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Overview: Norethindrone acetate/ethinyl estradiol and ferrous fumarate is a hormonal birth control pill that is used to prevent pregnancy. Norethindrone acetate/ethinyl estradiol and ferrous fumarate does not protect against sexually transmitted diseases, such as HIV. Common side effects include nausea and vomiting, breast tenderness, and bleeding between periods. Before taking norethindrone acetate/ethinyl estradiol and ferrous fumarate, 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 acetate/ethinyl estradiol and ferrous fumarate used for?

Norethindrone acetate/ethinyl estradiol and ferrous fumarate is a combination birth control pill used to prevent pregnancy. The medicine can also be used to help treat moderate acne in people who also want to use a combination birth control pill to prevent pregnancy for at least six months.

These uses may vary depending on the specific norethindrone acetate/ethinyl estradiol and ferrous fumarate product prescribed.

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

How does norethindrone acetate/ethinyl estradiol and ferrous fumarate work (mechanism of action)?

Norethindrone acetate/ethinyl estradiol and ferrous fumarate works in a few different ways. It works mainly by stopping the release of an egg from your ovaries. The medicine 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. Ferrous fumarate is a type of iron that makes up the last few pills in each pack. The number of iron pills depends on the product you use. Iron does not help prevent pregnancy, but these pills are included as “reminder” pills. You will take a pill every day, and your period may start when taking these iron pills.

Acne is caused by many things, including hormones that increase the amount of oil on your skin. Norethindrone acetate/ethinyl estradiol and ferrous fumarate may help improve acne by affecting hormones.

How is norethindrone acetate/ethinyl estradiol and ferrous fumarate supplied?

28-Day Monophasic (one phase)

Blisovi 24 Fe, Junel 24 Fe, Larin 24 Fe, Loestrin 24 Fe, Lomedia 24 Fe, Melodetta 24 Fe, Mibelas 24 Fe, Tarina 24 Fe

  • Days 1-24: Norethindrone acetate/ethinyl estradiol oral tablets (1 mg/0.02 mg)
  • Days 25-28: Ferrous fumarate oral tablets (75 mg)

Merzee, Minastrin 24 Fe, Taytulla

  • Days 1-24: Norethindrone acetate/ethinyl estradiol oral capsules (1 mg/0.02 mg)
  • Days 25-28: Ferrous fumarate oral capsules (75 mg)

Blisovi Fe 1.5/30, Junel Fe 1.5/30, Larin Fe 1.5/30, Loestrin Fe 1.5/30, Microgestin Fe 1.5/30

  • Days 1-21: Norethindrone acetate/ethinyl estradiol oral tablets (1.5 mg/0.03 mg)
  • Days 22-28: Ferrous fumarate oral tablets (75 mg)

Blisovi Fe 1/20, Junel Fe 1/20, Larin Fe 1/20, Loestrin Fe 1/20, Microgestin Fe 1/20, Tarina Fe 1/20

  • Days 1-21: Norethindrone acetate/ethinyl estradiol oral tablets (1 mg/0.02 mg)
  • Days 22-28: Ferrous fumarate oral tablets (75 mg)

Biphasic (two phases)

Lo Loestrin Fe, Lo Minastrin Fe

  • Days 1-24: Norethindrone acetate/ethinyl estradiol oral tablets (1 mg/0.01 mg)
  • Days 25-26: Ethinyl estradiol oral tablets (0.01 mg)
  • Days 27-28: Ferrous fumarate oral tablets (75 mg)

Triphasic (three phases)

Estrostep Fe, Tilia Fe, TriLegest Fe

  • Days 1-5: Norethindrone acetate/ethinyl estradiol oral tablets (1 mg/0.02 mg)
  • Days 6-12: Norethindrone acetate/ethinyl estradiol oral tablets (1 mg/0.03 mg)
  • Days 13-21: Norethindrone acetate/ethinyl estradiol oral tablets (1 mg/0.035 mg)
  • Days 22-28: Ferrous fumarate oral tablets (75 mg)

How should I store norethindrone acetate/ethinyl estradiol and ferrous fumarate?

Norethindrone acetate/ethinyl estradiol and ferrous fumarate 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. Protect from light.

