November 28, 2015
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"Today, the U.S. Food and Drug Administration announced it has approved the use of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential. This action complies with the April 5, 2013 order of the Uni"...


Norplant Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 10/05/2015

Norplant System (levonorgestrel) Implants is a hormonal contraceptive used to prevent pregnancy. Common side effects of Norplant include headache, nervousness, anxiety, nausea, vomiting, dizziness, rash, acne, changes in appetite, weight gain, scalp hair loss, prolonged menstrual bleeding, and spotting, missed menstrual periods, irregular onsets of menstrual bleeding, scanty menstrual bleeding, pain or itching near the implant site (usually temporary), infection at implant site, nervousness, anxiety, breast pain, and uterine enlargement.

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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Norplant FDA Prescribing Information: Side Effects
(Adverse Reactions)


The following adverse reactions have been associated with the NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM during the first year of use in clinical trials:

Many bleeding days or prolonged bleeding 27.6%
Spotting 17.1%
Amenorrhea 9.4%
Irregular (onsets of) bleeding 7.6%
Frequent bleeding onsets 7.0%
Scanty bleeding 5.2%
Pain or itching near implant site (usually transient) 3.7%
Infection at implant site 0.7%

In addition, removal difficulties affecting subjects (including multiple incisions, capsule fragments remaining, pain, multiple visits, deep placement, lengthy removal procedure, or other) have been reported with a frequency of 6.2%, which is based on 849 removals occurring through 5 years of use. See “WARNINGS” and “PRECAUTIONS.”

Clinical studies comparing NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM users with other contraceptive method users suggest that the following adverse reactions occurring during the first year are probably associated with NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM use. These adverse reactions have also been reported post-marketing:

Headache Acne
Nervousness/Anxiety Change of appetite
Nausea/Vomiting Mastalgia
Dizziness Weight gain
Adnexal enlargement Hirsutism, hypertrichosis,
Dermatitis/Rash and scalp-hair loss

In addition, the following adverse reactions have been reported in clinical trials with a frequency of 5% or greater during the first year and are possibly related to NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM use:

Breast discharge Abdominal discomfort
Cervicitis Leukorrhea
Musculoskeletal pain Vaginitis

The following adverse reactions have been reported post-marketing with an incidence of less than 1% and are possibly related to NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM use:

Arm pain
Gallbladder disease
Idiopathic intracranial hypertension (IIH) (pseudotumor cerebri, benign intracranial hypertension)
Insertion/removal site reactions including abscess, cellulitis; blistering; bruising; edema; excessive scarring; hyperpigmentation; induration; nerve injury; numbness; sloughing; tingling;
Migraine headaches
Ovarian cysts

The following adverse reactions have been reported post-marketing and a causal relationship to the NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM has not been established:

Asthenia (fatigue/weakness)
Breast cancer
Congenital anomalies
Deep vein thrombosis
Emotional lability and depression, sometimes severe
Myocardial infarction
Pulmonary embolism
Superficial venous thrombosis
Thrombotic thrombocytopenic purpura (TTP)
Urticaria, pruritus
Vaginal bleeding, heavy
Visual disturbances
Weight gain of more than 10 pounds

Read the entire FDA prescribing information for Norplant (Levonorgestrel Implants (Unavailable in US))

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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