Noritate Side Effects

Please note - some side effects for Noritate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Noritate Side Effects - for the Professional

Noritate

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.

Side Effects by Body System

Local

Local side effects have included skin irritation, dryness, redness, burning, and stinging. At times, the local effects of metronidazole may be difficult to distinguish from the clinical characteristics of acne rosacea. Watering or tearing may occur when metronidazole is applied too close to the eyes.

Genitourinary

Genitourinary side effects including vaginal or vulvar burning, irritation, or itching have been reported following administration of intravaginal metronidazole. In approximately 6% of patients, symptomatic vaginal candidiasis occurs during or immediately after metronidazole therapy. Uterine cramping has also been reported in less than 4% of patients.

Gastrointestinal

Gastrointestinal side effects including cramps/pain (3.4%), nausea (2.0%), and metallic or bad taste (1.7%) have been reported during vaginal administration of metronidazole.

Hematologic

A 58-year-old female with possible vaginal infection experienced TTP coincident with metronidazole therapy. She presented to the hospital with chest pain and blood in her urine three days after she was administered metronidazole 0.75% vaginal gel. She was diagnosed with TTP based on her laboratory and clinical findings. Her condition resolved after treatment.

Hematological side effects have included a case of thrombotic thrombocytopenic purpura (TTP).

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