Description
Estradiol 1 mg Tablets is available by prescription only. Go ahead and place your purchase. After making payment, we will ensure that a valid prescription is received from your prescriber.
Drug Label Highlights
Source: This information is taken from the official DailyMed drug label page when available. It is provided for educational purposes and is not a substitute for pharmacist counseling, prescriber instructions, or the full official labeling.
Boxed Warning
Estrogens Increase The Risk Of Endometrial Cancer
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of “natural” estrogens results in a different endometrial risk profile than “synthetic” estrogens at equivalent estrogen doses. (See WARNINGS, Malignant neoplasms, Endometrial cancer.)
Cardiovascular And Other Risks
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, Cardiovascular disorders.)
The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
DailyMed highlights last updated: 2026-06-24 22:38:33
Medication Guide
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 are a prescription estrogen medicine for oral use. The label lists uses that include treatment of moderate to severe menopause-related vasomotor symptoms, vulvar and vaginal atrophy symptoms, hypoestrogenism due to hypogonadism, castration, or primary ovarian failure, and palliation of certain cancers in appropriately selected patients. They are also indicated for prevention of osteoporosis in women at significant risk when non-estrogen options are not appropriate.
The label includes an important boxed warning that estrogens increase the risk of endometrial cancer. It also warns of cardiovascular and other serious risks, including heart attack, stroke, pulmonary embolism, and deep vein thrombosis. The medicine should be prescribed at the lowest effective dose for the shortest duration consistent with treatment goals and risks.
Estradiol tablets should not be used in people with certain conditions, including undiagnosed abnormal genital bleeding, breast cancer except in selected metastatic disease cases, estrogen-dependent neoplasia, active or recent blood clots or stroke/heart attack, liver dysfunction or disease, known hypersensitivity to the ingredients, or known or suspected pregnancy. The label also notes that blood pressure, liver issues, gallbladder disease, thyroid hormone needs, and other conditions may require monitoring or caution.
Storage Information
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Key Counseling Points
- This is a prescription estrogen tablet taken by mouth.
- Use is limited to the conditions listed on the label, such as menopause symptoms, certain low-estrogen states, and selected cancer-related uses.
- The label warns that estrogens can increase the risk of endometrial cancer.
- The label also warns about serious cardiovascular risks, including heart attack, stroke, blood clots, and pulmonary embolism.
- Report undiagnosed or recurring abnormal vaginal bleeding promptly, since the label calls for clinical evaluation.
- Do not use if you have any listed contraindications, such as active or recent blood clots, liver disease, or known or suspected pregnancy.
- The label says therapy should be prescribed at the lowest effective dose and for the shortest duration consistent with treatment goals and risks.
- The label notes that certain medicines and grapefruit juice may affect estrogen levels through CYP3A4 interactions.
- Blood pressure, thyroid status, and other lab or clinical effects may need monitoring during therapy.
- The label advises discussing the patient information leaflet with the prescriber or pharmacist.
Helpful Patient Education
Estradiol Tablets, USP are a prescription oral estrogen product used for several labeled indications, including moderate to severe menopause-related vasomotor symptoms, vulvar and vaginal atrophy symptoms, hypoestrogenism, and certain palliative cancer uses in appropriately selected patients. The label also includes an indication for prevention of osteoporosis in women at significant risk when non-estrogen options are not appropriate.
This product carries important safety warnings about endometrial cancer and cardiovascular risks, including blood clots, stroke, and heart attack. DailyMed label information also describes contraindications, precautions, and potential drug interactions, including effects on thyroid-related tests and possible interactions with CYP3A4 inducers or inhibitors.
Medication Summary last generated: 2026-07-17 03:07:23
Estradiol (Estrogen) 1 mg Tablets --- Generic For Estrace --- Ani Pharma may require patient-specific counseling based on your prescription, directions, allergies, medical history, and other medications.
This Medication Guide section is provided for general educational purposes only. It does not replace the official medication guide, patient information leaflet, counseling from your pharmacist, or medical advice from your prescriber.
Please read all information provided with your prescription. Contact Pill Pals Pharmacy or your prescriber with questions before using this medication.
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