Uses

What is levonorgestrel/ethinyl estradiol used for?

Levonorgestrel/ethinyl estradiol is a combination birth control medicine used to prevent pregnancy in women. Levonorgestrel/ethinyl estradiol contains 2 types of hormones: levonorgestrel (a progestin) and ethinyl estradiol (an estrogen).

Levonorgestrel/ethinyl estradiol may also be used for other conditions as determined by your healthcare provider.

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

Levonorgestrel/ethinyl estradiol works for pregnancy prevention in a few ways. Levonorgestrel/ethinyl estradiol works mainly to stop ovulation. Levonorgestrel/ethinyl estradiol also works to change your cervical mucus to prevent sperm cells from entering your uterus and causes changes in the tissue that lines the uterus (endometrium), which reduces the chances of a fertilized egg implanting in your uterus. 

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

Levonorgestrel/ethinyl estradiol is available in the following dosage forms that are applied to the skin or taken by mouth.

  • levonorgestrel and ethinyl estradiol oral tablets (0.15 mg/0.03 mg) 
  • levonorgestrel and ethinyl estradiol oral tablets (0.09 mg/0.02 mg) 
  • levonorgestrel and ethinyl estradiol oral tablets (0.1 mg/0.02 mg) 
  • levonorgestrel and ethinyl estradiol oral tablets (0.05 mg/0.03 mg; 0.75 mg/0.04 mg; 0.125 mg/0.03 mg) 
  • levonorgestrel and ethinyl estradiol oral tablets (0.15 mg/0.03 mg) and ethinyl estradiol oral tablets (0.01 mg)
  • levonorgestrel and ethinyl estradiol oral tablets (0.1 mg/0.02 mg) and ethinyl estradiol oral tablets (0.01 mg)
  • levonorgestrel and ethinyl estradiol oral tablets (0.15 mg/0.02 mg; 0.15 mg/0.025 mg; 0.15 mg/0.03 mg) and ethinyl estradiol oral tablets (0.01 mg)
  • 120 mcg/day levonorgestrel and 30 mcg/day ethinyl estradiol transdermal patch 

How should I store levonorgestrel/ethinyl estradiol?

Levonorgestrel/ethinyl estradiol should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C), for shorter periods of time, such as when transporting it. Store in a cool, dry place. Keep the medicine in the protective blister packaging or original unopened pouch.

Side Effects

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

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

  • Nausea or vomiting
  • Acne
  • Headache/migraine
  • Painful, heavy, or irregular periods (including bleeding between periods) 
  • Weight gain and fluid retention
  • New or increased feelings of anxiety, depression, or other unusual changes in your mood or behavior
  • Back pain
  • Pain, itching, swelling, or redness at the patch application site (Twirla)

There may be other side effects of levonorgestrel/ethinyl estradiol that are not listed here. Contact your healthcare 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. 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?

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

Severe Allergic Reactions. Levonorgestrel/ethinyl estradiol may cause allergic reactions, which can be serious. Stop using levonorgestrel/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, 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 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 using levonorgestrel/ethinyl estradiol 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

Increased Blood Pressure (Hypertension). Levonorgestrel/ethinyl estradiol may increase your blood pressure or make it worse if you have a history of high blood pressure. Stop taking levonorgestrel/ethinyl estradiol and call your healthcare provider if your blood pressure increases significantly 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, stop taking levonorgestrel/ethinyl estradiol and get medical attention right away. Increases in blood pressure may not be noticeable but look out for any of the following symptoms of severely high blood pressure.

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

Liver Problems. Levonorgestrel/ethinyl estradiol may cause changes to your liver function including liver tumors and an increase in your liver enzymes. Your healthcare provider may monitor your liver function while you are taking levonorgestrel/ethinyl estradiol. Stop taking levonorgestrel/ethinyl estradiol and call your healthcare provider if you have severe stomach pain or stomach tenderness, as this may be a symptom of a ruptured liver tumor. Call your healthcare provider 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)

Headache/Migraine. Stop taking levonorgestrel/ethinyl estradiol and call your healthcare provider right away if you develop new headaches/migraines that keep coming back or cause you a lot of pain.

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

Cancer. Levonorgestrel/ethinyl estradiol 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 healthcare provider.

Warnings & Precautions

Who should not use levonorgestrel/ethinyl estradiol?

