Elles Solo

Elles Solo

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Medically reviewed by Drugs.com. Last updated on Jul 14, 2022.
Note: This document contains side effect information about estradiol. Some of the dosage forms listed on this page may not apply to the brand name Elleste Solo.
Applies to estradiol: vaginal capsule liquid filled, vaginal cream, vaginal insert extended release, vaginal tablet
Vaginal route (Insert, Extended Release; Cream)
Estrogen Alone TherapyEndometrial Cancer - There is an increased risk of cancer in a woman with a uterus who uses unopposed estrogens . Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer . Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.Cardiovascular Disorders and Probable Dementia - Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia.Cardiovascular Disorders and Probable Dementia - The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis ( DVT ) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo.Cardiovascular Disorders and Probable Dementia - The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.Cardiovascular Disorders and Probable Dementia - Only daily oral 0.625 mg CE was studied in the estrogen -alone substudy of the WHI. Therefore, thee relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile.Cardiovascular Disorders and Probable Dementia - In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens .Cardiovascular Disorders and Probable Dementia - Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.Estrogen Plus Progestin TherapyCardiovascular Disorders and Probable Dementia - Estrogen and progestin therapy should not be used for the prevention of cardiovascular disease or dementia.Cardiovascular Disorders and Probable Dementia - The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with combined medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.Cardiovascular Disorders and Probable Dementia - The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. Breast Cancer - The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.Breast Cancer - Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia, and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen plus progestogen therapy, taking into account her individual risk profile.Breast Cancer - In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins .Breast Cancer - Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Vaginal route (Insert, Extended Release)
Use of unopposed estrogens increases the risk of endometrial cancer, while addition of a progestin decreases the risk of endometrial hyperplasia. Rule out malignancy if abnormal vaginal bleeding develops. Do not use estrogen alone or in combination with progestin to prevent cardiovascular disease or dementia. There is an increased risk of cardiovascular disorders (ie, DVT, pulmonary embolism, stroke, myocardial infarction) with combination therapy in women 50 years or older, and an increased risk of dementia in women 65 years or older with estrogen monotherapy or combination therapy. Combination therapy also increases the risk of invasive breast cancer. Prescribe estrogens with or without progestins at the lowest effective dose and for the shortest duration consistent with risks and treatment goals.
Along with its needed effects, estradiol (the active ingredient contained in Elleste Solo) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking estradiol:

Get emergency help immediately if any of the following symptoms of overdose occur while taking estradiol:

Some side effects of estradiol may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Applies to estradiol: compounding powder, intramuscular solution, oral tablet, transdermal emulsion, transdermal film extended release, transdermal gel, transdermal spray, vaginal ring
Very common (10% or more): Breast pain (29%)
Common (1% to 10%): Vulvovaginal pruritus , leukorrhea, vaginal hemorrhage, vaginal discharge, vaginal discomfort, menopause symptoms, breakthrough bleeding or spotting, dysmenorrhea, breast swelling, menorrhagia , metrorrhagia, endometrial hyperplasia
Uncommon (0.1% to 1%): Urinary problems
Rare (less than 0.1%): Galactorrhea
Postmarketing reports : Vaginal irritation, vaginal pain, genital pruritus, changes in bleeding pattern, pelvic pain , breast tenderness, vaginal ulceration, uterine fibroids [ Ref ]
Very common (10% or more): Abdominal pain (16%),
Common (1% to 10%): Flatulence , nausea, diarrhea
Postmarketing reports : Abdominal distension [ Ref ]
Very common (10% or more): Back pain (11%), arthralgia (11%)
Common (1% to 10%): Leg cramps [ Ref ]
Common (1% to 10%): Varicose veins , cardiac symptoms (e.g. palpitations )
Uncommon (0.1% to 1%): Hot flush, hypertension, venous thromboembolic disease
Rare (less than 0.1%): Arterial hypertension
Postmarketing reports : Deep vein thrombosis, changes in blood pressure [ Ref ]
Very common (10% or more): Headache (18%)
Uncommon (0.1% to 1%): Vertigo , migraine
Rare (less than 0.1%): Aggravation of epilepsy
Postmarketing reports : Migraine aggravated, paresthesia, dizziness [ Ref ]
Uncommon (0.1% to 1%): Benign breast neoplasm, increased volume of uterine leiomyoma
Postmarketing reports : Endometrial cancer, breast cancer [ Ref ]
Very common (10% or more): Pain (11%)
Uncommon (0.1% to 1%): Weight increased, asthenia
Postmarketing reports : Drug ineffectiveness, blood estrogen increase, fatigue, exacerbation of hereditary angioedema [ Ref ]
Uncommon (0.1% to 1%): Sleep disorders , nervousness , mood swings
Rare (less than 0.1%): Change in libido
Postmarketing reports : Vaginismus, insomnia , anxiety, irritability [ Ref ]
Rare (less than 0.1%): Skin discoloration, acne
Postmarketing reports : Urticaria , erythematous or pruritic rash, alopecia , hyperhidrosis , night sweats , contact dermatitis , eczema [ Ref ]
Uncommon (0.1% to 1%): Vision abnormal NOS
Postmarketing reports : Visual disturbances, contact lens intolerance [ Ref ]
Rare (less than 0.1%): Liver function tests abnormalities
Postmarketing reports : Cholestatic jaundice [ Ref ]
Rare (less than 0.1%): Glucose intolerance
Postmarketing reports : Fluid retention [ Ref ]
Rare (less than 0.1%): Anaphylactic reaction (with a past history of allergic reaction)
Postmarketing reports : Anaphylactic reactions, hypersensitivity [ Ref ]
Very common (10% or more): Upper respiratory tract infection (17%)
Common (1% to 10%): Vulvovaginal mycotic infection, pharyngitis , rhinitis, sinusitis, moniliasis genital
Uncommon (0.1% to 1%): Vaginitis/vaginal candidosis [ Ref ]
Common (1% to 10%): Skin irritation (topical gel)
Postmarketing reports : Application site reaction [ Ref ]
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10. Crane MG, Harris JJ "Estrogens and hypertension: effect of discontinuing estrogens on blood pressure, exchangeable sodium, and the renin-aldosterone system." Am J Med Sci 276 (1978): 33-55
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13. Jick H, Dinan B, Rothman KJ "Noncontraceptive estrogens and nonfatal myocardial infarction." JAMA 239 (1978): 1407-8
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16. Stampfer MJ, Colditz GA, Willett WC, et al. "Postmenopausal estrogen and cardiovascular disease. Ten-year follow-up from the Nurses' Health Study." N Engl J Med 325 (1991): 756-62
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41. Molitch ME, Oill P, Odell WD "Massive hyperlipemia during estrogen therapy." JAMA 227 (1974): 522-5
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA .
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Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Watson Micromedex (updated 12 Oct 2022), Cerner Multum™ (updated 21 Sep 2022), ASHP (updated 12 Oct 2022) and others.
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