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Important Safety Information about YAZ Prescribing Information, including Boxed WARNING
YAZ is associated with increased risks of several serious side effects, including blood clots, stroke, and heart attack. Women, especially those 35 and over, are strongly advised not to smoke because it increases these risks. In addition, YAZ contains drospirenone, a different kind of hormone that for some may increase potassium too much. continue reading below
YAZ is associated with increased risks of several serious side effects, including blood clots, stroke, and heart attack. Women, especially those 35 and over, are strongly advised not to smoke because it increases these risks. In addition, YAZ contains drospirenone, a different kind of hormone that for some may increase potassium too much. continue reading below
What to expect with YAZ
Every single pill in your pill pack is important
When you take YAZ® (drospirenone & ethinyl estradiol) as prescribed by your healthcare provider, YAZ is 99% effective at preventing pregnancy and can also give you shorter, lighter periods, regulate your cycle, and reduce cramps.
The 24 pink active pills and the 4 white inactive pills taken each month keep you in the habit of taking a pill every day. Missing pills—even just 1—increases your risk of becoming pregnant.
Even if a friend tells you its okay to skip certain pills, it's best to follow your healthcare provider's advice and take the Pill as directed.
Learn what to do if you miss a pill.
Keep a regular schedule for each new pill pack
As soon as you finish all 28 pills in one pack, immediately begin a new pack the next day. Do this whether or not you have your period.
Since you don't want to miss any pills, you shouldn't wait until the end of your pill pack to order your next refill. If you want help remembering, sign up for free reminders.
Remember, if you skip active pills, you are more likely to get pregnant. It's also important to take the inactive pills, since they remind you when to start taking the new pills.
If you have taken another brand of birth control pill that follows 21 active and 7 inactive days, chances are you got your period the week you were taking the inactive pills. You may have experienced some spotting or bleeding into your next pack.
With YAZ, you will also get your period during the "hormone-free" interval, which is the 4 days you are taking the inactive white pills. When you start taking the active pills in the new month's pack, you may still have some bleeding or spotting.
This is normal, and it's nothing to be concerned about. The most important thing is to keep to your routine of taking a pill at the same time every day.
Side effects and unexpected bleeding
Side effects and unexpected bleeding may happen between periods, and can occur with any birth control pill, especially in the first few months of use.
Irregular vaginal bleeding or spotting may occur while you are taking the pills. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding, which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of oral contraceptiive use, but may also occur after you have been taking the Pill for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue taking your pills on schedule. If the bleeding occurs in more than one cycle or lasts for more than a few days, talk with your healthcare provider.
Continue to take YAZ every day, and this type of bleeding should stop after the first few months, once your body adjusts.
If you have questions, contact your healthcare provider.
Important Safety Information About YAZ®
What is YAZ Prescribed For? YAZ® (drospirenone & ethinyl estradiol) is indicated for:
- The prevention of pregnancy in women who elect to use an oral contraceptive.
- Treatment of the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception.
- The effectiveness of YAZ for PMDD when used for more than 3 menstrual cycles has not been evaluated. YAZ has not been evaluated for the treatment of premenstrual syndrome (PMS).
- Treatment of moderate acne vulgaris
- In women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. YAZ should be used for the treatment of moderate acne only if the patient desires an oral contraceptive for birth control.
Who Shouldn't Take Any Oral Contraceptives (OCs)? Some women should not use OCs, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant.
In Addition, Who Shouldn't Take YAZ? YAZ contains drsp®, a different kind of hormone that for some may increase potassium too much. Therefore, you should not take YAZ if you have kidney, liver, or adrenal disease because this could cause serious heart and health problems. Tell your doctor if you are on daily long-term treatment for a chronic condition such as cardiovascular disease or chronic inflammatory disease. Women who take certain drugs (see below) should have their potassium levels checked in the first month of taking YAZ.
What Drugs May Increase Potassium? NSAIDs-ibuprofen (Motrin®, Advil®), naproxen (Naprosyn®, Aleve®, and others) when taken long-term and daily for arthritis or other diseases or conditions, 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 Risks Involved With Taking Any Oral Contraceptive (OC)? OCs can be associated with an increased risk of several serious cardiovascular side effects, including blood clots, stroke, and heart attack. Women, especially those 35 and over, are strongly advised not to smoke because it increases these risks. OCs do not protect against HIV infection or other STDs.
The most frequent (greater than 1%) side effects, which may or may not be related to YAZ, that were reported in all YAZ clinical trials included: upper respiratory infection, headache, breast pain, vaginal moniliasis, nausea, abdominal pain, dysmenorrhea, urinary tract infection, accidental injury, sinusitis, emotional lability, suspicious Papanicolaou smear, weight gain, depression, menstrual disorder, and asthenia.
The most frequent (greater than 1%) side effects, which may or may not be related to YAZ, that were either unique to each trial type or occurred in only two types of clinical trials included:
- In the contraception trial: leukorrhea, diarrhea, vomiting, vaginitis, flu syndrome, moniliasis, allergic reaction, cystitis, tooth disorder, sore throat, infection, fever, surgery, back pain, migraine, dyspepsia, rhinitis, acne, gastroenteritis, bronchitis, pharyngitis, skin disorder, intermenstrual bleeding, decreased libido, pain, increased cough, dizziness, pain in extremity, and pelvic pain.
- In the PMDD trials: intermenstrual bleeding, decreased libido, nervousness, menorrhagia, pain in extremity, migraine, vaginitis, hyperlipidemia, back pain, diarrhea, increased appetite, enlarged abdomen, and acne.
- In the acne trials: metrorrhagia, flu syndrome, menorrhagia, gastroenteritis, tooth disorder, infection, vomiting, pharyngitis, sore throat, arthralgia, bronchitis, rhinitis, amenorrhea, and urine abnormality.
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, please see the full prescribing information.
BAYER®, the Bayer Cross®, YAZ®, Aleve®, drsp®, Beyond Birth Control and YAZXpress are trademarks of Bayer. All other trademarks are the property of their respective owners.
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