Side Effects

What are the most common side effects of norethindrone acetate/ethinyl estradiol and ferrous fumarate?

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

  • Headache (see below)
  • Nausea and vomiting
  • Period cramps
  • Breast tenderness
  • Mood changes
  • Weight gain
  • Painful periods or bleeding between periods
  • Trouble wearing contact lenses

There may be other side effects of norethindrone acetate/ethinyl estradiol and ferrous fumarate 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 acetate/ethinyl estradiol and ferrous fumarate?

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

Severe Allergic Reactions. Norethindrone acetate/ethinyl estradiol and ferrous fumarate may cause allergic reactions, which can be serious. Stop taking norethindrone acetate/ethinyl estradiol and ferrous fumarate 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, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Blood Clots. Norethindrone acetate/ethinyl estradiol and ferrous fumarate may cause blood clots in your veins or arteries and could cause venous thromboembolism (VTE), stroke, heart attack, a blood clot in the lungs (pulmonary embolism), or a blood clot in the eyes. Stop taking norethindrone acetate/ethinyl estradiol and ferrous fumarate and get emergency help right away if you have any of the following signs of blood clots. 

  • 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

Liver Problems. Norethindrone acetate/ethinyl estradiol and ferrous fumarate may cause changes to your liver function, including liver tumors and an increase in your liver enzymes. Call your health care provider right away if you have any of the following symptoms of liver problems.

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

Increased Blood Pressure (Hypertension). Norethindrone acetate/ethinyl estradiol and ferrous fumarate may increase your blood pressure or make it worse if you have a history of high blood pressure. Keep all appointments with your health care provider. 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 or higher or the bottom number (diastolic) is 120 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 or other changes to vision
  • Anxiety
  • Buzzing in the ears
  • Nosebleed
  • Feeling of skipped heartbeats

Gallbladder Problems. Taking norethindrone acetate/ethinyl estradiol and ferrous fumarate 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
  • Clay-colored stool (poop)

Headache or Migraine. Stop taking norethindrone acetate/ethinyl estradiol and ferrous fumarate and call your health care provider right away if you get new headaches/migraines that keep coming back or cause you a lot of pain.

Changes in Menstrual Bleeding. Norethindrone acetate/ethinyl estradiol and ferrous fumarate can cause irregular bleeding, spotting, or light bleeding between periods, especially during the first three months of use. For some people, periods may stop. Call your health care provider right away if you continue to have spotting or breakthrough bleeding between periods or if you have spotting after having regular cycles while taking norethindrone acetate/ethinyl estradiol and ferrous fumarate.

Depression. Norethindrone acetate/ethinyl estradiol and ferrous fumarate may cause changes in mood, including depression. Stop taking norethindrone acetate/ethinyl estradiol and ferrous fumarate and call your health care provider right away if you have new or increased feelings of depression or other unusual changes in mood or behavior.

Cancer. Norethindrone acetate/ethinyl estradiol and ferrous fumarate is a combination birth control pill that contains two hormones. Certain cancers, including breast cancer and cervical cancer, are types of cancers that may be sensitive to hormones. Make sure you keep all appointments with your health care provider.

Warnings & Precautions

Who should not use norethindrone acetate/ethinyl estradiol and ferrous fumarate?

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

  • Blisovi Fe 1/20
  • Ethinyl estradiol
  • Ferrous fumarate (iron)
  • Junel Fe
  • Lo Loestrin Fe
  • Norethindrone acetate
  • Any of the ingredients in the specific product dispensed

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

Smoking. Norethindrone acetate/ethinyl estradiol and ferrous fumarate should not be used if you smoke and are 35 or older as this can increase your chances of having a heart attack, stroke, or blood clots.

History of Blood Clots. Norethindrone acetate/ethinyl estradiol and ferrous fumarate should not be used if you currently have or have had deep vein thrombosis (DVT) or pulmonary embolism (PE).

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

Blood and Blood Vessel Problems. Norethindrone acetate/ethinyl estradiol and ferrous fumarate should not be used if you have a condition that makes your blood more prone to forming blood clots (hypercoagulation). Norethindrone acetate/ethinyl estradiol and ferrous fumarate 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 the blood flow to your brain (cerebrovascular disease).

