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Overview: Norethindrone/ethinyl estradiol is a hormonal birth control pill that is used to prevent pregnancy. Common side effects include nausea, headache, and breast tenderness. Before taking norethindrone/ethinyl estradiol, make sure to tell your health care provider about any health conditions you have or medicines you are taking. Get emergency help if you have trouble breathing, chest pain, vision changes, or trouble speaking.

Uses

What is norethindrone/ethinyl estradiol  used for?

Norethindrone/ethinyl estradiol is a combination birth control pill that is commonly used to prevent pregnancy.

Norethindrone/ethinyl estradiol may also be used for other conditions as determined by your health care provider.

How does norethindrone/ethinyl estradiol work (mechanism of action)?

Norethindrone/ethinyl estradiol contains two types of hormones, norethindrone (a progestin) and ethinyl estradiol (an estrogen). It prevents pregnancy by stopping the release of an egg from your ovaries. Norethindrone/ethinyl estradiol also works by thickening the mucus in your cervix to block sperm from reaching the uterus and by changing the lining of your uterus to make it less likely for a pregnancy to happen.

How is norethindrone/ethinyl estradiol supplied?

21-Day Monophasic (one phase)

Nortrel 1/35

  • Days 1-21: norethindrone/ethinyl estradiol oral tablets (1 mg/0.035 mg)

28-Day Monophasic (one phase)

Balziva, Briellyn, Philith, Rhuzdah, Vyfemla

  • Days 1-21: norethindrone/ethinyl estradiol oral tablets (0.4 mg/0.035 mg)
  • Days 22-28:  inactive oral tablets

Necon, Nortrel 0.5/35

  • Days 1-21: norethindrone/ethinyl estradiol oral tablets (0.5 mg/0.035 mg)
  • Days 22-28:  inactive oral tablets

Alyacen 1/35, Dasetta 1/35, Nortrel 1/35, Nylia 1/35

  • Days 1-21: norethindrone/ethinyl estradiol oral tablets (1 mg/0.035 mg)
  • Days 22-28:  inactive oral tablets

28-Day Triphasic (three phases)

Aranelle, Leena

  • Days 1-7: norethindrone/ethinyl estradiol oral tablets (0.5 mg/0.035 mg)
  • Days 8-16: norethindrone/ethinyl estradiol oral tablets (1 mg/0.035 mg) 
  • Days 17-21: norethindrone/ethinyl estradiol oral tablets (0.5 mg/0.035 mg) 
  • Days 22-28: inactive oral tablets

Alyacen 7/7/7, Dasetta 7/7/7, Nortrel 7/7/7, Nylia 7/7/7

  • Days 1-7: norethindrone/ethinyl estradiol oral tablets (0.5 mg/0.035 mg)
  • Days 8-14: norethindrone/ethinyl estradiol oral tablets (0.75 mg/0.035 mg) 
  • Days 15-21: norethindrone/ethinyl estradiol oral tablets (1 mg/0.035 mg) 
  • Days 22-28: inactive oral tablets

How should I store norethindrone/ethinyl estradiol?

Norethindrone/ethinyl estradiol should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Only remove a tablet from the blister pack when you are ready to take it.

Side Effects

Consult your pharmacist or physician.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Warnings & Precautions

Who should not use norethindrone/ethinyl estradiol ?

Allergies to Ingredients. People who are allergic to any of the following should not take norethindrone/ethinyl estradiol.

  • Norethindrone
  • Ethinyl estradiol
  • Alyacen
  • Aranelle
  • Balziva
  • Briellyn
  • Cyclafem
  • Dasetta
  • Gildagia
  • Leena
  • Modicon
  • Necon
  • Norinyl
  • Nortrel
  • Nylia
  • Ortho Novum
  • Philith
  • Pirmella
  • Tri-Norinyl
  • Vyfemla
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific norethindrone/ethinyl estradiol products they stock.

Blood Clots. Norethindrone/ethinyl estradiol should not be used if you have or have had blood clots, including a blood clot in the lungs (pulmonary embolism) or deep vein thrombosis (DVT). This medicine should also not be used if you have a condition that makes your blood more prone to getting blood clots (thrombophilia). Norethindrone/ethinyl estradiol can increase the risk of developing a blood clot that could be dangerous or even deadly.

