🇺🇸 Antibiotic in United States

1,554 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. Drug Ineffective — 246 reports (15.83%)
  2. Nausea — 184 reports (11.84%)
  3. Diarrhoea — 178 reports (11.45%)
  4. Dyspnoea — 159 reports (10.23%)
  5. Rash — 138 reports (8.88%)
  6. Dizziness — 137 reports (8.82%)
  7. Fatigue — 134 reports (8.62%)
  8. Headache — 129 reports (8.3%)
  9. Vomiting — 126 reports (8.11%)
  10. Pneumonia — 123 reports (7.92%)

Source database →

Other Infectious Disease approved in United States

Frequently asked questions

Is Antibiotic approved in United States?

Yes. FDA has authorised it.

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

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