IMPORTANT SAFETY INFORMATION
Using estrogen-alone may increase your chance of getting cancer of the uterus
(womb). Report any unusual vaginal bleeding right away while you are using PREMARIN.
Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
Your healthcare provider should check any unusual vaginal bleeding to find out the
Do not use estrogens with or without progestins to prevent heart disease, heart
attacks, strokes or dementia (decline in brain function).
Using estrogen-alone may increase your chances of getting strokes or blood clots.
Using estrogens with progestins may increase your chances of getting heart attacks,
strokes, breast cancer, or blood clots.
Using estrogens, with or without progestins, may increase your chance of getting
dementia, based on a study of women 65 years of age or older.
You and your healthcare provider should talk regularly about whether you still
PREMARIN should not be used if you have unusual vaginal bleeding, have or had cancer,
had a stroke or heart attack, have or had blood clots or liver problems, have a
bleeding disorder, are allergic to any of its ingredients, or think you may be pregnant.
In general, the addition of a progestin is recommended for women with a uterus to
reduce the chance of getting cancer of the uterus.
Estrogens increase the risk of gallbladder disease. Discontinue estrogen if loss
of vision, pancreatitis, or liver problems occur. If you take thyroid medication,
consult your healthcare provider, as use of estrogens may change the amount needed.
The most common (≥5%) side effects are abdominal pain, asthenia, pain, back pain,
headache, flatulence, nausea, depression, insomnia, breast pain, endometrial hyperplasia,
leucorrhea, vaginal hemorrhage, and vaginitis.
PREMARIN is used after menopause to reduce moderate to severe hot flashes; to treat
moderate to severe menopausal changes in and around the vagina; and to help reduce
the chances of getting osteoporosis (thin, weak bones).
If you are using or are considering using PREMARIN only to treat vaginal symptoms,
consider topical therapies first. If you are using or are considering using PREMARIN
only to prevent osteoporosis due to menopause, talk with your healthcare provider
about whether a different treatment or medicine without estrogens might be better
for you. PREMARIN should be used at the lowest effective dose and for the shortest
duration consistent with your treatment goals and risks.
Please see Full Prescribing Information, including Boxed Warning
and Patient Information.
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit or call 1-800-FDA-1088. By clicking on this link, you
will be leaving PREMARIN.com. This website is neither owned nor controlled by Pfizer.
Pfizer does not endorse and is not responsible for the content or services of this
The health information contained herein is provided for educational purposes only
and is not intended to replace discussions with a healthcare provider. All decisions
regarding patient care must be made with a healthcare provider, considering the
unique characteristics of the patient.
The product information provided in this site is intended only for residents of
the United States. The products discussed herein may have different product labeling
in different countries.
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