SIDE EFFECTS
Estraderm
See WARNINGS and BOXED WARNING regarding potential adverse
effects on the fetus, induction of malignant neoplasms,
increased incidence of gallbladder disease, and adverse
effects similar to those of oral contraceptives, including
thromboembolism.
The most commonly reported adverse reaction to Estraderm
in clinical trials was redness and irritation at the application
site. This occurred in about 17% of the women treated
and caused approximately 2% to discontinue therapy. Reports
of rash have been rare.
The following additional adverse reactions have been
reported with estrogenic therapy, including oral contraceptives:
Genitourinary System: Breakthrough
bleeding, spotting, change in menstrual flow; increase
in size of uterine fibromyomata; change in cervical erosion
and amount of cervical secretion.
Endocrine: Breast tenderness,
breast enlargement.
Gastrointestinal: Nausea, vomiting;
abdominal cramps, bloating; cholestatic jaundice have
been observed with oral estrogen therapy.
Eyes: Steepening of corneal
curvature; intolerance to contact lenses.
Central Nervous System: Headache,
migraine, dizziness.
Miscellaneous: Change in weight,
edema, change in libido.
Climara
See WARNINGS and BOXED WARNING regarding induction of
neoplasia, adverse effects on the fetus, increased incidence
of gallbladder disease, cardiovascular disease, elevated
blood pressure, and hypercalcemia.
The most commonly reported adverse reaction to the Climara
system in clinical trials was skin irritation at the application
site. In two well-controlled clinical studies, the overall
rate of discontinuation due to skin irritation at the
application site was 6.8%; 7.9% for the 12.5 cm2 system
and 5.3% for the 25.0 cm2 system compared with 11.5% for
the placebo system. Patients with known skin irritation
to the patch were excluded from participation in the studies.
In a 3-week comparative skin irritation study with the
Estraderm system, in 95 subjects, no statistically significant
differences in irritation were observed. Some degree of
irritation at the end of week three was seen in 25% of
Estraderm and 31% of Climara subjects. Clinically significant
irritation (mild erythema associated with symptoms or
moderate to severe erythema) was evident at the end of
week three in 11% of Estraderm and 9% of Climara subjects.
The following additional adverse reactions have been
reported with estrogen therapy:
1. Genitourinary System:
Changes in vaginal bleeding pattern and abnormal
withdrawal bleeding or flow, breakthrough bleeding, spotting;
increase in size of uterine leiomyomata; vaginal candidiasis;
change in amount of cervical secretion.
2. Breasts: Tenderness, enlargement.
3. Gastrointestinal: Nausea,
vomiting; abdominal cramps, bloating; cholestatic jaundice;
increased incidence of gallbladder disease.
4. Skin: Chloasma or melasma
that may persist when drug is discontinued; , erythema
multiforme; erythema nodosum; hemorrhagic eruption; loss
of scalp hair; hirsutism.
5. Eyes: Steepening of corneal
curvature; intolerance to contact lenses.
6. Central Nervous System: Headache,
migraine, dizziness; mental depression; , chorea.
7. Miscellaneous: Increase
or decrease in weight; reduced carbohydrate tolerance; aggravation
of porphyria; edema; changes in libido.
DRUG INTERACTIONS
See PRECAUTIONS.
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