Estradiol: uses, dosing, side effects & brands

Estradiol is an estrogen sold in the U.S. under 17 brand and generic names, for breast neoplasms, hypogonadism and premature menopause. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class: Estrogen
Treats (across its forms): Breast Neoplasms, Hypogonadism and Premature Menopause
Available as: Topical, metered · System · Spray/Inhaler · Insert · Topical · Tablet · Film, extended release · Patch, extended release · Patch · Injectable · Ring
Sold as: 17 products — Elestrin, Estraderm and Evamist, and others
Prescription?: Prescription only
Generic available?: Yes
What the pharmacy pays: about $7 per gm — not your price
Boxed warning: Boxed warning

How Elestrin is dosed

From the FDA label for Elestrin (application NDA021813). Other estradiol products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, consider addition of a progestin to reduce the risk of endometrial cancer. Generally, a woman without a uterus does not need to take a progestin in addition to her estrogen therapy. In some cases, however, hysterectomized women who have a history of endometriosis may need a progestin [see Warnings and Precautions (5.2) , (5.14) ] . Use estrogen-alone, or in combination with a progestin, at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Reevaluate postmenopausal women periodically as clinically appropriate to determine if treatment is still necessary. ELESTRIN is applied onto the skin in a thin layer. The recommended area of application is the upper arm to shoulder (approximately 320 cm 2 ). Start therapy with daily administration of one pump actuation to deliver 0.87 grams of gel providing 0.52 mg estradiol to the upper arm. Dosage adjustment should be guided by the clinical response ( 2.1 ) 2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ELESTRIN is applied once daily to the upper arm for the treatment of moderate to severe vasomotor symptoms due to menopause using a metered-dose pump which delivers 0.87 grams of estradiol gel (0.52 mg estradiol) per actuation (1 pump). Start therapy with one pump…

Everything below is the FDA label for Elestrin (topical, metered). Estradiol is also sold as system, spray/inhaler, insert, topical, tablet, film, extended release, patch, extended release, patch, injectable and ring, and those are different medicines to take — follow the label for the one you were prescribed.

Elestrin side effects

The following serious adverse reactions are discussed elsewhere in the labeling: • Cardiovascular Disorders [see Boxed Warning , and Warnings and Precautions (5.1) ]. • Malignant Neoplasms [see Boxed Warning , and Warnings and Precautions (5.2) ]. The most common adverse reactions (≥ 5 percent) in any ELESTRIN treatment group are: breast tenderness, metrorrhagia, nasopharyngitis, and upper respiratory tract infections. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meda at 1-877-999-8401 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. ELESTRIN was studied in a placebo-controlled trial that included a total of 484 postmenopausal women. The adverse reactions that occurred at a rate greater than 5 percent in any of the treatment groups are summarized in Table 1. TABLE 1 - Incidence of Treatment-Emergent Adverse Reactions Occurring in ≥ 5 Percent of Women Body System / Signs and Symptoms Number (%) of Women Placebo (n = 137) ELESTRIN 0.87 g/day (n = 136) ELESTRIN 1.7 g/day (n = 142) Reproductive system & breast disorders Breast tenderness 5 (3.6) 9 (6.6) 11 (7.7) Metrorrhagia 3…

Who shouldn’t take Elestrin

ELESTRIN is contraindicated in women with any of the following conditions: • Undiagnosed abnormal genital bleeding [see Warnings and Precautions (5.2) ] . • Breast cancer or a history of breast cancer [see Warnings and precautions (5.2) ] . • Estrogen-dependent neoplasia [see Warnings and Precautions (5.2) ] . • Active DVT, PE, or history of these conditions [see Warnings and Precautions (5.1) ] . • Active arterial thromboembolic disease (for example, stroke and MI) or a history of these conditions [see warnings and Precautions (5.1) ] . • Known anaphylactic reaction, or angioedema, or hypersensitivity to ELESTRIN. • Hepatic impairment or disease. • Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. • Undiagnosed abnormal genital bleeding ( 4 ) • Breast cancer or a history of breast cancer ( 4 , 5.2 ) • Estrogen-dependent neoplasia ( 4 , 5.2 ) • Active DVT, PE, or history of these conditions ( 4 , 5.1 ) • Active arterial thromboembolic disease (for example, stroke and MI) or a history of these conditions ( 4 , 5.1 ) • Known anaphylactic reaction or angioedema or hypersensitivity with ELESTRIN ( 4 ) • Hepatic impairment or disease ( 4 , 5.10 ) • Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders ( 4 )

Elestrin 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 (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. Inhibitors of CYP3A4, such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, and grapefruit juice, may increase plasma concentrations of estrogens and result in adverse reactions. • Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism and decrease or increase the estrogen plasma concentrations ( 7 )

Every estradiol product we track (17)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Estradiol products
#	Drug	Rating	Type	Form	Generic?	Pharmacy pays
1	Elestrin Boxed warning	70/100	Prescription	Topical	Generic	$7	View →
2	Estraderm	70/100	Prescription	System	Generic	$7	View →
3	Evamist Boxed warning	70/100	Prescription	Spray/Inhaler	Generic	$7	View →
4	Imvexxy	70/100	Prescription	Insert	Generic	$7	View →
5	Vagifem Boxed warning	70/100	Prescription	Insert	Generic	$7	View →
6	Estradiol Boxed warning	68/100	Prescription	Topical	Generic	$7	View →
7	Vivelle	68/100	Prescription	System	Generic	$7	View →
8	Vivelle-Dot Boxed warning	68/100	Prescription	Patch	Generic	$7	View →
9	Estring	64/100	Prescription	System	Generic	$7	View →
10	Minivelle Boxed warning	60/100	Prescription	Film	Generic	$7	View →

Combination products containing estradiol

A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.

