This medication is not recommended for use if you have any of the following medical conditions: pregnancy or suspect you are pregnant, uterine problems (e.g., cancer, endometriosis, fibroids, pelvic inflammatory disease or PID), vaginal problems (e.g., infection), liver disease or tumors, disease affecting your immune system (e.g., AIDS, leukemia), breast cancer, previous ectopic pregnancy, other IUD (intrauterine device) still in place. Tell your doctor your medical history, especially of: bleeding problems (e.g., menstrual changes, clotting problems), heart problems (e.g., congenital valve conditions), migraine headaches, diabetes, and any allergies. This medication device must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. Consult your doctor about the risks associated with pregnancy while using this product. Levlen passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast- feeding.

Irregular vaginal bleeding (e.g., spotting), cramps, headache, nausea, breast pain, acne, rash, hair loss, or weight gain may occur. If any of these effects persist or worsen, notify your doctor. Tell your doctor immediately if any of these serious side effects occur: lack of menstrual period, fever, chills, stomach pain, trouble breathing, mental/mood changes, decreased interest in sex, vaginal swelling/itching, painful intercourse. Tell your doctor immediately if any of these unlikely but serious side effects occur: migraine headache, vomiting, fatigue, prolonged and severe vaginal bleeding. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: unusual vaginal discharge/odor or sores, severe lower stomach/pelvic pain, lumps in the breast, yellowing eyes or skin, dark urine, trouble urinating. If you notice other effects not listed above, contact your doctor or pharmacist.

Avoid smoking. Smoking increases the risk of developing a heart attack, stroke, or blood clot.