"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Vagifem Patient Information Including Side Effects
Brand Names: Estrace Vaginal Cream, Estring, Vagifem
Generic Name: estradiol vaginal (local) (Pronunciation: ess tra DYE ole VAJ in ul (LO kul))
- What is estradiol vaginal (local) (Vagifem)?
- What are the possible side effects of estradiol vaginal (local) (Vagifem)?
- What is the most important information I should know about estradiol vaginal (local) (Vagifem)?
- What should I discuss with my healthcare provider before using estradiol vaginal (local) (Vagifem)?
- How should I use estradiol vaginal (local) (Vagifem)?
- What happens if I miss a dose (Vagifem)?
- What happens if I overdose (Vagifem)?
- What should I avoid while using estradiol vaginal (local) (Vagifem)?
- What other drugs will affect estradiol vaginal (local) (Vagifem)?
- Where can I get more information?
What is estradiol vaginal (local) (Vagifem)?
Estradiol is a form of estrogen, a female sex hormone the regulates many processes in the body.
Estradiol vaginal (local) is used to treat certain symptoms of menopause such as dryness, burning, and itching of the vaginal area. Estradiol vaginal also reduces urgency or irritation of urination.
Estradiol vaginal (local) may also be used for purposes not listed in this medication guide.
What are the possible side effects of estradiol vaginal (local) (Vagifem)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden numbness or weakness, especially on one side of the body;
- sudden headache, confusion, problems with vision, speech, or balance;
- pain, swelling, warmth, or redness in one or both legs;
- abnormal vaginal bleeding;
- pain, swelling, or tenderness in your stomach;
- jaundice (yellowing of the skin or eyes); or
- a lump in your breast.
Less serious side effects may include:
- nausea, vomiting, loss of appetite;
- swollen breasts;
- acne or skin color changes;
- decreased sex drive, impotence, or difficulty having an orgasm;
- migraine headaches or dizziness;
- vaginal pain, dryness, or discomfort;
- swelling of your ankles or feet;
- depression; or
- changes in your menstrual periods, break-through bleeding.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the Vagifem (estradiol vaginal tablets) Side Effects Center for a complete guide to possible side effects »
What is the most important information I should know about estradiol vaginal (local) (Vagifem)?
Some estradiol products placed directly into the vagina are used for "local" treatment of vaginal menopause symptoms involving the secretions and surrounding tissues of the vagina. Other vaginal estradiol products are used for treating menopause symptoms affecting the vagina as well as other parts of the body (such as hot flashes). This type of vaginal estradiol has "systemic" effects, meaning that it can affect parts of the body other than where the medicine is placed or applied.
The information in this leaflet is specific to estradiol vaginal products that are used for local treatment of symptoms.
Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding.
Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol vaginal.
Long-term estradiol treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.
Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol.
Additional Vagifem Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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