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Important Safety Information
If you have a pelvic or genital infection, get infections easily, or have certain cancers, don’t use Skyla. Less than 1% of users get a serious pelvic infection called pelvic inflammatory disease (PID). If you have persistent pelvic or stomach pain, or excessive bleeding after placement tell your healthcare provider (HCP). ...Continue reading below
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Safety considerations

Skyla® isn't right for everyone. Prior to placement, you should review your health history with your healthcare professional and be aware of some serious but uncommon side effects that are associated with Skyla. You should also be aware of the possible common side effects that may occur after placement. For more information, talk to your healthcare professional and read the information below.

Who should not use Skyla?

Do not use Skyla if you:
  • are or might be pregnant; Skyla cannot be used as an emergency contraceptive
  • have a serious pelvic infection called pelvic inflammatory disease (PID) or have had PID in the past unless you have had a normal pregnancy after the infection went away
  • have an untreated genital 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 multiple sexual partners or your partner has multiple sexual partners
    • have problems with your immune system
    • use or abuse intravenous drugs
  • 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, silver, silica, barium sulfate or iron oxide
 
Before having Skyla placed, tell your healthcare professional about all of your medical conditions including if you:
  • have any of the conditions listed above
  • 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 are breastfeeding
  • have severe headaches or migraine headaches
  • have AIDS, HIV, or any other sexually transmitted infection

Tell your healthcare professional about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.  

What if I become pregnant while using Skyla?

  • Call your healthcare professional right away if you think you may be pregnant. If possible, also do a urine pregnancy test. If you get pregnant while using Skyla, you may have an ectopic pregnancy. This means that the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain may be a sign of ectopic pregnancy.
  • Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility, and even death.
  • There are also risks if you get pregnant while using Skyla 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 professional may try to remove Skyla, even though removing it may cause a miscarriage. If Skyla cannot be removed, talk with your healthcare professional about the benefits and risks of continuing the pregnancy and possible effects of the hormone on your unborn baby. 
  • If you continue your pregnancy, see your healthcare professional regularly. Call your healthcare professional right away if you get flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge, or fluid leaking from your vagina. These may be signs of infection.

What are the possible side effects of Skyla?

Skyla can cause serious side effects, including:
  • Ectopic pregnancy and intrauterine pregnancy risks. There are risks if you become pregnant while using Skyla. Call your healthcare professional right away if you think you may be pregnant. If possible, also do a urine pregnancy test. If you get pregnant while using Skyla, you may have an ectopic pregnancy. This means that the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain may be a sign of ectopic pregnancy. Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility, and even death. There are also risks if you get pregnant while using Skyla 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 professional may try to remove Skyla, even though removing it may cause a miscarriage. If Skyla cannot be removed, talk with your healthcare professional about the benefits and risks of continuing the pregnancy and possible effects of the hormone on your unborn baby. If you continue your pregnancy, see your healthcare professional regularly. Call your healthcare professional right away if you get flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge, or fluid leaking from your vagina. These may be signs of infection.
  • Life-threatening infection. Life-threatening infection can occur within the first few days after Skyla is placed. Call your healthcare professional immediately if you develop severe pain or fever shortly after Skyla is placed.
  • 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 has 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 including removal of the uterus (hysterectomy). In rare cases, infections that start as PID can even cause death. Tell your healthcare professional 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, fever, genital lesions or sores. 
  • Perforation. Skyla may go into the wall of the uterus (become embedded) or go through the wall of the uterus. This is called perforation. If this occurs, Skyla may no longer prevent pregnancy. If perforation occurs, Skyla may move outside the uterus and can cause internal scarring, infection, or damage to other organs, and you may need surgery to have Skyla removed. Excessive pain or vaginal bleeding during placement of Skyla, pain or bleeding that gets worse after placement, or not being able to feel the threads may happen with perforation. The risk of perforation is increased if Skyla is inserted while you are breastfeeding, or if you have recently given birth.
  • Expulsion. Skyla may come out by itself. This is called expulsion. Expulsion occurs in about 3 out of 100 women. Excessive pain or vaginal bleeding during placement of Skyla, pain or bleeding that gets worse after placement, or not being able to feel the threads may happen with expulsion. You may become pregnant if Skyla comes out. If you think that Skyla has come out, avoid intercourse or use a non-hormonal backup birth control (such as condoms or spermicide) and call your healthcare professional. The risk of expulsion is increased with insertion right after delivery or second-trimester abortion.
Common side effects of Skyla include:
  • Pain, bleeding, or dizziness during and after placement. If these symptoms do not stop 30 minutes after placement, Skyla may not have been placed correctly. Your healthcare professional will examine you to see if Skyla needs to be removed or replaced.
  • Changes in bleeding. You may have bleeding and spotting between menstrual periods, especially during the first 3–6 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 professional if the bleeding remains heavier than usual or increases after it has been light for a while.
  • Missed menstrual periods. About 1 out of 16 women stop having periods after 1 year of Skyla use. If you have any concerns that you may be pregnant while using Skyla, do a urine pregnancy test and call your healthcare professional. If you do not have a period for 6 weeks during Skyla use, call your healthcare professional. When Skyla is removed, your menstrual periods should return.
  • Cysts on the ovary. About 14 out of 100 women using Skyla develop a cyst on the ovary. These cysts usually disappear on their own in two to three months. However, cysts can cause pain and sometimes cysts will need surgery.
Other common side effects include:
  • abdominal or pelvic pain
  • acne or greasy skin
  • headache or migraine
  • inflammation or infection of the outer part of your vagina (vulvovaginitis)
  • painful periods

