Prescription medicine
Estradiol Brand names: Climara, Divigel, Minivelle, Vivelle-Dot, Delestrogen
Estradiol (Climara) is a prescription medicine with an FDA approval on record since 1954. FDA's NDC Directory lists it from 40 generic labelers, and pharmacies paid $0.0635 per estradiol 1 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the estradiol FDA label on DailyMed (effective April 3, 2024, Amneal Pharmaceuticals LLC); the NDA 9402 record on Drugs@FDA; every estradiol label on DailyMed.
Highlights of the record
FDA label of April 3, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA,.
and BREAST CANCER Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Perform adequate diagnostic measures, including directed or random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.3) ]. Cardiovascular Disorders and Probable Dementia The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo [see Warnings and Precautions (5.2) and Clinical Studies (14.2) ]. The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. […]
Used for
From the label: indications and usageYuvafem is an estrogen (estradiol) indicated for the treatment of atrophic vaginitis due to menopause ( 1.1 ) 1.1 Treatment of Atrophic Vaginitis due to Menopause
Forms and strengths
- 0.014 mg
- 0.025 mg
- 0.0375 mg
- 0.05 mg
- 0.06 mg
- 0.075 mg
- 0.1 mg
- 0.5 mg
- 1 mg
- 2 mg
- 0.1 mg/g
- 0.25 mg/.25g
Tablet; patch; gel; extended-release patch; cream.
On the market
- Earliest approval on file
- July 15, 1954 Delestrogen, Ph Health; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 51 first July 23, 1975; 37 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 52 of which 40 under generic applications, 12 under brand applications, repackagers included
- Last listed patent
- February 2, 2034 Imvexxy insert; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0635 per tablet Estradiol 1 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 60 since 2012 0 Class I among all firms' recalls; latest May 12, 2026; 69 more by firms not listed as its makers
- FAERS reports
- 87,788 through July 30, 2026
What is estradiol used for?
From the label: indications and usageYuvafem is an estrogen (estradiol) indicated for the treatment of atrophic vaginitis due to menopause ( 1.1 ) 1.1 Treatment of Atrophic Vaginitis due to Menopause
Conditions named in the indications of estradiol's FDA labels, with every medicine labeled for each:
From other estradiol labelsMenopause symptoms: INDICATIONS AND USAGE Estradiol Vaginal Cream, 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
Breast cancer: Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
Osteoporosis: Prevention of osteoporosis.
FDA pharmacologic class: Estrogen.
Source: FDA drug label (YUVAFEM), Amneal Pharmaceuticals LLC, effective April 3, 2024 (SPL set 30c7f6ba-7a9e-4853-b3e4-e00a46560224), via openFDA; the full label on DailyMed
What does the patient leaflet for estradiol say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Climara (an estrogen hormone)?Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using Climara. 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 estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function). Using estrogen-alone may increase your chances of getting strokes or blood clots. Using estrogen-alone may increase your chance of getting dementia, based on a study of women age 65 years of age and older. Do not use estrogens with progestogens to prevent heart disease, heart attacks, strokes or dementia. Using estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots. Using estrogens with progestogens may increase your chance of getting dementia, based on a study of women age 65 years of age and older. Only one estrogen-alone product and dose have been shown to increase your chances of getting strokes, blood clots, and dementia. Only one estrogen with progestogen product and dose have been shown to increase your chances of getting heart attacks, strokes, breast cancer, blood clots, and dementia. Because other products and doses have not been studied in the same way, it is not known how the use of Climara will affect your chances of these conditions. You and your healthcare provider should talk regularly about whether you still need treatment with Climara.
From the patient leaflet: How should I store and throw away used Climara?Store Climara at room temperature 68°F to 77°F (20°C to 25°C). Do not store Climara patches outside of their pouches. Apply immediately upon removal from the protective pouch. Used patches still contain estrogen. To throw away the patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place this container in the trash. Used patches should not be flushed in the toilet. Keep Climara and all medicines out of the reach of children.
Source: FDA drug label (Climara), Bayer HealthCare Pharmaceuticals Inc., effective March 26, 2026 (SPL set 1e9702c4-f2d7-4ea8-b6e8-7dca31671864), via openFDA; the full label on DailyMed
Is there a generic for estradiol (Climara)?
