Levonorgestrel (Intrauterine)

Levonorgestrel-releasing intrauterine system is a device that contains the female hormone, levonorgestrel. It is placed in the uterus (womb) where it slowly releases the hormone to prevent pregnancy for up to 3 years for Skyla®, up to 5 years for Kyleena®, or up to 8 years for Liletta® and Mirena®. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm, and fertilization (pregnancy) is prevented.

Levonorgestrel-releasing intrauterine system is also used to treat heavy menstrual bleeding for up to 5 years in women who choose this device as their method for birth control.

This medicine is to be given only by or under the supervision of your doctor.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly and does not cause unwanted effects. These visits will usually be 4 to 6 weeks after insertion and then once a year, but some doctors may require them more often.

There is a small chance that you could get pregnant while using an IUD, just like with any birth control. If you become pregnant, your doctor may remove your IUD to reduce the risk of miscarriage or other problems.

Call your doctor right away if you think you have become pregnant while using this medicine. You may have a higher risk of an ectopic pregnancy (which occurs outside the womb) if you get pregnant while your IUD is in place. This can be a serious and life-threatening condition. It can also lead to issues that may make it harder for you to become pregnant in the future.

An IUD can slip partly or completely out of your uterus without you knowing. If this happens, you will not have protection against pregnancy or may face an increased risk for serious problems. This is more likely during the first year you have your IUD, but it can occur at any time. Regularly checking the string of your IUD can help you confirm if it is still in place.

You may experience some spotting and cramping during the first few weeks after the IUD is inserted. These symptoms should go away within a few months. Rarely, the IUD may create a hole in the wall of your uterus when inserted. If this occurs, consult your doctor right away.

Using Kyleena®, Liletta®, Mirena®, or Skyla® can raise your risk for severe infections, including sepsis. This is a rare and life-threatening condition that needs immediate medical attention. Discuss this risk with your doctor if you have concerns.

An IUD can increase your risk of developing a serious infection of the female organs, called pelvic inflammatory disease (PID) or endometritis (related to pregnancy), which can be serious or even life-threatening. This infection could lead to scarring of the female organs, making it difficult for you to become pregnant in the future, and can increase your risk of ectopic pregnancy.

Call your doctor right away if you have flu-like symptoms, fever, chills, cramps, pain, bleeding, or fluid leaking from your vagina. These may be signs of an infection.

This medicine may increase your risk of developing ovarian cysts or cancer of the breast, uterus, or cervix. It may also cause yellowing of the skin or the whites of the eyes (jaundice). Discuss these concerns with your doctor.

This medicine may also raise your risk of high blood pressure (hypertension), clotting issues, or serious heart and blood vessel problems including heart attack or stroke. Contact your doctor immediately if you experience dizziness, fainting spells, severe tiredness, chest pain, trouble breathing, sudden or severe headache, problems with vision, speech, or walking, or unusual bleeding, bruising, or weakness.

This device will not protect you from HIV/AIDS, herpes, or other sexually transmitted diseases. Inform your doctor if you or your partner starts having sexual intercourse with other people, or if you or your partner tests positive for a sexually transmitted disease. If this is a concern, consult your doctor.

It is important to inform your doctor that you are using this medicine before any medical procedure, such as magnetic resonance imaging or MRI.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

In deciding to use a medicine, you and your doctor will need to consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Research so far has not shown any specific problems in teenage females that would limit the effectiveness of levonorgestrel. This medicine can be used for birth control in teenage females but is not recommended before menstruation begins.

Geriatric

Studies on the effects of levonorgestrel in older adults have not been conducted. This medicine is not recommended for elderly women.

Breast Feeding

There are no adequate studies on the risk to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. If you are receiving this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are important but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or may adjust your other medications.

• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both are prescribed together, your doctor may adjust the dose or how often you take one or both.

• Amoxicillin
• Ampicillin
• Amprenavir
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Bosentan
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Griseofulvin
• Guar Gum
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Meropenem
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rufinamide
• Secobarbital
• St John's Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thioridazine
• Ticarcillin
• Tigecycline
• Tirzepatide
• Tizanidine
• Topiramate
• Ulipristal

Using this medicine with any of the following medicines may raise the risk of certain side effects, but it might be necessary to use both. If both are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Acitretin
• Amitriptyline
• Atazanavir
• Clomipramine
• Diazepam
• Doxepin
• Imipramine
• Lamotrigine
• Licorice
• Lorazepam
• Perampanel
• Selegiline
• Tacrine
• Temazepam
• Triazolam
• Troleandomycin
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines can also lead to interactions. The following interactions are significant but may not be all-inclusive.

Using this medicine with any of the following may increase the risk of certain side effects, but it may be unavoidable in some cases. If used together, your doctor may adjust the dose or frequency of this medicine, or provide special instructions regarding food, alcohol, or tobacco.

• Caffeine

Other Medical Problems

Other medical conditions may affect how you can use this medicine. Make sure to inform your doctor about any other medical issues, especially:

• Abnormal or unusual vaginal bleeding or
• Abnormally-shaped uterus or uterine fibroids or
• Breast cancer, known or suspected, or a history of or
• Cancer of the uterus or cervix, known or suspected or
• Genital tract infections (e.g., bacterial vaginosis, cervicitis, endometritis, vaginitis), acute and untreated or
• Infection (e.g., leukemia, pneumonia, HIV/AIDS) or
• IUD that has not been removed, previous or
• Liver disease, including tumors or cancer or
• Pelvic infection (active or untreated), history of or
• Pelvic inflammatory disease (a serious pelvic infection) or endometritis, or history of—Should not be used in patients with these conditions.

