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Overview: Levonorgestrel/ethinyl estradiol and iron is a hormonal birth control pill that is used to prevent pregnancy. Levonorgestrel/ethinyl estradiol and iron 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 levonorgestrel/ethinyl estradiol and iron, 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 levonorgestrel/ethinyl estradiol and iron used for?

Levonorgestrel/ethinyl estradiol and iron is a combination birth control pill used to prevent pregnancy. 

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

How does levonorgestrel/ethinyl estradiol and iron work (mechanism of action)?

Levonorgestrel/ethinyl estradiol and iron works in a few different ways. It works mainly by stopping the release of an egg from your ovaries. Levonorgestrel/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. Ferrous bisglycinate and ferrous fumarate are types of iron that make up the last few pills in each pack. The type and number of iron pills depend 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.

How is levonorgestrel/ethinyl estradiol and iron supplied?

28-Day Monophasic (one phase)

Balcoltra, Joyeaux, Minzoya

  • Days 1-21: levonorgestrel/ethinyl estradiol oral tablets (0.1 mg/0.02 mg)
  • Days 22-28: ferrous fumarate oral tablets (75 mg) or ferrous bisglycinate oral tablets (36.5 mg)

How should I store levonorgestrel/ethinyl estradiol and iron?

Levonorgestrel/ethinyl estradiol and iron 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 levonorgestrel/ethinyl estradiol and iron?

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

  • Headache or migraine (see below)
  • Bleeding between periods
  • Painful periods 
  • Nausea
  • Stomach pain
  • Breast pain, tenderness, or discomfort
  • Changes in mood
  • Acne

There may be other side effects of levonorgestrel/ethinyl estradiol and iron 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 levonorgestrel/ethinyl estradiol and iron?

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

Severe Allergic Reactions. Levonorgestrel/ethinyl estradiol and iron may cause allergic reactions, which can be serious. Stop taking levonorgestrel/ethinyl estradiol and iron 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. Levonorgestrel/ethinyl estradiol and iron 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 levonorgestrel/ethinyl estradiol and iron 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. Levonorgestrel/ethinyl estradiol and iron 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). Levonorgestrel/ethinyl estradiol and iron 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 levonorgestrel/ethinyl estradiol and iron 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

Headache or Migraine. Stop taking levonorgestrel/ethinyl estradiol and iron 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. Levonorgestrel/ethinyl estradiol and iron 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 levonorgestrel/ethinyl estradiol and iron.

Depression. Levonorgestrel/ethinyl estradiol and iron may cause changes in mood, including depression. Stop taking levonorgestrel/ethinyl estradiol and iron and call your health care provider right away if you have new or increased depression or other unusual changes in mood or behavior.

Cancer. Levonorgestrel/ethinyl estradiol and iron is a combination birth control pill that contains two hormones. Certain cancers, including breast cancer and cervical cancer, can be sensitive to hormones. Make sure you keep all appointments with your health care provider. 

Warnings & Precautions

Who should not use levonorgestrel/ethinyl estradiol and iron?

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

  • Levonorgestrel
  • Ethinyl estradiol
  • Iron
  • Balcoltra
  • Joyeaux
  • Minzoya
  • Any of the ingredients in the specific product dispensed

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

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

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

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

Blood and Blood Vessel Problems. Levonorgestrel/ethinyl estradiol and iron should not be used if you have a condition that makes your blood more prone to getting blood clots (hypercoagulation). Levonorgestrel/ethinyl estradiol and iron 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. Levonorgestrel/ethinyl estradiol and iron 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). Levonorgestrel/ethinyl estradiol and iron should not be used if you have high blood pressure that is not controlled.

Diabetes. Levonorgestrel/ethinyl estradiol and iron should not be used if you have diabetes and have kidney, eye, nerve, or blood vessel damage. 

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

Liver Problems. Levonorgestrel/ethinyl estradiol and iron should not be used if you have tumors on your liver or liver disease.

Unusual Vaginal Bleeding. Levonorgestrel/ethinyl estradiol and iron 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.

