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Brand Names: Estrace Vaginal Cream, Estring

Generic Name: estradiol (topical) (Pronunciation: ess tra DYE ole)

• What is estradiol (Estrace Vaginal Cream)?
• What are the possible side effects of estradiol (Estrace Vaginal Cream)?
• What is the most important information I should know about estradiol (Estrace Vaginal Cream)?
• What should I discuss with my healthcare provider before using estradiol (Estrace Vaginal Cream)?
• How should I use estradiol (Estrace Vaginal Cream)?
• What happens if I miss a dose (Estrace Vaginal Cream)?
• What happens if I overdose (Estrace Vaginal Cream)?
• What should I avoid while using estradiol (Estrace Vaginal Cream)?
• What other drugs will affect estradiol (Estrace Vaginal Cream)?
• Where can I get more information?

What is estradiol (Estrace Vaginal Cream)?

Estradiol (a form of estrogen) is a female sex hormone necessary for many processes in the body. Estradiol vaginal products release estrogen that is absorbed directly through the skin of the vaginal wall.

Estradiol topical is used to treat certain symptoms of menopause such as dryness, burning, and itching of the vaginal area and urgency or irritation with urination.

Estradiol may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of estradiol (Estrace Vaginal Cream)?

Estradiol increases the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, while using estradiol lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together while using estradiol. Visit your doctor regularly and report any unusual vaginal bleeding right away.

Treatment with estradiol long-term may increase the risk of stroke. Because of this risk, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking estradiol long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

If you experience any of the following serious side effects, stop using estradiol and seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
• shortness or breath or pain in the chest;
• a painful, red, swollen leg;
• abnormal vaginal bleeding;
• pain, swelling, or tenderness in the abdomen;
• severe headache or vomiting, dizziness, faintness or changes in vision or speech;
• yellowing of the skin or eyes; or
• a lump in a breast.

Other, less serious side effects may be more likely to occur. Continue to use estradiol and talk to your doctor if you experience

• decreased appetite, nausea, or vomiting;
• swollen breasts;
• acne or skin color changes;
• decreased sex drive;
• migraine headaches or dizziness;
• vaginal pain, dryness, or discomfort;
• water retention (swollen hands, feet, or ankles);
• depression; or
• changes in your menstrual cycle or break-through bleeding.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What is the most important information I should know about estradiol (Estrace Vaginal Cream)?

Estradiol increases the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, while using estradiol lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together while using estradiol. Visit your doctor regularly and report any unusual vaginal bleeding right away.

Treatment with estradiol long-term may increase the risk of stroke. Because of this risk, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking estradiol long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while using estradiol.

Do not use this medication if you are pregnant.

The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50-79 years of age) during 5 years of treatment with oral conjugated estrogens combined with medroxyprogesterone acetate.

The Women's Health Initiative Memory Study (WHIMS) found that postmenopausal women 65 years of age or older who were treated with oral conjugated estrogens plus medroxyprogesterone acetate had an increased risk of developing dementia. It is unknown whether this finding applies to younger postmenopausal women or to women using estrogen only therapy.