FDA — authorised 22 November 1988
- Application: NDA019737
- Marketing authorisation holder: GALDERMA LABS LP
- Local brand name: METROGEL
- Indication: GEL — TOPICAL
- Status: approved
🇺🇸 Metronidazole Tablet in United States
FDA authorised Metronidazole Tablet on 22 November 1988 · 94 US adverse-event reports
Marketing authorisations
FDA — authorised 30 June 2005
- Application: NDA021789
- Marketing authorisation holder: GALDERMA LABS LP
- Local brand name: METROGEL
- Indication: GEL — TOPICAL
- 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.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 94
Most-reported reactions
- Nausea — 15 reports (15.96%)
- Headache — 13 reports (13.83%)
- Dizziness — 12 reports (12.77%)
- Dysgeusia — 9 reports (9.57%)
- Decreased Appetite — 8 reports (8.51%)
- Dyspnoea — 8 reports (8.51%)
- Malaise — 8 reports (8.51%)
- Lip Swelling — 7 reports (7.45%)
- Peripheral Swelling — 7 reports (7.45%)
- Pruritus — 7 reports (7.45%)
Other Infectious Disease approved in United States
Frequently asked questions
Is Metronidazole Tablet approved in United States?
Yes. FDA authorised it on 22 November 1988; FDA authorised it on 30 June 2005.
Who is the marketing authorisation holder for Metronidazole Tablet in United States?
GALDERMA LABS LP holds the US marketing authorisation.