Ethinyl estradiol and levonorgestrel transdermal (skin patch) is a combination birth control medicine used to prevent pregnancy.

Ethinyl estradiol and levonorgestrel may also be used for purposes not listed in this medication guide.

Using this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not use ethinyl estradiol and levonorgestrel if you smoke and are over 35 years old.

Your risk of serious blood clot may be higher with the use of birth control skin patches than with the use of birth control pills.

You should not use ethinyl estradiol and levonorgestrel if you have:

• untreated or uncontrolled high blood pressure;
• heart disease (chest pain, coronary artery disease, history of heart attack, stroke, or blood clot);
• an increased risk of having blood clots due to a heart problem or a hereditary blood disorder;
• diabetes (and you are over 35, have high blood pressure, have had diabetes longer than 20 years, or if diabetes has caused damage to your kidneys, eyes, nerves, or blood vessels);
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;
• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or liver cancer;
• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35; or
• if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir (Viekira).

Tell your doctor if you have ever had:

• heart disease, high blood pressure, or if you are prone to having blood clots;
• high cholesterol that is not controlled;
• depression;
• migraine headache;
• diabetes, gallbladder disease;
• jaundice caused by pregnancy or hormonal birth control;
• hereditary angioedema;
• irregular menstrual cycles; or
• dark patches of skin on your face (chloasma).

Do not use this medicine if you are pregnant. You may need to have a negative pregnancy test before using ethinyl estradiol and levonorgestrel. Tell your doctor if you think you may be pregnant.

Ethinyl estradiol and levonorgestrel can slow breast milk production. You should not breastfeed while using this medicine.

Use Twirla (Transdermal) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, problems with vision or speech;
• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, swelling or pain in an arm or leg;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• severe headache, pounding in your neck or ears;
• jaundice (yellowing of the skin or eyes);
• swelling in your hands, ankles, or feet;
• a change in the pattern or severity of migraine headaches; or
• symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

• menstrual cramps;
• nausea;
• weight gain;
• headache; or
• skin reactions where a patch was worn--bumps, redness, skin color changes, itching, rash, dryness, pain, swelling, 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.

Do not smoke while using this medicine, especially if you are older than 35 years of age.

Grapefruit may interact with ethinyl estradiol and levonorgestrel and lead to unwanted side effects. Avoid the use of grapefruit products.

This medicine may cause darkening of your facial skin (chloasma), especially if you've ever had chloasma during a pregnancy. Avoid sunlight or tanning beds. Use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid applying makeup, lotions, powders, or oils to the skin where you apply a skin patch.