A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Norplant Side Effects, and Drug Interactions - Levonorgestrel
Norplant Side Effects, and Drug Interactions - Levonorgestrel
SIDE EFFECTS
The following adverse reactions have been associated with the NORPLANT SYSTEM
during the first year of use. They include:
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 3.7%
(usually transient)
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® SYSTEM users with other contraceptive
method users suggest that the following adverse reactions occurring during the
first year are probably associated with NORPLANT SYSTEM use. These adverse reactions
have also been reported post-marketing:
Headache
Nervousness/Anxiety
Nausea/Vomiting
Dizziness
Adnexal enlargement
Dermatitis/Rash
Acne
Change of appetite
Mastalgia
Weight gain
Hirsutism, hypertrichosis, 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
Cervicitis
Musculoskeletal pain
Abdominal discomfort
Leukorrhea
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:
Emotional lability
Idiopathic intracranial hypertension (IIH, pseudotumor cerebri, benign intracranial
hypertension)
Induration
Bruising
Abscess, cellulitis
Dysmenorrhea
Migraine
Arm pain
Numbness
Tingling
Depression
Excessive scarring
Hyperpigmentation
Nerve injury
The following adverse reactions have been reported post-marketing with an incidence
of less than 1%. These events occurred under circumstances where a causal relationship
to the NORPLANT SYSTEM is unknown. These reactions are listed as information
for physicians:
Congenital anomalies
Pulmonary embolism
Superficial venous thrombosis
Deep-vein thrombosis
Myocardial infarction
Blistering, ulcerations, and sloughing
Thrombotic thrombocytopenic purpura (TTP)
Stroke
Pruritus
Urticaria
Asthenia (fatigue/weakness)
Phlebitis
DRUG INTERACTIONS
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.
Drug/Laboratory Test Interactions
Certain endocrine tests may be affected by NORPLANT SYSTEM use:
- Sex-hormone-binding globulin concentrations are decreased.
- Thyroxine concentrations may be slightly decreased and triiodothyronine
uptake increased.
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