ADVERSE REACTIONS
Safety data from 302 patients who used Metronidazole (n=200) or vehicle control (n=102) once daily in clinical trials and experienced an adverse event considered to be treatment-related include: application site reaction (Metronidazole 1, vehicle 1), condition aggravated (Metronidazole 1, vehicle 0), paresthesia (Metronidazole 0, vehicle 1), acne (Metronidazole 1, vehicle 0), dry skin (Metronidazole 0, vehicle 2). The majority of adverse reactions were mild to moderate in severity.
Two patients treated with Metronidazole once daily discontinued treatment because of adverse events: one for a severe flare of comedonal acne and one for rosacea aggravated.
Additional clinical adverse effects reported spontaneously since the drug was marketed are uncommon and include tingling or numbness of extremities, allergic reactions, skin and eye irritation, rash, headache, nausea and dry mouth.
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