Plan B One-Step Side Effects
Generic Name: levonorgestrel
Note: This page contains side effects data for the generic drug levonorgestrel. It is possible that some of the dosage forms included below may not apply to the brand name Plan B One-Step.
For the Consumer
Applies to levonorgestrel: oral tablet
Other dosage forms:
As well as its needed effects, levonorgestrel (the active ingredient contained in Plan B One-Step) may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking levonorgestrel, check with your doctor immediately:More common:
- Heavy or light menstrual bleeding
- Absent missed or irregular menstrual periods
- irregular menstruation
- pain in the pelvis
- stopping of menstrual bleeding
Some levonorgestrel side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them: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. Plan B (levonorgestrel)." Women's Capital Corporation, Bellevue, WA.
3. "Product Information. Mirena (levonorgestrel)." Berlex Laboratories, Richmond, CA.
4. Cerner Multum, Inc. "Australian Product Information." O 0
5. "Product Information. Skyla (levonorgestrel)." Bayer Pharmaceutical Inc, West Haven, CT.
6. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
It is possible that some side effects of Plan B One-Step may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
More about Plan B One-Step (levonorgestrel)
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