Kyleena (levonorgestrel) is a brand-name intrauterine device (IUD) that’s prescribed to help prevent pregnancy. It’s a form of birth control. As with other drugs, Kyleena can cause side effects, such as headache.

Kyleena comes as an IUD, a small flexible device that your doctor inserts into your uterus. Kyleena’s active drug, levonorgestrel, belongs to a drug class called progestins. The drug isn’t available in a generic version.

Read on to learn about potential common, mild, and serious side effects of Kyleena. For a general overview of the drug, including details about its uses, see this article.

Kyleena can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Kyleena in clinical trials:

Mild side effects can occur with Kyleena use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Kyleena’s prescribing information.

Mild side effects that have been reported with Kyleena include:

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Kyleena and want to tell the FDA about it, visit MedWatch.

* Dizziness can occur during Kyleena placement and for about 30 minutes afterward. To learn how Kyleena is placed, refer to this article.
† For more information about this side effect, see “Side effect specifics” below.

Kyleena may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Kyleena’s prescribing information.

If you develop serious side effects while taking Kyleena, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

* For more information about this side effect, see “Side effect specifics” below.
† An allergic reaction is possible after using Kyleena. However, it’s not clear whether this side effect occurred in clinical trials. To learn more, see the “Side effect specifics” section below.

Kyleena may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Are there side effect reviews for Kyleena?

It’s not clear whether there are side effect reviews for Kyleena. However, the manufacturer’s website presents stories by people who have used Kyleena.

If you’d like to know more about side effect reviews for Kyleena, talk with your doctor. They may be able to share information about Kyleena side effects that they have seen in their practice.

Can Kyleena cause long-term side effects, including side effects after 1 year or 3 years?

Based on clinical trials, Kyleena may cause mild but long-term side effects, such as changes in your period.*

In the first 6 months of use, changes in your period can include irregular bleeding, frequent bleeding, and bleeding longer than usual. These side effects often ease after using Kyleena for 1 year. They may ease further after 3 years of use.

However, after 1 year, you may bleed less often or not at all (amenorrhea). These changes in your period may persist or occur more regularly after 3 years. Any side effects related to changes in your periods are likely to stop after you stop using Kyleena.

If you’re concerned about long-term side effects with Kyleena, talk with your doctor about them. They’ll help determine whether Kyleena is right for you.

* To learn more about this side effect, see the “Side effect specifics” section below.

Is weight gain a side effect of Kyleena?

No, weight gain isn’t an expected side effect of Kyleena. Weight changes, including weight gain, weren’t reported by people in clinical trials.

However, Kyleena is a form of hormonal birth control. And weight gain has been reported with some other hormonal birth control drugs. (Kyleena contains levonorgestrel, which is a type of hormone called a progestin.)

If you’d like to learn more about weight gain and Kyleena, talk with your doctor. If you experience weight gain while using Kyleena, your doctor can help determine the cause.

Learn more about some of the side effects that Kyleena may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Kyleena.

Changes in periods

Some people reported changes in their periods in clinical trials of Kyleena. Some common changes include having:

In the first 6 months of using Kyleena, irregular periods, heavy periods, or spotting between periods is more likely. With longer Kyleena use, these changes in your period tend to decrease, but your period can still be irregular. After 1 year of using Kyleena, you may stop having a period. In clinical trials, some people stopped using Kyleena due to irregular periods or problems with their periods.

What you can do

If you’re concerned about changes in your periods, talk with your doctor about your options. If you stop having periods completely, be sure to tell your doctor. They’ll likely have you take a pregnancy test to determine whether you’re pregnant.

Ectopic pregnancy or intrauterine pregnancy

Ectopic pregnancy and intrauterine pregnancy rarely occurred in clinical trials of Kyleena. With an ectopic pregnancy, a fertilized egg implants outside the uterus.

Note that pregnancy can occur with Kyleena because no form of birth control is 100% effective. (The exception is abstinence, which is not having sexual intercourse.)

Symptoms of an ectopic pregnancy include:

With an intrauterine pregnancy, a fertilized egg implants inside the uterus, as it’s supposed to. However, if Kyleena is left in place during pregnancy, there’s a risk of pregnancy loss, sepsis, and preterm labor and delivery. Removing Kyleena during pregnancy also increases the risk of pregnancy loss.

