Estradiol 1 mg Tablet, 100-count — NDC 0555-0886-02 (Billing 00555-0886-02)
This is a package of 100 tablets of Estradiol 1 mg Tablet from Teva Pharmaceuticals USA, Inc., marketed since Oct 1997 and currently FDA-listed; retail pharmacies pay about $0.0635 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 0555-0886-02 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0555 labeler · 0886 product · 02 package
- Package marketed since
- Oct 28, 1997
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 100 EA per package
- Barcode (UPC-A, from the NDC)
- 3 0555088602 0
- Medicaid fills, this package
- 96,515 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Estradiol (different manufacturers) — 4 · tap to view
Past resolved recalls for this product (1)
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 003204
- GCN: 10770
- GPI-14 (Medi-Span): 24000035000305
- HICL (First Databank): 001421
- AHFS class code: 68:16.04.00
- RxCUI (RxNorm): 197657
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Radioactive Diagnostic Agent class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Estrogen may be used for the following: to treat hot flushes ('hot flashes'; sudden strong feelings of heat and sweating) in women who are experiencing menopause ('change of life', the end of monthly menstrual periods) to treat vaginal dryness, itching, or burning to prevent osteoporosis (a condition in which the bones become thin and weak and break easily) in women who are experiencing or have experienced menopause to relieve symptoms of low estrogen in young women who do not produce enough estrogen naturally to relieve the symptoms of certain types of breast and prostate (a male repro...
Read the full MedlinePlus article ↗- It's an estrogen used mainly for menopause symptoms like hot flashes and vaginal dryness. Some patches are also used for low estrogen from ovarian problems or to prevent osteoporos...
- That depends on the form. Patches go on the skin once or twice a week depending on the brand, and the injection goes into a muscle. Use the lowest dose that works for the shortest...
- Headache, breast tenderness, spotting or irregular bleeding, cold-like symptoms and skin irritation where a patch sits are the most common. Tell your doctor if they bother you or d...
- Get urgent help for chest pain, sudden weakness or trouble speaking, a swollen painful leg, sudden shortness of breath or sudden vision changes. These could be a stroke or blood cl...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Estradiol — tap one for details:
Estradiol may be associated with lower levels of 5 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.064 | $6.35 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.1759 | $17.59 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.1552 | $15.52 / 100 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00555-0886-02 You're viewing this Main listing | 100 TABLET in 1 BOTTLE | $0.0635 / ea | $6.35 | 1997-10-28 | — | Active |
| 00555-0886-04 0555-0886-04 | 500 TABLET in 1 BOTTLE | $0.0635 / ea | $31.74 | 1997-10-28 | — | Active |
You're viewing the smallest of 2 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0635 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 81% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 00555-0886-04?
What NDC number is used to bill for this package of Estradiol 1 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Estradiol 1 mgthis 00555-0886-02 | Teva | 100 tablets | $0.063 | AB | Availability likely | — |
| Estradiol 1 mg 24658-0703-01 | PURACAP | 100 tablets | $0.063 | AB | Availability likely | — |
| Estradiol 1 mg 42806-0088-01 | EPIC | 100 tablets | $0.063 | AB | Availability likely | — |
| Estradiol 1 mg 60687-0876-65 | American | 50 tablets | $0.063 | AB | Availability likely | — |
| Estradiol 1 mg 70954-0565-10 | ANI | 100 tablets | $0.063 | AB | Availability likely | — |
| Estradiol 1 mg 72603-0274-01 | NorthStar | 100 tablets | $0.063 | AB | Availability likely | — |
| Estradiol 1 mg 50090-1704-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 50090-6359-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 50090-6847-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 50090-7452-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 50090-7480-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 50090-7481-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 51655-0229-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 54348-0701-30 | PharmPak, | 30 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 63187-0741-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 68071-2487-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 68071-3394-02 | NuCare | 120 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 68071-3629-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 68788-7102-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 68788-8860-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 70518-3818-00 | REMEDYREPACK | 90 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 70518-3922-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 71335-0445-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 71335-0797-01 | Bryant | 100 tablets | — | AB | Discontinued | — |
| Estradiol 1 mg 71335-2387-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 72189-0502-60 | Direct_Rx | 60 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 72789-0299-90 | PD-Rx | 90 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 76420-0022-10 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 82868-0038-30 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Estradiol 1 mg 67296-2279-09 | Redpharm | 90 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII ZK64F7XSTX
A red synthetic colorant made by combining D&C Red No. 27 dye with aluminum salts. It's used to give tablets, capsules, or other medicines their red or pink color.
