LYSTEDA^® (tranexamic acid) tablets is a prescription medicine used to treat your heavy monthly period (menstruation) when your bleeding gets in the way of social, leisure and physical activities. LYSTEDA does not contain any hormones and is taken only during your period. It does not treat premenstrual symptoms, does not affect your fertility, and cannot be used as birth control. It does not protect against sexually transmitted diseases.

LYSTEDA has not been studied in adolescents younger than 18 years of age.

Important Safety Information

You should not take LYSTEDA if you currently have or have ever had a blood clot, have been told you are at risk for having a blood clot, or are allergic to LYSTEDA or tranexamic acid.

LYSTEDA can cause serious side effects, including:

• The risk of serious blood clots may be increased when LYSTEDA is taken with hormonal contraceptives, especially if you are taking higher than your normal dose of birth control, are overweight, or if you smoke cigarettes. Risk of serious blood clots may also be increased if you take LYSTEDA with medicines used to help your blood clot or some medicines used to treat leukemia.
• Stop taking LYSTEDA and promptly report any eye problems to your healthcare provider.
• If you have shortness of breath and your throat feels tight, stop taking LYSTEDA and get medical help right away.

Before taking LYSTEDA, tell your healthcare provider about all of your medical conditions, including whether: you have ever had a blood clot or been told that you are at risk of having a blood clot, you are using a form of birth control that contains hormones, you are pregnant or think you may be pregnant, you are breastfeeding or plan to breast-feed, the time between the start of your periods is less than 21 days or more than 35 days, or you have any other medical conditions.

Tell your healthcare provider about all the medicines you take, especially if you take: birth control pills or other hormonal birth control, medicines used to help your blood clot, medicines used to break up blood clots, or any medicines to treat leukemia.

The most common side effects of LYSTEDA include: headaches, sinus and nasal problems, back pain, pain in your abdomen, pain in your muscles or joints, anemia, and fatigue.

If you notice a change in your usual bleeding pattern that worries you, or your heavy bleeding continues, contact your healthcare provider right away. This may be a sign of a more serious condition.

You are encouraged to report side effects of prescription drugs. Contact Ferring at 1-888-FERRING (1-888-337-7464) or call 1-800-FDA-1088 or visit www.fda.gov/medwatch.

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Please see Full Prescribing Information »

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