WHAT IS THE MOST IMPORTANT RISK INFORMATION I SHOULD KNOW ABOUT EstroGel® (AN ESTROGEN HORMONE)?
Estrogens increase the chance of getting cancer of the uterus (womb).
Report any unusual vaginal bleeding right away while you are using EstroGel. 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 the cause.
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes, or dementia.
Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots.
Using estrogens, with or without progestins, may increase your risk of dementia, based on a study of women age 65 or older. You and your healthcare provider should talk regularly about whether you still need treatment with EstroGel.
Do not start using EstroGel if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack in the past year, currently have or have had blood clots, currently have or have had liver problems, are allergic to EstroGel or any of its ingredients, or think you may be pregnant.
Tell your healthcare provider if you are breastfeeding, about all of your medical problems and medicines you take, and if you are going to have surgery or will be on bed rest.
Serious but less common side effects of estrogens include gallbladder disease, ovarian cancer, high blood pressure, liver problems, high blood sugar, and enlargement of benign tumors of the uterus (“fibroids”).
Common side effects of estrogens include headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea, vomiting, hair loss, fluid retention, and vaginal yeast infection.
If you would like more information, talk with your healthcare provider.
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.
Please see full Patient Information (PDF) and boxed warning.
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