Yuvafem Side Effects

Generic name: estradiol topical

Medically reviewed by Drugs.com. Last updated on Apr 22, 2024.

Note: This document provides detailed information about Yuvafem Side Effects associated with estradiol topical. Some dosage forms listed on this page may not apply specifically to the brand name Yuvafem.

Applies to estradiol topical: transdermal film extended release, vaginal cream, vaginal insert, vaginal ring, vaginal tablet.

Other dosage forms:

• vaginal cream, vaginal insert, vaginal ring

Important warnings This medicine can cause some serious health issues

Estradiol increases the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus.

Taking progestins, another hormone drug, while using estradiol lowers the risk of developing this condition.

Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together while using estradiol.

Visit your doctor regularly and report any unusual vaginal bleeding right away.

Treatment with estradiol long-term may increase the risk of stroke.

Because of this risk, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking estradiol long-term.

You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while using estradiol.

Do not use this medication if you are pregnant.

The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50-79 years of age) during 5 years of treatment with oral conjugated estrogens combined with medroxyprogesterone acetate.

The Women’s Health Initiative Memory Study (WHIMS) found that postmenopausal women 65 years of age or older who were treated with oral conjugated estrogens plus medroxyprogesterone acetate had an increased risk of developing dementia.

It is unknown whether this finding applies to younger postmenopausal women or to women using estrogen only therapy.

Estradiol increases the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, while using estradiol lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together while using estradiol. Visit your doctor regularly and report any unusual vaginal bleeding right away.

Treatment with estradiol long-term may increase the risk of stroke. Because of this risk, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking estradiol long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

If you experience any of the following serious side effects, stop using estradiol and seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• shortness or breath or pain in the chest;

• a painful, red, swollen leg;

• abnormal vaginal bleeding;

• pain, swelling, or tenderness in the abdomen;

• severe headache or vomiting, dizziness, faintness or changes in vision or speech;

• yellowing of the skin or eyes; or

• a lump in a breast.

Other, less serious side effects may be more likely to occur. Continue to use estradiol and talk to your doctor if you experience

• decreased appetite, nausea, or vomiting;

• swollen breasts;

• acne or skin color changes;

• decreased sex drive;

• migraine headaches or dizziness;

• vaginal pain, dryness, or discomfort;

• water retention (swollen hands, feet, or ankles);

• depression; or

• changes in your menstrual cycle or break-through bleeding.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For healthcare professionals

Applies to estradiol topical: transdermal film extended release, vaginal cream, vaginal insert, vaginal ring, vaginal tablet.

General adverse events

The most commonly reported side effects were headache, upper respiratory tract infection, moniliasis, genital pruritus, vulvovaginal mycotic infection, and diarrhea.^[Ref]

Cardiovascular

• Common (1% to 10%): Hot flushes
• Frequency not reported: Deep and superficial venous thrombosis, thrombophlebitis, myocardial infarction, stroke, increase in blood pressure, congestive heart disease
• Postmarketing reports: Palpitations, ventricular extrasystoles, chest discomfort, increased heart rate^[Ref]

Oncologic

• Frequency not reported: Breast cancer, endometrial cancer, ovarian cancer^[Ref]

Hypersensitivity

• Frequency not reported: Hypersensitivity, anaphylactoid/anaphylactic reactions^[Ref]

Immunologic

• Very common (10% or more): Infection (12%)
• Common (1% to 10%): Allergy
• Postmarketing reports: Toxic shock syndrome (fever, nausea, vomiting, diarrhea, muscle pain, dizziness, faintness, or a sunburn-rash on face and body)^[Ref]

Genitourinary

• Very common (10% or more): Endometrial disorder (15%)
• Common (1% to 10%): Urinary tract infection, leukorrhea, vaginitis, vaginal discomfort/pain, vaginal hemorrhage, asymptomatic genital bacterial growth, genital moniliasis, vulvovaginal mycotic infection, vulvovaginal pruritus, bladder discomfort
• Frequency not reported: Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow, breakthrough bleeding, spotting, dysmenorrhea, increase in size of uterine leiomyomata, vaginal candidiasis, change in amount of cervical secretion, changes in cervical ectropion, application site reactions of vulvovaginal discomfort including burning and irritation, genital pruritus, endometrial hyperplasia
• Postmarketing reports: Ring adherence to the vaginal wall, genital edema, vulval disorder, micturition frequency, urethral disorder, endometrial hyperplasia, vaginal erosion, vaginal ulceration, ovarian cyst^[Ref]

Metabolic

• Frequency not reported: Increase or decrease in weight, reduced carbohydrate tolerance, aggravation of porphyria, hypocalcemia, increased triglycerides
• Postmarketing reports: Fluid retention^[Ref]

Gastrointestinal

• Common (1% to 10%): Abdominal pain, nausea, diarrhea, lower abdominal pain, abdominal discomfort, anorectal discomfort, dyspepsia
• Frequency not reported: Vomiting, abdominal cramps, bloating, cholestatic jaundice, increased incidence of gallbladder disease, pancreatitis
• Postmarketing reports: Bowel obstruction, enlarged abdomen, bloating, flatulence^[Ref]

Endocrine

• Very common (10% or more): Breast pain (10%)
• Frequency not reported: Increased thyroid-binding globulin (TBG) levels, breast (tenderness, enlargement), nipple discharge, galactorrhea, fibrocystic breast changes
• Postmarketing reports: Estrogen increase, gynecomastia^[Ref]

Hepatic

• Frequency not reported: Enlargement of hepatic hemangiomas^[Ref]

Ocular

• Frequency not reported: Retinal vascular thrombosis, intolerance to contact lenses, steepening of corneal curvature
• Postmarketing reports: Abnormal vision, retinal vein occlusion, blindness^[Ref]

Other

• Common (1% to 10%): Flu-like symptoms, peripheral edema
• Frequency not reported: Edema
• Postmarketing reports: Asthenia, fatigue, feeling abnormal, malaise^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia
• Uncommon (0.1% to 1%): Anxiety
• Frequency not reported: Changes in libido, nervousness, mood disturbances, irritability
• Postmarketing reports: Depression, insomnia^[Ref]

Nervous system

• Very common (10% or more): Headache (13%)
• Frequency not reported: Migraine, dizziness, chorea, exacerbation of epilepsy, dementia
• Postmarketing reports: Tremor^[Ref]

Dermatologic

• Common (1% to 10%): Hyperhidrosis
• Frequency not reported: Chloasma or melasma, erythema multiforme, erythema nodosum, hemorrhagic eruption, loss of scalp hair, hirsutism, pruritus, rash, urticaria, angioedema, vascular purpura
• Postmarketing reports: Pruritus ani, erythematous rash, urticaria^[Ref]

Respiratory

• Common (1% to 10%): Upper respiratory tract infection, sinusitis, pharyngitis
• Frequency not reported: Pulmonary embolism (venous thromboembolism or VTE), exacerbation of asthma^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain, arthritis, arthralgia, skeletal pain
• Frequency not reported: Leg cramps
• Postmarketing reports: Arthropathy (including arthrosis), muscle spasms, extremity pain^[Ref]

Local

• Frequency not reported: Local abrasion
• Postmarketing reports: Application site rash^[Ref]

Further information

Yuvafem side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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