🇺🇸 Antimicrobial in United States

FDA authorised Antimicrobial on 17 December 1985 · 158 US adverse-event reports

Marketing authorisations

FDA — authorised 17 December 1985

  • Application: NDA019422
  • Marketing authorisation holder: XTTRIUM
  • Status: supplemented

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. Drug Ineffective — 28 reports (17.72%)
  2. Death — 18 reports (11.39%)
  3. Dizziness — 15 reports (9.49%)
  4. Dyspnoea — 15 reports (9.49%)
  5. Adverse Event — 14 reports (8.86%)
  6. Diarrhoea — 14 reports (8.86%)
  7. Drug Interaction — 14 reports (8.86%)
  8. Unintended Pregnancy — 14 reports (8.86%)
  9. Nausea — 13 reports (8.23%)
  10. Rhabdomyolysis — 13 reports (8.23%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Antimicrobial approved in United States?

Yes. FDA authorised it on 17 December 1985; FDA has authorised it.

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

XTTRIUM holds the US marketing authorisation.