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Safety Information for Estrogen Vaginal Cream (Estradiol 0.01%)

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These highlights do not include all the information needed to use estradiol vaginal cream safely and effectively. Please see full prescribing information for estradiol vaginal cream.

Estradiol vaginal cream is a prescription medication that's FDA-approved to treat moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When you receive your vaginal estradiol (estrogen), you'll open the box and read an FDA warning that estrogens increase risk of cancer and heart disease. These warnings have only been substantiated with higher-dose oral forms of estrogen.

Estradiol vaginal cream is prescribed in very small doses and is applied only to the affected tissues. Vaginal estradiol is not shown to carry risk of cancer and heart disease. It can be safe for women with breast cancer, provided they have approval from their oncologist. Women's health groups and practicing clinicians have been lobbying the FDA to modify the confusing warnings.

At Interlude, we want you to feel safe and educated about your options for sexual wellness. If you are considering estradiol vaginal cream, our medical team will determine if you are a good candidate for vaginal estradiol cream. We're available 24/7 to answer any questions you may have - unlimited messaging is included with your treatment.

What does vaginal estradiol treat?

Estradiol vaginal cream (USP, 0.01%) is FDA-approved to treat moderate to severe dryness, itching, and burning in and around the vagina due to menopause. These changes are also known as vulvar and vaginal atrophy or the genitourinary syndrome of menopause.

What are the most important things I need to know about vaginal estradiol?

  • Boxed warning: endometrial cancer, cardiovascular disorders, breast cancer and probable dementia
  • Estradiol vaginal cream is considered an estrogen.
  • Estrogens increase the chances of getting cancer of the uterus.
  • Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
  • Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes.
  • Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots.
  • Using estrogens with progestins may increase your risk of dementia.
  • You and your healthcare provider should talk regularly about whether you still need treatment with estradiol vaginal cream.

Who should not take vaginal estradiol?

Do not use vaginal estradiol if you:

  • Have unusual vaginal bleeding
  • Currently have or have had certain cancers (Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use estradiol vaginal cream.)
  • Had a stroke or heart attack in the past year
  • Currently have or have had blood clots
  • Currently have or have had liver problems
  • Are allergic to estradiol vaginal cream or any of its ingredients
  • Think you may be pregnant

Tell your healthcare provider:

  • If you are breastfeeding
  • All of your medical problems
  • All the medicines you take
  • If you are going to have surgery or will be on bed rest.

What are the side effects of estradiol vaginal cream?

Although estradiol vaginal cream is only used in and around the vagina, the risks associated with oral estrogens should be taken into account.

Less common but serious side effects of oral estrogen include:

  • Breast cancer
  • Cancer of the uterus
  • Stroke
  • Heart attack
  • Blood clots
  • Dementia
  • Gallbladder disease
  • Ovarian cancer

These are some of the warning signs of serious side effects:

  • Breast lumps
  • Unusual vaginal bleeding
  • Dizziness and faintness
  • Changes in speech
  • Severe headaches
  • Chest pain
  • Shortness of breath
  • Pains in your legs
  • Changes in vision
  • Vomiting

Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

Common side effects include:

  • Headache
  • Breast tenderness
  • Irregular vaginal bleeding or spotting
  • Stomach/abdominal cramps, bloating
  • Nausea and vomiting
  • Hair loss
  • Vaginal burning, irritation, and itching

Other side effects:

  • High blood pressure
  • Liver problems
  • High blood sugar
  • Fluid retention
  • Enlargement of benign tumors of the uterus ("fibroids")
  • Vaginal yeast infection
  • Allergic reactions

These are not all the possible side effects of estradiol vaginal cream. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription products to the FDA. Visit or call 1-800-FDA-1088. Please see the full Prescribing Information, including the BOXED WARNING, for complete safety information.

Disclaimer: This information isn’t a substitute for professional medical advice, diagnosis, or treatment. You should never rely upon this article for specific medical advice. If you have any questions or concerns, please talk to your doctor.
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