Please see Patient Information and Boxed Warning for more details at www.estrogel.com
EstroGel® 0.06% is approved by the FDA for use after menopause to reduce moderate to severe hot flashes and to treat moderate to severe menopausal changes in and around the vagina. If you use EstroGel only to treat your menopausal changes in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.
WHAT IS THE MOST IMPORTANT RISK INFORMATION I SHOULD KNOW ABOUT EstroGel® (AN ESTROGEN HORMONE)?
- Using estrogen-alone may increase your 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 out the cause.
- Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline in brain function).
- Using estrogen-alone may increase your chances of getting strokes and blood clots.
- Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older.
- Do not use estrogens with progestins to prevent heart disease, heart attack, strokes or dementia.
- Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
- Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age 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, currently have or have had blood clots, currently have or have had liver problems, have been diagnosed with a bleeding disorder, are allergic to EstroGel or any of its ingredients, or think you may be pregnant.
Tell your healthcare provider if you have any unusual vaginal bleeding, have any other medical conditions, are going to have surgery or will be on bed rest, are breastfeeding, and about all the medicines you take.
Serious but less common side effects include heart attack, stroke, blood clots, dementia, breast cancer, cancer of the lining of the uterus (womb), cancer of the ovary, high blood pressure, high blood glucose, gallbladder disease, liver problems, changes in your thyroid hormone levels, and enlargement of benign tumors ("fibroids").
Common side effects of estrogens include headache, breast pain, stomach or abdominal cramps, bloating, nausea and vomiting, hair loss, fluid retention, and vaginal yeast infection.
If you would like more information, talk with your healthcare provider. You may report side effects to ASCEND Therapeutics US, LLC at 1-877-204-1013.
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.
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