• Bleeding problems or
• Blood clots or
• Bradycardia (slow heartbeat) or
• Diabetes or
• Fainting, history of or
• Heart attack, history of or
• Heart disease or other heart problems (e.g., congenital heart disease, heart valve problems) or
• Hypertension (high blood pressure), severe or
• Migraine headaches, severe or
• Ovarian cysts or
• Seizures or
• Stroke, history of—Use with caution. May make these conditions worse.

• Ectopic pregnancy (pregnancy outside the uterus), history of or
• Pelvic infection or
• Tubal surgery, history of—May increase the risk of having ectopic pregnancy.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Absent, missed, or irregular menstrual periods
• longer or heavier menstrual periods
• mild bloating
• stomach or pelvic pain or spasm
• stopping of menstrual bleeding
• unusually heavy or unexpected menstrual bleeding
• uterine bleeding between menstrual periods
• vaginal bleeding or spotting

Less common

• Blurred vision
• cramps
• dizziness
• headache
• heavy bleeding
• itching of the vagina or genital area
• nervousness
• pain
• pain during sexual intercourse
• pale skin
• pounding in the ears
• slow or fast heartbeat
• swelling
• thick, white vaginal discharge with mild or no odor
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• white or brownish vaginal discharge

Rare

• Chills
• confusion
• dizziness, lightheadedness, fainting
• fast heartbeat
• fast, weak pulse
• fever
• pale, cold, clammy skin
• rapid, shallow breathing
• sudden increase in stomach or shoulder pain
• sweating
• unusual or large amount of vaginal bleeding

Incidence not known

• Clear or bloody discharge from the nipple
• dimpling of the breast skin
• dull or aching stomach pain
• foul-smelling vaginal discharge
• increased blood pressure
• increased urge to urinate
• inverted nipple
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lump in the breast or under the arm
• pain during urination
• persistent crusting or scaling of the nipple
• redness or swelling of the breast
• severe stomach pain or cramping
• sharp pain on insertion
• shivering fever
• sores on the skin of the breast that does not heal

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Blemishes on the skin
• breast pain or discomfort
• dandruff
• depression
• nausea or vomiting
• oily skin
• pimples

Less common

• Back pain
• breast tenderness
• decreased interest in sexual intercourse
• full or bloated feeling
• hair loss
• hives or welts, itching, or rash
• increased hair growth, especially on the face
• increased weight
• loss in sexual ability, desire, drive, or performance
• pressure in the stomach
• redness of the skin
• skin rash, encrusted, scaly, and oozing
• swelling of the stomach area
• thinning of the hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Kyleena
• Liletta
• Mirena
• Skyla

Available Dosage Forms:

• Insert, Extended Release

Therapeutic Class: Contraceptive, Local

Pharmacologic Class: Progestin

Your doctor will give you this medicine in a hospital or clinic. This intrauterine device (IUD) is inserted into your uterus.

This medicine comes with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Your doctor may want to do tests to make sure you do not have an infection before putting in an IUD. The IUD is usually inserted during your monthly period, immediately after a miscarriage or an abortion in the first trimester of your pregnancy, at least 4 to 6 weeks after a miscarriage or an abortion in the second trimester of your pregnancy, or at least 4 to 6 weeks after giving birth. Putting an IUD in during a monthly period also helps to make sure that you are not pregnant. You will also need to see your doctor within 4 to 6 weeks of having your IUD inserted and then once a year. Use another form of birth control or refrain from having sex if the IUD is not inserted during the first 7 days of your menstrual cycle.

Levonorgestrel IUD has a string or "tail" which is made of plastic thread. About one or two inches of this string hangs into your vagina. You cannot see this string, and it will not cause problems when you have sex. Check your IUD string every few days during the first few months that you have your IUD. After that, check the string after each monthly period. You may not be protected against pregnancy if you cannot feel the string or if you feel the plastic. Do the following to check the placement of your IUD:

• Wash your hands with soap and warm water. Dry them with a clean towel.
• Bend your knees and squat low to the ground.
• Gently put your index (pointing) finger high inside your vagina. The cervix is at the top of the vagina and feels like the tip of your nose. Find the IUD string coming from your cervix. Never pull on the string. You should not be able to feel the firm plastic of the IUD itself.
• Wash your hands after you are finished checking your IUD.

If you are using levonorgestrel-releasing IUD to prevent pregnancy, you will need to have your device replaced every 3 years for Skyla®, 5 years for Kyleena®, or 8 years for Liletta® and Mirena®, or sooner if it comes out of your uterus unexpectedly.

If you are using Liletta® or Mirena® treat heavy menstrual bleeding, you will need to have it replaced every 5 years, or sooner if it comes out of your uterus unexpectedly.

If you are using Kyleena®, Liletta®, Mirena®, or Skyla®, and want to stop, your doctor can remove it at any time. However, you may become pregnant as soon as Kyleena®, Liletta®, Mirena®, or Skyla® is removed, or if you have intercourse the week before Liletta® is removed. Use another form of birth control (eg, condoms, spermicides) or have a new IUD inserted at the same day of removal to keep from getting pregnant.

• Can Plan B make your period late or cause bleeding?
• Can you drink alcohol after taking Plan B?
• How many times can you take Plan B?
• What's the weight limit for Plan B?
• What are my birth control options and how effective are they?
• Mirena, Kyleena, Skyla & Liletta - What's the difference?

View more FAQ