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Drospirenone/ethinyl estradiol/levomefolate (By mouth)

This is a birth control pill that contains a folic acid supplement. It is used to prevent pregnancy. It is also used to treat premenstrual dysphoric disorder (PMDD) and acne.

Brand Name(s):

Beyaz, Safyral

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

Do not use this medicine if you have had an allergic reaction to drospirenone, ethinyl estradiol, or levomefolate, or if you are pregnant or have unusual vaginal bleeding. You should not use this medicine if you have uncontrolled high blood pressure, certain heart problems, or diabetes with kidney, eye, nerve, or blood vessel damage. Do not use this medicine if you have adrenal problems, breast cancer, kidney disease, liver disease, or certain types of headaches. You should not use this medicine if you have a history of blood clots, heart attacks, or strokes. Do not use this medicine if you smoke cigarettes and you are over the age of 35.

How to Use This Medicine:

Tablet, Tablet

  • Take your medicine as directed.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
  • Take this medicine at the same time each day, preferably after your evening meal or at bedtime. Birth control pills work best when there is no more than 24 hours between doses.
  • When you begin using this medicine, your body will need at least 7 days to adjust before a pregnancy will be prevented. Use a second form of birth control, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.
  • Keep your pills in the blister pack you receive from the pharmacy. Take the pills in the order they appear in the container.
  • You may feel sick or nauseous, especially during the first few months that you take this medicine. If your nausea does not go away, call your doctor.
  • If you vomit or have diarrhea within 3 to 4 hours of taking this medicine, follow the instructions in the patient leaflet or call your doctor.

If a dose is missed:

  • This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.
  • To prevent pregnancy, use a second form of birth control for 7 days after you miss a dose.
  • If you miss your pills or change your schedule, you may not have a period for that month. Make sure your doctor knows if you miss your period 2 months in a row, because you may be pregnant.
  • You could have light bleeding or spotting if you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.

How to Store and Dispose of This Medicine:

  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you are using acetaminophen (Tylenol®), ascorbic acid (Vitamin C), atorvastatin (Lipitor®), bosentan (Tracleer®), cholestyramine (Questran®), felbamate (Felbatol®), rifampicin (Rifadin®, Rimactane®), St. John's wort, certain blood pressure medicine (such as captopril, enalapril, lisinopril, losartan, valsartan, Accupril®, Avapro®, Capoten®, Cozaar®, Diovan®, Hyzaar®, Prinivil®, Teveten®, Vasotec®, or Zestril®), diuretics or water pills (such as amiloride, spironolactone, triamterene, Aldactone®, or Moduretic®), or pain or arthritis medicine or NSAID (such as aspirin, ibuprofen, naproxen, phenylbutazone, Advil®, Aleve®, Feldene®, Motrin®, Orudis®, Relafen®, or Voltaren®).
  • Tell your doctor if you are also using folate supplements, potassium supplements, heparin, lamotrigine (Lamictal®), methotrexate (Folex®, Rheumatrex®), pyrimethamine (Daraprim®), sulfasalazine (Azulfidine®), medicine for seizures (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, topiramate, valproic acid, Depakene®, Dilantin®, Luminal®, Mysoline®, Tegretol®, Topamax®, or Trileptal®), medicine for HIV/AIDS (such as efavirenz, delavirdine, indinavir, nevirapine, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, Norvir®, Rescriptor®, Sustiva®, or Viramune®), antibiotics (such as griseofulvin, itraconazole, ketoconazole, Grifulvin V®, Nizoral®, or Sporanox®), or thyroid medicines (such as levothyroxine, Synthroid®).

Warnings While Using This Medicine:

  • Tell your doctor right away if you think you are pregnant. This medicine could harm your unborn baby if you take it while you are pregnant.
  • Make sure your doctor knows if you are breastfeeding, or if you have had a baby within 4 weeks before you start using this medicine. Tell your doctor if you have inherited angioedema (swelling of the face, tongue, or throat), diabetes, high blood pressure, high cholesterol, high potassium in the blood, or a history of depression or chloasma gravidarum (a skin disorder during pregnancy). Tell your doctor if you have ever had cholestasis caused by pregnancy or birth control pills.
  • If you smoke while using birth control pills, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are older than 35, or if you have diabetes, high blood pressure, high cholesterol, or you are overweight.
  • Using birth control pills may increase your risk for blood clots, especially in the first 6 months of use. This medicine contains drospirenone and ethinyl estradiol, which may increase your risk for blood clots more than other birth control pills. Stop using this medicine and check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, a sudden or severe headache, slurred speech, unexplained shortness of breath, or a sudden loss of coordination.
  • Stop using this medicine and check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine or pale stools, or yellow eyes or skin. These could be symptoms of a serious liver problem.
  • This medicine will not protect you from HIV/AIDS or other sexually transmitted diseases. If this is a concern for you, talk with your doctor.
  • Check with your doctor right away if you have problems wearing contact lenses, blurred vision, difficulty reading, or any other vision changes. Your doctor may want an eye doctor to check your eyes.
  • Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
  • Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
  • Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.Your doctor may also want to check your blood pressure while you take this medicine.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Chest pain, shortness of breath, or coughing up blood
  • Confusion, body weakness, uneven heartbeat, or numbness or tingling in your hands, feet, or lips
  • Dark-colored urine or pale stools
  • Heavy vaginal bleeding
  • Irregular or missed menstrual period
  • Nausea, vomiting, loss of appetite, or pain in your upper stomach
  • Numbness or weakness in your arm or leg, or on one side of your body
  • Pain in your lower leg (calf)
  • Severe stomach pain with nausea or vomiting
  • Sudden or severe headache, or problems with vision, speech, or walking
  • Yellowing of your skin or the whites of your eyes

If you notice these less serious side effects, talk with your doctor:

  • Bloating or weight gain and swelling in your hands, ankles, or feet
  • Breast pain, tenderness, or swelling
  • Depression or mood changes
  • Mild headache
  • Vaginal spotting or light bleeding, itching, or discharge

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088


Last Updated: 4/4/2014
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