Estradiol (Estrogen) 1 mg Tablets — Generic For Estrace — Ani Pharma

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 an estrogen medicine taken by mouth. The label says they are used for several conditions, including moderate to severe menopausal symptoms, symptoms of vulvar and vaginal atrophy, hypoestrogenism, palliation of metastatic breast cancer in appropriately selected women and men, palliation of advanced prostate cancer, and prevention of osteoporosis.

The label carries important warnings. Estrogens increase the risk of endometrial cancer, and they are also associated with increased risks of heart attack, stroke, blood clots, invasive breast cancer, and possible dementia in some postmenopausal women. The medicine should be used at the lowest effective dose for the shortest duration consistent with treatment goals and risks.

Estradiol tablets should not be used in people with undiagnosed abnormal genital bleeding, certain cancers or estrogen-dependent neoplasia, active or recent blood clots or arterial thromboembolic disease, liver dysfunction or disease, known hypersensitivity to the ingredients, or known or suspected pregnancy. The label also notes that women taking estrogen should have clinical surveillance and that abnormal vaginal bleeding should be evaluated.

The tablets contain micronized estradiol and inactive ingredients such as colloidal silicon dioxide, corn starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate, and sodium starch glycolate.

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 medicine is an estrogen tablet taken by mouth.
• Use only as directed and at the lowest effective dose for the shortest time consistent with treatment goals.
• Tell a healthcare professional promptly about any unusual or persistent vaginal bleeding.
• The label warns about serious risks including blood clots, stroke, heart attack, breast cancer, and endometrial cancer.
• Do not use if you have known or suspected pregnancy or any listed contraindication on the label.
• Tell your healthcare professional about a history of blood clots, stroke, heart disease, liver disease, or hormone-sensitive cancer.
• If vision changes such as sudden loss of vision occur, the label says the medicine should be stopped and examined.
• The label says blood pressure should be monitored regularly during estrogen use.
• Tell your healthcare professional about all medicines and supplements, including CYP3A4 inducers or inhibitors such as St. Johnu2019s Wort, rifampin, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, and grapefruit juice.

Helpful Patient Education

Estradiol tablets are prescription estrogen tablets used for several labeled indications, including relief of moderate to severe menopausal vasomotor symptoms and treatment of vulvar and vaginal atrophy associated with menopause. The product label also includes uses for hypoestrogenism, certain palliative cancer indications, and prevention of osteoporosis in selected patients.

This educational page is based on DailyMed label information and highlights key safety warnings, contraindications, and precautions associated with estradiol therapy. It is important to review the boxed warning and other safety information, including risks related to endometrial cancer, cardiovascular events, blood clots, breast cancer, and other labeled warnings.

Medication Summary last generated: 2026-07-10 03:11:37