Estradiolside effects

250 MG estradiol 0.001 MG/MG Topical Gel [Divigel]

Adverse reactions

The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders. Malignant Neoplasms. The most common adverse reactions (incidence >5 percent and greater than placebo) in any Divigel treatment group are metrorrhagia, breast tenderness, vaginal mycosis, nasopharyngitis, and upper respiratory tract infection. To report SUSPECTED ADVERSE REACTIONS, contact VERTICAL PHARMACEUTICALS, LLC at 1-800-541-4802 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. Divigel 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. In a 12-week placebo-controlled study of Divigel, application site reactions were seen in <1 percent of participating women. DivigelTable1

6.2 Postmarketing

Experience The following adverse reactions have been identified during post-approval use of Divigel. 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

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective February 27, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

Contraindications

Divigel is contraindicated in women with any of the following conditions: Abnormal genital bleeding of unknown etiology Current or history of breast cancer Estrogen-dependent neoplasia Active DVT, PE, or history of these conditions Active arterial thromboembolic disease (for example, stroke or MI), or a history of these conditions Known anaphylactic reaction, angioedema, or hypersensitivity to Divigel Hepatic impairment or disease Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders Undiagnosed abnormal genital bleeding Breast cancer or a history of breast cancer Estrogen-dependent neoplasia Active DVT, PE, or history of these conditions Active arterial thromboembolic disease (e.g., stroke and MI), or history of these conditions Known anaphylactic reaction, angioedema, or hypersensitivity to Divigel Hepatic impairment or disease Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders

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