Vagifem Side Effects
Generic Name: estradiol topical
Note: This document contains side effect information about estradiol topical. Some of the dosage forms listed on this page may not apply to the brand name Vagifem.
For the Consumer
Applies to estradiol topical: vaginal cream, vaginal insert, vaginal tablet
Other dosage forms:
- 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.
What are some side effects that I need to call my doctor about right away?
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.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Very upset stomach or throwing up.
- Very bad belly pain.
- Pelvic pain or pressure.
- Vaginal irritation.
- Vaginal itching or discharge.
- Vaginal bleeding.
- A lump in the breast, breast soreness, or nipple discharge.
- Breast pain.
- Low mood (depression).
- Mood changes.
- Memory problems or loss.
- Bulging eyes.
- Change in how contact lenses feel in the eyes.
- Change in eyesight.
- Loss of eyesight.
- 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.
What are some other side effects of this drug?
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:
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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to estradiol topical: transdermal film extended release, vaginal cream, vaginal insert, vaginal ring, vaginal tablet
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
Frequency not reported: Hypersensitivity, anaphylactoid/anaphylactic reactions[Ref]
Very common (10% or more): Infection (12%)
Common (1% to 10%): Allergy
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]
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]
Frequency not reported: Enlargement of hepatic hemangiomas[Ref]
Frequency not reported: Retinal vascular thrombosis, intolerance to contact lenses, steepening of corneal curvature
Postmarketing reports: Abnormal vision, retinal vein occlusion, blindness[Ref]
Common (1% to 10%): Flu-like symptoms, peripheral edema
Frequency not reported: Edema
Postmarketing reports: Asthenia, fatigue, feeling abnormal, malaise[Ref]
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]
Very common (10% or more): Headache (13%)
Postmarketing reports: Tremor[Ref]
Common (1% to 10%): Hyperhidrosis
Common (1% to 10%): Upper respiratory tract infection, sinusitis, pharyngitis
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]
Frequency not reported: Local abrasion
Postmarketing reports: Application site rash[Ref]
1. "Product Information. Estrace (estradiol)." Warner Chilcott Laboratories, Rockaway, NJ.
2. "Product Information. Imvexxy (estradiol topical)." TherapeuticsMD, Boca Raton, FL.
3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
4. Cerner Multum, Inc. "Australian Product Information." O 0
5. "Product Information. Estring (estradiol topical)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
6. "Product Information. Vagifem (estradiol topical)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.
Some side effects may not be reported. You may report them to the FDA.
More about Vagifem (estradiol topical)
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Compare Alternatives
- Support Group
- Pricing & Coupons
- En Español
- 33 Reviews
- Generic Availability
- Drug class: estrogens