"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.
Vivelle-Dot Patient Information Including Side Effects
Brand Names: Alora, Climara, Estraderm, Estradiol Patch, Menostar, Vivelle, Vivelle-Dot
Generic Name: estradiol transdermal (Pronunciation: ES tra DYE ole tranz DERM al)
- What is estradiol transdermal (Vivelle-Dot)?
- What are the possible side effects of estradiol transdermal?
- What is the most important information I should know about estradiol transdermal?
- What should I discuss with my healthcare provider before using estradiol transdermal?
- How should I use estradiol transdermal?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while using estradiol transdermal?
- What other drugs will affect estradiol transdermal?
- Where can I get more information?
What is estradiol transdermal (Vivelle-Dot)?
Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.
Estradiol transdermal skin patches are used to treat certain symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. This medication is also used to prevent postmenopausal osteoporosis, or to treat ovarian disorders.
Estradiol transdermal may also be used for purposes not listed in this medication guide.
What are the possible side effects of estradiol transdermal?
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 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, especially on one side of the body;
- 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;
- pain, 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:
- upset stomach, bloating, constipation;
- acne or skin color changes, increased facial hair, thinning scalp hair;
- mild headache, back pain, joint pain;
- cold symptoms such as stuffy nose, sneezing, sinus pain, sore throat;
- breast swelling and tenderness, nipple discharge; 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 Vivelle-Dot (estradiol transdermal system) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about estradiol transdermal?
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.
Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin while you are using estradiol, to help lower this risk. Report any unusual vaginal bleeding right away.
Long-term use of estradiol may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using estradiol transdermal long term.
Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol transdermal.
Estradiol transdermal should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.
Additional Vivelle-Dot 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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