Kyleena Side Effects
Generic name: levonorgestrel
Medically reviewed by Drugs.com. Last updated on Oct 7, 2024.
Note: This document provides detailed information about Kyleena.
For healthcare professionals
Applies to levonorgestrel: intrauterine device, oral tablet, subcutaneous implant Side Effects associated with levonorgestrel. Some dosage forms listed on this page may not apply specifically to the brand name Kyleena.
For healthcare professionals
Applies to levonorgestrel: intrauterine device, oral tablet, subcutaneous implant.
General adverse events
The most commonly reported adverse effects are alterations of menstrual bleeding patterns, nausea, abdominal/pelvic pain, headache/migraine, dizziness, fatigue, amenorrhea, ovarian cysts, genital discharge, acne/seborrhea, breast tenderness, and vulvovaginitis.[Ref]
Genitourinary
- Very common (10% or more): Irregular menstrual bleeding (67%), infrequent menstrual bleeding (up to 57%), ovarian cyst (31.2%), menstrual changes (up to 31.9%), decreased uterine bleeding (23.4%), prolonged menstrual bleeding (22%), vulvovaginitis (20.2%), amenorrhea (18.4%), genital discharge (up to 14.9%), heavier menstrual bleeding (13.8%),vaginal infections (13.6%), vulvovaginal infections (13.3%), lighter menstrual bleeding (12.5%), increased scheduled uterine bleeding (11.9%), breast tenderness (10.7%)
- Common (1% to 10%): Dysmenorrhea, breast pain/discomfort, upper genital tract infection, genital tract bleeding, pelvic inflammatory disease, endometritis, dyspareunia, pelvic discomfort/pain, delay of menses more than 7 days, vaginal discharge, bleeding not related to menses
- Uncommon (0.1% to 1%): Uterine spasm, cervicitis/Papanicolaou smear normal class II, change in vaginal secretion
- Rare (less than 0.1%): Uterine perforation
- Frequency not reported: Breast enlargement, vaginal candidiasis, changes in cervical erosion, changes in cervical secretion, ectopic pregnancy
- Postmarketing reports: Oligomenorrhea, irregular menstruation[Ref]
Gastrointestinal
- Very common (10% or more): Nausea (up to 23.1%), abdominal/pelvic pain (up to 22.6%)
- Common (1% to 10%): Diarrhea, vomiting
- Uncommon (0.1% to 1%): Abdominal distension
- Frequency not reported: Bloating, abdominal cramps[Ref]
Other
- Very common (10% or more): Fatigue (16.9%)
- Common (1% to 10%): Partial/complete IUS expulsion, weight increased
- Uncommon (0.1% to 1%): Edema, change in body weight
- Very rare (less than 0.01%): Face edema
- Frequency not reported: Decreased weight, sepsis, group A streptococcal sepsis
- Postmarketing reports: IUS breakage, procedural bleeding[Ref]
Nervous system
- Very common (10% or more): Headache (up to 16.8%), dizziness (11.2%)
- Common (1% to 10%): Migraine
- Postmarketing reports: Stroke, syncope, IUS insertion related vasovagal reaction or seizure[Ref]
Psychiatric
- Common (1% to 10%): Depression/depressed mood, mood changes, mood swings, decreased libido, nervousness
- Frequency not reported: Changes in libido[Ref]
Dermatologic
- Very common (10% or more): Acne/seborrhea (15%)
- Common (1% to 10%): Alopecia, hirsutism
- Uncommon (0.1% to 1%): Pruritus, eczema, pigmentation changes/hyperpigmentation
- Rare (less than 0.1%): Rash, urticaria
- Frequency not reported: Chloasma, melasma
- Postmarketing reports: Angioedema[Ref]
Cardiovascular
- Postmarketing reports: Increased blood pressure, arterial/venous thrombotic events, pulmonary emboli, deep vein thrombosis, stroke[Ref]
Musculoskeletal
- Common (1% to 10%): Back pain[Ref]
Oncologic
- Frequency not reported: Benign/malignant liver tumors
- Postmarketing reports: Breast cancer[Ref]
Ocular
- Frequency not reported: Contact lens intolerance[Ref]
Metabolic
- Frequency not reported: Diabetes mellitus[Ref]
Hypersensitivity
- Frequency not reported: Allergic reaction
- Postmarketing reports: Hypersensitivity reactions[Ref]
References
1. (2003) "Product Information. Mirena (levonorgestrel)." Berlex Laboratories
2. (2003) "Product Information. Plan B (levonorgestrel)." Women's Capital Corporation
3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
4. Cerner Multum, Inc. "Australian Product Information."
5. (2013) "Product Information. Skyla (levonorgestrel)." Bayer Pharmaceutical Inc
6. (2016) "Product Information. Liletta (levonorgestrel)." Actavis Pharma, Inc.
7. (2018) "Product Information. Kyleena (levonorgestrel)." Bayer Pharmaceutical Inc
Frequently asked questions
- What are the side effects of IUDs?
- Can antibiotics affect IUDs like Kyleena, Mirena, or Skyla?
- Can Kyleena cause weight gain?
- Can Kyleena cause acne?
- Can Kyleena make your period stop?
- How long does it take for Kyleena to work?
- How long does Kyleena last?
- Mirena, Kyleena, Skyla & Liletta - What's the difference?
- After having a Kyleena insertion, how long do I have to wait to have intercourse?
More about Kyleena (levonorgestrel)
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Further information
Kyleena side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.