"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
Norplant Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Norplant System (levonorgestrel) Implants is a hormonal contraceptive used to prevent pregnancy. Common side effects of Norplant include:
- changes in appetite,
- weight gain,
- scalp hair loss,
- prolonged menstrual bleeding,
- 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,
- breast pain, and
- uterine enlargement.
Side effects of the removal of Norplant include:
- multiple incisions,
- capsule fragments remaining,
- 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.
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
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%|
|Irregular (onsets of) bleeding||7.6%|
|Frequent bleeding onsets||7.0%|
|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:
|Nervousness/Anxiety||Change of appetite|
|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|
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:
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;
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:
Deep vein thrombosis
Emotional lability and depression, sometimes severe
Superficial venous thrombosis
Thrombotic thrombocytopenic purpura (TTP)
Vaginal bleeding, heavy
Weight gain of more than 10 pounds
Read the entire FDA prescribing information for Norplant (Levonorgestrel Implants (Unavailable in US))
Additional Norplant Information
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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