Drospirenone and Ethinyl Estradiol (Oral Route)

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Side Effects

Healthy women who do not smoke cigarettes have almost no chance of having a severe side effect from taking oral contraceptives. For most women, more problems occur because of pregnancy than will occur from taking oral contraceptives. But for some women who have special health problems, oral contraceptives can cause some unwanted effects. Some of these unwanted effects include benign (not cancerous) liver tumors, liver cancer, or blood clots or related problems, such as a stroke. Although these effects are very rare, they can be serious enough to cause death. You may want to discuss these effects with your doctor.

Smoking cigarettes during the use of oral contraceptives has been found to greatly increase the chances of these serious side effects occurring. To reduce the risk of serious side effects, do not smoke cigarettes while you are taking oral contraceptives.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach pain (sudden, severe, or continuing)
• Anxiety
• Burning pain in lower abdomen
• Changes in skin color
• Chill
• Convulsions
• Coughing up blood
• Feeling of heat
• Feeling of warmth in lips and tongue
• Fever
• Headache (severe or sudden)
• Loss of coordination (sudden)
• Loss of vision or change in vision (sudden)
• Nervousness
• Numbness of the fingertips
• Pain in lower back, pelvis, or stomach
• Pains in chest, groin, or leg (especially in calf of leg)
• Ringing in the ears
• Shortness of breath (sudden or unexplained)
• Slurring of speech (sudden)
• Sudden loss of consciousness
• Swelling of foot or leg
• Weakness, numbness, or pain in arm or leg (unexplained)

Check with your doctor as soon as possible if any of the following side effects occur:

• Changes in the uterine bleeding pattern at menses or between menses, such as decreased bleeding at menses, breakthrough bleeding or spotting between periods, prolonged bleeding at menses, complete stopping of menstrual bleeding that occurs over several months in a row, or stopping of menstrual bleeding that only occurs sometimes.

• Headaches or migraines (although headaches may lessen in many users, in others, they may increase in number or become worse)
• Increased blood pressure
• Vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge

• Mental depression
• Swelling, pain, or tenderness in upper abdominal area

• Pains in stomach, side, or abdomen
• Yellow eyes or skin

• Lumps in breast

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal cramping or bloating
• Acne (usually less common after first 3 months and may improve if acne already exists)
• Breast pain, tenderness, or swelling
• Dizziness
• Nausea
• Swelling of ankles and feet
• Unusual tiredness or weakness
• Vomiting

• Brown, blotchy spots on exposed skin
• Gain or loss of body or facial hair
• Increased or decreased interest in sexual intercourse
• Weight gain or loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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