What you can do

An ectopic pregnancy can be life threatening. If you have symptoms of an ectopic pregnancy, you should tell your doctor right away. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

If you become pregnant or think you are while using Kyleena, you should tell your doctor. They’ll likely order a pregnancy test. If you’re pregnant, your doctor can advise next steps, such as removing the device. For more information, see the “Pregnancy and breastfeeding with Kyleena” section below.

Expulsion

Expulsion was rare in clinical trials. With expulsion, Kyleena has moved out of place or has come out of your body. If this happens, Kyleena won’t be effective in helping prevent pregnancy.

In some cases, expulsion doesn’t cause symptoms and you may not know it happened. If symptoms occur, they typically include:

What you can do

If you notice an increase in the amount of blood with your period, tell your doctor. It could be a sign that Kyleena is no longer working because it isn’t inside your uterus. Your doctor will likely order imaging exams, such as ultrasound or X-ray, to determine whether Kyleena is in place. If you aren’t pregnant, your doctor may recommend inserting another Kyleena device.

Perforation

There were rare reports of perforation in clinical trials of Kyleena. A perforation is a hole or tear. This can happen if Kyleena gets stuck in the wall of the uterus or cervix. In some cases, Kyleena can go all the way through the wall.

Perforation may or may not cause symptoms. If symptoms occur, they can include pelvic pain or vaginal bleeding.

What you can do

If you have new or worsening pain or bleeding, tell your doctor. They’ll determine whether Kyleena is the cause of your symptoms. If you have a perforation, your doctor may recommend surgery to fix it.

Severe infection or sepsis

Severe infection leading to sepsis can occur after inserting Kyleena. This rarely occurred in clinical trials. Sepsis is a life threatening reaction to a serious infection.

Symptoms of sepsis can include:

What you can do

If you have symptoms of sepsis, seek immediate medical attention. Call 911 or your local emergency number.

Allergic reaction

As with most drugs and devices, Kyleena can cause an allergic reaction in some people. However, it’s not clear whether this side effect occurred in clinical trials. Kyleena is a small, flexible device known as an intrauterine device (IUD). It contains the active drug levonorgestrel. Either the drug or the device can cause an allergic reaction.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep using Kyleena. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Be sure to talk with your doctor about your health history before you take Kyleena. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:

Allergic reaction. If you’ve had an allergic reaction to Kyleena or any of its ingredients, your doctor will likely not prescribe it. Ask your doctor what other forms of birth control may be better options for you.

Blood clots, heart attack, or stroke. The active drug in Kyleena may increase the risk of blood clots, heart attack, or stroke. However, clinical trials haven’t confirmed this. To be safe, tell your doctor if you’ve ever had any of these conditions. They’ll help determine whether Kyleena is right for you.

Breast, cervical, or uterine cancer. The active drug in Kyleena could increase the growth of certain cancers that are sensitive to hormones. Due to this risk, you should not use Kyleena if you have or have ever had cancer of the breast, cervix, or uterus. (These cancers tend to be sensitive to hormones.)

Before using Kyleena, be sure to tell your doctor about any cancers you’ve had. They’ll advise whether Kyleena is right for you. They may also recommend another form of birth control.

Breastfeeding. The risk of perforation* with Kyleena insertion is higher in people who are breastfeeding. Perforation is a serious side effect of Kyleena. Due to this risk, be sure to tell your doctor if you’re breastfeeding or planning to do so. Your doctor may recommend waiting until you’re no longer breastfeeding to insert Kyleena. They’ll also determine the best time to insert Kyleena.

For more information, see the “Pregnancy and breastfeeding with Kyleena” section below.

High blood pressure. The active drug in Kyleena may increase the risk of high blood pressure. However, clinical trials haven’t confirmed this. If you have high blood pressure or develop it while using Kyleena, tell your doctor. They may suggest another form of birth control.

Immune system problems. If you have immune system problems, your risk of developing serious infections with Kyleena may increase. This includes severe infection or sepsis.*

Due to this risk, doctors typically won’t prescribe Kyleena to people with a condition that affects their immune system, such as leukemia. Be sure to talk with your doctor about your risk of infection before using Kyleena. They’ll help determine whether Kyleena is safe for you.

Liver disease or tumors. The active drug in Kyleena can cause liver damage in some people. Due to this risk, doctors don’t prescribe it to people who have liver disease or a liver tumor of any kind. Be sure to discuss your history of liver problems with your doctor before using Kyleena. They’ll help determine whether it’s the right birth control for you.

