First Transdermal Gel for Estrogen Therapy in the United States
The U.S. Food and Drug Administration (FDA) has approved EstroGel 0.06% (estradiol gel)—the first plant-based, transdermal estrogen gel formulation in the country that is similar to estrogen your body makes naturally—for the treatment of moderate to severe hot flashes and moderate to severe dryness, itching, and burning in and around the vagina due to menopause.
The first FDA-approved estrogen therapy available in gel form, EstroGel provides women with a once-daily estradiol treatment option that is similar to the estrogen naturally produced by a woman's body. EstroGel is also marketed in Europe.
The transdermal delivery of EstroGel allows the body to receive a consistent and continuous supply of estrogen. EstroGel is applied once daily on one arm from wrist to shoulder. The gel dries in as little as two-to-five minutes. EstroGel is approved at a dosage of 1.25 g per day and is packaged in a non-aerosol, metered-dose pump that is designed to deliver 1.25 g of gel per compression.
EstroGel is available by prescription only. Ask your healthcare provider if EstroGel is right for you.
To learn more about EstroGel, the first transdermal gel for estrogen therapy, visit our web site at www.estrogel.com.
Important Safety Information
Please refer to the Estrogel Patient Information by clicking on the link in the right-hand column.
What is the Most Important 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.
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.
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.
You and your healthcare provider should talk regularly about whether you still need treatment with EstroGel.
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.
Licensed medical practitioners may request EstroGel samples. Click on the Sample Request Form link in the right-hand column for more information. For complete safety and prescribing information, please click on the Patient and Prescribing Information links on the right.
