Description
Estradiol 0.5 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.
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 22:38:30
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. The label says they are used for moderate to severe menopause symptoms such as hot flashes and vaginal/vulvar dryness, for certain low-estrogen conditions, for palliation of some metastatic breast cancers and advanced prostate cancer, and for prevention of osteoporosis in selected women.
The label warns that estrogens can increase the risk of endometrial cancer, blood clots, stroke, heart attack, breast cancer, and other serious problems. It also says estrogens should be used at the lowest effective dose for the shortest time consistent with treatment goals.
This product contains estradiol and inactive ingredients including lactose monohydrate, corn starch, magnesium stearate, dibasic calcium phosphate, colloidal silicon dioxide, and sodium starch glycolate. The 2 mg tablet contains FD&C Yellow No. 5, which may cause allergic-type reactions in some people.
Storage Information
Store at 20º to 25º C (68º to 77ºF) [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
- Take this medicine exactly as prescribed on the label.
- Tell your healthcare provider about any unusual or persistent vaginal bleeding.
- Seek prompt medical attention for symptoms of a blood clot, stroke, or heart attack.
- Do not use estrogens for prevention of cardiovascular disease, according to the label.
- Tell your healthcare provider if you have a history of breast cancer, estrogen-dependent cancer, blood clots, stroke, liver disease, or pregnancy.
- The 2 mg tablet contains FD&C Yellow No. 5, which may cause allergic-type reactions in susceptible individuals.
- Some medicines and grapefruit juice may change estrogen levels; the label lists CYP3A4 inducers and inhibitors as possible interactions.
- Your healthcare provider may monitor blood pressure and other conditions during therapy.
- The label advises regular breast examinations and mammography based on age, risk factors, and prior results.
- If sudden vision loss or other serious vision changes occur, the label says to stop the medicine and get examined.
Helpful Patient Education
Estradiol Tablets, USP are a prescription estrogen product containing micronized estradiol for oral use. According to the DailyMed label, this medicine is indicated for certain menopausal symptoms, hypoestrogenism, palliation of some metastatic cancers, and prevention of osteoporosis in selected patients.
The label also includes important safety information about risks such as endometrial cancer, blood clots, stroke, breast cancer, and dementia reported in some studies of estrogen-containing hormone therapy. Patients should use the medicine only as directed and discuss the label’s warnings and precautions with a healthcare professional.
Medication Summary last generated: 2026-07-17 03:07:11
Estradiol (Estrogen) 0.5 mg Tablets --- Generic For Estrace --- TEVA 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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