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.
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 22:11:42
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 taken by mouth. The label lists uses including treatment of moderate to severe menopause-related hot flashes, vulvar and vaginal atrophy related to menopause, hypoestrogenism due to hypogonadism, castration, or primary ovarian failure, and palliation of certain advanced cancers in appropriately selected patients.
The label also includes use for prevention of osteoporosis in women at significant risk when non-estrogen medicines are not considered appropriate. For symptoms of vulvar and vaginal atrophy alone, topical vaginal products should be considered.
This medicine carries important boxed warnings. Estrogens can increase the risk of endometrial cancer, and they should not be used to prevent cardiovascular disease. The label also describes increased risks of stroke, blood clots, invasive breast cancer, and probable dementia in certain studies of estrogen-containing therapy.
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 described on the label for menopausal symptoms, hypoestrogenism, certain cancers, and prevention of osteoporosis in selected patients.
- The label says estrogens should not be used to prevent cardiovascular disease.
- Report any undiagnosed, persistent, or recurring abnormal vaginal bleeding promptly; the label warns about endometrial cancer risk.
- The label warns about increased risks of blood clots, stroke, heart attack, and invasive breast cancer with estrogen-containing therapy.
- If a dose is being used only for vulvar and vaginal atrophy, the label says topical vaginal products should be considered.
- Use the lowest effective dose for the shortest duration consistent with treatment goals and individual risk.
- Tell your healthcare professional about personal or family history of blood clots, stroke, heart disease, breast cancer, liver disease, or pregnancy, because these are listed in the labelu2019s contraindications or warnings.
- The label advises discussing the Patient Information leaflet with patients.
- The label notes that some medicines and grapefruit juice may affect estrogen levels, including CYP3A4 inducers and inhibitors.
Helpful Patient Education
Estradiol tablets, USP are a prescription estrogen medicine for oral use. DailyMed labeling lists uses including treatment of moderate to severe menopausal symptoms, vulvar and vaginal atrophy associated with menopause, hypoestrogenism due to hypogonadism, castration, or primary ovarian failure, and palliation of certain advanced breast or prostate cancers in appropriately selected patients.
The label also describes important safety warnings, including increased risks of endometrial cancer, blood clots, stroke, invasive breast cancer, and probable dementia in certain studies of estrogen-containing therapy. Education for patients should also include review of the Patient Information leaflet and awareness that this medicine should be used at the lowest effective dose for the shortest duration consistent with treatment goals.
Medication Summary last generated: 2026-07-05 12:32:24
Estradiol (Estrogen) 0.5 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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