Kyleena Side Effects
Generic Name: levonorgestrel
Note: This page contains information about the side effects of levonorgestrel. Some of the dosage forms included on this document may not apply to the brand name Kyleena.
For the Consumer
Applies to levonorgestrel: oral tablet
Other dosage forms:
In addition to its needed effects, some unwanted effects may be caused by levonorgestrel (the active ingredient contained in Kyleena). In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking levonorgestrel:More common:
- Heavy or light menstrual bleeding
- Absent missed or irregular menstrual periods
- irregular menstruation
- pain in the pelvis
- stopping of menstrual bleeding
Minor Side Effects
Some of the side effects that can occur with levonorgestrel may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common:
- Abdominal or stomach pain
- tenderness of the breasts
- unusual tiredness or weakness
For Healthcare Professionals
Applies to levonorgestrel: intrauterine device, oral tablet, subcutaneous implant
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]
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]
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]
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]
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]
Common (1% to 10%): Depression/depressed mood, mood changes, mood swings, decreased libido, nervousness
Frequency not reported: Changes in libido[Ref]
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]
Postmarketing reports: Increased blood pressure, arterial/venous thrombotic events, pulmonary emboli, deep vein thrombosis, stroke[Ref]
Common (1% to 10%): Back pain[Ref]
Frequency not reported: Benign/malignant liver tumors
Postmarketing reports: Breast cancer[Ref]
Frequency not reported: Contact lens intolerance[Ref]
Frequency not reported: Diabetes mellitus[Ref]
Frequency not reported: Allergic reaction
Postmarketing reports: Hypersensitivity reactions[Ref]
1. "Product Information. Liletta (levonorgestrel)." Actavis Pharma, Inc., Parsippany, NJ.
2. "Product Information. Mirena (levonorgestrel)." Berlex Laboratories, Richmond, CA.
3. "Product Information. Skyla (levonorgestrel)." Bayer Pharmaceutical Inc, West Haven, CT.
4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
5. "Product Information. Plan B (levonorgestrel)." Women's Capital Corporation, Bellevue, WA.
6. Cerner Multum, Inc. "Australian Product Information." O 0
Not all side effects for Kyleena may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
More about Kyleena (levonorgestrel)
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