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UNII O7TSZ97GEP
A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
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UNII J9EQA3S2JM
FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Teva Pharmaceuticals USA, Inc. labeler code 00555
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and 3.125 mg; 3.125 mg; 3.125 mg; 3.125 mg Tablet NDC 0555-0776-02
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg Tablet NDC 0555-0777-02
- Medroxyprogesterone Acetate 10 mg Tablet NDC 0555-0779-02
- Medroxyprogesterone Acetate 2.5 mg Tablet NDC 0555-0872-02
- Medroxyprogesterone Acetate 5 mg Tablet NDC 0555-0873-02
- Hydroxyurea 500 mg Capsule NDC 0555-0882-02
- Estradiol 2 mg Tablet NDC 0555-0887-02
- Estradiol .5 mg Tablet NDC 0555-0899-02
- Dextroamphetamine Sulfate 5 mg Tablet NDC 0555-0952-02
- Dextroamphetamine Sulfate 10 mg Tablet NDC 0555-0953-02
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg Tablet NDC 0555-0971-02
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg Tablet NDC 0555-0972-02
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 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.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Estradiol tablets are indicated in the: Treatment of moderate to severe vasomotor symptoms associated with the menopause. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (See CLINICAL PHARMACOLOGY , Clinical Studies . ) The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy.
Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400 to 800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman.
Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS ). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding. Patients should be started at the lowest dose for the indication.
1. For treatment of moderate to severe vasomotor symptoms, vulval and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible. Attempts to discontinue or taper medication should be made at 3-month to 6-month intervals.
The usual initial dosage range is 1 to 2 mg daily of estradiol adjusted as necessary to control presenting symptoms. The minimal effective dose for maintenance therapy should be determined by titration. Administration should be cyclic (e.g., 3 weeks on and 1 week off).
2. For treatment of female hypoestrogenism due to hypogonadism, castration, or primary ovarian failure. Treatment is usually initiated with a dose of 1 to 2 mg daily of estradiol, adjusted as necessary to control presenting symptoms; the minimal effective dose for maintenance therapy should be determined by titration.
3. For treatment of breast cancer, for palliation only, in appropriately selected women and men with metastatic disease. Suggested dosage is 10 mg three times daily for a period of at least three months.
4. For treatment of advanced androgen-dependent carcinoma of the prostate, for palliation only. Suggested dosage is 1 to 2 mg three times daily.
The effectiveness of therapy can be judged by phosphatase determinations as well as by symptomatic improvement of the patient. 5. For prevention of osteoporosis.
When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should be considered only for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. The lowest effective dose of estradiol has not been determined.
⛔ Contraindications ▾
CONTRAINDICATIONS Estrogens should not be used in individuals with any of the following conditions: Undiagnosed abnormal genital bleeding. Known, suspected or history of cancer of the breast except in appropriately selected patients being treated for metastatic disease. Known or suspected estrogen-dependent neoplasia.
Active deep vein thrombosis, pulmonary embolism or history of these conditions. Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction. Liver dysfunction or disease.
Estradiol tablets should not be used in patients with known hypersensitivity to its ingredients. Estradiol tablets 2 mg contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals.
Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. Known or suspected pregnancy.
There is no indication for estradiol tablets in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy. (See PRECAUTIONS .)
⚠️ Warnings ▾
WARNINGS See BOXED WARNINGS . 1. Cardiovascular disorders Estrogen and estrogen/progestin therapy has been associated with an increased risk of cardiovascular events such as myocardial infarction and stroke, as well as venous thrombosis and pulmonary embolism (venous thromboembolism or VTE).
Should any of these occur or be suspected estrogens should be discontinued immediately. Risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. a. Coronary heart disease and stroke In the Women’s Health Initiative (WHI) study, an increase in the number of myocardial infarctions and strokes has been observed in women receiving CE compared to placebo.
