What are estradiol and levonorgestrel?

Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body. Levonorgestrel is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Estradiol and levonorgestrel is a combination medicine used to treat menopause symptoms such as hot flashes, and to prevent osteoporosis (bone loss) in menopausal women.

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

Estradiol and levonorgestrel side effects

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

Estradiol and levonorgestrel may cause serious side effects. Call your doctor at once if you have:

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• 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;

• memory problems, confusion, unusual behavior;

• unusual vaginal bleeding, pelvic pain;

• a lump in your breast; 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 of estradiol and levonorgestrel may include:

• nausea, vomiting, bloating, stomach cramps;

• fluid retention (swelling, rapid weight gain);

• headache;

• breast pain;

• redness or irritation where the patch was worn;

• thinning scalp hair; or

• vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.

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.

You should not use estradiol and levonorgestrel if you have had a hysterectomy, or if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Do not use if you are pregnant.

Estradiol and levonorgestrel may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.

Using this medicine can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Estradiol and levonorgestrel should not be used to prevent heart disease, stroke, or dementia.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Apply the skin patch to clean, dry skin on your lower stomach. The patch should be worn around-the-clock for one week. Choose a different place on your lower stomach each time you apply a new patch. Avoid skin that is oily, irritated, or damaged.

Change your patch on the same day each week to stay on schedule.

Do not apply a skin patch to your breasts. Do not apply a patch where it might be rubbed off by tight clothing, such as under an elastic waistband.

If a patch falls off, try putting it back on to a different skin area, pressing the patch into place for 10 seconds. If the patch will not stick you may apply a new one.

If you need major surgery or will be on long-term bed rest, you may need to stop using estradiol and levonorgestrel for a short time. Any doctor or surgeon who treats you should know that you are using estradiol and levonorgestrel.

Your doctor should check your progress on a regular basis to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while using estradiol and levonorgestrel.

Store patches at room temperature away from moisture and heat. Keep each patch in its pouch until you are ready to use it.

After removing a skin patch, fold it in half so it sticks together. Discard the folded patch in a place children and pets cannot get to.

You should not use this medicine if you are allergic to estradiol or levonorgestrel, if you have had a hysterectomy, or if you have:

• unusual vaginal bleeding that has not been checked by a doctor;

• liver 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 and levonorgestrel if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Using this medicine 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 and levonorgestrel 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;

• hereditary angioedema (an immune system disorder);

• kidney disease;

• gallbladder disease;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• lupus;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• endometriosis or uterine fibroid tumors;

• a thyroid disorder; or

• high levels of calcium in your blood.

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

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

Apply a skin patch as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Avoid exposing the patch to sunlight or tanning beds while you are wearing it on your skin.

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

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

Estradiol and levonorgestrel may cause serious side effects. Call your doctor at once if you have:

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• 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;

• memory problems, confusion, unusual behavior;

• unusual vaginal bleeding, pelvic pain;

• a lump in your breast; 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 of estradiol and levonorgestrel may include:

• nausea, vomiting, bloating, stomach cramps;

• fluid retention (swelling, rapid weight gain);

• headache;

• breast pain;

• redness or irritation where the patch was worn;

• thinning scalp hair; or

• vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.

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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect estradiol and levonorgestrel. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.