The FDA approved the first generic estradiol on July 23, 1975. 51 generic applications are approved; 37 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists estradiol from 40 labelers under a generic (ANDA) application and from 12 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Climara film; a patent listed only for Imvexxy insert runs to February 2, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1954 earliest approval on file
- 1975 first generic approved
- 2034 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for estradiol (Climara)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0635 per Estradiol 1 mg tablet, down 8% from $0.069 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Estradiol 1 mg tablet (generic)
- Vagifem 10 mcg vaginal tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dotti 0.025 mg patch | Generic | $7.76 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +19% |
| Dotti 0.0375 mg patch | Generic | $8.26 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +19% |
| Dotti 0.05 mg patch | Generic | $8.50 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +17% |
| Dotti 0.075 mg patch | Generic | $8.11 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +17% |
| Dotti 0.1 mg patch | Generic | $8.57 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +24% |
| Estradiol 0.01% cream | Generic | $0.465 per gram | n/a | -1% |
| Estradiol 0.025 mg patch(1/wk) | Generic | $11.75 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +5% |
| Estradiol 0.025 mg patch(2/wk) | Generic | $7.76 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +19% |
| Estradiol 0.0375 mg patch(1/wk) | Generic | $11.93 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +8% |
| Estradiol 0.0375 mg patch(2/wk) | Generic | $8.26 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +19% |
| Estradiol 0.05 mg patch (1/wk) | Generic | $11.28 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -6% |
| Estradiol 0.05 mg patch (2/wk) | Generic | $8.50 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +17% |
| Estradiol 0.06 mg patch (1/wk) | Generic | $12.25 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +7% |
| Estradiol 0.06% 1.25g gel pump | Generic | $3.39 per gram | n/a | -4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has estradiol been recalled?
The FDA's Enforcement Report lists 129 recalls naming estradiol since 2012: 0 Class I (the most serious), 122 Class II, 7 Class III; 16 still ongoing. 69 of them are by firms that FDA's NDC Directory does not list as a maker of estradiol and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 12, 2026 | Class II | ANI Pharmaceuticals, Inc. | Defective Container; packets were found to be either empty or partially full. |
| January 26, 2026 | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) | Presence of Foreign substance - potential presence of metal particulate matter |
| February 6, 2025 | Class II | Padagis US LLC | Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product. |
| May 16, 2024 | Class III | Zydus Pharmaceuticals (USA) Inc | Failed Impurities/Degradation Specifications. |
| February 21, 2023 | Class III | Padagis US LLC | Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month … |
| March 7, 2022 | Class II | TMC Acquisition LLC dba Tailor Made Compounding not a listed maker | Lack of Assurance of Sterility |
| January 26, 2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| October 12, 2021 | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy not a listed maker | Lack of assurance of sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the estradiol label say about other medicines?
The estradiol label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 16 other medicines name estradiol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | Inducers of CYP3A4, such as St. John’s wort ( Hypericum perforatum ) preparations, 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. |
| Clarithromycin | drug interactions | Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in adverse reactions. |
| Erythromycin | drug interactions | Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in adverse reactions. |
| Itraconazole | drug interactions | Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in adverse reactions. |
| Ketoconazole | drug interactions | Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in adverse reactions. |
| Medroxyprogesterone | boxed warning | … postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [see Warnings and Precautions (5.2) and Clinical Studies (14.2) ]. |
| Phenobarbital | drug interactions | Inducers of CYP3A4, such as St. John’s wort ( Hypericum perforatum ) preparations, 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. |
| Rifampin | drug interactions | Inducers of CYP3A4, such as St. John’s wort ( Hypericum perforatum ) preparations, 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. |
| Ritonavir | drug interactions | Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in adverse reactions. |
| Testosterone | warnings and precautions | Free hormone concentrations, such as testosterone and estradiol, may be decreased. |
Other labels that name estradiol
Source: FDA drug label (YUVAFEM), Amneal Pharmaceuticals LLC, effective April 3, 2024 (SPL set 30c7f6ba-7a9e-4853-b3e4-e00a46560224), via openFDA; the full label on DailyMed
What do FAERS reports show for estradiol?
The FDA Adverse Event Reporting System holds 87,788 reports that list estradiol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,562 are coded as a death and 11,970 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other estrogens
- the pharmacologic class, with prices and generics
- Estradiol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other