Ethinyl estradiol and norethindrone is a combination birth control pill containing female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone is used as contraception to prevent pregnancy. This medicine is also used to treat moderate acne in women who are at least 15 years old and have started having menstrual periods, and who wish to use birth control pills. There are many available brands of ethinyl estradiol and norethindrone. Not all brands are listed on this leaflet.

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

Taking birth control pills 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. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart birth control pills after not taking them for 4 weeks or longer.

Tell your doctor if you have ever had:

Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills, especially if you are older than 35.

Do not use if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant, or if you miss 2 menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.

You should not take birth control pills if you have:

Ask a doctor if it is safe to breastfeed while using this medicine.

• untreated or uncontrolled high blood pressure, or 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;
• circulation problems (especially if caused by diabetes);
• 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;
• a history of jaundice caused by pregnancy or birth control pills;
• if you smoke and are over 35 years old; or
• if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir with or without dasabuvir.

• heart problems, high blood pressure, or if you are prone to having blood clots;
• high cholesterol or triglycerides, or if you are overweight;
• depression;
• a seizure or migraine headache;
• diabetes, gallbladder disease, underactive thyroid;
• liver or kidney disease; or
• irregular menstrual cycles, or fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

Use Genora 1/35 (Oral) 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 : hives; difficult breathing; swelling of your face, lips, tongue, or throat. signs of an allergic reaction

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

• signs of a stroke--sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot in the lung--chest pain, sudden cough or shortness of breath, dizziness, coughing up blood;
• signs of a blood clot deep in the body--pain, swelling, or warmth in one leg;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems--swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears;
• depression--mood changes, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself;
• swelling in your hands, ankles, or feet, or a breast lump; or
• a change in the pattern or severity of migraine headaches.

• nausea, vomiting;
• breast tenderness, or breakthrough bleeding; or
• headache, or problems with contact lenses.

Common side effects may include:

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 taking birth control pills, especially if you are older than 35 years of age.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.