What to know about breakthrough bleeding and spotting.

Unscheduled bleeding or spotting is likely to occur while you are taking LYBREL®. Unscheduled bleeding or spotting occurs most often during the first six months of LYBREL use. This usually decreases over time, but for some it may continue.

Clinical study results show that, during month 12, 59% of women taking LYBREL had no bleeding at all and 20% of women taking LYBREL had spotting that did not require any sanitary protection. 21% of women taking LYBREL had bleeding that required sanitary protection.Breakthrough bleeding chart

You should know that, regardless of any unexpected bleeding, LYBREL remains highly effective.

Missed pills can cause spotting or light bleeding, even if you make them up. It’s important to take LYBREL at the same time every day, even if you are having unscheduled bleeding and spotting, so it will work effectively.

If you have breakthrough bleeding and/or spotting for an extended period of time (for example, 7 consecutive days) or if the bleeding is heavy, contact your health care professional.

You can monitor your breakthrough bleeding and spotting while taking LYBREL with our convenient Progress Tracker.

If, like other women, you've started using LYBREL, sign up for LYBREL LIVING™. It's a free informational program that lets you know what you can expect while taking LYBREL. It also provides tips and other information to help you weigh the convenience of having no regular monthly periods with the inconvenience of unscheduled breakthrough bleeding and spotting.

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Important Safety Information

  • The Pill does not protect against HIV or other sexually transmitted diseases.

  • Unscheduled bleeding or spotting is likely to occur while you are taking LYBREL. The convenience of having no regular menstrual periods should be weighed against the inconvenience of unscheduled or unplanned breakthrough bleeding and spotting.

  • Some women should not use the Pill, including women who have blood clots; breast, uterine, or liver cancers; a history of heart attack, stroke, or breast cancer; as well as those who are or may be pregnant.

  • Serious risks associated with the Pill which can be life threatening, include blood clots, stroke, and heart attacks and are increased if you smoke cigarettes.

Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral contraceptive use, especially if you are over 35. Women who use the Pill are strongly advised not to smoke.

  • LYBREL provides women with more hormonal exposure on a yearly basis (13 additional weeks of hormone intake per year) than conventional cyclic oral contraceptives containing the same strength of synthetic estrogens and similar strength of progestins.

  • Because regular monthly bleeding does not occur on LYBREL, it may be difficult to recognize if you get pregnant. If you suspect that you may be pregnant, or if you have symptoms of pregnancy such as nausea/vomiting or unusual breast tenderness, you should have a pregnancy test and you should contact your health care professional.

  • The most common side effects reported with LYBREL in a clinical trial were headache, menstrual cramps, upper respiratory infection, vaginal bleeding, and nausea.