Ethinyl Estradiol, Drospirenone, and Levomefolate

This information from Lexicomp^® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.

Brand Names: US

Beyaz; Safyral; Tydemy

Brand Names: Canada

YAZ Plus

What is this drug used for?

• It is used to prevent pregnancy.
• It is used to treat premenstrual dysphoric disorder (PMDD).
• It is used to treat pimples (acne).
• Levomefolate is a vitamin used to aid the diet needs of people who may get pregnant.
• It may be given to your child for other reasons. Talk with the doctor.

What do I need to tell the doctor BEFORE my child takes this drug?

• If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
• If your child has had any of these health problems: Blood clots, blood clotting problem, breast cancer or other cancer where hormones make it grow, diseased blood vessels in the brain or heart, heart valve problems, heart disease, certain types of abnormal heartbeats like atrial fibrillation, chest pain caused by angina, heart attack, stroke, high blood pressure, endometrial cancer, cancer of the cervix or vagina, liver disease, liver tumor, very bad headache or migraine, diabetes, or vaginal bleeding where the cause is not known.
• If your child has any of these health problems: Adrenal gland problems, high potassium levels, or kidney problems.
• If your child has turned yellow while pregnant or with estrogen use like hormonal birth control.
• If your child has taken ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks.

If your child is pregnant:

• Do not give this drug to your child during pregnancy.

If your child is breast-feeding a baby:

• Talk with the doctor if your child is breast-feeding a baby or plans to breast-feed a baby.

This is not a list of all drugs or health problems that interact with this drug.

Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe to give this drug with all of your child’s other drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while my child takes this drug?

For all uses of this drug:

• Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists. This drug may need to be stopped before certain types of surgery as the doctor has told you. If this drug is stopped, the doctor will tell you when to start giving this drug again after your child’s surgery or procedure.
• This drug may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
• This drug has the hormone drospirenone. The chance of blood clots may be greater with birth control that has drospirenone than with other birth control pills. Talk with the doctor.
• Talk with the doctor if your child will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise the chance of blood clots.
• If your child has high blood sugar (diabetes), talk with the doctor. This drug can raise blood sugar.
• Check your child’s blood sugar as you have been told by the doctor.
• If your child is taking a salt substitute that has potassium in it, a potassium-sparing diuretic, or a potassium product, talk with your child’s doctor.
• High blood pressure has happened with drugs like this one. Have your child’s blood pressure checked as you have been told by the doctor.
• High cholesterol and triglyceride levels have happened with this drug. If your child has high cholesterol or triglycerides, talk with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Be sure your child has regular breast exams and gynecology check-ups. Your child will also need to do breast self-exams as the doctor has told you.
• This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
• Certain drugs, herbal products, or health problems may cause hormone-based birth control to not work as well. Be sure the doctor knows about all of your child’s drugs and health problems. You will need to see if your child also needs to use a non-hormone form of birth control like condoms.
• The chance of getting cervical cancer may be higher in people who take hormone-based birth control. However, this may be due to other reasons. If you have questions, talk with the doctor.
• Some studies have shown the risk of breast cancer is raised when taking hormone-based birth control for a long time. However, other studies have not shown this risk. If you have questions, talk with the doctor.
• Do not use in children who have not had their first menstrual period.

If your child is or may be sexually active:

• This drug does not stop the spread of diseases like HIV or hepatitis that are passed through having sex. Be sure your child does not have any kind of sex without using a latex or polyurethane condom.
• If your child has any signs of pregnancy or a positive pregnancy test, call the doctor right away.

What are some side effects that I need to call my child’s doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or very upset stomach or throwing up.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Depression or other mood changes.
• Not able to pass urine or change in how much urine is passed.
• A lump in the breast, breast pain or soreness, or nipple discharge.
• Vaginal itching or discharge.
• Eyesight changes or loss, bulging eyes, or change in how contact lenses feel.
• Call the doctor right away if your child has signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

• Appetite changes.
• Weight gain.
• Headache.
• Upset stomach or throwing up.
• Cramps.
• Bloating.
• Period (menstrual) changes. These include spotting or bleeding between cycles.
• Enlarged breasts.
• Tender breasts.
• Feeling tired or weak.
• This drug may cause dark patches of skin on your child’s face. Avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and dress your child in clothing and eyewear that protects from the sun.

If your child is or may be sexually active:

• Lowered interest in sex.

These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.

You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

For all uses of this drug:

• Give this drug at the same time of day.
• Give after the evening meal or at bedtime.
• Give this drug with or without food. Give with food if it causes an upset stomach.
• If your child drinks grapefruit juice or eats grapefruit often, talk with your child’s doctor.

Birth control:

• After starting this drug, your child may need to use a non-hormone type of birth control like condoms to prevent pregnancy for some time. Have your child follow what the doctor has told you about using a non-hormone type of birth control.
• Do not skip doses, even if your child does not have sex or does not have sex very often.
• If your child throws up or has diarrhea, this drug may not work as well to prevent pregnancy. If this happens within 3 to 4 hours after your child takes an active tablet, give another tablet. If it goes on for more than 1 day, your child must use an extra form of birth control and you must call the doctor. Call the doctor if your child throws up or has diarrhea and you are not sure what to do.
• If your child misses 2 periods in a row, have your child take a pregnancy test before starting a new dosing cycle.

What do I do if my child misses a dose?

• If a dose is missed, check the package insert or call the doctor to find out what to do. If using this drug to prevent pregnancy, a non-hormone form of birth control like condoms may need to be used for some time to prevent pregnancy.

How do I store and/or throw out this drug?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

• If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
• Do not share your child’s drug with others and do not give anyone else’s drug to your child.
• Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider’s examination and assessment of a patient’s specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof. The use of this information is governed by the Terms of Use, available at https://www.wolterskluwer.com/en/know/clinical-effectiveness-terms.

Last Reviewed Date

2023-09-11

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