Mirena trademark (levonorgestrel-releasing intrauterine system) 52 mg

Important Safety Information

If you have a pelvic infection, get infections easily, or have certain cancers, don't use Mirena. Less than 1% of users get a serious pelvic infection called pelvic inflammatory disease (PID). If you have persistent pelvic or stomach pain or if Mirena comes out, tell your healthcare provider (HCP)... Continue below

Safety Considerations


Keep this in mind:

Only you and your healthcare provider can decide if Mirena is right for you. As the two of you discuss your options, there are a number of things you should consider—like your general health, current or past health conditions, sexual history and the possibility that you'd like to have more children in the future.

Mirena is not appropriate for women who:

  • Are or might be pregnant; Mirena cannot be used as an emergency contraceptive
  • Have had a serious pelvic infection called pelvic inflammatory disease (PID) unless you have had a normal pregnancy after the infection went away
  • Have had a serious pelvic infection in the past 3 months after a pregnancy
  • Can get infections easily. For example, if you have:
    • Multiple sexual partners or your partner has multiple sexual partners
    • Problems with your immune system
    • Intravenous drug abuse
  • Have or suspect you might have cancer of the uterus or cervix
  • Have bleeding from the vagina that has not been explained
  • Have liver disease or a liver tumor
  • Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past
  • Have an intrauterine device in your uterus already
  • 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 sulphate or iron oxide

Tell your healthcare provider if you:

  • Have had a heart attack
  • Have had a stroke
  • Were born with heart disease or have problems with your heart valves
  • Have problems with blood clotting or take medicine to reduce clotting
  • Have high blood pressure
  • Recently had a baby or if you are breastfeeding
  • Have severe migraine headaches

Some serious but uncommon side effects of Mirena include:

Pelvic inflammatory disease (PID). Some IUD users get a serious pelvic infection called pelvic inflammatory disease. PID is usually sexually transmitted. You have a higher chance of getting PID if you or your partner have sex with other partners. PID can cause serious problems such as infertility, ectopic pregnancy or pelvic pain that does not go away. PID is usually treated with antibiotics. More serious cases of PID may require surgery. A hysterectomy (removal of the uterus) is sometimes needed. In rare cases, infections that start as PID can even cause death.

Tell your healthcare provider right away if you have any of these signs of PID: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal (stomach area) pain, painful sex, chills, or fever.

A life-threatening infection called sepsis, including Group A streptococcal sepsis (GAS), may occur within the first few days after Mirena is placed. Call your healthcare provider immediately if you experience severe pain or unexplained fever shortly after Mirena is placed.

Perforation. Mirena may become attached to (embedded) or go through the wall of the uterus. This is called perforation. If this occurs, Mirena may no longer prevent pregnancy. If perforation occurs, Mirena may move outside the uterus and can cause internal scarring, infection or damage to other organs. Surgery may be needed to have Mirena removed. The risk of perforation is increased if Mirena is inserted while you are breastfeeding.

Possible common side effects of Mirena include:

Placement discomfort. Pain, bleeding or dizziness may occur during and after placement. This is common. Let your healthcare provider know if your symptoms are severe or do not stop within 30 minutes after placement.

Expulsion. Mirena may come out by itself and no longer prevent pregnancy. Symptoms of partial or complete expulsion may include bleeding, pain and an increase in menstrual flow. If this occurs, Mirena may be replaced within 7 days of a menstrual period after pregnancy has been ruled out. If you think that Mirena has come out, use a backup form of birth control such as condoms and spermicide and call your healthcare provider.

Missed menstrual periods. About 20% of women stop having periods after 1 year of Mirena use. Your periods will return once Mirena is removed. If you do not have a period for 6 weeks during Mirena use, contact your healthcare provider to rule out pregnancy.

Changes in bleeding. You may have bleeding and spotting between menstrual periods, especially during the first 3 to 6 months. Sometimes the bleeding is heavier than usual at first. However, the bleeding usually becomes lighter than usual and may be irregular. Call your healthcare provider if the bleeding remains heavier than usual or increases after it has been light for a while.

Cysts on the ovary. About 12 out of 100 women using Mirena develop a cyst on the ovary. These cysts usually disappear on their own in a month or two. However, cysts can cause pain and may sometimes require surgery.

This is not a complete list of side effects with Mirena. For more information, ask your healthcare provider. Call your healthcare provider for medical advice about side effects. You may report side effects to the manufacturer at 1-888-842-29371-888-842-2937, or at 1-800-FDA-1088 1-800-FDA-1088 or www.fda.gov/medwatch.

Every individual responds differently to medication, so talk to your healthcare provider about your individual risk factors and to see if Mirena is right for you.

Mirena does not protect against STDs (sexually transmitted diseases) or HIV. So, if while using Mirena you think you or your partner might be at risk of getting an STD, use a condom and call your healthcare provider.

After Mirena has been placed, when should I call my healthcare provider?

Call your healthcare provider if you have any concerns about Mirena. Be sure to call if you:

  • Think you are pregnant
  • Have pelvic pain or pain during sex
  • Have unusual vaginal discharge or genital sores
  • Have unexplained fever, flu-like symptoms or chills
  • Might be exposed to sexually transmitted infection (STIs)
  • Cannot feel Mirena’s threads
  • Develop very severe or migraine headaches
  • Have yellowing of the skin or whites of the eyes. These may be signs of liver problems
  • Have had a stroke or heart attack
  • Or your partner becomes HIV positive
  • Have several vaginal bleeding or bleeding that lasts a long time

What if I become pregnant while using Mirena?

Less than 8 in 1,000 women (0.8%) become pregnant over the course of the five years using Mirena. One risk of becoming pregnant while using Mirena is called ectopic pregnancy. This means that the pregnancy is not in the uterus. It may occur in the fallopian tubes. Signs of ectopic pregnancy may include unusual vaginal bleeding or abdominal pain. Ectopic pregnancy is an emergency that requires immediate medical attention and often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility and even death, so it is important to call your healthcare provider right away if you think that you're pregnant.

There are also risks if you become pregnant while using Mirena and the pregnancy is in the uterus. Severe infection, miscarriage, premature delivery and even death can occur with pregnancies that continue with an intrauterine device (IUD). Because of this, your healthcare provider may try to remove Mirena, even though removing it may cause a miscarriage. If Mirena cannot be removed, talk with your healthcare provider about the benefits and risks of continuing the pregnancy.