For important information about Vagifem® (estradiol vaginal tablets) click here

For FDA-approved Patient Labeling click here

Important Safety Information

 
 

What is the most important information I should know about Vagifem® (an estrogen hormone)?

  • 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 Vagifem®. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your health care 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 of brain function)
  • Using estrogen-alone may increase your chances of getting strokes or blood clots
  • Using estrogen-alone may increase your chance of getting dementia, based on a study of women
    age 65 years or older
  • Do not use estrogens with progestins to prevent heart disease, heart attack, or dementia
  • Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
  • Using estrogens with progestin may increase your chance of getting dementia, based on a study of women 65 years and older
  • You and your health care provider should talk regularly about whether you still need treatment with Vagifem®
  
 

Vagifem® is used after menopause to treat menopausal changes in and around the vagina.

Do not start using Vagifem® if you: have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack, currently have or have had blood clots, currently have or have had liver problems, are allergic to Vagifem® or any of its ingredients, or think you may be pregnant.

The most commonly reported side effects of Vagifem® included: headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, hair loss, fluid retention, and vaginal yeast infection.

Please click here for FDA-Approved Patient Labeling.

Vagifem® is only available by prescription. For more information about Vagifem®, please call 1-866-668-6336.

Novo Nordisk provides patient assistance for those who qualify. Please call 1-866-310-7549 to learn more about Novo Nordisk assistance programs.

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.

Vagifem® is a registered trademark of Novo Nordisk FemCare AG.
© 2010 Novo Nordisk FemCare AG.   0510-00000728-1   June 2010

FDA-Approved Patient Labeling | Privacy Statement