🇺🇸 Metronidazole Vaginal in United States

FDA authorised Metronidazole Vaginal on 20 May 2005 · 45 US adverse-event reports

Marketing authorisation

FDA — authorised 20 May 2005

  • Application: NDA021806
  • Marketing authorisation holder: TEVA PHARMS
  • Local brand name: VANDAZOLE
  • Indication: GEL — VAGINAL
  • Status: approved

Read official source →

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. Fatigue — 7 reports (15.56%)
  2. Vaginal Discharge — 7 reports (15.56%)
  3. Nausea — 5 reports (11.11%)
  4. Vaginal Haemorrhage — 5 reports (11.11%)
  5. Abortion Spontaneous — 4 reports (8.89%)
  6. Dry Mouth — 4 reports (8.89%)
  7. Vulvovaginal Discomfort — 4 reports (8.89%)
  8. Back Pain — 3 reports (6.67%)
  9. Bacterial Vaginosis — 3 reports (6.67%)
  10. Diarrhoea — 3 reports (6.67%)

Source database →

Other Infectious Disease approved in United States

Frequently asked questions

Is Metronidazole Vaginal approved in United States?

Yes. FDA authorised it on 20 May 2005.

Who is the marketing authorisation holder for Metronidazole Vaginal in United States?

TEVA PHARMS holds the US marketing authorisation.