IMVEXXY (estradiol vaginal inserts) are small, light pink, tear-shaped, vaginal inserts for manual placement into the vagina. Inserts contain 4 mcg or 10 mcg of estradiol, an estrogen. Each insert is imprinted in white ink on one side with "04" or "10" corresponding to the insert's dosage strength. IMVEXXY vaginal inserts are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol is released into the vagina. Estradiol is chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is C 18 H 24 O 2 with a molecular weight of 272.38. The structural formula is: IMVEXXY (estradiol vaginal inserts) contain the following inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, ethylene glycol palmitostearate, FD&C Red #40, gelatin, glycerin, isopropyl alcohol, lecithin, medium chain triglycerides, polyethylene glycol, polyethylene glycol stearates, polyvinyl acetate phthalate, propylene glycol, purified water, sorbitol-sorbitan solution, and titanium dioxide. FDA approved acceptance criteria for assay, organic impurities, and dissolution tolerances differ from the USP test. Chemical Structure

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.: Imvexxy, Evamist, Vagifem, Elestrin, Estraderm, 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 insert, spray/inhaler, topical, metered, system, topical, film, extended release, patch, patch, extended release, tablet, 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: Alyacen 7/7/7 (May 27, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

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) sourcesHow we research

Key facts

Drug class: Estrogen
Treats: Breast Neoplasms, Hypogonadism and Premature Menopause
Available as: Insert · Spray/Inhaler · Topical, metered · System · Topical · Film, extended release · Patch · Patch, extended release · Tablet · Injectable · Ring
Sold as: 17 products — Imvexxy, Evamist and Vagifem, and others
Prescription?: Prescription only
Generic available?: Yes
Typical price: $7–$22 for a 30-count supply, depending on the brand
Boxed warning: Boxed warning

How estradiol is dosed

From the FDA label for Imvexxy (application NDA208564). 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 progestogen to reduce the risk of endometrial cancer. Generally, a woman without a uterus does not need to use a progestogen in addition to her estrogen therapy. In some cases, however, hysterectomized women with a history of endometriosis may need a progestogen [see Warnings and Precautions (5.3 , 5.15) ]. Use estrogen-alone, or in combination with a progestogen, at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Re-evaluate postmenopausal women periodically as clinically appropriate to determine if treatment is still necessary. Administer IMVEXXY intravaginally: 1 vaginal insert daily for 2 weeks, followed by 1 insert twice weekly (for example, Monday and Thursday). ( 2.1 ) 2.1 Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, Due to Menopause Generally, start therapy with the IMVEXXY 4 mcg dosage strength administered intravaginally; insert with the smaller end up for a depth of about two inches into the vaginal canal. Administer 1 insert daily at approximately the same time for 2 weeks, followed by 1 insert twice weekly, every three to four days (for example, Monday and Thursday). Make dosage adjustment based on the clinical response.

Estradiol side effects

The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders [see Boxed Warning , Warnings and Precautions (5.2) ]. Malignant Neoplasms [see Boxed Warning , Warnings and Precautions (5.3) ]. The most common adverse reaction with IMVEXXY (incidence ≥ 3% and greater than placebo) is headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 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. The safety of IMVEXXY 4 mcg and 10 mcg was assessed in a single, double-blind, parallel-group, placebo-controlled trial (N = 382). The duration of treatment in this trial was 12 weeks (dosing occurred every day for 14 days and then twice weekly thereafter for maintenance). Adverse reactions with an incidence of ≥ 3% in any IMVEXXY group and numerically greater than those reported in the placebo group are listed in Table 1. Table 1: Treatment-Emergent Adverse Reactions Reported at a Frequency of ≥ 3% and Numerically More Common in Women Receiving IMVEXXY Preferred Term IMVEXXY 4 mcg (N=191) IMVEXXY 10 mcg (N=191) Placebo…

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?	Typical price
1	Imvexxy Boxed warning	72/100	Prescription	Insert	Generic	$7	View →
2	Evamist

What estradiol pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Estradiol pill imprints
Imprint	Strength	Colour	Shape	Maker
Y;12	1.5 mg / 0.03 mg	green	round	—
G;16	1 mg / 0.02 mg	white	round	—
1C1	1 mg / 100 mg	pink	capsule	—
5C1	0.5 mg / 100 mg	pink	capsule	—
1C1	1 mg / 100 mg	pink, pink	oval	—
5C1	0.5 mg / 100 mg

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.

Frequently asked questions

What is estradiol?: IMVEXXY (estradiol vaginal inserts) are small, light pink, tear-shaped, vaginal inserts for manual placement into the vagina. Inserts contain 4 mcg or 10 mcg of estradiol, an estrogen. Each insert is imprinted in white ink on one side with "04" or "10" corresponding to the insert's dosage strength. IMVEXXY vaginal inserts are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol is released into the vagina. Estradiol is chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is C 18 H 24 O 2 with a molecular weight of 272.38. The structural formula is: IMVEXXY (estradiol vaginal inserts) contain the following inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, ethylene glycol palmitostearate, FD&C Red #40, gelatin, glycerin, isopropyl alcohol, lecithin, medium chain triglycerides, polyethylene glycol, polyethylene glycol stearates, polyvinyl acetate phthalate, propylene glycol, purified water, sorbitol-sorbitan solution, and titanium dioxide. FDA approved acceptance criteria for assay, organic impurities, and dissolution tolerances differ from the USP test. Chemical Structure
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.: Imvexxy, Evamist, Vagifem, Elestrin, Estraderm, Estradiol, Vivelle and Vivelle-Dot, and 9 more. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

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.