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Norplant

Last reviewed on RxList: 12/31/2008
Norplant Side Effects Center

Last reviewed on RxList 12/13/2016

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,
  • spotting,
  • missed menstrual periods,
  • irregular onsets of menstrual bleeding,
  • frequent bleeding onsets,
  • scanty menstrual bleeding,
  • pain or itching near the implant site (usually temporary),
  • infection at implant site,
  • nervousness,
  • anxiety,
  • breast pain, and
  • uterine enlargement.

Side effects of the removal of Norplant include:

  • multiple incisions,
  • capsule fragments remaining,
  • pain,
  • multiple visits, and
  • lengthy removal procedure.

The Norplant System consists of six Silastic capsules, each containing 36 mg of the progestin, levonorgestrel. The total administered (implanted) dose is 216 mg. Norplant System may interact with phenytoin, carbamazepine, rifampin, and hepatic enzyme inducers. Tell your doctor all medications and supplements you use. Norplant System is not recommended for use during pregnancy. The medication in Norplant System passes into breast milk. Consult your doctor before breastfeeding.

Our Norplant System (levonorgestrel) Implants Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Norplant Professional Information

SIDE EFFECTS

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
Hypertension
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;
ulcerations
Migraine headaches
Ovarian cysts
Phlebitis

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
Dysmenorrhea
Emotional lability and depression, sometimes severe
Myocardial infarction
Pulmonary embolism
Stroke
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))

Related Resources for Norplant

© Norplant Patient Information is supplied by Cerner Multum, Inc. and Norplant Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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