Generic Name: norgestrel/ethinyl estradiol (nor-JES-trel/ETH-in-il es-tra-DYE-ole)
Brand Name: Examples include Lo/Ovral and Ogestrel
Smoking cigarettes while using norgestrel/ethinyl estradiol increases your chance of having heart problems. Do not smoke while using norgestrel/ethinyl estradiol. The risk of heart problems increases with age and with frequent smoking. Women older than 35 years of age and women who smoke 15 or more cigarettes per day are at a greater risk for heart problems.
Norgestrel/ethinyl estradiol is used for:
Preventing pregnancy. It may also be used for other conditions as determined by your doctor.
Norgestrel/ethinyl estradiol is a combination birth control pill. It works by preventing ovulation, altering the cervical mucus, and changing the lining of the uterus.
Do NOT use norgestrel/ethinyl estradiol if:
- you are allergic to any ingredient in norgestrel/ethinyl estradiol
- you have a history of blood clotting problems; heart disease; irregular heartbeat due to clotting problems; blood vessel problems (eg, blood flow problems in the brain or heart, stroke); chest pain (eg, heart attack, angina); certain types of headaches or migraines; uncontrolled high blood pressure; diabetes that affects circulation; breast cancer; endometrial, cervical, or vaginal cancer; estrogen-dependent growths; undiagnosed vaginal bleeding; yellowing of the eyes or skin due to pregnancy or prior birth control use; or liver disease or tumors
- you know or suspect that you are pregnant
- you have had surgery and are confined to a bed or a chair for an extended period of time
Contact your doctor or health care provider right away if any of these apply to you.
Before using norgestrel/ethinyl estradiol:
Some medical conditions may interact with norgestrel/ethinyl estradiol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have endometriosis, growths in the uterus, abnormal mammogram, irregular menstrual periods, a lump in the breast, heart problems, diabetes, headaches or migraines, gallbladder problems, high blood pressure, high blood cholesterol or lipid levels, kidney problems, blood problems (eg, porphyria), blood in the urine, depression or other mental/mood problems, lupus, chorea, high blood calcium levels, yellowing of the eyes or skin, pancreas problems (eg, pancreatitis), seizures (eg, epilepsy), or a history of cancer
- if you are overweight, you have not yet had your first menstrual period, or you use tobacco
Some MEDICINES MAY INTERACT with norgestrel/ethinyl estradiol. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Aprepitant, azole antifungals (eg, ketoconazole, itraconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, dexamethasone, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, penicillins (eg, amoxicillin), rifabutin, rifampin, phenylbutazone, primidone, tetracyclines (eg, doxycycline), topiramate, troglitazone, or St. John's wort because the effectiveness of norgestrel/ethinyl estradiol may be decreased, resulting in breakthrough bleeding or pregnancy
- Atorvastatin, indinavir, or troleandomycin because they may increase the risk of norgestrel/ethinyl estradiol's side effects.
- Beta-blockers (eg, propranolol), corticosteroids (eg, prednisolone), cyclosporine, or theophylline because the risk of their side effects may be increased by norgestrel/ethinyl estradiol
- Clofibric acid, morphine, lamotrigine, salicylic acid, or temazepam because their effectiveness may be decreased by norgestrel/ethinyl estradiol
This may not be a complete list of all interactions that may occur. Ask your health care provider if norgestrel/ethinyl estradiol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use norgestrel/ethinyl estradiol:
Use norgestrel/ethinyl estradiol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take norgestrel/ethinyl estradiol by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Begin taking norgestrel/ethinyl estradiol on the first Sunday following the start of your period, unless otherwise directed by your doctor. If your period begins on a Sunday, begin taking norgestrel/ethinyl estradiol on that day. Try to take norgestrel/ethinyl estradiol at the same time every day, not more than 24 hours apart. After taking the last pill in the pack, start taking the first pill from a new pack the very next day.
- Norgestrel/ethinyl estradiol works best if it is taken at the same time each day. Do not skip doses.
