Metronidazole
RxNorm 311679· METRONIDAZOLE· TOPICAL
Nitroimidazole Antimicrobial [EPC] · Viona Pharmaceuticals Inc
Indications and usage
INDICATIONS AND USAGE Metronidazole Gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
Dosage and administration
DOSAGE AND ADMINISTRATION Apply and rub in a thin film of metronidazole gel twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be cleansed before application of metronidazole gel. Patients may use cosmetics after application of metronidazole gel.
Contraindications
CONTRAINDICATIONS Metronidazole Gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens or other ingredients of the formulation.
Adverse events
Most frequently reported events (FDA FAERS). Report frequency does not imply causation.
- drug ineffective5,596
- nausea4,880
- diarrhoea4,251
- off label use4,209
- vomiting3,409
- pyrexia3,312
- pain3,196
- drug hypersensitivity3,176
- abdominal pain3,061
- headache3,044
- fatigue2,981
- dyspnoea2,328
- dizziness2,305
- condition aggravated2,172
- malaise2,076
- rash2,060
Adverse reactions (label)
ADVERSE REACTIONS The following adverse experiences have been reported with the topical use of metronidazole: burning, skin irritation, dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea. T o report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
View more: Full FDA label on DailyMed →Label effective 20260219