Medical Editor: John P. Cunha, DO, FACOEP
- vaginal and vulvovaginal infections,
- headache or migraine,
- difficult or painful sexual intercourse,
- abdominal discomfort or pain,
- breast tenderness or pain,
- pelvic pain or discomfort,
- mood changes,
- expulsion of the device,
- vaginal bleeding, and
- uterine spasm.
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. Liletta may interact with other drugs. Tell your doctor all medications and supplements you use. 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.
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.
The following serious or otherwise 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 16- to 45-year-old women to LILETTA in a large, multi-center contraceptive trial conducted in the US, including 1,412 exposed for 1 year and 383 subjects who completed 3 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 women who received LILETTA were Caucasian (78.4%) or Black/African American (13.3%); 14.7% of women were of Hispanic ethnicity. The clinical trial had no upper or lower weight or BMI limit. Mean BMI of LILETTA subjects was 26.9 kg/m² (range 15.8 – 61.6 kg/m²); 25.1% had a BMI ≥ 30 kg/m², and 5.3% had a BMI ≥ 40 kg/m². The data cover more than 22,000 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% users) are shown in Table 3.
Table 3: Adverse Reactions in ≥ 5% of
LILETTA Users in Phase 3 Clinical Study
|System Organ Class/
|% LILETTA Subjects
(N = 1,751)
|Headache or migraine||9.8%|
|Nausea or vomiting||7.9%|
|Abdominal discomfort or pain||6.8%|
|Breast tenderness or pain||6.7%|
|Pelvic discomfort or pain||6.1%|
|Depression or depressed mood||5.4%|
In the contraceptive trial, 12.3% of LILETTA users discontinued prematurely due to an adverse reaction. The most common adverse reaction leading to discontinuation was expulsion (3.5%), bleeding complaints (a total of 1.5%). The next most common adverse reactions causing discontinuation were acne (1.3%), mood swings (1.3%), dysmenorrhea (0.6%), and uterine spasm (0.6%). Two women discontinued the clinical study due to PID and one due to endometritis.
In the clinical trial, serious adverse reactions included: suicidality and exacerbations of depression and bipolar disorder, ectopic pregnancy, ovarian cysts, and IUS perforation requiring a laparoscopic surgery.
The following adverse reactions have been identified during post-approval use of other 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.
Read the entire FDA prescribing information for Liletta (Levonorgestrel-releasing Intrauterine System)