🇺🇸 metronidazole 400mg in United States

40 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. Chromaturia — 5 reports (12.5%)
  2. Dysgeusia — 5 reports (12.5%)
  3. Headache — 5 reports (12.5%)
  4. Oral Candidiasis — 5 reports (12.5%)
  5. Fatigue — 4 reports (10%)
  6. Malaise — 4 reports (10%)
  7. Confusional State — 3 reports (7.5%)
  8. Diarrhoea — 3 reports (7.5%)
  9. Dizziness — 3 reports (7.5%)
  10. Dysuria — 3 reports (7.5%)

Source database →

metronidazole 400mg 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 metronidazole 400mg approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for metronidazole 400mg in United States?

Dow University of Health Sciences is the originator. The local marketing authorisation holder may differ — check the official source linked above.