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Mirena Consumer (continued)

SIDE EFFECTS: Irregular vaginal bleeding (e.g., spotting), cramps, headache, nausea, breast pain, acne, rash, hair loss, weight gain, or decreased interest in sex may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication device because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication device do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur: lack of menstrual period, unexplained fever, chills, trouble breathing, mental/mood changes (e.g., depression, nervousness), vaginal swelling/itching, painful intercourse.

Tell your doctor immediately if any of these unlikely but serious side effects occur: migraine/severe headache, vomiting, tiredness, fast/pounding heartbeat.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: prolonged or heavy vaginal bleeding, unusual vaginal discharge/odor, vaginal sores, abdominal/pelvic pain or tenderness, lumps in the breast, yellowing eyes/skin, dark urine, persistent nausea, trouble urinating.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Mirena (levonorgestrel-releasing intrauterine system) Side Effects Center for a complete guide to possible side effects

PRECAUTIONS: Before using this medication device, tell your doctor or pharmacist if you are allergic to levonorgestrel, or to any other progestins (e.g., norethindrone, desogestrel); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication device should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: current known or suspected pregnancy, previous ectopic pregnancy, uterus problems (e.g., cancer, endometriosis, fibroids, pelvic inflammatory disease-PID), other IUD (intrauterine device) still in place, vaginal problems (e.g., infection), breast cancer, liver disease/tumors, any condition that affects your immune system (e.g., AIDS, leukemia).

Before using this product, tell your doctor your medical history, especially of: bleeding problems (e.g., menstrual changes, clotting problems), heart problems (e.g., congenital valve conditions), high blood pressure, migraine headaches, stroke, diabetes.

If you have diabetes, this medication may make it harder to control your blood sugar levels. Monitor your blood sugar regularly as directed by your doctor. Tell your doctor the results and any symptoms such as increased thirst/urination. Your anti-diabetic medication or diet may need to be adjusted.

This medication device may sometimes come out by itself or move out of place. This may result in unwanted pregnancy or other problems. After each menstrual period, check to make sure it is in the right place. Talk to your doctor about how to check your device. If it comes out or you cannot feel its threads, call your doctor promptly, and use a backup birth control method such as condoms.

If you or partner has any other sexual partners, this medication device may no longer be a good choice for pregnancy prevention. If you or your partner becomes HIV positive, or if you think you may have been exposed to any sexually transmitted disease, contact your doctor immediately. You should consider having this device removed.

This medication device must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. If you have just given birth and are not breast-feeding, or if you have had a pregnancy loss or abortion after the 3 months of pregnancy, wait at least 6 weeks (or as directed by your doctor) before using this medication device. Consult your doctor about the problems that may occur during pregnancy while using this product.

Levonorgestrel passes into breast milk. Consult your doctor before breast-feeding.


Mirena - User Reviews

Mirena User Reviews

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Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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