Estradiol is a form of estrogen, a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Estradiol transdermal skin patches are used to treat certain symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. This medicine is also used to prevent postmenopausal osteoporosis, or to treat ovarian disorders.

Estradiol transdermal may also be used for purposes not listed in this medication guide.

You should not use estradiol if you are allergic to it, or if you have:

• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease;
• coronary artery disease;
• a bleeding disorder;
• a history of heart attack, stroke, or blood clot; or
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

Do not use estradiol if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Using estradiol can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Estradiol should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

Tell your doctor if you have ever had:

• heart disease;
• liver problems, or jaundice caused by pregnancy or taking hormones;
• a thyroid disorder;
• gallbladder disease;
• kidney disease;
• asthma;
• epilepsy or other seizure disorder;
• migraine headaches;
• lupus;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• endometriosis or uterine fibroid tumors;
• high levels of calcium in your blood; or
• hereditary angioedema (an immune system disorder).

Using estradiol may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

Estradiol can slow breast milk production. Tell your doctor if you are breast-feeding.

Use Vivelle-Dot (Transdermal) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Remove the skin patch and call your doctor at once if you have:

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• swelling or tenderness in your stomach;
• jaundice (yellowing of the skin or eyes);
• unusual vaginal bleeding, pelvic pain;
• a breast lump;
• memory problems, confusion, unusual behavior; or
• high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

• headache, back pain;
• stuffy nose, sinus pain, sore throat;
• vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;
• bloating, stomach cramps, nausea, vomiting;
• breast pain;
• redness or irritation where the patch was worn;
• thinning scalp hair; or
• fluid retention (swelling, rapid weight gain).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using estradiol.

Grapefruit may interact with estradiol and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid using creams, lotions, or powders on the skin where you apply the patch, or it may not stick to your skin.