Estrace® Vaginal Cream is used to treat moderate to severe dryness, itching, and burning in and around the vagina due to menopause.
Important Safety Information about Estrace® Vaginal Cream (estradiol vaginal cream, USP, 0.01%)
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ESTRACE® VAGINAL CREAM (AN ESTROGEN HORMONE)?
• Estrogens increase the chances of getting cancer of the uterus.
Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
• Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes.
Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer and blood clots. Using estrogens with progestins may increase your risk of dementia. You and your healthcare provider should talk regularly about whether you still need treatment with Estrace® Vaginal Cream.
Estrace® Vaginal Cream should not be used if you have unusual vaginal bleeding, have or have had certain cancers (including cancer of the breast or uterus), had a stroke or heart attack, have or have had blood clots or liver problems, are allergic to any of the ingredients in ESTRACE Vaginal Cream, think you may be pregnant or if you are breastfeeding.
Estrace® Vaginal Cream should be used at the lowest dose possible for your treatment only as long as needed. Although ESTRACE Vaginal Cream is only used in and around the vagina, the risks associated with oral estrogens should be taken into account.
The most common side effects include headache; breast tenderness; irregular vaginal bleeding or spotting; stomach/abdominal cramps and/or bloating; nausea and vomiting; hair loss; vaginal burning, irritation, and itching.
Please see Full Prescribing Information, which includes the Patient Information and Boxed Warning.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Estrace® is a registered trademark of Warner Chilcott Company, LLC.