Liletta Side Effects Center

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Medical Editor: John P. Cunha, DO, FACOEP

What Is Liletta?

Liletta (levonorgestrel-releasing intrauterine system) is an intrauterine device (IUD) used to prevent pregnancy for up to 3 years.

What Are Side Effects of Liletta?

Liletta may cause serious side effects including:

perforation,
partial or complete expulsion,
irregular bowel movements,
irregular or missed menstrual periods,
pregnancy,
shoulder pain,
nausea,
bloating,
vomiting,
vaginal bleeding,
cramping,
pain in your lower abdomen,
fever,
unusual smell and vaginal discharge,
pain or bleeding during sexual intercourse,
burning sensation when urination

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Liletta include:

vaginal and vulvovaginal infections,
acne,
headache or migraine,
nausea,
vomiting,
difficult or painful sexual intercourse,
abdominal discomfort or pain,
breast tenderness or pain,
pelvic pain or discomfort,
depression,
mood changes,
expulsion of the device,
vaginal bleeding, and
uterine spasm.

Seek medical care or call 911 at once if you have the following serious side effects:

Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Liletta

The dose of Liletta is one intrauterine system consisting of a T-shaped polyethylene frame with a drug reservoir containing 52mg LNG, packaged within a sterile inserter.

What Drugs, Substances, or Supplements Interact with Liletta?

Liletta may interact with other drugs. Tell your doctor all medications and supplements you use.

Liletta During Pregnancy or Breastfeeding

Liletta is not intended for use during pregnancy. Tell your doctor if you become pregnant while using Liletta as the device may need to be removed; leaving it in place may increase the risk of spontaneous abortion or preterm labor. You may use Liletta when you are breastfeeding if more than 6 weeks have passed since you had your baby. Consult your doctor before breastfeeding.

Additional Information

Our Liletta (levonorgestrel-releasing intrauterine system) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Choosing Your Birth Control Method See Slideshow

Liletta Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy.

The IUD may become embedded into the wall of the uterus, or may perforate (form a hole) in the uterus. If this occurs, the device may no longer prevent pregnancy, or it may move outside the uterus and cause scarring, infection, or damage to other organs. Your doctor may need to surgically remove the device.

Call your doctor at once if you have:

severe cramps or pelvic pain, pain during sexual intercourse;
extreme dizziness or light-headed feeling;
severe migraine headache;
heavy or ongoing vaginal bleeding, vaginal sores, vaginal discharge that is watery, foul-smelling discharge, or otherwise unusual;
pale skin, weakness, easy bruising or bleeding, fever, chills, or other signs of infection;
jaundice (yellowing of the skin or eyes); or
sudden numbness or weakness (especially on one side of the body), confusion, problems with vision, sensitivity to light.

Common side effects may include:

pelvic pain, painful or irregular menstrual periods, changes in bleeding patterns or flow;
vaginal swelling, itching or infection;
temporary pain, bleeding, or dizziness during insertion of the IUD;
ovarian cysts (pelvic pain that disappears within 3 months);
stomach pain, nausea, vomiting, bloating;
headache, migraine, depression, mood changes;
back pain, breast tenderness or pain;
weight gain, acne, oily skin, changes in hair growth, loss of interest in sex; or
puffiness in your face, hands, ankles, or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Which of the following are methods for contraception? See Answer

Liletta Professional Information

SIDE EFFECTS

The following serious or important adverse reactions are discussed elsewhere in the labeling:

Ectopic Pregnancy [see WARNINGS AND PRECAUTIONS]
Intrauterine Pregnancy [see WARNINGS AND PRECAUTIONS]
Group A Streptococcal Sepsis (GAS) [see WARNINGS AND PRECAUTIONS]
Pelvic Inflammatory Disease or Endometritis [see WARNINGS AND PRECAUTIONS]
Perforation [see WARNINGS AND PRECAUTIONS]
Expulsion [see WARNINGS AND PRECAUTIONS]
Ovarian Cysts [see WARNINGS AND PRECAUTIONS]
Bleeding Pattern Alterations [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure of 1,751 generally healthy participants, 16 to 45 years of age, to LILETTA in a large, multi-center contraceptive trial conducted in the US. Participants included 1,401 exposed for 1 year and 380 who completed 8 years of use; 58% were nulliparous (mean age 25.1 ± 4.3 years) and 42% were parous (mean age 30.3 ± 6.1 years). Most participants who received LILETTA were Caucasian (78.4%) or Black/African American (13.3%); 14.7% of participants were of Hispanic ethnicity. Mean BMI of LILETTA participants was 26.9 kg/m² (range 15.8 - 61.6 kg/m²); 25.1% had a BMI ≥ 30 kg/m² of which 5.3% had a BMI ≥ 40 kg/m². The data cover more than 80,221 28-day cycles of LILETTA exposure. The frequencies of reported adverse drug reactions represent crude incidences.

The most common adverse reactions during the LILETTA clinical trial (occurring in ≥ 5% of users) are shown in Table 4Table . The most common adverse reactions during the first year of use were acne (11.4%), bacterial vaginitis (9.0%), and vulvovaginal mycotic infection (7.9%).

Table 4: Adverse Reactions in ≥ 5% of LILETTA Users in the Phase 3 Clinical Trial

Adverse Reaction	% LILETTA Participants (N = 1,751)
Vulvovaginal mycotic infections	20.2%
Vaginal bacterial infections	19.2%
Acne	15.5%
Nausea or vomiting	10.5%
Headache	10.1%
Breast tenderness or pain	10.1%
Abdominal discomfort or pain	10.0%
Dyspareunia	9.6%
Anxiety	9.6%
Depression	9.1%
Pelvic discomfort or pain	8.7%
Dysmenorrhea	7.3%
Mood changes	6.5%
Back pain	6.5%
Weight increased	6.1%
Vaginal discharge	5.8%

In the clinical trial, 20.1% of LILETTA users discontinued prematurely due to an adverse reaction. The most common adverse reactions reported by participants as reason for discontinuation were expulsion (4.1%), bleeding complaints (2.5%), acne (1.4%), dysmenorrhea (1.0%), weight increased (1.0%), mood swings (0.8%), uterine spasm (0.7%), dyspareunia (0.6%) and pelvic pain (0.6%). Two participants discontinued the clinical trial due to PID and one due to endometritis. The most common adverse reactions reported by participants as reason for discontinuation during the first year of use were expulsion (2.9%) and acne (0.7%).

In the clinical trial, serious adverse reactions related to LILETTA were ectopic pregnancies, ovarian cysts, and IUS perforation requiring laparoscopic surgery.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of LNG-releasing IUSs. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli, deep vein thrombosis, and stroke
Hypersensitivity (including rash, urticaria, and angioedema)
Increased blood pressure
Dizziness
Device breakage

DRUG INTERACTIONS

No drug-drug interaction studies have been conducted with LILETTA.

Read the entire FDA prescribing information for Liletta (Levonorgestrel-releasing Intrauterine System)