Estrace Vaginal Cream Side Effects
Generic name: estradiol topical
Medically reviewed by Drugs.com. Last updated on Apr 22, 2024.
Note: This document contains side effect information about estradiol topical. Some dosage forms listed on this page may not apply to the brand name Estrace Vaginal Cream.
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]
Frequently asked questions
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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
Further information
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.