What are the Premarin Vaginal Cream side effects?
The most commonly reported side effects of Premarin 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:
- Breast cancer
- Cancer of the uterus
- Stroke
- Heart attack
- Blood clots
- Dementia
- Gallbladder disease
- Ovarian cancer
- High blood pressure
- Liver problems
- High blood sugar
- Enlargement of benign tumors of the uterus (fibroids)
Some of the warning signs of these serious side effects include:
- Breast lumps
- Unusual vaginal bleeding
- Dizziness and faintness
- Changes in speech
- Severe headaches
- Chest pain
- Shortness of breath
- Pains in your legs
- Changes in vision
- Vomiting
- Yellowing of the skin, eyes, or nail beds
- 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 bleeding or spotting
- Stomach/abdominal cramps, bloating
- Nausea and vomiting
- Hair loss
- Fluid retention
- Vaginal yeast infection
- 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.
Important Safety Information
What is the most important information I should know about PREMARIN Vaginal Cream (an estrogen mixture)?
- 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 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 the cause
- Do not use estrogen-alone 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
- Do not use estrogens with progestins to prevent heart disease, heart attacks, or dementia
- Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
- Using estrogens with progestins may increase your chance of getting dementia, based on a study of women age 65 years or older
- You and your healthcare provider should talk regularly about whether you still need treatment with PREMARIN Vaginal Cream
PREMARIN® Vaginal Cream is used after menopause to treat menopausal changes in and around the vagina and painful intercourse caused by these changes.
It 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, have or had blood clots or liver problems, are allergic to any of its ingredients, or think you may be pregnant.
Most common side effects include headache, infection, abdominal pain, back pain, accidental injury, and vaginitis.
Please see 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.