Important Safety Information About YAZ Prescribing Information, including Boxed WARNING Important Safety Information About BEYAZ Prescribing Information, including Boxed WARNING
WARNING TO WOMEN WHO SMOKE: Do not use YAZ or Beyaz if you smoke and are over age 35. Smoking increases your risk of serious side effects from the Pill, which can be life-threatening, including blood clots, stroke, or heart attack. This risk increases with age and number of cigarettes smoked.
See additional important risk information below
  
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Indications & Usage

What are Beyaz® and YAZ® prescribed for?
For women who choose the Pill for birth control, Beyaz and YAZ are approved to:

  • Prevent pregnancy - 99% effective when taken as directed
  • Treat premenstrual dysphoric disorder (PMDD)
    • Beyaz and YAZ are not approved to treat Premenstrual Syndrome (PMS), a less serious set of symptoms occurring before your period
  • Treat moderate acne in women at least 14 years of age

Beyaz is also approved for women who choose the Pill for birth control to:

  • Provide a daily dose of folate supplementation, which is recommended for women in their reproductive years. Folate lowers the risk of having rare neural tube birth defects in a pregnancy occurring during Beyaz use or shortly after stopping

Who should not take Beyaz or YAZ?

Do not use Beyaz or YAZ if you smoke and are over age 35. Smoking increases your risk of serious side effects from the Pill, which can be life-threatening, including blood clots, stroke or heart attack. This risk increases with age and number of cigarettes smoked.

Do not use Beyaz or YAZ if you have kidney, liver, or adrenal disease because this could cause serious heart and health problems, or if you have or have had blood clots, certain cancers, history of heart attack or stroke, or if you are or may be pregnant.

What are the most serious risks of taking Beyaz or YAZ?
Beyaz and YAZ increase the risk of serious conditions including blood clots, stroke, and heart attack. These can be life-threatening or lead to permanent disability. The risk of blood clots is highest during the first year of use. This increased risk is highest when you first start taking birth control pills and when you restart the same or different birth control pills after not using them for a month or more. Users of drospirenone-containing pills (like Beyaz and YAZ) may have a higher risk of blood clots than users of birth control pills that do not contain drospirenone. Talk to your healthcare provider about your risk of blood clots before deciding which Pill is right for you.

In addition, drospirenone is a different kind of hormone that for some may increase potassium too much. Consult your healthcare provider if you are on daily long-term treatment for a chronic condition with medications that may also increase potassium (see below), as you should have a blood test to check your potassium level during the first month of taking Beyaz or YAZ.

Call your healthcare provider right away if you have:

  • Persistent leg pain; sudden shortness of breath; sudden blindness, partial or complete; severe pain in your chest; sudden, severe headache unlike your usual headaches; weakness or numbness in an arm or leg, or trouble speaking; yellowing of the skin or eyes

What medications may increase potassium?
NSAIDs—ibuprofen (Motrin®, Advil®), naproxen (Aleve® and others) when taken long-term and daily for arthritis or other problems, potassium-sparing diuretics (spironolactone and others), potassium supplementation, ACE inhibitors (Capoten®, Vasotec®, Zestril®, and others), angiotensin-II receptor antagonists (Cozaar®, Diovan®, Avapro®, and others), aldosterone antagonists, and heparin.

What are the most common side effects in Beyaz and YAZ clinical trials?
The most common side effects were headache/migraine, menstrual irregularities, nausea/vomiting, breast pain/tenderness, fatigue, irritability, decreased libido, weight gain, and mood changes.

Beyaz and YAZ do not protect against HIV infection (AIDS) or other STDs.

Please see full Prescribing Information about Beyaz, including boxed warning.

Please see full Prescribing Information about YAZ, including boxed warning.

BAYER®, the Bayer Cross®, YAZ®, Beyaz®, Aleve®, and drsp® are trademarks of Bayer. All other trademarks are the property of their respective owners.


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.

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