Important Safety Information | Full Prescribing Information

See for Yourself

Mirena is an IUD made of soft, flexible plastic that’s placed into your uterus by a healthcare provider.

Other Videos

Kim’s StoryKim’s Story

Kim wanted birth control
with no daily routine.

Important Safety Information | Full Prescribing Information

Kim’s Story

Kim wanted birth control with no daily routine.

Other Videos

See for YourselfSee for Yourself

Effective birth control that lasts for as
long as Kim wants, for up to 5 years.

Important Safety Information | Full Prescribing Information

A Mother’s Thoughts

A mother considers her reasons
for choosing Mirena.

Other Videos

Kim’s StoryKim’s Story

Kim wanted birth control
with no daily routine.

Sign Up to Learn More

Get more information about Mirena by signing up for helpful e-mails.

Enroll today

Safety Considerations

Keep this in mind:

Mirena is not appropriate for everyone

Share your health history with your healthcare provider before placement

There are some serious but uncommon side effects associated with Mirena

Review possible common side effects of Mirena after placement

Although uncommon, pregnancy while using Mirena can be life threatening and may result in loss of pregnancy or fertility

For more safety information you should know about Mirena, continue reading below

Safety considerations and side effects of Mirena Only you and your healthcare provider can decide if Mirena (levonorgestrel-releasing intrauterine system) 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:

Might be pregnant

Have had a serious pelvic infection called pelvic inflammatory disease (PID), unless you have had a normal pregnancy after the infection went away

Have an untreated pelvic infection now

Have had a serious pelvic infection in the past 3 months after a pregnancy

Can get infections easily. For example, if you have

More than one sexual partner or your partner has more than one partner

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 now or in the past or suspect you have breast cancer

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 or polyethylene

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 diabetes (high blood sugar)

Use corticosteroid medications on a long-term basis

Have severe migraine headaches

Some serious but uncommon side effects of Mirena include:

Pelvic inflammatory disease (PID) Use of Mirena (levonorgestrel-releasing intrauterine system) and other IUDs has been associated with an increased risk of PID. The percentage of women who develop PID while using Mirena is less than 1%. The risk is highest shortly after placement—especially within the first 20 days—and if you have a vaginal infection at the time of placement. After the first 20 days, the risk of PID is reduced.

PID is an infection of the uterus and other organs of the upper reproductive system. It is caused by bacterial infections that are usually sexually transmitted, such as gonorrhea or chlamydia, that travel beyond the vagina and cervix into the uterus and other organs in the reproductive system. The risk of PID is greater if you or your partner have sex with multiple partners. If not treated quickly and appropriately, PID can lead to serious problems, including infertility, ectopic pregnancy or constant pelvic pain. 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.¹

Before placement of Mirena, be sure to tell your healthcare provider if you have signs of a vaginal infection or PID. Signs of PID include long-lasting or heavy bleeding, unusual vaginal discharge, abdominal or pelvic pain or tenderness, or painful sex, chills or fever.

After placement, contact your healthcare provider if any of these symptoms listed above occur and persist.

A rare life-threatening infection like sepsis may occur within the first few days after Mirena is placed. As of September 2006, 9 sepsis cases out of an estimated 9.9 million Mirena users had been reported. Call your healthcare provider immediately if you experience severe pain or unexplained fever after Mirena is placed.

Embedment is when Mirena attaches to the uterine wall. If embedment occurs, Mirena may no longer prevent pregnancy and you may need surgery to have it removed.

Perforation. Mirena may go through (perforate) the uterine wall. If your uterus is perforated. Mirena may no longer prevent pregnancy. It may move outside the uterus and can cause scarring, infection or damage to other organs. Surgery may be needed to have Mirena removed. The risk of perforation is increased in breastfeeding women.

Reference:

1. Pelvic inflammatory disease–CDC fact sheet. Centers for Disease Control and Prevention Web site. http://cdc.gov/STD/PID/stdfact-pid.htm. Accessed May 13, 2011.

Possible common side effects of Mirena include:

Discomfort during placement. Dizziness, bleeding or cramping may occur during placement. This is common. Let your healthcare provider know if the cramping is severe.

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 notice Mirena has come out, use a back-up form of birth control like condoms and call your healthcare provider.

More than 10% of Mirena users may experience:

Missed menstrual periods. About 2 out of 10 women stop having periods after 1 year of Mirena (levonorgestrel-releasing intrauterine system) use. Your periods come back when 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. Your period may become irregular and you may have bleeding and spotting between menstrual periods, especially during the first 3 to 6 months. A few women have heavy bleeding during this time. After your body adjusts, periods usually get lighter and the number of bleeding days is likely to decrease, but may remain irregular. Or you may even find that your periods stop altogether. In which case, you should contact your healthcare provider to rule out pregnancy.
Call your healthcare provider if the bleeding remains heavier than usual or if the bleeding becomes heavy after it has been light for a while.

Pelvic and/or abdominal pain may occur. Talk to your healthcare provider if the pain is persistent.

Cyst on the ovary. These cysts may develop as long Mirena is in place. They are generally harmless and usually disappear in a month or two. However, cysts can cause pain and may sometimes require surgery.

Between 5% and 10% of Mirena users may experience:

Headache/Migraine

Acne

Depressed mood

Heavy or prolonged menstrual bleeding.

Less than 5% of Mirena users may experience:

Vaginal discharge

Breast pain or tenderness

Nausea

Nervousness

Inflammation of cervix, vulva or vagina

Pelvic pain during your period

Back pain

Weight increase

Decreased sex drive

Pain during intercourse

Anemia

Unusual hair growth or loss

Skin irritations (such as hives, rash, eczema or itching)

Feeling bloated

Swelling of hands and feet

Expulsion

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 (levonorgestrel-releasing intrauterine system) 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.

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 using Mirena is called ectopic pregnancy, when the pregnancy is not in the uterus. It may occur in the fallopian tubes. Signs of ectopic pregnancy may include unusual bleeding or abdominal pain. Ectopic pregnancy is an emergency that requires immediate medical attention and often surgery. Ectopic pregnancy can cause internal bleeding, infertility and even death. 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.