These are not all the possible side effects with Skyla. For more information, ask your healthcare professional.  

Call your healthcare professional for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Bayer Healthcare Pharmaceuticals at 1-888-842-2937.  

After Skyla has been placed, when should I call my healthcare professional?

If Skyla is accidentally removed and you had vaginal intercourse within the preceding week, you may be at risk of pregnancy, and you should talk to a healthcare professional.

 

Call your healthcare professional if you have any concerns about Skyla. Be sure to call if you:
  • think you are pregnant
  • have pelvic pain, abdominal 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 infections (STIs)
  • are concerned that Skyla may have been expelled (came out)
  • cannot feel Skyla'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
  • become HIV positive, or your partner becomes HIV positive
  • have severe vaginal bleeding or bleeding that lasts a long time or concerns you

Indication for SKYLA

Skyla® (levonorgestrel-releasing intrauterine system) is a hormone-releasing IUD that prevents pregnancy for up to 3 years.

 

Important safety information

  • If you have a pelvic or genital infection, get infections easily, or have certain cancers, don’t use Skyla. Less than 1% of users get a serious pelvic infection called pelvic inflammatory disease (PID).
  • If you have persistent pelvic or stomach pain, or excessive bleeding after placement tell your healthcare provider (HCP). If Skyla comes out, call your HCP and avoid intercourse or use non-hormonal back-up birth control (such as condoms or spermicide). Skyla may go into or through the wall of the uterus and cause other problems.
  • Pregnancy while using Skyla is uncommon but can be life threatening and may result in loss of pregnancy or fertility.
  • Ovarian cysts may occur but usually disappear.
  • Bleeding and spotting may increase in the first 3 to 6 months and remain irregular. Periods over time usually become shorter, lighter, or may stop.

Skyla does not protect against HIV or STIs.

Only you and your HCP can decide if Skyla is right for you. Skyla is available by prescription only.

For important risk and use information about Skyla, please see the Full Prescribing Information.

 

You are encouraged to report side effects or quality complaints of products to the FDA.
by visiting www.fda.gov/medwatch, or calling 1-800-FDA-1088.
For Bayer products, you can report these directly to Bayer clicking here.

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Last updated on 9/2023