Healthcare Professionals

Possible side effects of
PREMARIN Vaginal Cream

The most commonly reported side effects of PREMARIN® (conjugated estrogens) Vaginal Cream include headache, infection, abdominal pain, back pain, accidental injury, and vaginitis.

PREMARIN Vaginal Cream is only used in and around the vagina; however, the risks associated with oral estrogens should be taken into account.

Serious, but less common side effects include:

Heart attack Stroke Blood clots
Dementia Breast cancer Cancer of the lining of the uterus (womb)
Cancer of the ovary High blood pressure High blood sugar
Gallbladder disease Liver problems Severe allergic reaction
Enlargement of benign tumors of the uterus ("fibroids")

Some of the warning signs of these serious side effects include:

New breast lumps Unusual vaginal bleeding Changes in vision or speech
Sudden new severe headaches Swollen lips, tongue or face
Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue

Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptoms that concern you.

Less serious, but common, side effects include:

Headache Breast pain Irregular vaginal bleeding or spotting
Hair loss Fluid retention Vaginal yeast infection
Stomach or abdominal cramps, bloating Nausea and vomiting
Reactions from inserting PREMARIN Vaginal Cream, such as vaginal burning, irritation, and itching

These are not all the possible side effects of PREMARIN Vaginal Cream. For more information, ask your healthcare provider or pharmacist for advice about side effects and to decide how long you need treatment.

Patients should always ask their doctors for medical advice about adverse events.

You may report an adverse event related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where health care professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call
1-800-FDA-1088.

Next: How Your Doctor Can Help

 

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® (conjugated estrogens) Vaginal Cream. 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 cause.

Do not use estrogens, with or without progestins, to prevent heart disease, heart attacks, strokes or dementia (decline in brain function). 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.

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.

You and your healthcare provider should talk regularly about whether you still need treatment with PREMARIN® (conjugated estrogens) Vaginal Cream.

PREMARIN® (conjugated estrogens) Vaginal Cream 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.

Common side effects include headache, pelvic pain, breast pain, vaginal bleeding and vaginitis.

INDICATION

PREMARIN® (conjugated estrogens) Vaginal Cream is used after menopause to treat menopausal changes in and around the vagina and to treat moderate to severe painful intercourse caused by these changes.

Each gram contains 0.625 mg of conjugated estrogens, USP.

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 www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Scroll for Important Safety Information and Indication

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® (conjugated estrogens) Vaginal Cream. 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 cause.

Do not use estrogens, with or without progestins, to prevent heart disease, heart attacks, strokes or dementia (decline in brain function). 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.

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.

You and your healthcare provider should talk regularly about whether you still need treatment with PREMARIN® (conjugated estrogens) Vaginal Cream.

PREMARIN® (conjugated estrogens) Vaginal Cream 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.

Common side effects include headache, pelvic pain, breast pain, vaginal bleeding and vaginitis.

INDICATION

PREMARIN® (conjugated estrogens) Vaginal Cream is used after menopause to treat menopausal changes in and around the vagina and to treat moderate to severe painful intercourse caused by these changes.

Each gram contains 0.625 mg of conjugated estrogens, USP.

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 www.fda.gov/medwatch or call 1-800-FDA-1088.