These observations are preliminary, and the study is continuing . (See CLINICAL PHARMACOLOGY, Clinical Studies .) In the CE/MPA substudy of WHI, an increased risk of coronary heart disease (CHD) events (defined as nonfatal myocardial infarction and CHD death) was observed in women receiving CE/MPA compared to women receiving placebo (37 vs 30 per 10,000 women years). The increase in risk was observed in year one and persisted.
In the same substudy of WHI, an increased risk of stroke was observed in women receiving CE/MPA compared to women receiving placebo (29 vs 21 per 10,000 women-years). The increase in risk was observed after the first year and persisted. In postmenopausal women with documented heart disease (n = 2,763, average age 66.7 years) a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen/Progestin Replacement Study; HERS) treatment with CE/MPA (0.625 mg/2.5 mg per day) demonstrated no cardiovascular benefit.
During an average follow-up of 4.1 years, treatment with CE/MPA did not reduce the overall rate of CHD events in postmenopausal women with established coronary heart disease. There were more CHD events in the CE/MPA-treated group than in the placebo group in year 1, but not during the subsequent years. Two thousand three hundred and twenty one women from the original HERS trial agreed to participate in an open label extension of HERS, HERS II.
Average follow-up in HERS II was an additional 2.7 years, for a total of 6.8 years overall. Rates of CHD events were comparable among women in the CE/MPA group and the placebo group in HERS, HERS II, and overall. Large doses of estrogen (5 mg conjugated estrogens per day), comparable to those used to treat cancer of the prostate and breast, have been shown in a large prospective clinical trial in men to increase the risks of nonfatal myocardial infarction, pulmonary embolism, and thrombophlebitis. b.
Venous thromboembolism (VTE) In the Women’s Health Initiative (WHI) study, an increase in VTE has been observed in women receiving CE compared to placebo. These observations are preliminary, and the study is continuing. (See CLINICAL PHARMACOLOGY, Clinical Studies .) In the CE/MPA substudy of WHI, a 2fold greater rate of VTE, including deep venous thrombosis and pulmonary embolism, was observed in women receiving CE/MPA compared to women receiving placebo.
The rate of VTE was 34 per 10,000 womenyears in the CE/MPA group compared to 16 per 10,000 womenyears in the placebo group. The increase in VTE risk was observed during the first year and persisted. If feasible, estrogens should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization.
2. Malignant neoplasms a. Endometrial cancer The use of unopposed estrogens in women with intact uteri has been associated with an increased risk of endometrial cancer.
The reported endometrial cancer risk among unopposed estrogen users is about 2- to 12- fold greater than in non-users, and appears dependent on duration of treatme… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
ADVERSE REACTIONS See BOXED WARNINGS , WARNINGS , and PRECAUTIONS . The following additional adverse reactions have been reported with estrogen and/or progestin therapy. 1.
Genitourinary system Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding, spotting, dysmenorrhea Increase in size of uterine leiomyomata Vaginitis, including vaginal candidiasis Change in amount of cervical secretion Changes in cervical ectropion Ovarian cancer; endometrial hyperplasia; endometrial cancer 2. Breasts Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer 3. Cardiovascular Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure 4.
Gastrointestinal Nausea, vomiting Abdominal cramps, bloating Cholestatic jaundice Increased incidence of gallbladder disease Pancreatitis Enlargement of hepatic hemangiomas 5. Skin Chloasma or melasma that may persist when drug is discontinued Erythema multiforme Erythema nodosum Hemorrhagic eruption Loss of scalp hair Hirsutism Pruritus, rash 6. Eyes Retinal vascular thrombosis Steepening of corneal curvature Intolerance to contact lenses 7.
Central Nervous System Headache, migraine, dizziness Mental depression Chorea Nervousness, mood disturbances, irritability Exacerbation of epilepsy Dementia 8. Miscellaneous Increase or decrease in weight Reduced carbohydrate tolerance Aggravation of porphyria Edema Arthralgias; leg cramps Changes in libido Urticaria Angioedema Anaphylactoid/anaphylactic reactions Hypocalcemia Exacerbation of asthma Increased triglycerides To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
🔄 Drug Interactions ▾
Drug Interactions In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St.