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

  • Levonorgestrel
  • Ethinyl estradiol
  • Twirla
  • Vienva
  • Trivora-28
  • Quartette
  • Lo-Simpesse
  • Dolishale
  • Ayuna
  • Ashlyna
  • Any of the ingredients in the specific product dispensed

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

Drug Interactions. Levonorgestrel/ethinyl estradiol should not be taken while you are using certain other medicines. Before taking levonorgestrel/ethinyl estradiol, tell your healthcare 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. Do not take levonorgestrel/ethinyl estradiol if you are pregnant. If you become pregnant, contact your healthcare professional right away. See the Pregnancy section for more details.

Smoking. Levonorgestrel/ethinyl estradiol should not be taken 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 should not be taken if you currently have or have had deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, or heart attack.

Blood and Blood Vessel Problems. Levonorgestrel/ethinyl estradiol should not be taken if you have a condition that makes your blood more prone to getting blood clots (hypercoagulation or thrombophilia). Levonorgestrel/ethinyl estradiol should not be taken 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 should not be taken 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 should not be taken 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. Levonorgestrel/ethinyl estradiol should not be taken if you have diabetes and are over the age of 35, diabetes with high blood pressure, or diabetes with kidney, eye, nerve, or blood vessel damage. Levonorgestrel/ethinyl estradiol should not be taken if you have had diabetes for more than 20 years.

Headaches/Migraines. Levonorgestrel/ethinyl estradiol should not be taken if you have migraines with vision or hearing changes, muscle weakness, tingling, or trouble speaking (aura) or certain types of headaches, as this can increase your risk of having a stroke. Levonorgestrel/ethinyl estradiol should not be taken if you are 35 or older with migraine headaches (with or without aura). 

Liver Problems. Levonorgestrel/ethinyl estradiol should not be taken if you have tumors on your liver, acute hepatitis (inflammation of the liver), decompensated cirrhosis (scar tissue on your liver), or liver disease.

Spotting. Levonorgestrel/ethinyl estradiol should not be taken if you are bleeding between your monthly periods without any specific causes. Tell your healthcare provider if you are bleeding between your monthly periods while on levonorgestrel/ethinyl estradiol. Your healthcare provider will find out why this is happening and may do tests to determine if you are able to take this medicine.

Cancer. Levonorgestrel/ethinyl estradiol should not be taken if you have or have had breast cancer or have endometrial cancer.

Jaundice. Levonorgestrel/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).

Major Surgeries. Levonorgestrel/ethinyl estradiol should not be taken if you are undergoing a major surgery and will be immobilized for a long period of time. Your healthcare provider may ask you to stop taking levonorgestrel/ethinyl estradiol at least 4 weeks before your surgery and may wait at least 2 weeks after your surgery to start you on levonorgestrel/ethinyl estradiol. If your healthcare provider decides to stop levonorgestrel/ethinyl estradiol because of an upcoming surgery, your healthcare provider will talk to you about other forms of contraception to use during that time.

Weight. Levonorgestrel/ethinyl estradiol patch should not be used if you have a body mass index (BMI) greater than or equal to 30 kg/m2 as this may affect how well levonorgestrel/ethinyl estradiol may work and may increase your chances of having a venous thromboembolism. Your healthcare provider will calculate your BMI to see if you can use levonorgestrel/ethinyl estradiol patch.

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

Levonorgestrel/ethinyl estradiol does not protect against human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or other sexually transmitted infections (STIs).

Follow the Instructions for Use when using the levonorgestrel/ethinyl estradiol patch. Do not cut the levonorgestrel/ethinyl estradiol patch, as it may not work as well.

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. Talk to your healthcare provider about backup contraception options (condoms, spermicide). 

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

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

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

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

What should I tell my healthcare provider before using levonorgestrel/ethinyl estradiol?

Tell your healthcare 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 levonorgestrel/ethinyl estradiol is right for you.

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

Immobilization. Talk to your healthcare provider if you are unable to walk for an extended period of time (immobile). Taking levonorgestrel/ethinyl estradiol while you are immobile may increase your risk of having blood clots.

Gallbladder Problems. Tell your healthcare provider if you have or have had gallbladder problems, including jaundice, cholestasis (slowed flow of bile from the liver), or a history of cholestasis, especially during pregnancy. Taking levonorgestrel/ethinyl estradiol can increase your chances of having cholestasis, which can increase your chances of having jaundice, and may worsen your gallbladder problems.