Estradiol recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

How long estradiol keeps

No estradiol label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.

Does estradiol expire? The in-use limits and storage rules from its labels

Estradiol and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Limited information on the use of estradiol during breastfeeding indicates that the route of administration and dosage form have influences on the amount transferred into breastmilk. Vaginal administration results in measurable amounts in milk, but transdermal patches do not. Maternal doses of up to 200 mcg daily transdermally do not increase estradiol or estriol in breastfed infants or cause any adverse effects in breastfed infants. Vaginal administration results in unpredictable peak times for estradiol in breastmilk, so timing of the dose with respect to breastfeeding is probably not useful. Milk estradiol levels have not been studied after use of the estradiol gel, but maternal blood levels only increase slightly in a dose-dependent manner.

Full LactMed record for estradiol: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised January 15, 2026. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about estradiol

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 77,924 reports naming estradiol, and the FDA flagged 52% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

product adhesion issue7,555 reports
fatigue6,171 reports
headache5,240 reports
nausea5,157 reports
dyspnoea4,523 reports
rash4,402 reports
pruritus4,303 reports
arthralgia4,288 reports

Read these as a signal, not a rate. A report does not mean estradiol caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

Related calculators

How long it stays in your system →

Frequently asked questions

What is Elestrin?

ELESTRIN (estradiol gel) contains 0.06% of estradiol, in a colorless, non-staining hydroalcoholic gel base. One pump actuation delivers ELESTRIN in a unit dose of 0.52 mg of estradiol in 0.87 g of gel.

What kind of drug is estradiol?

The FDA classifies estradiol as an estrogen. Estrogen is a sex hormone that enters cells and binds estrogen receptors; the hormone-receptor complex then moves into the nucleus and switches target genes on or off. Through this it thickens the uterine lining, helps protect bone, supports breast and vaginal tissue, and shapes cholesterol levels. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take estradiol with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run estradiol against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is estradiol sold under?

We track 17 estradiol-containing products in the U.S.: Elestrin, Estraderm, Evamist, Imvexxy, Vagifem, Estradiol, Vivelle and Vivelle-Dot, and 9 more. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does estradiol come in?

Across the brands we track, estradiol is currently marketed as topical, metered, system, spray/inhaler, insert, topical, tablet, film, extended release, patch, extended release, patch, injectable and ring, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic estradiol?

Yes. Our catalog lists 1 generic estradiol product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.

Has estradiol been recalled?

The FDA's Enforcement database lists at least 5 recall records whose product description mentions estradiol. The most recent: Estradiol Gel (May 12, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

What are the common side effects of estradiol?

Frequent effects include breast tenderness or enlargement, headache, nausea, bloating, and spotting or breakthrough bleeding, which is common in the first few months as your body adjusts. Some people notice mood changes or fluid retention. Many of these ease over time; persistent or heavy irregular bleeding should be evaluated.

What are the serious, boxed-warning risks of estradiol?

Estrogens carry a boxed warning for blood clots and stroke. Seek emergency care for signs of a clot or stroke: leg pain or swelling, sudden chest pain or shortness of breath, sudden severe headache, vision loss, or face drooping, weakness on one side, or slurred speech. In women with a uterus, taking estrogen without a progestin raises the risk of endometrial (uterine) cancer, which is why unexplained vaginal bleeding must be reported. Long-term estrogen-plus-progestin use is associated with a higher risk of breast cancer, and in women 65 and older, of probable dementia.

When should I call my doctor while taking estradiol?

Beyond emergency clot and stroke symptoms, call for any unusual or heavy vaginal bleeding, a new breast lump, severe or new migraines, yellowing of the skin or eyes, or a marked rise in blood pressure. Report a personal or family history of clots, breast cancer, or heart disease before starting.

How do I tell routine estradiol effects from dangerous ones?

Mild breast tenderness, bloating, nausea, and early spotting are usually expected and settle over the first few months. The signals that are never routine are one-sided leg swelling or pain, chest pain, breathlessness, sudden severe headache or vision change, stroke-like symptoms, or abnormal bleeding after the first few months, all of which warrant urgent evaluation.

Cite this page

APA: pharmaranks. (2026, July 24). Estradiol: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/estradiol
MLA: “Estradiol: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/estradiol.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for estradiol on DailyMed (NIH) ↗ — including its boxed warning in full.