Skyla

Last updated on RxList: 5/21/2021
Skyla Side Effects Center

What Is Skyla?

Skyla (levonorgestrel-releasing intrauterine system) is an intrauterine device (IUD) that contains the female hormone progestin, and is a contraceptive used to prevent pregnancy for up to 3 years.

What Are Side Effects of Skyla?

Common side effects of Skyla include:

  • pain,
  • bleeding,
  • dizziness,
  • inflammation or itching of the vulva or vagina,
  • abdominal or pelvic pain,
  • irregular menstrual periods,
  • changes in menstrual periods,
  • acne,
  • dry skin,
  • ovarian cysts,
  • nausea,
  • vomiting,
  • bloating,
  • weight gain,
  • depression,
  • mood changes,
  • headache (including migraine),
  • changes in hair growth,
  • hair loss,
  • loss of interest in sex,
  • breast tenderness/pain/discomfort,
  • vaginal discharge,
  • genital infection,
  • back pain, and
  • hypersensitivity reactions (rash, hives, skin swelling).

Skyla may come out by itself and you may become pregnant if this happens. Contact your doctor if you think this occurs, and use backup birth control.

Dosage for Skyla

Skyla is available as one sterile intrauterine system with a 13.5 mg levonorgestrel dose. Skyla must be removed or replaced after 3 years.

What Drugs, Substances, or Supplements Interact with Skyla?

Other drugs may interact with Skyla. Tell your doctor all medications you use. Patients should avoid grapefruit juice while using Skyla. Women who have a current pelvic infection, get infections easily, or have certain cancers should not use Skyla.

Skyla During Pregnancy or Breastfeeding

Pregnancy while using Skyla is uncommon but can be life threatening and may result in loss of pregnancy or fertility. Progestins, hormones found in Skyla, do pass into breast milk. No side effects of Skyla have been found to affect breastfeeding or the health, growth, or development of infants.

Additional Information

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

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
Skyla Consumer Information

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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 (a pregnancy that implants in the fallopian tube instead of the uterus). A tubal pregnancy is a medical emergency.

The levonorgestrel 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, vaginal itching or infection, missed or irregular menstrual periods, changes in bleeding patterns or flow (especially during the first 3 to 6 months);
  • 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, 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.

Read the entire detailed patient monograph for Skyla (Levonorgestrel-Releasing Intrauterine System)

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Skyla Professional Information

SIDE EFFECTS

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

Clinical Trials 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 clinical practice.

The data described below reflect exposure to Skyla in 1,672 patients in two contraception studies, including 1,383 exposed for one year and 993 who completed the three year studies. The population was generally healthy, 18 to 40-year old females requesting contraception and predominately Caucasian (82.6%). The data cover more than 40,000 cycles of exposure. The frequencies of reported adverse drug reactions represent crude incidences.

Most common adverse reactions (occurring in ≥ 5% users) were increased bleeding (7.8%), vulvovaginitis (20.2%), abdominal/pelvic pain (18.9%), acne/seborrhea (15.0%), ovarian cyst (13.2%), headache (12.4%), dysmenorrhea (8.6%), breast pain/discomfort (8.6%) and nausea (5.5%).

In the contraception studies, 18% discontinued prematurely due to an adverse reaction. The most common adverse reactions leading to discontinuation (in >1% of users) were uterine bleeding complaints (4.6%), device expulsion (3.2%), acne/seborrhea (2.9%), abdominal pain (2.5%) dysmenorrhea/uterine spasms (2.0%) and pelvic pain (1.8%).

Other common adverse reactions (occurring in ≥1% users) by System Organ Class (SOC): The frequencies of adverse reactions observed in clinical trials are summarized in Table 3 by SOC (presented as crude incidences).

Table 3: Adverse reactions that occurred in at least 1% of Skyla users in clinical trials by SOC

System Organ Class Adverse Reaction Incidence (%) (N=1,672)
Reproductive System and Breast Disorders Vulvovaginitis 20.2
Ovarian cysta 13.2
Dysmenorrhea 8.6
Increased bleeding b 7.8
Breast pain/discomfort 5.3/3.3
Genital discharge 4.2
Device expulsion (complete and partial) 3.2
Upper genital tract infection 1.4
Gastrointestinal Disorders Abdominal pain/pelvic pain 12.7/6.2
Nausea 5.5
Skin and Subcutaneous Tissue Disorders Acne/Seborrhea 13.6/1.4
Alopecia 1.2
Nervous System Disorders Headache 12.4
Migraine 2.3
Psychiatric Disorders Depression/Depressed mood 3.8/0.5
a Ovarian cysts were reported as adverse events if they were abnormal, non-functional cysts and/or had a diameter >3 cm on ultrasound examination
b Not all bleeding alterations were captured as adverse reactions [see WARNINGS AND PRECAUTIONS].

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 embolism, deep vein thrombosis and stroke
  • Device breakage
  • Hypersensitivity (including rash, urticaria, and angioedema)
  • Increased blood pressure

Read the entire FDA prescribing information for Skyla (Levonorgestrel-Releasing Intrauterine System)

© Skyla Patient Information is supplied by Cerner Multum, Inc. and Skyla Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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