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Overview: Norethindrone/ethinyl estradiol is used to treat hot flashes due to hormonal changes in menopause. It may also be used to prevent bone loss (osteoporosis) after menopause. Common side effects include stomach pain and headaches. Before using 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, or vision changes.

Uses

What is norethindrone/ethinyl estradiol used for?

Norethindrone/ethinyl estradiol is commonly used to treat hot flashes due to hormonal changes in menopause. It may also be used to prevent bone loss (osteoporosis) after menopause.

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 kinds of hormones: ethinyl estradiol (an estrogen) and norethindrone (a progestin). Ethinyl estradiol works by replacing estrogen, a hormone your body makes less of during menopause. Norethindrone is a progestin hormone that helps balance the effect of estrogen, decreasing the chance of uterine cancer while taking an estrogen-containing medicine.

How is norethindrone/ethinyl estradiol supplied (dosage forms)?

Brands and other names

  • Amabelz
  • FemHRT
  • Fyavolv
  • Jinteli

Dosage forms and strengths

  • 0.5 mg/0.0025 mg, 1 mg/0.005 mg 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 you’re transporting it. Store it in a cool, dry place.

Side Effects

What are the most common side effects of norethindrone/ethinyl estradiol?

The most common side effects of norethindrone/ethinyl estradiol are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Headache
  • Stomach pain or bloating
  • Breast pain and tenderness
  • Fluid retention (see below)
  • Nausea or vomiting
  • Irregular vaginal bleeding or spotting
  • Hair loss
  • Vaginal yeast infection 

There may be other side effects of norethindrone/ethinyl estradiol that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of norethindrone/ethinyl estradiol?

While less common, the most serious side effects of norethindrone/ethinyl estradiol are described below, along with what to do if they happen.

Severe Allergic Reactions. Norethindrone/ethinyl estradiol may cause allergic reactions, which can be serious. Stop taking norethindrone/ethinyl estradiol and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown, depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Blood Clots. Norethindrone/ethinyl estradiol may cause a blood clot in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism (VTE), including a blood clot in the lungs (pulmonary embolism), in the back of your eye (retinal vein occlusion), or in your legs or arms (deep venous thrombosis). Stop taking norethindrone/ethinyl estradiol and get emergency help if you have any of the following signs of a blood clot.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Pain, swelling, or tenderness in your arm or leg
  • Vision loss
  • Bulging eyes
  • Double vision

Cancer. Norethindrone/ethinyl estradiol can cause a new cancer to develop, such as  breast cancer, ovarian cancer, or endometrial cancer. Tell your health care provider about any new symptoms that you may get. Call your health care provider right away if you have any of the following symptoms.

  • New lump in your breast or armpit
  • Changes in the size, shape, texture, or temperature of your breast
  • Nipple changes
  • Unusual vaginal discharge
  • Belly or back pain
  • Need to pee more often or urgently
  • Unusual vaginal bleeding

Dementia. Norethindrone/ethinyl estradiol may affect your brain, especially if you are 65 or older. Tell your health care provider right away if you or your friends or family notice that you have any of the following.

  • Memory problems, such as asking the same question over and over
  • Confusion or disorientation
  • Trouble with complex but familiar tasks, such as cooking a meal or paying your bills
  • Personality changes, such as depression, agitation, paranoia, and mood swings

Gallbladder Problems. Taking norethindrone/ethinyl estradiol can cause gallbladder problems, including cholecystitis and cholelithiasis (also known as gallstones). Call your health care provider right away if you have any of the following symptoms.

  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Fever
  • Pain in your upper stomach area
  • Stool (poop) that is clay-colored

Increased Blood Pressure (Hypertension). Norethindrone/ethinyl estradiol may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your health care provider if your blood pressure increases while taking this medicine.

If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but look out for and tell your health care provider right away if you have any of the following symptoms of severely high blood pressure.

  • Sudden severe headache
  • Chest pain
  • Dizziness or confusion
  • Trouble breathing
  • Nausea or vomiting
  • Blurry vision or other changes to vision
  • Anxiety
  • Buzzing in the ears
  • Nosebleed
  • Feeling of skipped heartbeats

Fluid Retention (Edema). Norethindrone/ethinyl estradiol can cause fluid retention, also called edema. Fluid retention can cause serious issues in people with certain conditions, such as heart failure or kidney problems. Call your health care provider right away if you have any of the following symptoms.

