The following adverse reactions have been associated with the NORPLANT 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 ."

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 with a frequency of 5% or greater during the first year and are possibly related to NORPLANT 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 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 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

Reduced efficacy (pregnancy) has been reported for NORPLANT SYSTEM users taking phenytoin and carbamazepine. These drugs may increase the metabolism of levonorgestrel through induction of microsomal liver enzymes. NORPLANT 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.

Certain endocrine tests may be affected by NORPLANT SYSTEM use:

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