ADVERSE REACTIONS:
During controlled clinical studies conducted in the United States, 284 patients with vulvovaginal candidiasis were treated with terconazole vaginal suppositories 80 mg. Based on comparative analyses with placebo (295 patients), the adverse experiences considered adverse reactions most likely related to terconazole vaginal suppositories 80 mg, were headache (30.3% vs.20.7% with placebo) and pain of the female genitalia (4.2% vs. 0.7% with placebo). Adverse reactions that were reported but were not statistically significantly different from placebo were burning (15.2% vs. 11.2% with placebo) and body pain (3.9% vs. 1.7% with placebo). Fever (2.8% vs. 1.4% with placebo) and chills (1.8% vs. 0.7% with placebo) have also been reported. The therapy-related dropout rate was 3.5% and the placebo therapy-related dropout rate was 2.7%. The adverse drug experience on terconazole most frequently causing discontinuation was burning (2.5% vs 1.4% with placebo) and pruritus (1.8% vs. 1.4% with placebo).
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