"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, Estring, Vagifem
Generic Name: estradiol vaginal (local) (Pronunciation: ES tra DYE ole VA jin 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 that regulates many processes in the body.
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. Estradiol vaginal (local) is used to treat vaginal symptoms of menopause such as dryness, burning, and itching. Estradiol vaginal also reduces urgency or irritation of urination.
Estradiol should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.
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.
Remove the vaginal ring and seek emergency medical attention if you have: fever with nausea, vomiting, diarrhea, muscle pain, dizziness, fainting, and/or sunburn-like skin rash. These may be signs of a life-threatening disease called toxic shock syndrome.
Stop using this medication and call your doctor at once if you have a serious side effect such as:
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden numbness or weakness, sudden severe headache, sudden vision changes, problems with speech or balance;
- sudden cough, wheezing, rapid breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
- swelling or tenderness in your stomach;
- jaundice (yellowing of the skin or eyes);
- unusual vaginal bleeding;
- a lump in your breast;
- numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes; or
- dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
- breast swelling and tenderness, nipple discharge;
- vaginal itching or discharge;
- mild nausea, stomach cramps, diarrhea, bloating;
- swelling of your ankles or feet;
- migraine headaches or dizziness;
- cold symptoms such as stuffy nose, sneezing, sore throat;
- acne or skin color changes, increased facial hair, thinning scalp hair;
- depressed mood; 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)?
Estradiol can harm an unborn baby or cause birth defects. Do not use if you are pregnant.
You should not use this medication if you have any of the following conditions: liver disease, a bleeding disorder, unusual vaginal bleeding, a history of breast or uterine cancer, or if you have ever had a heart attack, stroke, or a blood clot.
Long-term use of estradiol may increase your risk of breast cancer, uterine cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using estradiol vaginal long term.
Report any unusual vaginal bleeding right away. Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol vaginal.
Estradiol vaginal should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.
Additional Vagifem Information
- Vagifem Drug Interactions Center: estradiol vagl
- Vagifem Side Effects Center
- Vagifem Overview including Precautions
- Vagifem FDA Approved Prescribing Information including Dosage
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