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
Mirena Side Effects, and Drug Interactions - Levonorgestrel-releasing IUD
Mirena Side Effects, and Drug Interactions - Levonorgestrel-releasing IUD
SIDE EFFECTS
The most serious adverse reactions associated with the use
of MIRENA® are discussed in the WARNINGS
section. Others are presented in the PRECAUTIONS
section. Other adverse events reported by 5% or more subjects include: Abdominal
pain Breast pain Nausea Decreased libido Leukorrhea Acne Nervousness
Abnormal Pap smear Headache Depression Dysmenorrhea Sinusitis Vaginitis Hypertension Weight
increase Back pain Upper respiratory infection Skin disorder Other reported
adverse reactions occurring in less than 3% of patients include:failed insertion,migraine,
vomiting, anemia, cervicitis, dyspareunia, hair loss, eczema.
DRUG INTERACTIONS
The effect of hormonal contraceptives may be impaired by drugs
which induce liver enzymes. The influence of these drugs on the contraceptive
efficacy of MIRENA® has not been studied.
CARCINOGENESIS
Long-term studies in animals to assess the carcinogenic potential
of levonorgestrel releasing intrauterine system have not been performed. See
WARNINGS section.
PREGNANCY
Pregnancy Category X.See WARNINGS
section.
NURSING MOTHERS
Levonorgestrel has been identified in small quantities in the
breast milk of lactating women using
MIRENA®. In a study of 14 breastfeeding
women using a MIRENA® prototype during lactation, mean
infant serum levels of levonorgestrel were approximately 7% of maternal serum
levels. Hormonal contraceptives are not recommended as the contraceptive method
of first choice during lactation.
PEDIATRIC USE
Safety and efficacy of MIRENA® have been
established in women of reproductive age. Use of this product before menarche
is not indicated.
GERIATRIC USE
MIRENA® has not been studied in women
over age 65 and is not currently approved for use in this population.
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