Estradiol

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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 ( 5.2 , 5.14 )] .
• 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.
• Reevaluate postmenopausal women periodically as clinically appropriate to determine if treatment is still necessary.
• Metered-dose pump:
• Daily administration of estradiol gel, 0.06% 1.25 g per day (1 pump depression) to the arm ( 2.1 , 2.2 )
• 2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Estradiol gel, 0.06% 1.25 g per day is the single approved dose for the treatment of moderate to severe vasomotor symptoms due to menopause.
• The lowest effective dose of estradiol gel, 0.06% for this indication has not been determined.
• Before using the canister for the first time, it must be primed.
• Remove the large canister cover, and fully depress the pump 5 times.
• Discard the unused gel by thoroughly rinsing down the sink or placing it in the household trash.
• After priming, the pump is ready to use.
• The recommended area of application is the arm.
• Apply a thin layer over the entire arm on the inside and outside from wrist to shoulder.
• 2.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Estradiol gel, 0.06% 1.25 g per day is the single approved dose for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
• The lowest effective dose of estradiol gel, 0.06% for this indication has not been determined.
• When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products.
• Before using the canister for the first time, it must be primed.
• Remove the large canister cover, and fully depress the pump 5 times.
• Discard the unused gel by thoroughly rinsing down the sink or placing it in the household trash.
• After priming, the pump is ready to use.
• The recommended area of application is the arm.
• Apply a thin layer over the entire arm on the inside and outside from wrist to shoulder.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

Estradiol gel is not indicated for use in pediatric patients. Clinical studies have not been conducted in the pediatric population.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• There have not been sufficient numbers of geriatric women involved in clinical studies utilizing estradiol gel to determine whether those over 65 years of age differ from younger subjects in their response to estradiol gel.
• The Women’s Health Initiative Studies In the WHI estrogen-alone substudy (daily CE [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see Warnings and Precautions (5.1) and Clinical Studies ( 14.3 )] .
• In the WHI estrogen plus progestin substudy (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see Warnings and Precautions (5.1) and Clinical Studies ( 14.3 )] .
• The Women’s Health Initiative Memory Study In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see Warnings and Precautions ( 5.3 ), and Clinical Studies ( 14.4 )] .
• Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women 8 [see Warnings and Precautions ( 5.3 ), and Clinical Studies ( 14.4 )] .

Quoted from the official label, section “Geriatric Use”.

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 with estradiol gel (≥5 percent) are:
• headache, flatulence, and breast pain.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Solaris Pharma Corporation at 1-833-919-0527 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 clinical practice.
• Estradiol gel was studied in 2 well-controlled, 12-week clinical trials.
• Incidence of adverse drug reactions ≥5 percent for 1.25 g estradiol gel, 0.06% and placebo is given in Table 1 .
• Table 1:
• Incidence of Adverse Drug Reactions ≥5 Percent Occurrence in the Estradiol Gel Treatment Group for the Intent-to-Treat Safety Population in 2 Well-controlled Clinical Studies (Expressed as Percent of Treatment Group) Body System/ Adverse Drug Reactions Estradiol Gel, 0.06% 1.25 g /day (n=168) Placebo (n=73) BODY AS A WHOLE Headache 9.5
• 2.7 DIGESTIVE SYSTEM Flatulence 5.4
• 4.1 UROGENITAL SYSTEM Breast pain 10.7
• 8.2 In 2 controlled clinical trials, application site reactions were reported by 0.6 percent of patients who received 1.25 g of estradiol gel.
• Other skin reactions, such as pruritus and rash, were also noted.
• 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of estradiol gel.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Genitourinary system Endometrial cancer Breast Pain; tenderness; breast cancer Cardiovascular Deep vein thrombosis; myocardial ischemia; phlebitis Gastrointestinal Nausea; abdominal distension; diarrhea; stomach discomfort Skin Alopecia; rash; pruritus; application site:
• dryness, pain, discoloration, reaction, rash Eyes Retinal vein occlusion Central nervous system Headache; dizziness; insomnia; hypoesthesia; meningioma; aphasia; bradyphrenia; paresthesia Miscellaneous Drug ineffective; hot flush; arthralgia; night sweats; drug effect decreased; pain in extremity; fatigue; weight increased; pain; hypersensitivity; dyspnea; malignant mesenchymoma; angioedema; hepatitis acute; face edema; accidental exposure; myoclonus; gait disturbance; flushing