  • Chest pain
  • Irregular heartbeat
  • Shortness of breath
  • Stretched or shiny skin
  • Swollen body parts, such as the belly or ankles

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking norethindrone/ethinyl estradiol. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Uterine Fibroids. Norethindrone/ethinyl estradiol may cause tumors (fibroids) in your uterus  to get bigger. Some fibroids are small and cause no symptoms, while others may grow and cause problems. Talk to your health care provider if you have any of the following symptoms.

  • Heavy, long, painful periods
  • Pain in the lower belly or back
  • Painful sex
  • Peeing often 
  • Discomfort in the rectum

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
  • Amabelz
  • FemHRT
  • Fyavolv
  • Jinteli
  • 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.

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 unusual. 

Cancer. Norethindrone/ethinyl estradiol should not be used if you have, suspect, or had breast cancer, or a cancer that is sensitive to estrogen. These conditions could worsen if you take norethindrone/ethinyl estradiol.

Blood Clots. Norethindrone/ethinyl estradiol should not be used if you have or had blood clots, including a blood clot in the lungs (pulmonary embolism) or deep venous thrombosis (DVT). Also, the medicine should 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 having a blood clot that could be dangerous, even life-threatening.

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

Liver Problems. Norethindrone/ethinyl estradiol should not be used if 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 find out if it is working well enough to take this medicine. 

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.

If your medicine comes in a blister pack, start the next pack right after you finish one. Each pack of norethindrone/ethinyl estradiol contains 28 tablets. 

Make sure to keep all follow-up appointments with your health care provider. They will use these appointments to check if your dose or medicine needs to be changed. Estrogen-containing medicines should be used at the lowest possible dose for only as long as they are needed.

Perform monthly self-breast exams and have regular pelvic exams (female exam), breast exams (done by a health care provider), and mammograms (X-ray to look closely at breast tissue) before taking norethindrone/ethinyl estradiol and during treatment with it.

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 know 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.

Tobacco Use. Smoking and tobacco use 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 use any tobacco products before starting norethindrone/ethinyl estradiol. 

Upcoming Surgery or Bed Rest. You may have a higher risk of some side effects of norethindrone/ethinyl estradiol if you do not move around normally for an extended period of time. Tell your health care provider if you have any upcoming surgeries or need to be on bed rest. Your health care provider can tell you if or when you need to stop taking norethindrone/ethinyl estradiol.

High Triglyceride Levels. If you have high triglyceride levels, norethindrone/ethinyl estradiol may make your triglycerides even higher. Very high triglyceride levels can lead to inflammation of the pancreas, which is called pancreatitis. Tell your health care provider if you have high triglyceride levels.

Hysterectomy. Norethindrone/ethinyl estradiol contains a progestin to decrease the chances of getting cancer of the uterus. Tell your health care provider if you have had a hysterectomy and do not have a uterus.

Other Medicines and Supplements. Norethindrone/ethinyl estradiol may interact with other medicines and supplements. 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.

Pregnancy. People who can become pregnant are not usually prescribed norethindrone/ethinyl estradiol. Tell your health care provider if you are pregnant or plan to become pregnant. If you become pregnant while taking norethindrone/ethinyl estradiol, stop taking the medicine 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. 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 increases levels of the medicine in your body and increases 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.

  • St. John’s wort, which is a supplement that may be used for depression
  • Carbamazepine (Carbatrol, Tegretol, and others), which is a medicine commonly used to treat seizures or nerve pain
  • Lamotrigine (Lamictal), which is a medicine commonly used for seizures
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Clarithromycin or erythromycin (Ery-Tab and others), which are medicines used for bacterial infections
  • Itraconazole (Sporanox, Tolsura) or ketoconazole, which are medicines used for fungal infections
  • Ritonavir (Norvir), which is a medicine commonly used to treat HIV

Some other medicines may alter the blood levels of norethindrone/ethinyl estradiol, or 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?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

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