Heart Problems. Norethindrone acetate/ethinyl estradiol and ferrous fumarate should not be used if you have heart rhythm problems (such as atrial fibrillation) or heart valve problems as this may increase your chances of having a blood clot.

Increased Blood Pressure (Hypertension). Norethindrone acetate/ethinyl estradiol and ferrous fumarate should not be used if you have high blood pressure that is not controlled or high blood pressure with a condition that affects your blood vessels (vascular disease).

Diabetes. Norethindrone acetate/ethinyl estradiol and ferrous fumarate should not be used if you have diabetes and are over the age of 35; have high blood pressure; or have kidney, eye, nerve, or blood vessel damage. Norethindrone acetate/ethinyl estradiol and ferrous fumarate should also not be used if you have had diabetes for more than 20 years.

Headaches or Migraine. Norethindrone acetate/ethinyl estradiol and ferrous fumarate 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. Norethindrone acetate/ethinyl estradiol and ferrous fumarate should not be used if you are 35 or older with migraine headaches (with or without aura). 

Cancer. Norethindrone acetate/ethinyl estradiol and ferrous fumarate should not be used if you have or have had breast cancer. Some products should not be used if you have endometrial cancer or any other known or suspected cancer that is estrogen-dependent.

Liver Problems. Norethindrone acetate/ethinyl estradiol and ferrous fumarate should not be used if you have tumors on your liver or liver disease.

Unusual Vaginal Bleeding. Norethindrone acetate/ethinyl estradiol and ferrous fumarate 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 acetate/ethinyl estradiol and ferrous fumarate should not be used if you have had a history of jaundice when using birth control or have had cholestatic jaundice during pregnancy (bile from the liver not flowing properly).

Pregnancy. Do not use norethindrone acetate/ethinyl estradiol and ferrous fumarate if you are pregnant. If you become pregnant, contact your health care professional right away. See the Pregnancy section for more details.

Drug Interactions. Norethindrone acetate/ethinyl estradiol and ferrous fumarate should not be taken while you are using certain other medicines. Before taking norethindrone acetate/ethinyl estradiol and ferrous fumarate, 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.

What should I know about norethindrone acetate/ethinyl estradiol and ferrous fumarate before using it?

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

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

Keep norethindrone acetate/ethinyl estradiol and ferrous fumarate out of the reach of children.

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

Follow the Patient Labeling that comes with your medicine on how to start norethindrone acetate/ethinyl estradiol and ferrous fumarate.

Take norethindrone acetate/ethinyl estradiol and ferrous fumarate at the same time everyday. Consider using a calendar or app to help you remember to take norethindrone acetate/ethinyl estradiol and ferrous fumarate at the same time each day. If you miss a period, check for pregnancy. The risk of pregnancy increases with missed pills.

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 acetate/ethinyl estradiol and ferrous fumarate at the same time each day. If you miss a period, check for pregnancy. The risk of pregnancy increases with missed pills.

Talk to your health care provider about backup birth control options (condoms, spermicide). 

Your periods may be irregular, lighter, and/or shorter than usual while you are taking norethindrone acetate/ethinyl estradiol and ferrous fumarate. If you miss your period and have not taken norethindrone acetate/ethinyl estradiol and ferrous fumarate as directed, call your health care provider right away.

If you throw up (vomit) or have diarrhea, this medicine may not work well. If you throw up or have severe diarrhea up to four hours after taking an active tablet, count this as a missed tablet. See the Missed Dose section for more details. You may need to use backup birth control.

If you feel sick to your stomach or have nausea during the first few months of taking norethindrone acetate/ethinyl estradiol and ferrous fumarate, do not stop taking the medicine. This should usually go away on its own. If your nausea does not go away or gets worse, call your health care provider.

What should I tell my health care provider before using norethindrone acetate/ethinyl estradiol and ferrous fumarate?

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 acetate/ethinyl estradiol and ferrous fumarate 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.

  • High blood pressure
  • Headaches/migraines
  • Irregular periods
  • Gallbladder, liver, or heart problems

Major Surgeries. Tell your health care provider if you have any upcoming major surgeries. Your health care provider may ask you to stop taking norethindrone acetate/ethinyl estradiol and ferrous fumarate at least four weeks before your surgery and may wait at least two weeks after your surgery to start you on norethindrone acetate/ethinyl estradiol and ferrous fumarate. If your health care provider decides to stop norethindrone acetate/ethinyl estradiol and ferrous fumarate because of an upcoming surgery, your health care provider will talk to you about other forms of birth control to use during that time.