Heart Attack or Stroke. Norethindrone/ethinyl estradiol should not be used if you have had a stroke or heart attack. Norethindrone/ethinyl estradiol can increase the risk of having a heart attack or stroke that could be dangerous or even deadly.

Blood Vessel Problems. Norethindrone/ethinyl estradiol should not be used if you have or have had a history of plaque buildup in your blood vessels (coronary artery disease) or if you have or have had a condition that affects blood flow to your brain (cerebrovascular disease). Norethindrone/ethinyl estradiol could increase your chances of having a heart attack, stroke, or blood clots.

Cancer. Norethindrone/ethinyl estradiol should not be used if you have, suspect you have, or have had breast cancer, uterine cancer, or if you have a tumor or cancer that is sensitive to hormones. These conditions could get worse if you use norethindrone/ethinyl estradiol.

Unusual Vaginal Bleeding. Norethindrone/ethinyl estradiol should not be used if you have bleeding from the uterus or vagina that is not part of your menstrual cycle or is abnormal. Any unusual uterine bleeding needs to be checked out by your health care provider.

Jaundice. Norethindrone/ethinyl estradiol should not be taken if you have had a history of jaundice when taking birth control or have had cholestatic jaundice during pregnancy (bile from the liver not flowing properly).

Liver Problems. Norethindrone/ethinyl estradiol should not be used if you have a liver tumor or your liver is not working as well as it should be. If there is a concern about the health of your liver, your health care provider may do tests to see if it is working well enough to take this medicine.

Pregnancy. Do not take norethindrone/ethinyl estradiol if you are pregnant. If you become pregnant, contact your health care provider right away. See the Pregnancy section for more details.

Drug Interactions. Norethindrone/ethinyl estradiol should not be taken while you are using certain other medicines. Before taking norethindrone/ethinyl estradiol, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Increased Blood Pressure (Hypertension). Norethindrone/ethinyl estradiol should not be used if you have high blood pressure that is not managed or high blood pressure with a condition that affects your blood vessels (vascular disease). Norethindrone/ethinyl estradiol could increase your chances of having a heart attack, stroke, or blood clots.

Diabetes. Norethindrone/ethinyl estradiol should not be used if you have diabetes with kidney, eye, nerve, or blood vessel damage. This can increase your chance of having a heart attack, stroke, or blood clots.

Headaches or Migraine. Norethindrone/ethinyl estradiol should not be used if you have migraine with vision or hearing changes, muscle weakness, tingling, or trouble speaking (known as migraine with aura) or certain other types of headaches. This can increase your risk of having a stroke.

Upcoming Surgery or Bed Rest. Norethindrone/ethinyl estradiol should not be taken if you have any upcoming major surgeries or need to be on bed rest. You may be at increased risk for some side effects of norethindrone/ethinyl estradiol if you do not move around normally for an extended period of time.

What should I know about norethindrone/ethinyl estradiol before using it?

Do not take norethindrone/ethinyl estradiol unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share norethindrone/ethinyl estradiol with other people, even if they have the same condition as you. It may harm them.

Keep norethindrone/ethinyl estradiol out of the reach of children.

Norethindrone/ethinyl estradiol does not protect you from HIV, AIDS, or other sexually transmitted diseases (STDs).

Expect to start norethindrone/ethinyl estradiol during a specific time of your menstrual period or within a certain time after having a baby or an abortion. The timing will determine whether and for how long you need to use backup birth control (such as condoms or spermicide) after starting norethindrone/ethinyl estradiol. Ask your health care provider if you are not sure how or when to start norethindrone/ethinyl estradiol.

Take tablets in order (from left to right) at the same time every day until the pack is finished and swallow the tablets whole. After taking the last tablet in the blister pack, start with the first tablet in a new blister pack.

Consider using a calendar or app to help you remember to take norethindrone/ethinyl estradiol at the same time each day.

If you have vomiting or diarrhea within a few hours of taking norethindrone/ethinyl estradiol, it may not work as well. Follow the Patient Labeling on what to do if this happens or call your health care provider.

Norethindrone/ethinyl estradiol may affect your blood sugar or cholesterol levels. Make sure to keep all follow-up appointments, including for blood work and blood pressure checks, with your health care provider.

If you miss a period, check for pregnancy. The risk of pregnancy increases with missed pills.

