Hypotension — 2 reports (12.5%)
  5. Pruritus — 2 reports (12.5%)
  6. Urticaria — 2 reports (12.5%)
  7. Acute Generalised Exanthematous Pustulosis — 1 report (6.25%)
  8. Agitation — 1 report (6.25%)
  9. Angioedema — 1 report (6.25%)
  10. Anhedonia — 1 report (6.25%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Ioxaglate approved in United States?

Yes. FDA authorised it on 26 July 1985; FDA has authorised it.

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

GUERBET holds the US marketing authorisation.