Estradiol Topical Side Effects
Medically reviewed by Drugs.com. Last updated on Apr 22, 2024.
Applies to estradiol topical: vaginal cream, vaginal insert, vaginal tablet.
Other dosage forms:
Important Warnings
This medicine can cause some serious health issues
- Estrogens may raise the chance of uterine cancer.
Progestins may lower this chance.
A warning sign for cancer of the uterus is vaginal bleeding.
Report any vaginal bleeding to the doctor.
- Do not use estrogens to prevent heart disease or dementia.
Using estrogens may raise the chances of having a heart attack, a stroke, breast cancer, ovarian cancer, a blood clot, or dementia.
- Use estrogens with or without progestin for the shortest time needed at the lowest useful dose.
Serious side effects of estradiol topical
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; change in stools; dark urine or yellow skin or eyes; or fever with chills.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Signs of low thyroid levels like constipation; not able to handle cold; memory problems; mood changes; or a burning, numbness, or tingling feeling that is not normal.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Pelvic pain or pressure.
- Vaginal irritation.
- Vaginal itching or discharge.
- Vaginal bleeding that is not normal.
- A lump in the breast, breast pain or soreness, or nipple discharge.
- Depression or other mood changes.
- Memory problems or loss.
- Eyesight changes or loss, bulging eyes, or change in how contact lenses feel.
- This drug may cause you to swell or keep fluid in your body. Tell your doctor if you have swelling, weight gain, or trouble breathing.
- Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
Other side effects of estradiol topical
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Headache.
- Hair loss.
- Tender breasts.
- Upset stomach or throwing up.
- Stomach pain or cramps.
- Bloating.
- Back pain.
- Diarrhea.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to estradiol topical: transdermal film extended release, vaginal cream, vaginal insert, vaginal ring, vaginal tablet.
General
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]
References
1. (2001) "Product Information. Estrace (estradiol)." Warner Chilcott Laboratories
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
4. (2017) "Product Information. Vagifem (estradiol topical)." Novo Nordisk Pharmaceuticals Inc
5. (2017) "Product Information. Estring (estradiol topical)." Pfizer U.S. Pharmaceuticals Group
6. (2018) "Product Information. Imvexxy (estradiol topical)." TherapeuticsMD
More about estradiol topical
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Patient resources
- Estradiol vaginal local drug information
- Estradiol Vaginal Tablets
- Estradiol Vaginal Cream
- Estradiol Vaginal Insert
- Estradiol Vaginal Ring (Estring)
Other brands
Yuvafem, Vagifem, Estring, Estrace Vaginal Cream, Imvexxy
Professional resources
Other brands
Yuvafem, Estrace Vaginal Cream
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Further information
Estradiol topical 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.
Some side effects may not be reported. You may report them to the FDA.