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise women to read the FDA-approved patient labeling (Patient Information and Instructions for Use) Vaginal Bleeding Inform postmenopausal women to report any vaginal bleeding to their healthcare provider as soon as possible [see Warnings and Precautions ( 5.2 )] .
• Possible Serious Adverse Reactions with Estrogen-Alone Therapy Inform postmenopausal women of the possible serious adverse reactions of estrogen-alone therapy including Cardiovascular Disorders, Malignant Neoplasms, and Probable Dementia [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )] .
• Possible Common Adverse Reactions with Estrogen-Alone Therapy Inform postmenopausal women of possible less serious but common adverse reactions of estrogen-alone therapy such as headache, breast pain and tenderness, nausea, and vomiting.
• Manufactured for:
• Solaris Pharma Corporation Bridgewater, NJ 08807 Patient Information Estradiol Gel, 0.06% (ES-tra-DYE-ol jĕl) Read this Patient Information before you start using estradiol gel, and each time
• you get a refill.
• There may be new information.
• This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.
• What is the most important information I should know about estradiol gel (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 estradiol gel.
• 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 and blood clots.
• Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age and older.
• Do not use estrogens with progestogens to prevent heart disease, heart attack, 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 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 estradiol gel will affect your chances of these conditions.
• You and your healthcare provider should talk regularly about whether you still need treatment with estradiol gel.
• What is estradiol gel? Estradiol gel is a prescription medicine gel that contains estradiol (an estrogen hormone).
• What is estradiol gel used for? Estradiol gel is used after menopause to:
• Reduce moderate to severe hot flashes Estrogens are hormones made by a woman’s ovaries.
• The ovaries normally stop making estrogens when a woman is between 45 and 55 years old.
• This drop in body estrogen levels 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 intense feelings of heat and sweating (“hot flashes” or “hot flushes”).
• In some women, the symptoms are mild, and they will not need to use estrogens.
• In other women, symptoms can be more severe.
• Treat moderate to severe menopausal changes in and around the vagina You and your healthcare provider should talk regularly about whether you need treatment with estradiol gel to control these problems.
• If you use estradiol gel only to treat your menopausal changes in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.
• Who should not use estradiol gel? Do not start using estradiol gel
• if you:
• have unusual vaginal bleeding 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. have been diagnosed with a bleeding disorder currently have or have had certain cancers Estrogens may increase the chance of getting certain types of cancer, including cancer of the breast or uterus.
• If you have or have had cancer, talk with your healthcare provider about whether you should use estradiol gel. had a stroke or heart attack currently have or have had blood clots currently have or have had liver problems are allergic to estradiol gel or any of its ingredients See the list of ingredients in estradiol gel at the end of this leaflet.
• Before you use estradiol gel, tell your healthcare provider about all of your medical conditions, including
• if you:
• have any unusual vaginal bleeding 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. have any other medical conditions that may become worse while
• you are using estradiol gel Your healthcare provider may need to check you more carefully
• if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), problems with your heart, liver, thyroid, kidneys, or high calcium levels in your blood. are going to have surgery or will be on bed rest Your healthcare provider will let you know
• if you need to stop using estradiol gel. are pregnant or think you may be pregnant Estradiol gel is not for pregnant women. are breastfeeding The hormone in estradiol gel can pass into your breast milk.
• Tell your healthcare provider about all the medicines
• you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Some medicines may affect how estradiol gel works.
• Estradiol gel may also affect how your other medicines work.
• Keep a list of your medicines and show it to your healthcare provider and pharmacist when
• you get a new medicine.
• How should I use estradiol gel? For detailed instructions, see the step-by-step instructions for using estradiol gel at the end of this Patient Information.
• Use estradiol gel exactly as your healthcare provider tells you to use it.
• Estradiol gel is for skin use only.
• Estradiol gel contains alcohol, which is flammable.
• Avoid fire, flame or smoking until estradiol gel has dried.
• You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose
• you are using and whether you still need treatment with estradiol gel.
• What are the possible side effects of estradiol gel? Side effects are grouped by how serious they are and how often they happen when
• you are treated.
• Serious, but less common side effects include:
• heart attack stroke blood clots breast cancer cancer of the lining of the uterus (womb) cancer of the ovary dementia high or low blood calcium gallbladder disease visual abnormalities high blood pressure high levels of fat (triglycerides) in your blood liver problems changes in your thyroid hormone levels fluid retention cancer changes of endometriosis enlargement of benign tumors of the uterus (“fibroids”) worsening of swelling of face and tongue (angioedema) in women with a history of angioedema changes in laboratory test results such as bleeding time and high blood sugar Call your healthcare provider right away
• if you get any of the following warning signs or any other unusual symptoms that concern you:
