"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"...
Safyral Consumer (continued)
Nausea, vomiting, headache, bloating, breast tenderness, swelling of the ankles/feet (fluid retention), or weight change may occur. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use. If any of these effects persist or worsen, tell your doctor promptly. If you miss 2 periods in a row (or 1 period if the pill has not been used properly), contact your doctor for a pregnancy test.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these serious side effects occur: unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods).
This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, pulmonary embolism, stroke, heart attack). Talk to your doctor about the risks and benefits of this birth control pill. Get medical help right away if you experience: pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, sudden shortness of breath, coughing up blood, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, confusion, slurred speech, weakness on one side of the body, sudden vision changes (such as partial/complete blindness), unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches).
Get medical help right away if any of these rare but serious side effects occur: lumps in the breast, stomach/abdominal pain, yellowing eyes/skin, mental/mood changes (such as new/worsening depression, suicidal thoughts).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate) Side Effects Center for a complete guide to possible side effects »
PRECAUTIONS: See also Warning section.
Before taking this medication, tell your doctor or pharmacist if you are allergic to drospirenone, ethinyl estradiol, or folate supplements; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this product, tell your doctor or pharmacist your medical history, especially of: adrenal gland problems, stroke, blood clots (such as in the legs, eyes, lungs), untreated/uncontrolled high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), diabetes that has caused kidney/eye/nerve/blood vessel disease, severe headaches/migraines, heart disease (such as heart attack, chest pain), heart valve disease, irregular heartbeat, kidney problems, liver problems (such as liver tumor, active liver disease), blood clotting disorders (such as protein C or protein S deficiency), history of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills, unexplained vaginal bleeding, high cholesterol or triglyceride (blood fat) levels, depression, swelling (edema), gallbladder problems, obesity.
If you have diabetes, this medication may make it harder to control your blood sugar level. Check your blood sugar level regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication or diet.
Tell your doctor if you just had or will be having major surgery, or if you will be confined to a chair or bed for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are taking hormonal birth control products. You may need to stop this medication for a time or take special precautions.
This medication may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, sunlamps, and tanning booths. Use a sunscreen, and wear protective clothing when outdoors.
If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.
It may take longer for you to become pregnant after you stop taking birth control pills. Consult your doctor.
This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication.
This medication passes into breast milk. It may affect milk production and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
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