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Brand Names: Divigel 0.25 mg/packet, Divigel 0.5 mg/packet, Divigel 1 mg/packet, Elestrin Pump, Estrasorb, EstroGel Pump, Evamist

Generic Name: estradiol topical (for use on skin) (Pronunciation: ess tra DYE ol TOP ik al)

• What is estradiol topical (Divigel 0.25 mg/packet, Divigel 0.5 mg/packet, Divigel 1 mg/packet, Elestrin Pump, Estrasorb, EstroGel Pump, Evamist)?
• What are the possible side effects of estradiol topical?
• What is the most important information I should know about estradiol topical?
• What should I discuss with my health care provider before using estradiol topical?
• How should I use estradiol topical?
• What happens if I miss a dose?
• What happens if I overdose?
• What should I avoid while using estradiol topical?
• What other drugs will affect estradiol topical?
• Where can I get more information?

What is estradiol topical (Divigel 0.25 mg/packet, Divigel 0.5 mg/packet, Divigel 1 mg/packet, Elestrin Pump, Estrasorb, EstroGel Pump, Evamist)?

Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.

Estradiol topical (for the skin) is used to treat certain symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation.

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

What are the possible side effects of estradiol topical?

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

Stop using estradiol topical and call your doctor at once if you have a serious side effect such as:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• sudden numbness or weakness, headache, confusion, or problems with vision, speech, or balance;
• pain, swelling, warmth, or redness in one or both legs;
• abnormal vaginal bleeding;
• pain, swelling, or tenderness in your stomach;
• jaundice (yellowing of the skin or eyes); or
• a lump in your breast.

Less serious side effects may include:

• nausea, vomiting, loss of appetite;
• swollen breasts;
• acne or skin color changes;
• vaginal pain, dryness, or discomfort, decreased sex drive, or difficulty having an orgasm;
• swelling, weight gain;
• migraine headaches, dizziness, depression; or
• break-through bleeding, vaginal itching or discharge.

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.

What is the most important information I should know about estradiol topical?

Do not use this medication if you have any of the following conditions: liver disease, a bleeding disorder, a history of stroke or circulation problems, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding.

Children should avoid coming into contact with skin areas where you have applied estradiol topical. If contact does occur, wash with soap and water right away. Cover treated areas with clothing to protect others from coming into contact with the skin where you apply this medicine.

Estrogens will not prevent heart disease, heart attack, stroke, breast cancer, or dementia, and may actually increase your risk of developing these conditions. Estrogens may also increase your risk of uterine or ovarian cancer.

Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

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