John’s Wort preparations (Hypericum perforatum), phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in side effects.
🆘 Overdosage ▾
OVERDOSAGE Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing oral contraceptives by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol at the receptor level. The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle.
After menopause, most endogenous estrogen is produced by conversion of androstenedione, secreted by the adrenal cortex, to estrone by peripheral tissues. Thus, estrone and the sulfate conjugated form, estrone sulfate, are the most abundant circulating estrogens in postmenopausal women. Estrogens act through binding to nuclear receptors in estrogen-responsive tissues.
To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), through a negative feedback mechanism.
Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women. Pharmacokinetics Distribution The distribution of exogenous estrogens is similar to that of endogenous estrogens. Estrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs.
Estrogens circulate in the blood largely bound to sex hormone binding globulin (SHBG) and albumin. Metabolism Exogenous estrogens are metabolized in the same manner as endogenous estrogens. Circulating estrogens exist in a dynamic equilibrium of metabolic interconversions.
These transformations take place mainly in the liver. Estradiol is converted reversibly to estrone, and both can be converted to estriol, which is the major urinary metabolite. Estrogens also undergo enterohepatic recirculation via sulfate and glucuronide conjugation in the liver, biliary secretion of conjugates into the intestine, and hydrolysis in the gut followed by reabsorption.
In postmenopausal women, a significant proportion of the circulating estrogens exist as sulfate conjugates, especially estrone sulfate, which serves as a circulating reservoir for the formation of more active estrogens. Excretion Estradiol, estrone, and estriol are excreted in the urine along with glucuronide and sulfate conjugates. Special Populations No pharmacokinetic studies were conducted in special populations, including patients with renal or hepatic impairment.
Drug Interactions In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St.
John’s Wort preparations (Hypericum perforatum), phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in side effects. Clinical Studies Osteoporosis Most prospective studies of efficacy for this indication have been carried out in white menopausal women, without stratification by other risk factors, and tend to show a universally salutary effect on bone.
The results of a two-year, randomized, placebo-controlled, double-blind, dose-ranging study have shown that treatment with 0.5 mg estradiol daily for 23 days (of a 28 day cycle) prevents vertebral bone mass loss in postmenopausal women. When estrogen therapy is discontinued, bone mass declines at a rate comparable to the immediate postmenopausal pe… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Estradiol Tablets, USP are available as: 0.5 mg: White to off-white, oval, flat-faced, beveled-edge, scored tablet. Debossed with 899 / 1/2 on the scored side and stylized b on the other side, packaged in bottles of 100 (NDC 0555-0899-02). 1 mg: Light purple, oval, flat-faced, beveled-edge, scored tablet.
Debossed with 886 / 1 on the scored side and stylized b on the other side, packaged in bottles of 100 (NDC 0555-0886-02) and 500 (NDC 0555-0886-04). 2 mg: Green, oval, flat-faced, beveled-edge, scored tablet. Debossed with 887 / 2 on the scored side and stylized b on the other side, packaged in bottles of 100 (NDC 0555-0887-02) and 500 (NDC 0555-0887-04).
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). Keep this and all medications out of the reach of children.
Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. D 2/2024
📋 Description ▾
DESCRIPTION Estradiol Tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W.
272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no.
27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and FD&C yellow no.
5 (tartrazine) aluminum lake. structual formula
⚠️ Precautions ▾
PRECAUTIONS This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No.
5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. A. General 1.
Addition of a progestin when a woman has not had a hysterectomy Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer. There are, however, possible risks which may be associated with the use of progestins with estrogens compared to estrogen-alone regimens.
These include a possible increased risk of breast cancer. 2. Elevated blood pressure In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to estrogens.
In a large, randomized, placebo-controlled clinical trial, a generalized effect of estrogens on blood pressure was not seen. Blood pressure should be monitored at regular intervals with estrogen use. 3.
Hypertriglyceridemia In patients with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications. 4. Impaired liver function and past history of cholestatic jaundice Estrogens may be poorly metabolized in patients with impaired liver function.
