Ethinyl estradiol/norgestimate biphasic (By mouth)

Prevents pregnancy and treats acne. This medicine is commonly called a birth control pill.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Each brand of birth control pills has specific directions. Read and follow the patient instructions for your prescribed brand. Talk to your doctor or pharmacist if you have any questions.
• Ask your doctor if you should use a second form of birth control for the first 7 days of your first cycle of pills.
• Take your pill at the same time every day. Birth control pills work best when there is no more than 24 hours between doses. Keep the pills in the original container. Take the pills in the order that they appear in the container.
• Follow the instructions in the patient leaflet or call your doctor if you vomit or have diarrhea within 3 to 4 hours of taking this medicine.
• Missed dose: Read and carefully follow the patient instructions if you miss a dose. You may need to use a second form of birth control for 1 week. You could have light bleeding or spotting any time you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the medicine in its original package.

Drugs and Foods to Avoid:

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

• Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
• Some foods and medicines can affect how birth control pills work. Tell your doctor if you are also using the following:
  • Acetaminophen, aprepitant, ascorbic acid, aspirin, atorvastatin, bosentan, clofibrate, colesevelam, cyclosporine, morphine, prednisolone, rosuvastatin, St John's wort, temazepam, theophylline, tizanidine
  • Medicine to treat an infection (including griseofulvin, fluconazole, itraconazole, ketoconazole, rifabutin, rifampicin, voriconazole
  • Medicine to treat HIV/AIDS (including amprenavir/ritonavir, atazanavir/ritonavir, boceprevir, darunavir/ritonavir, etravirine, fosamprenavir/ritonavir, indinavir, lopinavir/ritonavir, nelfinavir, nevirapine, ritonavir, telaprevir, tipranavir/ritonavir)
  • Medicine to treat seizures (including carbamazepine, felbamate, lamotrigine, oxcarbazepine, phenytoin, rufinamide, topiramate)
  • Thyroid replacement medicine
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor right away if you think you have become pregnant. If you miss 2 monthly periods in a row, call your doctor for a pregnancy test before you take any more pills.
• Tell your doctor if you are breastfeeding, or if you had given birth within 4 weeks before you start using this medicine. Tell your doctor if you have cervical cancer, diabetes, epilepsy, gallbladder disease, migraine headaches, heart or blood vessel disease, high cholesterol, a history of chloasma gravidarum (skin discoloration of the face during pregnancy), or depression, or a family history of breast cancer. Tell your doctor if you smoke or if you are having a surgery that requires inactivity for a long time.
• This medicine may cause the following problems:
  • Increased risk of heart attack, stroke, or blood clots
  • Liver problems (including cancer or tumors)
  • High blood pressure
  • Gallbladder disease
  • High cholesterol or fats in the blood
  • Possible increased risk of breast or cervical cancer
• This medicine will not protect you from HIV/AIDS or other sexually transmitted diseases.
• You might have spotting or irregular bleeding when you first start using this medicine. You might have unplanned bleeding if you miss a dose or are late taking it. However, if you have heavy bleeding, call your doctor.
• If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.
• 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.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Blistering, peeling, red skin rash
• Breast lumps, tenderness, pain, swelling, or discharge
• Chest pain or tightness, trouble breathing, or coughing up blood
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Pain in your lower leg (calf)
• Sudden and severe stomach pain, nausea, vomiting, lightheadedness
• Unusual or unexpected vaginal bleeding or heavy bleeding
• Unusual sweating, fainting
• Vision loss, double vision
• Yellow skin or eyes

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

• Darkened skin on your face
• Depression, mood changes
• Headaches
• Light spotting or bleeding between periods

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: 12/4/2023