Estradiol (Estrogen) 2 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 contain estradiol, a form of estrogen, and are taken by mouth. They are prescription-only tablets available in different strengths and are used for several hormone-related conditions.

The label includes a boxed warning that estrogens can increase the risk of endometrial cancer. It also warns that estrogens should not be used to prevent heart disease and have been linked to increased risks of stroke, blood clots, breast cancer, and probable dementia in certain studies.

Estradiol tablets are indicated for moderate to severe menopausal symptoms, vulvar and vaginal atrophy associated with menopause, hypoestrogenism due to hypogonadism, castration, or primary ovarian failure, palliative treatment of some breast cancers and advanced prostate cancer, and prevention of osteoporosis in selected patients.

The label also notes several conditions in which estradiol should not be used, including undiagnosed abnormal genital bleeding, certain cancers, active or recent blood clots or arterial thromboembolic disease, liver disease, pregnancy, and hypersensitivity to ingredients.

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 available by prescription only.
• It contains estradiol, a form of estrogen taken by mouth.
• The label warns that estrogens may increase the risk of endometrial cancer, especially with unopposed use in women with a uterus.
• Estrogens should not be used to prevent cardiovascular disease.
• Tell a healthcare professional about any unexplained vaginal bleeding.
• The label warns about risks including stroke, blood clots, breast cancer, and probable dementia in certain groups studied.
• Do not use if you have a history of certain blood clots, estrogen-dependent cancer, liver disease, pregnancy, or allergy to the ingredients.
• The label says blood pressure should be monitored at regular intervals with estrogen use.
• Some medicines and grapefruit juice may affect estrogen levels; the label also lists St. Johnu2019s Wort and certain antibiotics and antifungals.
• Discuss the patient information leaflet with the prescriber or pharmacist.

Helpful Patient Education

Estradiol Tablets, USP are oral prescription estrogen tablets containing micronized estradiol. According to the DailyMed label, they are indicated for several hormone-related uses, including relief of moderate to severe menopausal vasomotor symptoms and vulvar or vaginal atrophy associated with menopause, as well as selected other estrogen deficiency and palliative cancer indications.

This product label also includes important safety information about estrogen therapy, including boxed warnings about endometrial cancer and cardiovascular risks. The label advises using the lowest effective dose for the shortest duration consistent with treatment goals and highlights that estradiol should not be used in people with certain contraindications, including undiagnosed abnormal genital bleeding, some cancers, active blood clots, liver disease, pregnancy, or hypersensitivity to ingredients.

Medication Summary last generated: 2026-07-05 12:32:52