- If you miss 1 dose of norgestrel/ethinyl estradiol, take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. If you miss more than 1 dose of norgestrel/ethinyl estradiol, read the extra patient information leaflet that comes with norgestrel/ethinyl estradiol or contact your doctor for instructions. If you miss 1 or more doses of norgestrel/ethinyl estradiol, you must use a backup form of birth control for 7 days after you start to take it again. If you are not sure about how to handle miss doses, use an extra form of birth control (eg, condoms) and talk with your doctor.
Ask your health care provider any questions you may have about how to use norgestrel/ethinyl estradiol.
Important safety information:
- Norgestrel/ethinyl estradiol may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use norgestrel/ethinyl estradiol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Follow your doctor's instructions for examining your own breasts and report any lumps immediately.
- If you will be having surgery or will be confined to a bed or chair for a long period of time (such as a long plane flight), notify your doctor 3 to 4 weeks ahead of time. Special precautions may need to be taken in these circumstances while taking norgestrel/ethinyl estradiol.
- Norgestrel/ethinyl estradiol may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protected clothing when exposed to the sun, sunlamps, or tanning booths.
- Use of norgestrel/ethinyl estradiol will not prevent the spread of sexually transmitted diseases (STDs).
- Bleeding or spotting may occur while taking norgestrel/ethinyl estradiol. Do not stop taking norgestrel/ethinyl estradiol if this occurs. If bleeding or spotting continues for more than 7 days or is heavy, contact your doctor.
- Norgestrel/ethinyl estradiol may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.
- Norgestrel/ethinyl estradiol may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking norgestrel/ethinyl estradiol.
- Taking certain antibiotics, anticonvulsants, or other medicines, as listed in the interactions section, while you are using norgestrel/ethinyl estradiol may decrease the effectiveness of norgestrel/ethinyl estradiol. To prevent pregnancy, use an extra form of birth control until your next period.
- If you wear contact lens and you develop problems with them, contact your doctor.
- If you miss your period during the week of inactive pills, call your doctor immediately. A missed period may indicate that you are pregnant.
- Norgestrel/ethinyl estradiol may take time to wear off after your last dose. You may not be able to become pregnant for several months after stopping norgestrel/ethinyl estradiol. Discuss any concerns with your doctor or pharmacist.
- Lab tests, including PAP tests, may be performed while you use norgestrel/ethinyl estradiol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Norgestrel/ethinyl estradiol is not recommended for use in CHILDREN who have not had their first menstrual period. Safety and effectiveness in this age group have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use norgestrel/ethinyl estradiol if you are pregnant. If you think you may be pregnant, contact your doctor right away. Norgestrel/ethinyl estradiol is found in breast milk. Do not breast-feed while taking norgestrel/ethinyl estradiol.
Possible side effects of norgestrel/ethinyl estradiol:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Acne; breast tenderness or enlargement; changes in appetite; changes in weight; dizziness; headache; mild hair loss; nausea; nervousness; stomach cramps or bloating; vaginal spotting or breakthrough bleeding.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue, unusual hoarseness); absent menstrual period; breast discharge; breast lumps; calf or leg pain, swelling, or tenderness; change in the amount of urine produced; chest pain or heaviness; confusion; coughing of blood; dark urine; fainting; mental or mood changes (eg, depression); migraines; numbness of an arm or leg; one-sided weakness; pale stools; persistent, severe, or recurring headache or dizziness; persistent vaginal spotting; severe pain or tenderness in the stomach; shortness of breath; slurred speech; sudden severe headache or vomiting; swelling of the fingers, hands, legs, or ankles; unusual or severe vaginal bleeding; unusual tiredness or weakness; vaginal irritation, discharge, or change in secretions; vision changes (eg, sudden vision loss, double vision); yellowing of the skin or eyes (with or without fever).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include nausea; vaginal bleeding; vomiting.Proper storage of norgestrel/ethinyl estradiol:
Store norgestrel/ethinyl estradiol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep norgestrel/ethinyl estradiol out of the reach of children and away from pets.
- If you have any questions about norgestrel/ethinyl estradiol, please talk with your doctor, pharmacist, or other health care provider.
- Norgestrel/ethinyl estradiol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take norgestrel/ethinyl estradiol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about norgestrel/ethinyl estradiol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to norgestrel/ethinyl estradiol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using norgestrel/ethinyl estradiol.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.