Important Safety Information
What is the most important information I should know about PREMARIN Vaginal Cream (an estrogen mixture)?
- Using estrogen-alone may increase your chance of getting cancer of the uterus (womb)
- Report any unusual vaginal bleeding right away while you are using PREMARIN Vaginal Cream. 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 the cause
- Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline in brain function)
- Using estrogen-alone may increase your chances of getting strokes or blood clots
- Do not use estrogens with progestins to prevent heart disease, heart attacks, or dementia
- Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
- Using estrogens with progestins may increase your chance of getting dementia, based on a study of women age 65 years or older
- You and your healthcare provider should talk regularly about whether you still need treatment with PREMARIN Vaginal Cream
PREMARIN® Vaginal Cream is used after menopause to treat menopausal changes in and around the vagina and painful intercourse caused by these changes.
It should not be used if you have unusual vaginal bleeding, have or had cancer of the breast or uterus, had a stroke or heart attack, have or had blood clots or liver problems, are allergic to any of its ingredients, or think you may be pregnant.
Most common side effects include headache, infection, abdominal pain, back pain, accidental injury, and vaginitis.
Please see Patient Information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.