Estradiol Gel

Estradiol Gel is an FDA-registered drug product whose active ingredient is ESTRADIOL. It is labelled by Encube Ethicals, Inc. taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 21922-086, application ANDA218507, label effective 20260429. It is one of 33 FDA drug label records sharing the active ingredient ESTRADIOL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ESTRADIOL are most often described in connection with: treatment moderate, severe vasomotor, symptoms due, usage estradiol, gel estrogen. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Estradiol gel 0.1% is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause ( 1.1 ). 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

2 DOSAGE AND ADMINISTRATION 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 a progestogen in addition to her estrogen therapy. In some cases, however, hysterectomized women who have 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 whether treatment is still necessary. Daily administration of 0.25 to 1.25 grams of estradiol gel 0.1% 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 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 0.1% to the right or left upper thigh on alternating days. Do not apply estradiol gel 0.1% 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 0.1%. Avoid contact of the gel with eyes. Wash hands after application.

4 CONTRAINDICATIONS Estradiol gel 0.1% is contraindicated in women with any of the following conditions: • Undiagnosed abnormal genital bleeding [see Warning and Precautions ( 5.2 )] • Breast cancer or history of breast cancer [see Warning and Precautions ( 5.2 )] • Estrogen-dependent neoplasia [see Warning and Precautions ( 5.2 )] • Active DVT, PE, or history of these conditions [see Warning and Precautions ( 5.1 )] • Active arterial thromboembolic disease (e.g., stroke and MI), or a history of these conditions [see Warning and Precautions ( 5.1 )] • Known anaphylactic reaction, angioedema, or hypersensitivity to estradiol gel 0.1% • 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 (e.g., stroke and MI), or history of these conditions ( 4 , 5.1 ) • Known anaphylactic reaction, angioedema, or hypersensitivity to estradiol gel 0.1% ( 4 ) • Hepatic impairment or disease ( 4 , 5.10 ) • Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders ( 4 )

6 ADVERSE REACTIONS The most common adverse reactions (incidence ＞5 percent and greater than placebo) in any estradiol gel 0.1% treatment group are metrorrhagia, breast tenderness, vaginal mycosis, nasopharyngitis, and upper respiratory tract infection ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Pvt. Ltd. 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . The most common adverse reactions (incidence ＞5 percent and greater than placebo) in any estradiol gel 0.1% treatment group are metrorrhagia, breast tenderness, vaginal mycosis, nasopharyngitis, and upper respiratory tract infection ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Pvt. Ltd. 1-833-285-4151 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 0.1% 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 0.1% Estradiol Gel 0.1% 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 Upper Respiratory Tract Infection Vaginal mycosis 7 (5.7) 7 (5.7) 1 (0.8) 5 (4.1) 3 (2.4) 3 (2.4) 6 (4.8) 2 (1.6) 8 (6.4) 5 (4.0) 2 (1.6) 4 (3.2) REPRODUCTIVE SYSTEM & BREAST DISORDERS Breast Tenderness Metrorrhagia 3 (2.5) 5 (4.1) 7 (5.7) 7 (5.7) 11 (8.8) 12 (9.6) 2 (1.6) 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 0.1%, 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 0.1%. 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

FDA lists 33 drug label records with ESTRADIOL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

4 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Estradiol Gel used for?
1 INDICATIONS AND USAGE Estradiol gel 0.1% is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause ( 1.1 ). 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

Who makes Estradiol Gel?
Encube Ethicals, Inc. is the labeler of record for Estradiol Gel. 33 FDA label records share the active ingredient ESTRADIOL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Estradiol Gel come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Estradiol Gel prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ESTRADIOL?
Yes. 33 FDA drug label records list ESTRADIOL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Estradiol Gel been recalled?
4 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.