Estradiol (Estrogen) 0.5 mg Tablets — Generic For Estrace — Epic

Medication Summary

Medication Summary: This section summarizes DailyMed drug label information to make the label easier to understand. It is not a substitute for the official label, pharmacist counseling, prescriber instructions, or medical advice.

Overview

Estradiol tablets contain micronized estradiol for oral use. The label lists several uses, including treatment of moderate to severe menopausal vasomotor symptoms, vulvar and vaginal atrophy symptoms associated with menopause, hypoestrogenism due to hypogonadism, castration, or primary ovarian failure, palliation of certain breast cancers, palliation of advanced androgen-dependent prostate cancer, and prevention of osteoporosis.

The label includes a boxed warning that estrogens increase the risk of endometrial cancer and that women taking estrogens need close clinical surveillance. It also warns that estrogens, with or without progestins, should not be used to prevent cardiovascular disease and are associated with increased risks such as myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis, and probable dementia in certain study populations.

Estradiol tablets should not be used in people with undiagnosed abnormal genital bleeding, certain breast cancers or estrogen-dependent cancers, active or recent blood clots or stroke/heart attack, liver disease, known hypersensitivity to the ingredients, or pregnancy. The label also notes important precautions and possible drug interactions, including effects on blood pressure, triglycerides, thyroid replacement therapy, and CYP3A4-related interactions.

Storage Information

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required.

Key Counseling Points

• Use exactly as prescribed, and follow the dosing schedule on the label.
• Report any undiagnosed, persistent, or recurring abnormal vaginal bleeding to a healthcare professional.
• Tell a healthcare professional right away about symptoms that could suggest a blood clot, stroke, heart attack, or pulmonary embolism.
• Do not use if you have a known allergy to estradiol tablet ingredients.
• Let a healthcare professional know about any history of breast cancer, estrogen-dependent cancer, liver disease, blood clots, stroke, or heart attack.
• If you take thyroid hormone, blood thinners, or other long-term medicines, tell your healthcare professional because estrogens can affect lab tests and some drug therapies.
• The label notes that blood pressure and triglycerides may need monitoring during estrogen use.
• Patients taking estrogen should have clinical surveillance and follow recommended breast and gynecologic screening.
• The label advises discussing the Patient Information leaflet with patients.

Helpful Patient Education

Estradiol tablets, USP contain oral micronized estradiol and are described in the DailyMed label for several uses, including menopausal vasomotor symptoms, vulvar and vaginal atrophy symptoms associated with menopause, hypoestrogenism, prevention of osteoporosis, and selected cancer-related palliative uses. The label also includes important boxed warnings and precautions about cancer, cardiovascular risks, blood clots, and dementia in certain populations.

Educational product information should emphasize that estradiol is a prescription estrogen with significant safety warnings and multiple contraindications. Patients and caregivers should review the label’s safety information, possible drug interactions, and the need for ongoing clinical monitoring when this medicine is used.

Medication Summary last generated: 2026-07-17 03:07:07