• new breast lumps unusual vaginal bleeding changes in vision or speech sudden new severe headaches severe pains in your chest or legs with or without shortness of breath, weakness and fatigue swelling of face, lips, and tongue with or without red, itchy bumps Common side effects of estradiol gel include:
• headache breast tenderness or pain stomach or abdominal cramps, bloating nausea and vomiting hair loss fluid retention vaginal yeast infection These are not all of the possible side effects of estradiol gel.
• For more information, ask your healthcare provider or pharmacist.
• Tell your healthcare provider
• if you have any side effects that bother you or do not go away.
• You may report side effects to Solaris Pharma Corporation at 1-833-919-0527 or to FDA at 1-800-FDA-1088.
• What can I do to lower my chances of a serious side effect with estradiol gel? Talk with your healthcare provider regularly about whether you should continue using estradiol gel.
• If you have a uterus, talk with your healthcare provider about whether the addition of a progestogen is right for you.
• In general, the addition of a progestogen is recommended for women with a uterus to reduce the chance of getting cancer of the uterus (womb).
• See your healthcare provider right away
• if you get vaginal bleeding while using estradiol gel.
• Have a pelvic exam, breast exam and mammogram (breast x-ray) every year unless your healthcare provider tells you something else.
• If members of your family have had breast cancer or
• if you have ever had breast lumps or an abnormal mammogram (breast x-ray), you may need to have breast exams more often.
• If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or
• if you use tobacco, you may have higher chances of getting heart disease.
• Ask your healthcare provider for ways to lower your chances of getting heart disease.
• How should I store estradiol gel? Store estradiol gel at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep estradiol gel and all medicines out of the reach of children.
• General information about the safe and effective use of estradiol gel Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets.
• Do not use estradiol gel for conditions for which it was not prescribed.
• Do not give estradiol gel to other people, even if they have the same symptoms you have.
• It may harm them.
• You can ask your healthcare provider or pharmacist for information about estradiol gel that is written for health professionals.
• For more information, go to www.solaris-pharma.com, or call Solaris Pharma Corporation at 1-833-919-0527.
• What are the ingredients in estradiol gel? Active ingredient:
• estradiol Inactive ingredients:
• purified water, alcohol (44.89% v/v), triethanolamine, and carbomer 974P.
• Instructions for Use Estradiol Gel, 0.06% (ES-tra-DYE-ol jĕl) Read this Instructions for Use before you start using estradiol gel and each time
• you get a refill.
• There may be new information.
• This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.
• You will need the following supplies to use estradiol gel: See Figure A.
• Figure A Estradiol gel is supplied in a metered-dose pump that delivers a measured amount of estradiol to your skin each time you press the pump.
• Estradiol gel is available in a 50-gram canister.
• Step 1.
• Priming the estradiol gel pump Before using the estradiol gel pump for the first time, the pump must be primed.
• The estradiol gel canister contains enough medicine to allow you to prime the pump before you use it for the first time.
• Remove the large cap from the canister.
• See Figure B.
• Figure B Slowly push the pump all the way down 5 times.
• Do not use any estradiol gel that came out while priming.
• Wash it down the sink to avoid accidental exposure to others.
• After priming, the estradiol gel pump is ready to use.
• One complete press of the pump will give the same amount of estradiol gel each time.
• Step 2.
• Applying estradiol gel to your skin Do not allow other people to apply estradiol gel to your skin for you.
• Apply estradiol gel to clean, dry, unbroken skin.
• Apply estradiol gel after your bath or shower.
• If you go swimming, try to leave as much time as possible between using your estradiol gel and going swimming.
• Remove the small cover on the tip of the pump if you have not done so already.
• See Figure C.
• Figure C To use estradiol gel, press the estradiol gel pump firmly and fully 1 time into the palm of your hand.
• See Figure D.
• Figure D Using your hand, apply estradiol gel to the skin of your other arm.
• See Figure E.
• Spread the gel as thinly as possible over the entire area on the inside and outside of your arm from your wrist to your shoulder.
• See Figure F.
• Figure E Figure F Do not apply estradiol gel directly to your breasts or in and around your vagina.
• Do not massage or rub in estradiol gel.
• Allow the gel to dry for 5 minutes before you get dressed.
• Step 3.
• After you use estradiol gel Place the small cap back on the tip of the pump.
• Place the large cap over the top of the canister.
• Wash your hands right away with soap and water after applying estradiol gel.
• This will lower the chance that the medicine will spread from your hands to other people.
• Do not allow others to make contact with the area of skin where you applied the gel for at least 1 hour after application.
• Estradiol gel is flammable until dry.
• Let estradiol gel dry before smoking or going near an open flame.
• Step 4.
• Throwing away used estradiol gel canisters The estradiol gel 50-gram canister contains enough medicine to allow for priming your canister with up to 5 full pump depressions and delivery of 30 daily doses.
• After
• you have first primed your canister and used 30 doses, you will need to throw away the canister.
• Do not use the canister for more than 30 doses even though the canister may not be completely empty.
• You may not get the correct dose.
• This Patient Information and Instructions for Use has been approved by the U.S.
• Food and Drug Administration.
• Manufactured for: Solaris Pharma Corporation Bridgewater, NJ 08807 Revised: 04/2024
• 17.2 FDA-approved patient labeling . figurea figureb figurec figured figuree figuref

