"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
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
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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