During controlled clinical studies conducted in the United States, 521 patients with vulvovaginal candidiasis were treated with terconazole vaginal cream 0.4%. Based on comparative analyses with placebo, the adverse experiences considered most likely related to terconazole vaginal cream 0.4% were headache (26% vs 17% with placebo) and body pain (2.1% vs 0% with placebo). Vulvovaginal burning (5.2%), itching (2.3%) or irritation (3.1%) occurred less frequently with terconazole vaginal cream 0.4% than with the vehicle placebo. Fever (1.7% vs 0.5% with placebo) and chills (0.4% vs 0.0% with placebo) have also been reported. The therapy-related dropout rate was 1.9%. The adverse drug experience on terconazole most frequently causing discontinuation of therapy was vulvovaginal itching (0.6%), which was lower than the incidence for placebo (0.9%).