Norplant System Side Effects
Generic name: levonorgestrel
Medically reviewed by Drugs.com. Last updated on Jan 4, 2025.
Note: This document provides detailed information about Norplant System Side Effects associated with levonorgestrel. Some dosage forms listed on this page may not apply specifically to the brand name Norplant System.
Applies to levonorgestrel: oral tablet.
Other dosage forms:
Serious side effects of Norplant System
Along with its needed effects, levonorgestrel (the active ingredient contained in Norplant System) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking levonorgestrel:
More common side effects
- heavy or light menstrual bleeding
Incidence not known
- absent missed or irregular menstrual periods
- cramps
- irregular menstruation
- pain
- pain in the pelvis
- stopping of menstrual bleeding
Other side effects of Norplant System
Some side effects of levonorgestrel may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- abdominal or stomach pain
- dizziness
- headache
- nausea
- tenderness of the breasts
- unusual tiredness or weakness
- vomiting
Less common side effects
- diarrhea
Precautions
It is very important that your doctor check you closely to make sure this medicine is working properly and does not cause unwanted effects.
Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. Your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Call your doctor right away if you have severe lower abdominal or stomach pain 3 to 5 weeks after taking this medicine. You may have a pregnancy outside of the uterus (womb), which is called an ectopic pregnancy. An ectopic pregnancy can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.
You may have some blood spotting a few days after taking this medicine. If the bleeding continues for more than 1 week, check with your doctor right away.
This medicine may make your next monthly period later than expected by a few days. If your next period after taking this medicine is more than 1 week late, check with your doctor right away for a pregnancy test.
This medicine will not protect you from getting HIV/AIDS or other sexually transmitted infections. If this is a concern for you, talk with your doctor.
Your regular birth control method such as birth control pills or patch may not work as well while you are using this medicine. After using this medicine, you must use two forms of birth control. Use birth control pills or patch together with another form of birth control, such as a condom, diaphragm, or contraceptive foam or jelly, during any other times that you have sex in the same monthly period you used this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
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]
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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
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More about Norplant System (levonorgestrel)
- Check interactions
- Compare alternatives
- Reviews (1)
- Latest FDA alerts (2)
- Dosage information
- During pregnancy
- Drug class: contraceptives
Patient resources
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Professional resources
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Further information
Norplant System 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.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.