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Norplant

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Norplant

Side Effects
Interactions

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 Norplant (levonorgestrel implants (unavailable in us)) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Reduced efficacy (pregnancy) has been reported for NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM users taking phenytoin and carbamazepine. These drugs may increase the metabolism of levonorgestrel through induction of microsomal liver enzymes. NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM users should be warned of the possibility of decreased efficacy with the use of drugs exhibiting enzyme-inducing activity such as those noted above and rifampin. For women receiving long-term therapy with hepatic enzyme inducers, another method of contraception should be considered.

Drug/Laboratory Test Interactions

Certain endocrine tests may be affected by NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM use:

  1. Sex-hormone-binding globulin concentrations are decreased.
  2. Thyroxine concentrations may be slightly decreased and triiodothyronine uptake increased.

Last reviewed on RxList: 1/5/2009
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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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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