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.

• Daily administration of 0.25 to 1.25 grams of estradiol gel to the right or left upper thigh on alternating days.
• Women should be started with the lowest effective dose and the dose should be evaluated periodically ( 2 ).
• 2.1 Important Use Information The timing of estradiol gel initiation can affect the overall benefit-risk profile.
• Consider initiating estradiol gel in women <60 years old or <10 years since menopause onset [see Warnings and Precautions (5), Use in Specific Populations ( 8.5 ) and Clinical Studies ( 14 )] .
• When estrogen is prescribed for a menopausal woman with a uterus, the addition of a progestogen has been shown to reduce the risk of endometrial cancer.
• There are possible risks associated with the use of progestogens plus estrogens that differ from those of estrogen-alone regimens.
• See prescribing information for progestogens indicated for the prevention of endometrial hyperplasia in non-hysterectomized menopausal women receiving estrogens [see Warnings and Precautions ( 5.2 , 5.3 )] .
• Generally, a woman without a uterus, does not need to use a progestogen with estrogen therapy.
• In some cases, however, hysterectomized women with a history of endometriosis may benefit from the addition of a progestogen [see Warnings and Precautions ( 5.13 )] .
• 2.2 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Start therapy with the 0.25 grams applied once daily on the skin of either the right or left upper thigh.
• Adjust the dose up to a maximum of 1.25 grams, as needed.
• The application surface area should be about 5 by 7 inches (approximately the size of two palm prints).
• The entire contents of a unit dose packet should be applied each day.
• To avoid potential skin irritation, apply estradiol gel to the right or left upper thigh on alternating days.
• Do not apply estradiol gel on the face, breasts, or irritated skin or in or around the vagina.
• Allow gel to dry after application before dressing.
• Do not wash the application site within 1 hour after applying estradiol gel.
• Avoid contact of the gel with eyes.
• Wash hands after application.

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 trial (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 Clinical Studies ( 14.2 )].
• 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 probable dementia in women receiving estrogen-alone [see Clinical Studies ( 14.3 )] .
• Since the trial was conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women [see Clinical Studies ( 14.3 )] .
• The safety and efficacy of estradiol gel for the prevention of dementia has not been established.

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, Warnings and Precautions ( 5.1 )] .
• Malignant Neoplasms [see Boxed Warning, Warnings and Precautions ( 5.2 )] . The most common adverse reactions (incidence >5 percent and greater than placebo) in any estradiol gel treatment group are metrorrhagia, breast tenderness, vaginal mycosis, nasopharyngitis, and upper respiratory tract infection ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 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. Estradiol gel was studied at doses of 0.25, 0.5 and 1.0 gram per day in a 12-week, double-blind, placebo-controlled study that included a total of 495 postmenopausal women (86.5 percent Caucasian). The adverse reactions that occurred at a rate greater than 5 percent and greater than placebo in any of the treatment groups are summarized in Table 1. Table 1:
• Number (%) of Subjects with Common Adverse Reactions* in a 12-Week Placebo-Controlled Study of Estradiol Gel Estradiol Gel Placebo SYSTEM ORGAN CLASS Preferred Term 0.25 grams/day N=122 n (%) 0.5 grams/day N=123 n (%) 1.0 gram/day N=125 n (%) N=125 n (%) INFECTIONS & INFESTATIONS Nasopharyngitis 7 (5.7) 5 (4.1) 6 (4.8) 5 (4.0) Upper Respiratory Tract Infection 7 (5.7) 3 (2.4) 2 (1.6) 2 (1.6) Vaginal mycosis 1 (0.8) 3 (2.4) 8 (6.4) 4 (3.2) REPRODUCTIVE SYSTEM & BREAST DISORDERS Breast Tenderness 3 (2.5) 7 (5.7) 11 (8.8) 2 (1.6) Metrorrhagia 5 (4.1) 7 (5.7) 12 (9.6) 2 (1.6) *Adverse reactions reported by >5 percent of patients in any treatment group. In a 12-week placebo-controlled study of estradiol gel, application site reactions were seen in <1 percent of participating women. 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 Amenorrhea, dysmenorrhea, ovarian cyst, vaginal discharge Breasts Gynecomastia Cardiovascular Palpitations, ventricular extrasystoles Gastrointestinal Flatulence Skin Rash pruritic, urticaria Eyes Retinal vein occlusion Central Nervous System Tremor Miscellaneous Arthralgia, application site rash, asthenia, chest discomfort, fatigue, feeling abnormal, heart rate increased, insomnia, malaise, muscle spasms, pain in extremity, weight increased

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 )] . Unintentional Secondary Exposure to Estradiol Gel Inform women about the possibility of secondary exposure to estradiol gel:
• Apply estradiol gel as directed and keep children from contacting exposed application site(s). If direct contact with the application site occurs, wash the contact area thoroughly with soap and water.
• Look for signs of unexpected sexual development, such as breast mass or increased breast size in prepubertal children.
• If signs of unintentional secondary exposure are noticed:
• Have the child(ren) evaluated by a healthcare provider.
• Have women contact their healthcare provider to discuss the appropriate use and handling of estradiol gel when around children.
• Pets may also be unintentionally exposed to estradiol gel if above precautions are not followed. Possible Serious Adverse Reactions with Estrogen-Alone Therapy Inform postmenopausal women of possible serious adverse reactions of estrogen-alone therapy including Cardiovascular Disorders and Malignant Neoplasms [see Warnings and Precautions ( 5.1 , 5.2 )] . Possible Less Serious but Common Adverse Reactions with Estrogen-Alone Therapy Inform postmenopausal women of possible less serious but common adverse reactions of estrogen-alone therapy such as headaches, breast pain and tenderness, nausea and vomiting. Manufactured by Padagis ® , Yeruham, Israel www.padagis.com Rev 02-26 97S00 RC PH7 PADAGIS is a registered trademark of Padagis US LLC.

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

Strengths and forms

• FORMS AND STRENGTHS Estradiol gel is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for transdermal application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively).
• Estradiol gel is a clear, colorless gel, which is odorless when dry.
• Gel:
• 0.25, 0.5, 0.75, 1.0, and 1.25 gram-filled single-dose foil packets containing 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively ( 3 )

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

What it looks like and how it is packed

• 16.1 How Supplied Estradiol Gel, 0.1% is a clear, colorless, smooth, opalescent gel supplied in single-dose foil packets of 0.25, 0.5, 0.75, 1.0, and 1.25 grams, corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively.
• NDC 45802-134-30, carton of 30 packets, 0.25 mg estradiol per single-dose foil packet NDC 45802-202-30, carton of 30 packets, 0.5 mg estradiol per single-dose foil packet NDC 45802-310-30, carton of 30 packets, 0.75 mg estradiol per single-dose foil packet NDC 45802-452-30, carton of 30 packets, 1.0 mg estradiol per single-dose foil packet NDC 45802-573-30, carton of 30 packets, 1.25 mg estradiol per single-dose foil packet
• Keep out of the reach of children.
• 16.2 Storage and Handling 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 0.1 percent, is a clear, colorless gel, which is odorless when dry.
• It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin.
• The gel is applied to a small area (200 cm 2 ) of the thigh in a thin layer.
• Estradiol gel is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively).
• The active component of the topical gel is estradiol, an estrogen.
• 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 remaining components of the gel (carbomer, ethanol, propylene glycol, purified water, and triethanolamine) are pharmacologically inactive.
• Estradiol gel contains 56% alcohol. estradiol chemical 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.

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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