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

Cancer. Levonorgestrel/ethinyl estradiol and iron should not be used if you have or have had breast cancer.

Drug Interactions. Levonorgestrel/ethinyl estradiol and iron should not be taken while you are using certain other medicines. Before taking levonorgestrel/ethinyl estradiol and iron, 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 levonorgestrel/ethinyl estradiol and iron before using it?

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

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

Keep levonorgestrel/ethinyl estradiol and iron out of the reach of children.

Levonorgestrel/ethinyl estradiol and iron 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 levonorgestrel/ethinyl estradiol and iron.

Take levonorgestrel/ethinyl estradiol and iron at the same time every day. Consider using a calendar or app to help you remember to take levonorgestrel/ethinyl estradiol and iron 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 levonorgestrel/ethinyl estradiol and iron. If you miss your period and have not taken levonorgestrel/ethinyl estradiol and iron as directed, call your health care provider right away.

If you feel sick to your stomach or have nausea during the first few months of taking levonorgestrel/ethinyl estradiol and iron, 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 levonorgestrel/ethinyl estradiol and iron?

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 levonorgestrel/ethinyl estradiol and iron 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

Allergies or Allergic-Type Reactions. Some levonorgestrel/ethinyl estradiol and iron products contain tartrazine. Tell your health care provider if you have a sensitivity to FD&C Yellow No. 5, which is also known as tartrazine. Some people have allergic-type reactions to this food and drink dye, especially if they also have aspirin hypersensitivity. 

Major Surgeries. Tell your health care provider if you have any upcoming major surgeries. Your health care provider may ask you to stop taking levonorgestrel/ethinyl estradiol and iron at least four weeks before your surgery and may wait at least two weeks after your surgery to start you on levonorgestrel/ethinyl estradiol and iron. If your health care provider decides to stop levonorgestrel/ethinyl estradiol and iron 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 levonorgestrel/ethinyl estradiol and iron.

Diabetes. Tell your health care provider if you have prediabetes or diabetes. Levonorgestrel/ethinyl estradiol and iron may increase your blood sugar.

High Triglycerides. Tell your health care provider if you have high triglyceride levels or you have a family history of high triglyceride levels, as taking levonorgestrel/ethinyl estradiol and iron 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 levonorgestrel/ethinyl estradiol and iron.

Depression. Talk to your health care provider if you have a history of depression. Taking levonorgestrel/ethinyl estradiol and iron 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 levonorgestrel/ethinyl estradiol and iron 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 around your mouth (chloasma), especially during pregnancy  because you may have an increased chance of having chloasma while taking levonorgestrel/ethinyl estradiol and iron. 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 levonorgestrel/ethinyl estradiol and iron and tell your health care provider if you are pregnant or plan to become pregnant. If you become pregnant, stop taking levonorgestrel/ethinyl estradiol and iron right away and contact your health care provider.

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

Interactions

Does levonorgestrel/ethinyl estradiol and iron interact with foods or drinks?

Eating grapefruit or drinking grapefruit juice while taking levonorgestrel/ethinyl estradiol and iron 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 levonorgestrel/ethinyl estradiol and iron. 

Does levonorgestrel/ethinyl estradiol and iron 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 levonorgestrel/ethinyl estradiol and iron.

  • 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 levonorgestrel/ethinyl estradiol and iron, 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 levonorgestrel/ethinyl estradiol and iron. 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 levonorgestrel/ethinyl estradiol and iron?

If you or someone else has used too much levonorgestrel/ethinyl estradiol and iron, 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 levonorgestrel/ethinyl estradiol and iron?

Levonorgestrel/ethinyl estradiol and iron may not work well if you miss tablets. If you vomit or have severe diarrhea within four hours after taking levonorgestrel/ethinyl estradiol and iron, this is considered a “missed tablet” because your body may not have fully absorbed the medicine. Levonorgestrel/ethinyl estradiol and iron may not work as it should if you miss tablets. Follow the Patient Labeling on how to take levonorgestrel/ethinyl estradiol and iron 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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