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
Climara Side Effects, and Drug Interactions - Estradiol transdermal
Climara Side Effects, and Drug Interactions - Estradiol transdermal
SIDE EFFECTS
Because clinical trials are conducted under widely varying
conditions, adverse reaction rates observed in the clinical trials of a drug
cannot be directly compared to rates in the clinical trials of another drug
and may not reflect the rates observed in practice. The adverse reaction information
from clinical trials does, however, provide a basis for identifying the adverse
events that appear to be related to drug use and for approximating rates.
See WARNINGS regarding induction
of neoplasia, increased incidence of gallbladder disease, cardiovascular disease,
and hypercalcemia; see PRECAUTIONS regarding
cardiovascular risk and elevated blood pressure.
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. The following additional adverse
reactions have been reported with estrogen therapy:
|
Summary of Most Frequently Reported Adverse Experiences/Medical
Events (³5%) by Treatment Groups Climara®
|
|
AE per Body System
|
0.025 mg/day (N=219)
|
0.05 mg/day (N=201)
|
0.1 mg/day (N=194)
|
Placebo (N=72)
|
|
Body as a Whole
|
21%
|
39%
|
37%
|
29%
|
|
Headache
|
5%
|
18%
|
13%
|
10%
|
|
Pain
|
1%
|
8%
|
11%
|
7%
|
|
Back Pain
|
4%
|
8%
|
9%
|
6%
|
|
Edema
|
0.5%
|
13%
|
10%
|
6%
|
|
Gastro-Intestinal
|
9%
|
21%
|
29%
|
18%
|
|
Abdominal Pain
|
0.0%
|
11%
|
16%
|
8%
|
|
Nausea
|
1%
|
5%
|
6%
|
3%
|
|
Flatulence
|
1%
|
3%
|
7%
|
1%
|
|
Musculo-Skeletal
|
7%
|
9%
|
11%
|
4%
|
|
Arthralgia
|
1%
|
5%
|
5%
|
3%
|
|
Psychiatric
|
13%
|
10%
|
11%
|
1%
|
|
Depression
|
1%
|
5%
|
8%
|
0%
|
|
Reproductive
|
12%
|
18%
|
41%
|
11%
|
|
Breast Pain
|
5%
|
8%
|
29%
|
4%
|
|
Leukorrhea
|
1%
|
6%
|
7%
|
1%
|
|
Respiratory
|
15%
|
26%
|
29%
|
14%
|
|
URTI
|
6%
|
17%
|
17%
|
8%
|
|
Pharyngitis
|
0.5%
|
3%
|
7%
|
3%
|
|
Sinusitis
|
4%
|
4%
|
5%
|
3%
|
|
Rhinitis
|
2%
|
4%
|
6%
|
1%
|
|
Skin and Appendages
|
19%
|
12%
|
12%
|
15%
|
|
Pruritus
|
0.5%
|
6%
|
3%
|
6%
|
The following adverse events have been reported spontaneously
in association with Climara® use:
1. Genitourinary system. Changes in vaginal bleeding
pattern and abnormal withdrawal bleeding or flow, breakthrough bleeding, spotting.
Vaginal candidiasis. Changed amount of cervical secretion.
2. Breasts. Tenderness, enlargement.
3. Gastrointestinal. Nausea, vomiting. Abdominal
cramps, bloating.
4. Skin. Chloasma or melasma that may persist when
drug is discontinued. Loss of scalp hair, hirsutism.
5. Eyes. Steepening of corneal curvature. Intolerance
of contact lenses.
6. Central nervous system. Headache, migraine, dizziness.
Mental depression.
7. Miscellaneous. Increase or decease in weight.
Changes in libido. Muscle cramps.
DRUG INTERACTIONS
D. Drug/Laboratory Test Interactions
1. Accelerated prothrombin time, partial thromboplastin time,
and platelet aggregation time; increased platelet count; increased factors II,
VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex,
II-VII-X complex, and betathromboglobulin; decreased levels of anti-factor Xa
and antithrombin III, decreased antithrombin III activity; increased levels
of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.
2. Increased thyroid-binding globulin (TBG) leading to increased
circulating total thyroid hormone, as measured by protein-bound iodine (PBI),
T4 levels (by column or by radioimmunoassay) or T3 levels by radioim-munoassay.
T3 resin uptake is decreased, reflecting the elevated TBG.
Free T4 and free T3 concentrations are unaltered.
3. Other binding proteins may be elevated in serum, i.e.,
corticosteroid binding globulin (CBG), sex hormone-binding globulin (SHBG),
leading to increased circulating corticosteroids and sex steroids respectively.
Free or biologically active hormone concentrations are unchanged. Other plasma
proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin,
ceruloplasmin).
4. Increased plasma HDL and HDL-2 subfraction concentrations,
reduced LDL cholesterol concentration, increased triglycerides levels.
5. Impaired glucose tolerance.
6. Reduced response to metyrapone test.
7. Reduced serum folate concentration.
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