Bayer

Important Safety Information About Menostar®      Prescribing Information, including Boxed WARNING

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 attack, strokes, breast cancer, and blood clots. Using estrogens with or without progestins may increase your risk of dementia. You and your healthcare provider should talk regularly about whether you still need treatment with Menostar. continue reading below

What is Menostar used for?

Menostar is used after menopause to:

  • Reduce your chances of getting osteoporosis (thin weak bones)
  • Therapy should be considered only for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered

Menostar: Important Safety Information

What is the most important information I should know about Menostar (an osteoporosis prevention containing an estrogen hormone)?

  • 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 attack, strokes, breast cancer, and blood clots.
  • Using estrogens with or without progestins may increase your risk of dementia.
  • You and your healthcare provider should talk regularly about whether you still need treatment with Menostar.

Who should not use Menostar?

Do not use Menostar if you have unusual vaginal bleeding, had a stroke or heart attack in the past year, currently have or have had blood clots or liver problems, are allergic to Menostar or any of its ingredients, think you may be pregnant, or currently have or have had certain cancers. Estrogens increase the chances of getting cancer of the breast or uterus.

What are less common but serious side effects of Menostar?

Less common but serious side effects include breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease, and ovarian cancer.

What are the warning signs of less common but serious side effects of Menostar?

Warning signs of less common but serious side effects of Menostar include: 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, and vomiting. Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptoms that concern you.

What are the common side effects of Menostar?

Common side effects of Menostar include headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting and hair loss.

Menostar is available by prescription only.

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.

For important risk and use information about Menostar, please see the full prescribing information.