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

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Estradiol (Estrogen) 1 mg Tablets — Generic For Estrace — Ani Pharma is available through Pill Pals Pharmacy with cash-pay pharmacy pricing and free shipping where available. Prescription required.

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Description

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prescription required

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 22:24:55

Additional information

Size/Count

1 Count

Dose/Strength

1 MG

Form

Tablet

Medication Guide

Official DailyMed Drug Label Information

This product has a DailyMed drug label PDF from the National Library of Medicine.

View / Download PDF View on DailyMed

  • Source: DailyMed, National Library of Medicine
  • DailyMed Label: ESTRADIOL TABLET [ANI PHARMACEUTICALS, INC.]
  • Matched NDC: 70954-565-20
  • Published Date: Sep 26, 2024

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 says they are used for moderate to severe menopausal hot flashes, moderate to severe vulvar and vaginal atrophy symptoms related to menopause, low estrogen from hypogonadism, castration, or primary ovarian failure, palliation of certain metastatic breast cancers, palliation of advanced androgen-dependent prostate cancer, and prevention of osteoporosis in selected patients.

The label includes a boxed warning that estrogens increase the risk of endometrial cancer. It also warns about increased risks of cardiovascular problems, blood clots, stroke, invasive breast cancer, pulmonary embolism, deep vein thrombosis, and probable dementia in certain postmenopausal women based on studies of hormone therapy.

Estradiol tablets should be used at the lowest effective dose for the shortest duration consistent with treatment goals and risks. The product contains 0.5 mg, 1 mg, or 2 mg estradiol tablets, with different tablet colors and inactive ingredients listed in the label.

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 medicine taken by mouth.
  • The label says it is used for several hormone-related conditions, including menopausal symptoms and prevention of osteoporosis in selected patients.
  • The label warns that estrogens can increase the risk of endometrial cancer.
  • The label warns about possible risks including stroke, blood clots, heart attack, breast cancer, and dementia in certain postmenopausal women.
  • Use the lowest effective dose for the shortest time consistent with treatment goals, as stated in the label.
  • The label says to consider topical vaginal products when treating only symptoms of vulvar and vaginal atrophy.
  • Tell a healthcare provider about any unexplained persistent or recurring abnormal vaginal bleeding.
  • The label says estrogen should not be used in pregnancy, and it should not be used with undiagnosed abnormal genital bleeding, certain cancers, active blood clots, liver disease, or known hypersensitivity to the ingredients.
  • The label notes that some medicines and grapefruit juice may change estrogen levels.
  • The label says blood pressure should be monitored at regular intervals during estrogen use.

Helpful Patient Education

Estradiol Tablets, USP are a prescription oral estrogen product available in 0.5 mg, 1 mg, and 2 mg strengths. According to the DailyMed label, estradiol tablets are used for moderate to severe menopausal vasomotor symptoms, vulvar and vaginal atrophy symptoms associated with menopause, hypoestrogenism, palliation of certain metastatic breast cancers, palliation of advanced prostate cancer, and prevention of osteoporosis in selected patients.

DailyMed labeling also includes important safety information about estrogen therapy, including warnings about endometrial cancer, cardiovascular risks, blood clots, breast cancer, and dementia in certain postmenopausal women. Product labeling advises using the lowest effective dose for the shortest duration consistent with treatment goals and risks.

Medication Summary last generated: 2026-07-10 03:11:45


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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