Mirena (levonorgestrel-releasing intrauterine device) is a progestin-containing intrauterine system (IUS, also called an intrauterine device, or IUD) indicated for:
- Prevention of pregnancy for up to 7 years
- Treatment of heavy menstrual bleeding for women who choose to use
- Intrauterine contraception as their method of contraception for up to 5 years
Common side effects of Mirena include:
- Missed periods (amenorrhea)
- Bleeding and spotting between periods
- Heavier bleeding during the first few weeks after device insertion
- Abdominal/pelvic pain
- Vaginal discharge
- Inflammation or irritation of the vagina/vulva
- Ovarian cysts
- Back pain
- Headache
- Migraine
- Nervousness
- Dizziness
- Nausea
- Vomiting
- Bloating
- Breast tenderness or pain
- Weight gain
- Changes in hair growth
- Acne
- Depression
- Mood changes
- Loss of interest in sex
- Itching
- Skin rash
- Puffiness in the face, hands, ankles, or feet
Possible serious side effects of Mirena include:
- Risk of ectopic pregnancy, which is when a pregnancy occurs outside the uterus
- Severe infection or sepsis (which may be life-threatening), including Group A streptococcal sepsis (GAS)
- Pelvic inflammatory disease (PID)
- Perforation (total or partial, including penetration/embedment of Mirena in the uterine wall or cervix)
- Partial or complete expulsion of Mirena
- Ovarian cysts
- If left in place during pregnancy:
- Severe infection
- Miscarriage
- Premature birth
- Death of the mother
Who Should Not Use Mirena?
Mirena is not recommended for all women, including those who:
- Are or might be pregnant
- Have had pelvic inflammatory disease (PID)
- Have a current untreated pelvic infection
- Have had a serious pelvic infection in the past 3 months after a pregnancy
- Get infections easily, such as:
- Women who have multiple sexual partners or who have a partner who has multiple sexual partners
- Women who are immunocompromised
- Women who use or abuse intravenous drugs
- Have or suspect they might have uterine or cervical cancer
- Have unexplained vaginal bleeding
- Have liver disease or a liver tumor
- Have or have had breast cancer or any other cancer that is sensitive to progestin
- Already have an intrauterine device
- Have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors
- Are allergic to levonorgestrel, silicone, polyethylene, silica, barium sulfate or iron oxide
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References
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021225s042lbl.pdf