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Estradiol gel, 0.06% is an estradiol transdermal gel. One pump depression delivers 1.25 g of gel that contains 0.75 mg estradiol. Gel:
• 1 pump depression of estradiol gel, 0.06% delivers 1.25 g of gel containing 0.75 mg estradiol

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.1 How Supplied Estradiol gel is a clear, colorless, hydroalcoholic 0.06 percent estradiol gel supplied in a non-aerosol, metered-dose pump.
• The pump consists of an LDPE inner liner encased in rigid plastic with a resealable polypropylene cap.
• Estradiol gel, 0.06% is available in a 50-gram (1.75 oz) size.
• Each individually packaged 50-gram pump contains 50 grams of gel and can deliver 30 metered 1.25-g doses.
• NDC: 73473-308-50.............................
• (50-gram pump)
• 16.2 Storage and Handling Keep out of reach of children.
• 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].

Quoted from the official label, section “How Supplied”.

What is in it

• Estradiol gel contains 0.06 percent estradiol in an absorptive hydroalcoholic gel base for topical application.
• It is a clear, colorless gel, which is odorless when dry.
• One pump depression of estradiol gel, 0.06% delivers 1.25 g of gel containing 0.75 mg estradiol.
• Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17β-diol.
• It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.39.
• The structural formula is: The active component of the gel is estradiol.
• The remaining components of the gel (purified water, alcohol (44.89% v/v), triethanolamine and carbomer 974P) are pharmacologically inactive. structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

143 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Estradiol