Estradiolside effects

estradiol 0.01 MG Vaginal Insert

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) with estradiol are: back pain, vulvovaginal pruritus, vulvovaginal mycotic infection and diarrhea. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 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. In a 12-month randomized, double-blind, parallel group, placebo-controlled study, a total of 309 postmenopausal women were randomized to receive either placebo or estradiol 10 mcg vaginal inserts. Adverse reactions with an incidence of ≥5 percent in the estradiol 10 mcg group and greater than those reported in the placebo group are listed in Table 1.

Table 1: Treatment-Emergent Adverse Reactions Reported at a Frequency of ≥ 5 Percent in Women Receiving Estradiol 10 mcg Body System Treatment Adverse Reaction Number (%) of Women Placebo N = 103 n (%) Estradiol N = 205 n (%) N = Total number of women in study. n = Number of women who experienced adverse reactions. Body As A Whole Back Pain 2 14 Digestive System Diarrhea 0 11 Urogenital System Vulvovaginal Mycotic Infection 3 17 Vulvovaginal Pruritus 2 16

6.2 Postmarketing

Experience The following adverse reactions have been identified during post-approval use of estradiol 10 mcg. 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. Gastrointestinal disorders Diarrhea General disorders and administration site conditions Drug ineffective Immune system disorders Hypersensitivity Investigations Blood estrogen increased Weight increased Metabolism and nutrition disorders Fluid retention Neoplasms benign and malignant Breast cancer Endometrial cancer Psychiatric disorders Depression Insomnia Central Nervous System Aggravated migraine Reproductive system and breast disorders Endometrial hyperplasia Vulvovaginal burning sensation Vulvovaginal pain Genital pruritus Vulvovaginal rash Vulvovaginal swelling Vaginismus Vaginal ulceration Skin and subcutaneous tissue disorders Rash Rash erythematous Rash pruritic Urticaria Vascular disorders Deep vein thrombosis

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective April 3, 2024. 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

Estradiol is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding. Breast cancer 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, or angioedema, or hypersensitivity to estradiol. 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 (for example, stroke or MI), or a history of these conditions Known anaphylactic reaction, angioedema, or hypersensitivity to estradiol Hepatic impairment or disease Protein C, protein S, or antithrombin deficient, or other known thrombophilic disorders

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