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Norethindrone acetate/ethinyl estradiol/ferrous fumarate (By mouth)

Prevents pregnancy. This medicine contains an iron supplement.

Brand Name(s):

Lo Loestrin Fe

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. Do not use it if you had an allergic reaction to norethindrone, ethinyl estradiol, or ferrous fumarate, or if you are pregnant. Do not use it if you have vaginal bleeding that has not been checked by a doctor, liver disease or liver cancer, jaundice (yellow skin or eyes) caused by pregnancy or birth control pills, breast cancer, problems with blood clots, or certain heart problems or headaches.

How to Use This Medicine:

Tablet, Chewable Tablet, Tablet, Tablet

  • Your doctor will tell you how much medicine to use. Do not use more than directed. .
  • Take your pills at the same time every day in the order they appear in the container. Birth control pills work best when there is no more than 24 hours between doses.
  • Chewable tablets: The tablets may be chewed before swallowing, or swallowed whole. Drink a full glass of water (8 ounces) right after you take the tablet.
  • Use a second form of birth control for the first 7 days of your first cycle of pills. Your body will need at least 7 days to adjust to the new medicine before a pregnancy will be prevented.
  • If you vomit or have diarrhea within 3 to 4 hours of taking this medicine, treat this as a missed dose and follow the patient instructions or call your doctor.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
  • Missed dose:
    • This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.
    • Use a second form of birth control for the next 7 days after you miss a dose.
    • You could have light bleeding or spotting any time you do not take a pill on schedule. The more pills you miss, the more likely you are to have bleeding.
    • If you miss a pill or change your schedule, you may not have a period that month. Tell your doctor if you miss your period 2 months in a row, because you may be pregnant.
  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

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 this medicine works. Tell your doctor if you are using any of the following:
    • Acetaminophen, ascorbic acid (Vitamin C), atorvastatin, bosentan, clofibric acid, colesevelam, cyclosporine, morphine, prednisolone, rosuvastatin, salicylic acid, St John's wort, temazepam, theophylline, tizanidine
    • Thyroid medicines
    • Medicine to treat an infection (including ampicillin, fluconazole, griseofulvin, itraconazole, ketoconazole, rifabutin, rifampicin, tetracycline, voriconazole)
    • Medicine to treat HIV/AIDS (including amprenavir/ritonavir, atazanavir/ritonavir, darunavir/ritonavir, etravirine, fosamprenavir/ritonavir, indinavir, lopinavir/ritonavir, nelfinavir, nevirapine, ritonavir, tipranavir/ritonavir)
    • Medicine to treat seizures (including carbamazepine, felbamate, lamotrigine, oxcarbazepine, phenobarbital, phenytoin, rufinamide, topiramate)
  • Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

  • It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
  • 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 kidney disease, diabetes, gallbladder disease, hereditary angioedema, high blood pressure, high cholesterol, migraines, or a history of cervical cancer, depression, or chloasma gravidarum (skin disorder during pregnancy). Tell your doctor if you smoke or if you are having a surgery that requires inactivity for a long time. Tell your doctor if you wear contact lenses.
  • This medicine may cause the following problems:
    • Increased risk of heart attack, stroke, or blood clots
    • Increased risk of breast, endometrial, ovarian, or cervical cancer
    • Liver problems (including liver tumor or cancer)
    • High blood pressure
    • Gallbladder disease
    • High cholesterol in the blood
    • Eye or vision problems
  • This medicine will not protect you from getting HIV/AIDS or other sexually transmitted infections.
  • This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
  • 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 do lab tests at regular visits to check on the effects of this medicine. 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
  • Breast lumps, tenderness, pain, swelling, or discharge
  • Chest pain that may spread, trouble breathing, unusual sweating, fainting
  • Dark urine or pale stools, loss of appetite, yellow skin or eyes
  • Heavy vaginal bleeding, irregular or missed menstrual period
  • Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg (calf), sudden or severe headache, or problems with vision, speech, or walking
  • Sudden and severe stomach pain, nausea, vomiting, lightheadedness
  • Vision loss, double or blurred vision

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

  • Mood changes, depression, nervousness
  • Vaginal spotting or light bleeding, itching, or discharge

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: 5/1/2020

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