Skin Issues. Talk to your healthcare 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. If you have had chloasma, avoid exposure to the sun and to ultraviolet (UV) rays from tanning booths or sun lamps.

Angioedema. Talk to your healthcare 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 may increase your chances of having angioedema or make your angioedema symptoms worse if you have a history of angioedema. 

Depression. Talk to your healthcare provider if you have a history of depression. Taking levonorgestrel/ethinyl estradiol may worsen depression.

Diabetes. Tell your healthcare provider if you have prediabetes or diabetes. Levonorgestrel/ethinyl estradiol may increase your blood sugar.

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

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

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

Interactions

Does levonorgestrel/ethinyl estradiol interact with foods or drinks?

Eating grapefruit or drinking grapefruit juice while taking levonorgestrel/ethinyl estradiol can increase the level of ethinyl estradiol in your body. Talk to your healthcare provider if you eat grapefruit or drink grapefruit juice. Your healthcare provider will advise you if you can eat grapefruit/drink grapefruit juice while taking levonorgestrel/ethinyl estradiol.

There are no known interactions between levonorgestrel/ethinyl estradiol and alcohol.

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

Always tell your healthcare 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 using levonorgestrel/ethinyl estradiol.

  • Aprepitant, which is a medicine used to prevent nausea and vomiting caused by chemotherapy 
  • A barbiturate, such as phenobarbital, butalbital, or primidone which is a medicine that may be used to treat insomnia, migraines, or seizures
  • Bosentan, which is a medicine used to treat a condition called pulmonary arterial hypertension (PAH)
  • Carbamazepine (Tegretol, Carbatrol, and others), which is a medicine used to control seizures and treat nerve pain
  • Griseofulvin, itraconazole, voriconazole, fluconazole, or ketoconazole, which are medicines used to treat certain types of fungal infections
  • Phenytoin (Dilantin, Phenytek, and others), felbamate, oxcarbazepine, rufinamide, or lamotrigine which are medicines to control seizures
  • Rifampin, which is a medicine commonly used to treat an infection called tuberculosis
  • Rifabutin, which is a medicine used to treat certain bacterial infections 
  • Topiramate, which is a medicine used to control seizures and to prevent migraine headaches
  • St. John’s wort, which is a supplement that may be used to treat depression
  • A medicine for HIV, AIDS, or hepatitis C
  • Atorvastatin, rosuvastatin, or colesevelam, which are medicines used for high cholesterol
  • Vitamin C (ascorbic acid) which is a medicine used to treat/prevent low vitamin C levels
  • Acetaminophen (Tylenol), which is used to treat pain and fever
  • A thyroid medicine, such as levothyroxine, which is used to raise thyroid hormone levels 
  • A corticosteroid, which is a medicine for certain inflammatory conditions
  • Morphine, which is used to treat pain
  • Temazepam, which is a medicine used to treat insomnia
  • Cyclosporine (Gengraf, Neoral, Sandimmune, and others), which is a medicine to suppress your immune system
  • Prednisolone, which is a medicine used for certain inflammatory conditions
  • Theophylline, which is a medicine used to treat asthma and other lung problems
  • Tizanidine (Zanaflex), which is a muscle relaxant
  • A nonsteroidal anti-inflammatory drug (NSAID), which is used for pain, swelling, and fever
  • Dexamethasone, which is a medicine used to treat inflammation of the skin, joints, lungs and other organs
  • Modafinil, which is a medicine used to treat excessive sleepiness
  • Certain antibiotics, such as ampicillin, penicillins, and tetracyclines, which are used to treat certain bacterial infections

Some other medicines may alter the blood levels of levonorgestrel/ethinyl estradiol, and vice versa. This can cause levonorgestrel/ethinyl estradiol to not work as well, may cause bleeding between your monthly periods, or higher than normal levels of hormones in your body. Tell your healthcare 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. Always check with your healthcare provider.

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Overdose/Missed Dose

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

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

Levonorgestrel/ethinyl estradiol may not work as it should if you miss tablets. Follow the Instructions for Use or the Patient Labeling on how to take levonorgestrel/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.

Levonorgestrel/ethinyl estradiol may not work as it should if you forget to remove and replace the patch. Follow the Instructions for Use on how to use levonorgestrel/ethinyl estradiol if you forget to remove and replace the patch, as this can change depending on which week you forgot to replace the patch.

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