For patients with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised and in the case of recurrence, medication should be discontinued. 5. Hypothyroidism Estrogen administration leads to increased thyroid-binding globulin (TBG) levels.
Patients with normal thyroid function can compensate for the increased TBG by making more thyroid hormone, thus maintaining free T 4 and T 3 serum concentrations in the normal range. Patients dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy. These patients should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range.
6. Fluid retention Because estrogens may cause some degree of fluid retention, patients with conditions that might be influenced by this factor, such as asthma, epilepsy, migraine, and cardiac or renal dysfunction, warrant careful observation when estrogens are prescribed. 7.
Hypocalcemia Estrogens should be used with caution in individuals with severe hypocalcemia. 8. Exacerbation of endometriosis Endometriosis may be exacerbated with administration of estrogens.
A few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen alone therapy. For patients known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered. 9.
Exacerbation of other conditions Estrogens may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine or porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions. Estradiol tablets 2 mg contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals.
Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. B.
Patient Information Physicians are advised to discuss the PATIENT INFORMATION leaflet with patients for whom they prescribe estradiol tablets. C. Laboratory Tests Estrogen administration should be initiated at the… [Excerpted — this section continues on DailyMed.]
🔬 Clinical Studies ▾
Clinical Studies Osteoporosis Most prospective studies of efficacy for this indication have been carried out in white menopausal women, without stratification by other risk factors, and tend to show a universally salutary effect on bone. The results of a two-year, randomized, placebo-controlled, double-blind, dose-ranging study have shown that treatment with 0.5 mg estradiol daily for 23 days (of a 28 day cycle) prevents vertebral bone mass loss in postmenopausal women. When estrogen therapy is discontinued, bone mass declines at a rate comparable to the immediate postmenopausal period.
There is no evidence that estrogen replacement therapy restores bone mass to premenopausal levels. Women’s Health Initiative Studies The Women’s Health Initiative (WHI) enrolled a total of 27,000 predominantly healthy postmenopausal women to assess the risks and benefits of either the use of oral 0.625 mg conjugated estrogens (CE) per day alone or the use of oral 0.625 mg conjugated estrogens plus 2.5 mg medroxyprogesterone acetate (MPA) per day compared to placebo in the prevention of certain chronic diseases. The primary endpoint was the incidence of coronary heart disease (CHD) (nonfatal myocardial infarction and CHD death), with invasive breast cancer as the primary adverse outcome studied.
A “global index” included the earliest occurrence of CHD, invasive breast cancer, stroke, pulmonary embolism (PE), endometrial cancer, colorectal cancer, hip fracture, or death due to other cause. The study did not evaluate the effects of CE or CE/MPA on menopausal symptoms. The CE/MPA substudy was stopped early because, according to the predefined stopping rule, the increased risk of breast cancer and cardiovascular events exceeded the specified benefits included in the “global index.” Results of the CE/MPA substudy, which included 16,608 women (average age of 63 years, range 50 to 79; 83.9% White, 6.5% Black, 5.5% Hispanic), after an average follow-up of 5.2 years are presented in Table 1 below: Table 1: RELATIVE AND ABSOLUTE RISK SEEN IN THE CE/MPA SUBSTUDY OF WHI adapted from JAMA, 2002; 288:321-333 Event a subset of the events was combined in a “global index”, defined as the earliest occurrence of CHD events, invasive breast cancer, stroke, pulmonary embolism, endometrial cancer, colorectal cancer, hip fracture, or death due to other causes Relative Risk CE/MPA vs placebo at
5.2Years (95% CI nominal confidence intervals unadjusted for multiple looks and multiple comparisons ) Placebo n = 8102 CE/MPA n = 8506 Absolute Risk per 10,000 Women-Years CHD events Non-fatal MI CHD death 1.29 (1.02 to 1.63) 1.32 (1.02 to 1.72) 1.18 (0.70 to 1.97) 30 23 6 37 30 7 Invasive breast cancer includes metastatic and non-metastatic breast cancer with the exception of in situ breast cancer 1.26 (1.00 to 1.59) 30 38 Stroke 1.41 (1.07 to 1.85) 21 29 Pulmonary embolism 2.13 (1.39 to 3.25) 8 16 Colorectal cancer 0.63 (0.43 to 0.92) 16 10 Endometrial cancer 0.83 (0.47 to 1.47) 6 5 Hip fracture 0.66 (0.45 to 0.98) 15 10 Death due to causes other than the events above 0.92 (0.74 to 1.14) 40 37 Global Index 1.15 (1.03 to 1.28) 151 170 Deep vein thrombosis not included in Global Index 2.07 (1.49 to 2.87) 13 26 Vertebral fractures 0.66 (0.44 to 0.98) 15 9 Other osteoporotic fractures 0.77 (0.69 to 0.86) 170 131 For those outcomes included in the “global index,” the absolute excess risks per 10,000 women-years in the group treated with CE/MPA were 7 more CHD events, 8 more strokes, 8 more PEs, and 8 more invasive breast cancers, while the absolute risk reductions per 10,000 women-years were 6 fewer colorectal cancers and 5 fewer hip fractures.
