Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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 The most common adverse reactions observed in adult clinical studies (incidence ≥1%) were vulvovaginal candidiasis, headache, vulvovaginal pruritus, nausea, diarrhea, and dysmenorrhea.
The most common adverse reactions observed in pediatric clinical studies (incidence ≥1%) was vulvovaginal discomfort.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact.
Encube Ethicals Private Limited, at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Clinical Trial Experience in Adult Patients The safety of metronidazole vaginal gel was evaluated in a randomized, double-blind, vehicle-controlled study in subjects with bacterial vaginosis.
A total of 321 non-pregnant females with a mean age of 33.4 years (range 18 to 67 years) received metronidazole vaginal gel.
Subjects were primarily Black/African American (58.3%) or White (39.3%).Subjects administered a single dose of metronidazole vaginal gel at bedtime on the first day of the study.
There were no deaths or serious adverse reactions in this trial.
Adverse reactions were reported by 19.0% of subjects treated with metronidazole vaginal gel versus 16.1% of subjects treated with Vehicle Gel.
Adverse reactions occurring in ≥1% of subjects receiving metronidazole vaginal gel were: vulvovaginal candidiasis (5.6%), headache (2.2%), vulvovaginal pruritus (1.6%), nausea (1.6%), diarrhea (1.2%), and dysmenorrhea (1.2%).
5 WARNINGS AND PRECAUTIONS • Central and peripheral nervous system effects: Convulsive seizures and peripheral neuropathy have been reported in patients treated with oral or intravenous metronidazole.
Discontinue promptly if abnormal neurologic signs develop.
( 5.1 ) • Interference with laboratory tests: Metronidazole may interfere with certain serum chemistry laboratory values.
( 5.3 ) 5.1 Central and Peripheral Nervous System Effects Convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with oral or intravenous metronidazole.
Metronidazole vaginal gel should be administered with caution to patients with central nervous system diseases.
Like all medications, Metronidazole Vaginal Gel can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: