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.
ADVERSE REACTIONS Adverse Reactions from Clinical Trials 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 clinical practice.
During controlled clinical studies conducted in the United States, 521 patients with vulvovaginal candidiasis were treated with terconazole 0.4% vaginal cream.
Based on comparative analyses with placebo, the adverse experiences considered most likely related to terconazole 0.4% vaginal cream were headache (26% vs.
17% with placebo) and body pain (2.1% vs.
0% with placebo).
Fever (1.7% vs.
0.5% with placebo) and chills (0.4% vs.
0.0% with placebo), vulvovaginal burning, itching and irritation have also been reported.
The adverse drug experience on terconazole most frequently causing discontinuation was vulvovaginal itching.
Post-marketing Experience The following adverse drug reactions have been first identified during post-marketing experience with terconazole vaginal cream 0.4%.
WARNINGS Anaphylaxis and toxic epidermal necrolysis have been reported during terconazole therapy.
Terconazole therapy should be discontinued if anaphylaxis or toxic epidermal necrolysis develops.
Like all medications, Terconazole 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: