Metronidazole
Generic: METRONIDAZOLE
Basic Information
Manufacturer
Fougera Pharmaceuticals, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
43ed872b-63ac-4a22-9c9e-cc0e05bcc41e
Indications & Usage
INDICATIONS AND USAGE Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
Adverse Reactions
ADVERSE REACTIONS In controlled clinical trials, the total incidence of adverse reactions associated with the use of metronidazole topical cream was approximately 10%.
Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea.
All individual events occurred in less than 3% of patients.
The following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.
Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea.
All individual events occurred in less than 3% of patients.
The following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.