IMPORTANT SAFETY INFORMATION WARNING-IMPORTANT INFORMATION ABOUT COMBINING ESTROGEN AND PROGESTIN: Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function). 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 65 years of age or older. Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia.

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Important Safety Information

What is the most important information I should know about Climara Pro® (combination of estrogen and a progestin)?

  • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
  • 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 65 years of age or older.
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia.
  • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb).
  • 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 65 years of age or older.
  • You and your healthcare provider should talk regularly about whether you still need treatment with the Climara Pro.

Who should not use Climara Pro?

Do not use Climara Pro if you have had your uterus (womb) removed (hysterectomy). Climara Pro contains a progestin to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and should not use Climara Pro.

Do not start using Climara Pro if you:

Have unusual vaginal bleeding; currently have or have had certain cancers, such as cancer of the breast or uterus; had a stroke or heart attack; currently have or have had blood clots or liver problems; have been diagnosed with a bleeding disorder; are allergic to Climara Pro or any of its ingredients; or think you may be pregnant.

Before using Climara Pro, tell your Healthcare Provider if you:

Have any unusual vaginal bleeding, have any other medical conditions, are going to have surgery or will be on bed rest, or are breastfeeding.

What are possible side effects of Climara Pro?

Serious, but less common side effects of Climara Pro include heart attack, stroke, blood clots, dementia, breast cancer, cancer of the lining of the uterus (womb), cancer of the ovary, high blood pressure, high blood sugar, gallbladder disease, liver problems, changes in your thyroid hormone levels and enlargement of benign tumors of the uterus (“fibroids”).

Call your Healthcare Provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

New breast lumps, unusual vaginal bleeding, changes in vision or speech, sudden new severe headaches and severe pains in your chest or legs with or without shortness of breath, weakness and fatigue.

Less serious, but common side effects include:

Headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, hair loss, fluid retention, vaginal yeast infection and redness or irritation at the patch placement site.

These are not all the possible side effects of Climara Pro. For more information, ask your Healthcare Provider or pharmacist. Tell your Healthcare Provider if you have any side effects that bother you or do not go away.

Climara Pro is available by prescription only.


For important risk and use information, including Boxed Warning, about Climara Pro, please see the Full Prescribing Information.