Divigel® in the News
- June 30, 2009: New Data: Efficacy and Responder Analyses of Divigel® (estradiol gel) 0.1% for the Treatment of Menopause
- February 17, 2009: Newly Published Menopause Study: "Bioidentical" and FDA-Approved Divigel® (estradiol gel) 0.1% Safe and Effective Treatment for Moderate to Severe Hot Flashes Associated with Menopause
- September 25, 2008: New Analyses Indicate that Divigel® (estradiol gel) 0.1% is a Valuable Option for Certain Postmenopausal Women with Hot Flashes
- October 3, 2007: New Data Reveal Topical Divigel® (estradiol gel) 0.1% Significantly Reduces Frequency and Severity of Hot Flashes
- August 1, 2007: Upsher-Smith Announces Launch of Divigel® (estradiol gel) 0.1% for Treatment of Moderate to Severe Hot Flashes Associated with Menopause
- June 5, 2007: FDA Approves Divigel® (estradiol gel) 0.1% for Treatment of Moderate to Severe Hot Flashes Associated with Menopause
Important Safety Information for Patients
The following are not all the possible risks for Divigel®. Please read the full Patient Information leaflet and talk to your healthcare provider.
Estrogens increase the chance 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. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.
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 chance of getting heart attacks, strokes, breast cancer, and blood clots.
Do not use estrogens, with or without progestins, to prevent dementia. Using estrogens, with or without progestins, may increase your risk of dementia.
Do not use estrogen products, including Divigel®, 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 any Divigel® ingredients, or think you may be pregnant.
The most common side effects for all estrogen products are headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps and bloating, nausea and vomiting, and hair loss. The less common but serious side effects include breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease, and ovarian cancer.
In Divigel® clinical trials, the most common side effects were inflammation of the nasal passages and pharynx, upper respiratory tract infection, vaginal yeast infection, breast tenderness and vaginal bleeding. Call your healthcare provider right away if you have any symptoms that concern you.
Estrogen products should be used at the lowest dose possible for your treatment and only as long as needed. You and your healthcare provider should talk regularly about whether you still need treatment with Divigel®.
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.
For more information, call 1-800-654-2299.
©2010 Upsher-Smith Laboratories, Inc., Maple Grove, MN 55369
*Once-daily dosing of estradiol.