Smoking. 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 acetate/ethinyl estradiol and ferrous fumarate.

Diabetes. Tell your health care provider if you have prediabetes or diabetes. Norethindrone acetate/ethinyl estradiol and ferrous fumarate may increase your blood sugar.

High Triglycerides. Tell your health care provider if you have high triglyceride levels or have a family history of high triglyceride levels as taking norethindrone acetate/ethinyl estradiol and ferrous fumarate may cause an increase in your triglyceride levels and may increase your chances of having pancreatitis. Your health care provider will decide if you should take norethindrone acetate/ethinyl estradiol and ferrous fumarate.

Depression. Talk to your health care provider if you have a history of depression. Taking norethindrone acetate/ethinyl estradiol and ferrous fumarate may worsen depression.

Angioedema. Talk to your health care provider if you have a condition called hereditary angioedema that leads to swelling in different parts of your body, including your lips, face, tongue, or throat. Taking norethindrone acetate/ethinyl estradiol and ferrous fumarate may increase your chances of having angioedema or make your angioedema symptoms worse if you have a history of angioedema.

Skin Issues. 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 mouth (chloasma), especially during pregnancy, because you may have an increased chance of having chloasma while taking norethindrone acetate/ethinyl estradiol and ferrous fumarate. 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 acetate/ethinyl estradiol and ferrous fumarate and tell your health care provider if you are pregnant or plan to become pregnant. If you become pregnant, stop taking norethindrone acetate/ethinyl estradiol and ferrous fumarate right away and contact your health care provider.

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

Interactions

Does norethindrone acetate/ethinyl estradiol and ferrous fumarate interact with foods or drinks?

Eating grapefruit or drinking grapefruit juice while taking norethindrone acetate/ethinyl estradiol and ferrous fumarate 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 acetate/ethinyl estradiol and ferrous fumarate.

Does norethindrone acetate/ethinyl estradiol and ferrous fumarate 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 acetate/ethinyl estradiol and ferrous fumarate.

  • A medicine for HIV, AIDS, or hepatitis C
  • A barbiturate, such as butalbital, phenobarbital, or primidone, which is a medicine 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)
  • 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), rufinamide (Banzel), or topiramate (Qudexy XR, Topamax, Trokendi XR)
  • Fluconazole (Diflucan), griseofulvin, itraconazole (Sporanox, Tolsura), ketoconazole, or voriconazole (Vfend), which are medicines used for fungal infections
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Rifabutin (Mycobutin), which is a medicine used to prevent Mycobacterium avium complex infection 
  • 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
  • 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
  • Morphine, which is used to treat certain types of pain
  • Temazepam (Restoril), which is a medicine used to treat insomnia
  • A thyroid medicine, such as levothyroxine, which is used to raise thyroid hormone levels

Some other medicines may alter the blood levels of norethindrone acetate/ethinyl estradiol and ferrous fumarate, 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 acetate/ethinyl estradiol and ferrous fumarate. Always check with your health care provider.

Does interact with other drugs you are taking?

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Overdose/Missed Dose

What should I do if I accidentally use too much norethindrone acetate/ethinyl estradiol and ferrous fumarate?

If you or someone else has used too much norethindrone acetate/ethinyl estradiol and ferrous fumarate, 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 acetate/ethinyl estradiol and ferrous fumarate?

Norethindrone acetate/ethinyl estradiol and ferrous fumarate may not work well if you miss tablets. If you vomit or have severe diarrhea within four hours after taking norethindrone acetate/ethinyl estradiol and ferrous fumarate, this is considered a “missed tablet” because your body may not have fully absorbed the medicine. Norethindrone acetate/ethinyl estradiol and ferrous fumarate may not work as it should if you miss tablets. Follow the Patient Labeling on how to take norethindrone acetate/ethinyl estradiol and ferrous fumarate when you miss a dose, as this can change depending on how many tablets you have missed and which weeks they were missed. Talk to your health care provider about backup birth control options (such as condoms or spermicide).

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