Prescribing Information Important Safety Information

INDICATION for ESTRACE® (estradiol vaginal cream, USP, 0.01%) ESTRACE vaginal cream is used to treat moderate to severe dryness, itching, and burning in and around the vagina due to menopause. Please read additional safety information below.

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.
Menopause can't be Reversed

IMPORTANT SAFETY INFORMATION for ESTRACE® (estradiol vaginal cream, USP, 0.01%), including Boxed Warning

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 had certain cancers (including cancer of the breast or uterus); had a stroke or heart attack; have or had blood clots or liver problems; are allergic to any of the ingredients in ESTRACE vaginal cream; or think you may be pregnant.

Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.

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.