"Dec. 9, 2011 -- An FDA panel has voted 15-11 that the benefits of newer oral contraceptives outweigh their risks of dangerous blood clots.
But the panel voted 21-5 that the contraceptives' labels don't adequately reflect that risk/ben"...
Yaz Patient Information Including Side Effects
Brand Names: Gianvi, Loryna, Ocella, Syeda, Vestura, Yasmin, Yaz, Zarah
Generic Name: drospirenone and ethinyl estradiol (Pronunciation: dro SPY re nown, ETH in il, ESS tra dy ol)
- What is drospirenone and ethinyl estradiol (Yaz)?
- What are the possible side effects of drospirenone and ethinyl estradiol?
- What is the most important information I should know about drospirenone and ethinyl estradiol?
- What should I discuss with my healthcare provider before taking drospirenone and ethinyl estradiol?
- How should I take drospirenone and ethinyl estradiol?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while taking drospirenone and ethinyl estradiol?
- What other drugs will affect drospirenone and ethinyl estradiol?
- Where can I get more information?
What is drospirenone and ethinyl estradiol (Yaz)?
Drospirenone and ethinyl estradiol prevent ovulation (the release of an egg from an ovary) and also cause changes in your cervical and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.
The combination of drospirenone and ethinyl estradiol is used as contraception to prevent pregnancy. It is also used to treat moderate acne in women who are at least 14 years old and have started having menstrual periods, and who wish to use birth control pills to prevent pregnancy.
This medication is also used to treat the symptoms of premenstrual dysphoric disorder (PMDD), such as anxiety, depression, irritability, trouble concentrating, lack of energy, sleep or appetite changes, breast tenderness, joint or muscle pain, headache, and weight gain.
Drospirenone and ethinyl estradiol may also be used for purposes not listed in this medication guide.
What are the possible side effects of drospirenone and ethinyl estradiol?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using birth control pills and call your doctor at once if you have a serious side effect such as:
- sudden numbness or weakness, especially on one side of the body;
- sudden and severe headache, confusion, problems with vision, speech, or balance;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden cough, wheezing, rapid breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
- a change in the pattern or severity of migraine headaches;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- swelling in your hands, ankles, or feet;
- a breast lump; or
- symptoms of depression (sleep problems, weakness, tired feeling, mood changes).
Less serious side effects may include:
- mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;
- breast tenderness or swelling, nipple discharge;
- freckles or darkening of facial skin, increased hair growth, loss of scalp hair;
- changes in weight or appetite;
- problems with contact lenses;
- vaginal itching or discharge; or
- changes in your menstrual periods, decreased sex drive.
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 Yaz (drospirenone and ethinyl estradiol) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about drospirenone and ethinyl estradiol?
Do not use birth control pills if you are pregnant or if you have recently had a baby.
You should not take birth control pills if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer, jaundice caused by birth control pills, a heart attack, a stroke, or a blood clot.
Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills, especially if you are older than 35. Drospirenone may be more likely to cause blood clots than other types of birth control pills.
You may need to use back up birth control, such as condoms or a spermicide, when you first start using this medication or if you miss a dose. Follow your doctor's instructions.
Missing a pill increases your risk of becoming pregnant. Carefully follow the "missed dose" instructions if you forget to take your birth control pills.
Some drugs can make birth control pills less effective in preventing pregnancy, including antibiotics, hepatitis C medications, HIV/AIDS medications, seizure medications, or barbiturate sedatives. Tell your doctor about all other medications you use.
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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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