Overview: Levonorgestrel/ethinyl estradiol is used to help prevent pregnancy in women. Common side effects include nausea and vomiting, acne, painful or irregular periods, and headache. Levonorgestrel/ethinyl estradiol does not protect against HIV/AIDS or sexually transmitted infections. If you miss a dose, your risk of pregnancy may be higher. Follow the directions for your medicine if you miss doses and consider the need to use another method of birth control such as condoms.
Uses
What is levonorgestrel/ethinyl estradiol used for?
Levonorgestrel/ethinyl estradiol is a combination birth control medicine that is commonly 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 health care provider.
How does levonorgestrel/ethinyl estradiol work (mechanism of action)?
Levonorgestrel/ethinyl estradiol works for pregnancy prevention in a few ways. Levonorgestrel/ethinyl estradiol mainly works by stopping ovulation. It also works to change your cervical mucus to prevent sperm cells from entering your uterus and causes changes in the lining of 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 as oral tablets in 28-day and extended-cycle packs under many different brand and generic names.
- Levonorgestrel/ethinyl estradiol 28-day cycle products include Altavera, Amethyst, Aviane, Falmina, Kurvelo, Portia, Vienva, and others.
- Levonorgestrel/ethinyl estradiol extended-cycle products include Camrese Lo, Daysee, Introvale, Jolessa, Simpesse, and others.
Some packs contain one strength of active tablets, while others contain multiple phases with different strengths. Depending on the product, the active tablets may contain levonorgestrel/ethinyl estradiol in strengths ranging from 0.05 mg/0.02 mg to 0.15 mg/0.04 mg. Some packs also include inactive tablets, while others include tablets that contain only ethinyl estradiol (0.01 mg).
How should I store levonorgestrel/ethinyl estradiol?
Levonorgestrel/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. 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 health care 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
There may be other side effects of levonorgestrel/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 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 taking 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 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. 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 taking 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 health care 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 health care provider may monitor your liver function while you are taking levonorgestrel/ethinyl estradiol. Stop taking levonorgestrel/ethinyl estradiol and call your health care provider if you have severe stomach pain or stomach tenderness, as this may be a symptom of a ruptured liver tumor. Call your health care 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 or Migraine. Stop taking levonorgestrel/ethinyl estradiol and call your health care provider right away if you have new headaches or 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 health care 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 health care provider.
Warnings & Precautions
Who should not use levonorgestrel/ethinyl estradiol?
Allergies to Ingredients. People who are allergic to any of the following should not take levonorgestrel/ethinyl estradiol.
- Levonorgestrel
- Ethinyl estradiol
- 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 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. Do not take levonorgestrel/ethinyl estradiol if you are pregnant. If you become pregnant, contact your health care 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 health care provider if you are bleeding between your monthly periods while on levonorgestrel/ethinyl estradiol. Your health care provider will find out why this is happening and may do tests to check if you are able to take this medicine.
Certain Cancers. 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 health care 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 health care provider decides to stop levonorgestrel/ethinyl estradiol because of an upcoming surgery, your health care provider will talk to you about other forms of contraception to use during that time.
What should I know about levonorgestrel/ethinyl estradiol before using it?
Do not take levonorgestrel/ethinyl estradiol unless it has been prescribed to you by a health care 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.
Levonorgestrel/ethinyl estradiol does not protect against human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or other sexually transmitted infections (STIs).
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 health care 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 health care provider right away.
What should I tell my health care provider before using levonorgestrel/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 levonorgestrel/ethinyl estradiol is right for you.
In particular, make sure that you discuss any of the following.
Immobilization. Talk to your health care 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 blood clots.
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. 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 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 may increase your chances of having angioedema or make your symptoms worse if you have had this condition.
Other Current and Past Health Conditions. Tell your health care provider if you have any of the following.
- Liver or gallbladder problems, including jaundice or cholestasis (slowed flow of bile from the liver)
- Depression
- Diabetes
- High triglyceride levels, which is a type of fat in your blood
- Blood clots or blood vessel problems
- Heart problems or high blood pressure
- Migraine or headaches
- Unexplained spotting
- Cancer
Pregnancy. Do not take levonorgestrel/ethinyl estradiol and tell your health care provider if you are or plan to become pregnant. If you become pregnant, stop taking levonorgestrel/ethinyl estradiol right away and contact your health care provider.
Breastfeeding. Levonorgestrel/ethinyl estradiol passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Levonorgestrel/ethinyl estradiol may decrease the amount of breastmilk you make. Your health care provider will let you know 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 health care provider if you eat grapefruit or drink grapefruit juice. Your health care provider will let you know if you can eat grapefruit or 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 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.
- 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 for 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
- 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), such as ibuprofen, 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 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. Always check with your health care provider.
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 product labeling or check with your health care provider for how to take levonorgestrel/ethinyl estradiol when you miss a dose. The instructions can change depending on the specific product, how many tablets you have missed, and when they were missed.
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