Pelvic, vaginal, or cervical infection. Infection of the pelvis, vagina, or cervix can increase the risk of developing another infection with Kyleena. Due to this risk, doctors typically won’t prescribe Kyleena if you have or have recently had any of these infections. Be sure to talk with your doctor about the risk of infection before using Kyleena. They’ll help determine whether it’s safe for you. They can also recommend another form of birth control.

Pregnancy. Kyleena is not meant to be used during pregnancy. For details about pregnancy and Kyleena, see the “Pregnancy and breastfeeding with Kyleena” section below.

Problems with the position or shape of the uterus. It can be more difficult for doctors to insert Kyleena into a uterus that has an unusual shape or position.† This can also increase the risk of expulsion* or perforation* with Kyleena.

Due to these risks, doctors don’t recommend Kyleena for people with conditions that may affect the shape or position of their uterus. An example is fibroids. So, tell your doctor if you’ve ever been told you have an unusually shaped uterus.

Recent birth, miscarriage, or abortion. The risk of expulsion or perforation is higher in people who’ve recently given birth or had pregnancy loss or abortion. Due to this risk, doctors typically suggest waiting 6 weeks after any of these events before inserting Kyleena.† In some cases, they may recommend waiting 3 months before insertion. Your doctor will determine the best time to insert Kyleena based on your specific circumstances.

Unexplained uterine bleeding. Your doctor won’t recommend Kyleena if you have uterine bleeding. Before using Kyleena, be sure to tell your doctor if you’re experiencing unusual or irregular bleeding. This may include irregular periods or vaginal bleeding between periods. Your doctor will help determine the cause and recommend treatment options. They can also advise using another form of birth control.

* To learn more about this side effect, see the “Side effect specifics” section above.
† Kyleena is a small, flexible device known as an intrauterine device (IUD). Your doctor or other healthcare professional inserts the IUD into your uterus. To learn more about how it’s placed, refer to this article.

Alcohol with Kyleena

There aren’t any known interactions between alcohol and Kyleena. However, alcohol can cause some of the same side effects as Kyleena, such as headache and nausea. So, consuming alcohol during Kyleena use could make these side effects worse.

If you drink alcohol and have concerns about side effects with Kyleena, talk with your doctor about it. They can help determine whether Kyleena is right for you. Depending on your situation, they can also suggest other forms of birth control without these side effects.

Pregnancy and breastfeeding with Kyleena

Below is information about pregnancy and breastfeeding while using Kyleena.

Pregnancy with Kyleena

Kyleena isn’t safe to use during pregnancy. It’s a form of birth control to help prevent pregnancy. So Kyleena is not meant for use during pregnancy. Your doctor will confirm that you aren’t pregnant before inserting Kyleena.

If you become pregnant while using Kyleena, tell your doctor right away. This is because keeping the IUD in place during pregnancy increases the risk of pregnancy loss and other serious problems.

If you become pregnant while using Kyleena, your doctor may try to remove the device. However, removing Kyleena may cause pregnancy loss. So, if your doctor can’t remove Kyleena, they’ll discuss the benefits and risks of continuing the pregnancy.

If you’d like more details about the possibility of pregnancy with Kyleena, talk with your doctor. You can also read this article.

Note: Pregnancy can occur with Kyleena because no form of birth control is 100% effective. (The exception is abstinence, which is not having sexual intercourse.)

Breastfeeding with Kyleena

During Kyleena use, it’s possible for a small amount of the active drug to pass into breast milk. However, clinical trials haven’t reported any negative effects in children who are breastfed. Keep in mind that breastfeeding at the time of Kyleena insertion increases the risk of perforation.*

Be sure to talk with your doctor if you’re breastfeeding or planning to do so. They’ll advise whether Kyleena is safe to use while you’re breastfeeding. They can also recommend other forms of birth control that may be safer for you.

* To learn more about this serious side effect, see the “Side effect specifics” section above.

Kyleena has some common side effects, most of which are mild and temporary. However, serious side effects are possible. If you’d like to learn more about Kyleena, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

  • More information about Kyleena. For details about other aspects of Kyleena, refer to this article.
  • Drug comparison. To learn how Kyleena compares with Mirena and Liletta, read this article.
  • A look at birth control. For details about birth control, see our women’s health hub.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.