Estradiol (Menopause Hormone Therapy)

Important Safety Information — Estradiol (Menopause Hormone Therapy)

What is it approved for?

Estradiol patches, gels and tablets are FDA-approved to treat moderate to severe vasomotor symptoms (hot flashes) due to menopause. Depending on the product, the label may also cover: treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause (when prescribing only for these symptoms, the labels say topical vaginal products should be considered first); treatment of low estrogen (hypoestrogenism) due to hypogonadism, castration or primary ovarian failure; and prevention of postmenopausal osteoporosis, limited to women at significant risk for whom non-estrogen medicines are not considered appropriate. Estradiol tablets are additionally approved, for palliation only, in certain metastatic breast cancers and in advanced androgen-dependent prostate cancer. Some estradiol gels are approved for vasomotor symptoms only. This page discusses estradiol for menopause symptoms; the approved uses of the exact product you are prescribed are listed on its label.

Do not use if

• Unusual or abnormal vaginal bleeding that has not been evaluated
• Current or past breast cancer, or a known or suspected estrogen-dependent cancer
• Current or past blood clots in the legs or lungs (deep vein thrombosis or pulmonary embolism)
• A stroke, heart attack or other arterial clotting event, now or in the past
• A known clotting disorder such as protein C, protein S or antithrombin deficiency
• Liver problems or liver disease
• A past anaphylactic reaction, angioedema or other allergy to estradiol or any ingredient of the product
• Known or suspected pregnancy

Before starting, tell your provider if

• Whether you still have your uterus (have not had a hysterectomy)
• Asthma, epilepsy (seizures), migraine, endometriosis, lupus, porphyria, diabetes, hereditary angioedema, high or low calcium levels, liver hemangiomas, or problems with your heart, liver, thyroid or kidneys
• High blood pressure, high triglycerides, high cholesterol, tobacco use, or a past episode of cholestatic jaundice (yellowing of the skin or eyes)
• Thyroid hormone use, because estrogen can change how much thyroid medicine you need
• All medicines and supplements, including St. John's wort, phenobarbital, carbamazepine, rifampin, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice, which can change estrogen levels
• Planned surgery or a period of bed rest, since estrogen may need to be stopped beforehand
• If you use the gel: sunscreen or lotion on the application area, which the label says has not been studied with this gel and may change absorption
• Breastfeeding

Serious side effects — get medical help right away

• Stroke, heart attack and blood clots. Get emergency help for chest pain, pain in your calves, sudden shortness of breath or coughing up blood, a severe headache or vomiting, dizziness or faintness, changes in vision or speech, or weakness or numbness of an arm or leg.
• Cancer of the uterus (endometrial cancer). Report any unusual vaginal bleeding right away. After menopause, vaginal bleeding may be a warning sign of uterine cancer.
• Breast cancer. Tell your provider about any breast lump. The labels advise a breast exam and mammogram every year unless your health care professional advises otherwise.
• Ovarian cancer. Studies have reported an increased risk of ovarian cancer in women who used hormone therapy for menopause symptoms.
• Dementia. In a study of women 65 and older, hormone therapy was linked with a higher risk of probable dementia.
• Gallbladder disease and liver problems. Tell your provider about pain, swelling or tenderness in the abdomen, or yellowing of the skin or eyes.
• Vision problems. Blood clots in the retina have been reported with estrogen. Stop and get prompt care for sudden partial or complete loss of vision, sudden bulging of the eyes, double vision or migraine.
• High blood pressure, fluid retention and high triglycerides. The labels list raised blood pressure, fluid retention and worsening of high triglycerides, which can lead to pancreatitis, among the warnings. Keep your usual check-ups and report swelling or severe abdominal pain.

Common side effects

Common side effects: headache, breast pain or tenderness, irregular vaginal bleeding or spotting, stomach cramps, bloating or abdominal pain, nausea and vomiting, hair loss, fluid retention (swelling), vaginal yeast infection, cold-like symptoms and upper respiratory infections, and, with the patch or gel, skin irritation where it is applied. These are not all the possible side effects.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Pregnancy and breastfeeding

Estradiol should not be used during pregnancy; there is no indication for it in pregnancy. Estrogen passes into breast milk and has been shown to reduce the amount and quality of milk, so tell your provider if you are breastfeeding.

Estradiol gel contains alcohol and is flammable: avoid fire, flames and smoking until it has dried. Let it dry before dressing, wash your hands with soap and water after applying, do not wash the area for at least an hour, and keep children and pets away from the application site; if someone touches wet gel, have them wash the area promptly.

Apply the patch to clean, dry skin of the lower abdomen or upper buttock, never on or near the breasts or on irritated skin, and rotate sites. Fold a used patch sticky side in and place it in a child-proof container in the trash; do not flush it.

Prescription only. Estradiol is available only after an online visit with a licensed provider, who determines whether treatment is appropriate for you. This summary does not replace the full prescribing information. Not medical advice. Results may vary.