Important
Safety Information
Estrasorb is indicated for the treatment of moderate
to severe vasomotor symptoms associated with menopause. Estrasorb should
not be used in women with any of the following conditions: undiagnosed
abnormal genital bleeding; known, suspected, or history of cancer of
the breast; known or suspected estrogen-dependent neoplasia; active
deep-vein thrombosis, pulmonary embolism or history of these conditions;
active or recent (eg, within the past year) arterial thromboembolic
disease (eg, stroke, myocardial infarction); liver dysfunction or
disease. Estrasorb should not be used in patients with known
hypersensitivity to its ingredients; known or suspected pregnancy. There
is no indication for Estrasorb in pregnancy. There appears to
be little or no increased risk of birth defects in women who have used
estrogens and progestins from oral contraceptives inadvertently during
early pregnancy (See PRECAUTIONS in full Prescribing Information).
The most frequently reported adverse events (≥5% and more frequently
than placebo) in clinical trials for Estrasorb were: Infection; Sinusitis;
Pruritus; Breast pain; and Endometrial disorder. |
Important
safety information you should know about estrogen.
Estrogens increase the chances of getting cancer of the uterus.
Report any unusual vaginal bleeding right away while you are using
Estrasorb. Vaginal bleeding after menopause may be a warning sign of
cancer of the uterus (womb). Your healthcare professional should check
any unusual vaginal bleeding to find out the cause.
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes, or dementia.
Using estrogens with or without progestins may increase your chances of getting
heart attacks, strokes, breast cancer, and blood clots. Using
estrogens with or without progestins may increase your risk of
dementia, based on a study of women aged 65 years or older. You
and your healthcare professional should talk regularly about whether
you still need treatment with Estrasorb.
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Please see Full
Prescribing Information for Estrasorb.
For medical questions and to report adverse
events, please call 1-866-230-0375.
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