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Learn more >Important Safety Information
What is the most important information you should know about PREMARIN (estrogens), PREMPRO (a combination of estrogens and a progestin), or PREMARIN Vaginal Cream (a cream of estrogens)?
Estrogens increase the chances of getting cancer of the uterus.
Report any unusual vaginal bleeding right away while you are using these products. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your health care provider 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 age 65 years or older. You and your health care provider should talk regularly about whether you still need treatment with estrogens.
PREMARIN® (conjugated estrogens tablets, USP) is used after menopause to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones).
PREMPRO® (conjugated estrogens/medroxyprogesterone acetate tablets) is used after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones).
PREMARIN® (conjugated estrogens) Vaginal Cream is used after menopause to treat dryness, itching, and burning, in and around the vagina.
PREMARIN and PREMPRO should be used at the lowest effective dose and for the shortest duration consistent with your treatment goals and risks. If using PREMARIN or PREMPRO only to treat your symptoms of vaginal dryness, consider topical therapies first. If you do not have symptoms, non-estrogen treatments should be carefully considered before taking PREMARIN and PREMPRO solely for the prevention of postmenopausal osteoporosis.
In a clinical trial, the most commonly reported (≥5%) side effects that occurred more frequently with PREMARIN than with placebo were vaginitis due to yeast or other causes, vaginal bleeding, painful menstruation, and leg cramps.
In a clinical trial, the most commonly reported (≥5%) side effects that occurred more frequently with PREMPRO 0.45 mg/1.5 mg and PREMPRO 0.625 mg/2.5 mg than with placebo were breast pain/enlargement, vaginitis due to yeast or other causes, leg cramps, vaginal spotting/bleeding, and painful menstruation. In a clinical trial, there was no difference in the commonly reported (≥5%) side effects for women taking PREMPRO 0.3 mg/1.5 mg compared to those taking placebo.
The most commonly reported side effects of PREMARIN Vaginal Cream include vaginal discomfort or pain, breast pain, vaginitis, and itching.
PREMARIN, PREMPRO, and PREMARIN Vaginal Cream should not be used if you have unusual vaginal bleeding, have or had cancer of the breast or uterus, had a stroke or heart attack in the past year, have or had blood clots, have liver problems, are allergic to any of the ingredients in PREMARIN, PREMPRO, or PREMARIN Vaginal Cream, 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.
