Metronidazoleside effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Neurologic Disease Contact Dermatitis Eye Irritation Most common adverse reactions (incidence > 2%) are nasopharyngitis, upper respiratory tract infection, and headache. To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma, at 1-844-825-8500, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1 Clinical

Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a controlled clinical trial, 557 subjects used Metronidazole Gel and 189 subjects used the gel vehicle once daily for up to 10 weeks. The following table summarizes selected adverse reactions that occurred at a rate of ≥1% and at a higher rate than vehicle: Table 1: Adverse Reactions That Occurred at a Rate of ≥1% and Higher Than Vehicle in Subjects Treated with Metronidazole Gel for Up to 10 Weeks Preferred Term Metronidazole Gel Gel Vehicle Influenza 8 1 Upper respiratory tract infection 14 4 Urinary tract infection 6 1 Headache 12 1 Contact dermatitis 7 1 Hypertension 6 1 Table 2: Local Cutaneous Signs and Symptoms of Irritation That Were Worse Than Baseline in Subjects Treated with Metronidazole Gel for Up to 10 Weeks Metronidazole Gel Gel Vehicle Sign/Symptom N= 544 N (%) N= 184 N (%) Dryness 138 63 Mild 93 41 Moderate 42 20 Severe 3 2 Scaling 134 60 Mild 88 32 Moderate 43 27 Severe 3 1 Pruritus 86 35 Mild 53 21 Moderate 27 13 Severe 6 1 Stinging/burning 56 28 Mild 39 18 Moderate 7 9 Severe 10 1 The following additional adverse experiences have been reported with the topical use of metronidazole: transient redness, metallic taste, tingling or numbness of extremities, and nausea.

6.2 Post Marketing

Experience The following adverse reaction has been identified during post- approval use of topical metronidazole. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

Nervous System Disorders: Peripheral neuropathy Ophthalmic Adverse Reactions: Tearing of the eyes