What should I tell my health care provider before using norethindrone/ethinyl estradiol?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if norethindrone/ethinyl estradiol  is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Nodules or fibroids in the breast
  • Diabetes
  • High cholesterol or triglycerides
  • High blood pressure
  • Headaches or migraine
  • Seizures
  • Depression 
  • Gallbladder, kidney, liver, or heart problems
  • Irregular periods 
  • Hereditary angioedema

Smoking.  Norethindrone/ethinyl estradiol should not be used if you smoke and are over age 35.

Smoking can increase your risk of getting heart disease, which increases your risk of having a heart attack, stroke, or blood clots. Tell your health care provider if you smoke before starting norethindrone/ethinyl estradiol.

Skin Darkening. Talk to your health care provider if you have had a condition that led to dark patches of skin around your forehead, nose, cheeks, and around your mouth (chloasma) during pregnancy because you may have an increased chance of having chloasma while taking norethindrone/ethinyl estradiol. If you have had chloasma, avoid exposure to the sun and to ultraviolet (UV) rays from tanning booths or sun lamps.

Pregnancy. Do not take norethindrone/ethinyl estradiol and tell your health care provider if you are pregnant or plan to become pregnant. If you become pregnant, stop taking norethindrone/ethinyl estradiol right away and contact your health care provider.

Breastfeeding. Norethindrone/ethinyl estradiol passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Norethindrone/ethinyl estradiol may decrease the amount of breastmilk you make. Your health care provider will let you know if you should take norethindrone/ethinyl estradiol while breastfeeding.

Interactions

Does norethindrone/ethinyl estradiol interact with foods or drinks?

Eating grapefruit or drinking grapefruit juice while taking norethindrone/ethinyl estradiol can increase the levels of medicine in your body and increase the risk of side effects. Talk to your health care provider if you eat grapefruit or drink grapefruit juice.

It is unknown if drinking alcohol will affect norethindrone/ethinyl estradiol.

Does norethindrone/ethinyl estradiol interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

 In particular, make sure that you discuss if you are using any of the following before taking norethindrone/ethinyl estradiol.

  • A medicine for HIV, AIDS, or hepatitis C
  • Any medicine that may be used to treat seizures, such as carbamazepine (Carbatrol, Tegretol, and others), felbamate, lamotrigine (Lamictal), oxcarbazepine (Oxtellar XR, Trileptal), phenytoin (Dilantin, Phenytek, and others), or topiramate (Qudexy XR, Topamax, Trokendi XR)
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • A barbiturate, such as butalbital, phenobarbital, or primidone, which are medicines that may be used to treat insomnia, migraine, or seizures
  • Bosentan, which is a medicine used to treat a condition called pulmonary arterial hypertension (PAH)
  • Aprepitant, which is a medicine used to prevent nausea and vomiting caused by chemotherapy 
  • St. John’s wort, which is a supplement that may be used to treat depression
  • Colesevelam (Welchol), which is a medicine for high cholesterol and high blood sugar from type 2 diabetes
  • Fluconazole (Diflucan), griseofulvin, itraconazole (Sporanox, Tolsura), ketoconazole, or voriconazole (Vfend), which are medicines used for fungal infections
  • Cyclosporine (Gengraf, Neoral, Sandimmune, and others), which is a medicine that suppresses your immune system
  • Prednisolone, which is a medicine for certain inflammatory conditions
  • Theophylline (Elixophyllin, Theo-24), which is a medicine for asthma or certain other breathing problems
  • Tizanidine (Zanaflex), which is a muscle relaxant
  • A tetracycline, such as doxycycline, minocycline, omadacycline (Nuzyra), sarecycline (Seysara), or tetracycline, which are medicines used to treat infections or other conditions

Some other medicines may alter the blood levels of norethindrone/ethinyl estradiol, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with norethindrone/ethinyl estradiol . Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much norethindrone/ethinyl estradiol?

If you or someone else has used too much norethindrone/ethinyl estradiol, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of norethindrone/ethinyl estradiol?

Norethindrone/ethinyl estradiol may not work well if you miss tablets. Follow the Patient Labeling on how to take norethindrone/ethinyl estradiol when you miss a dose, as this can change depending on how many tablets you have missed and which weeks they were missed on. In some cases, you may need to avoid sexual intercourse or use backup birth control (such as condoms or spermicide).

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