The absolute excess risk of events included in the “global index” was 19 per 10,000 women-years. There was no difference between the groups in terms of all-cause mortality. (See BOXED WARNINGS , WARNINGS , and PRECAUTIONS .) Women’s Health Initiative Memory Study The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, enroll… [Excerpted — this section continues on DailyMed.]
📄 Patient Package Insert ▾
PATIENT INFORMATION Estradiol (es″ tra dye′ ol) Tablets Read this PATIENT INFORMATION before you start taking estradiol tablets and read what you get each time you refill estradiol tablets. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ESTRADIOL TABLETS (AN ESTROGEN HORMONE)? Estrogens increase the chances of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are taking estrogens.
Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes.
Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia. You and your healthcare provider should talk regularly about whether you still need treatment with estradiol tablets.
WHAT ARE ESTRADIOL TABLETS? Estradiol tablets are a medicine that contains estrogen hormones. WHAT IS ESTRADIOL USED FOR?
Estradiol is used to: reduce moderate to severe hot flashes Estrogens are hormones made by a woman's ovaries. Between ages 45 and 55, the ovaries normally stop making estrogens. This leads to a drop in body estrogen levels which causes the “change of life” or menopause (the end of monthly menstrual periods).
Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes “surgical menopause.” When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (“hot flashes” or “hot flushes”). In some women, the symptoms are mild, and they will not need estrogens.
In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with estradiol. Weight-bearing exercise, like walking or running, and taking calcium with vitamin D supplements may also lower your chances for getting postmenopausal osteoporosis.
It is important to talk about exercise and supplements with your healthcare provider before starting them. treat dryness , itching, and burning in or around the vagina, difficulty or burning on urination associated with menopause You and your healthcare provider should talk regularly about whether you still need treatment with estradiol to control these problems. If you use estradiol only to treat your dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you. treat certain conditions in which a young woman's ovaries do not produce enough estrogen naturally treat certain types of abnormal vaginal bleeding due to hormonal imbalance when your doctor has found no serious cause of the bleeding treat certain cancers in special situations, in men and women prevent thinning of bones Osteoporosis from menopause is a thinning of the bones that makes them weaker and easier to break.
If you use estradiol only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you. You and your healthcare provider should talk regularly about whether you should continue with estradiol. WHO SHOULD NOT USE ESTRADIOL?
Do not start taking estradiol if you: have unusual vaginal bleeding which has not been evaluated by your doctor (see BOXED WARNINGS) Unusual vaginal bleeding can be a warning sign of cancer of the uterus, especially if it happens after menopause. Your doctor must find out the cause of the… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
NDC 0555-0899-02 Estradiol Tablets, USP 0.5 mg PHARMACIST: Dispense the accompanying Patient Information Leaflet to each patient. Rx only 100 Tablets 1
NDC 0555-0886-02 Estradiol Tablets, USP 1 mg PHARMACIST: Dispense the accompanying Patient Information Leaflet to each patient. Rx only 100 Tablets 2
NDC 0555-0887-02 Estradiol Tablets, USP 2 mg PHARMACIST: Dispense the accompanying Patient Information Leaflet to each patient. Contains FD&C Yellow No. 5 (tartrazine) as a color additive. Rx only 100 Tablets 3