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 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]

See also:

Frequently asked questions

• Estrace Vaginal Cream - How long before improvement in atrophic vaginitis ?

Further information

Estrace Vaginal Cream 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.

Medical Disclaimer