Cyproterone and Ethinyl Estradiol

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: Canada

Cleo-35; Cyestra-35; Diane-35; TARO-Cyproterone/Eth Estradiol; TEVA-Cyproterone/Eth Estradiol

Warning

  • This drug may raise the chance of blood clots. Do not take this drug if you have a blood clot or have had blood clots in the past. Talk with your doctor.
  • There are many other drugs like this drug. Do not take this drug with these drugs. Talk with your doctor if you are not sure.
  • This drug is not to be used for birth control. However, this drug may provide birth control if taken as told. Talk with the doctor.
  • Keep taking this drug until your doctor tells you to stop taking it.
  • Do not smoke while taking this drug. Cigarette smoking raises the chance of very bad heart problems. This chance is higher with age (older than 35 years of age) and with heavy smoking (15 or more cigarettes per day).

What is this drug used for?

  • It is used to treat pimples (acne).

What do I need to tell my doctor BEFORE I take this drug?

For all patients taking this drug:

  • If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have had any of these health problems: Blood clots, blood clotting problem, breast cancer, chest pain caused by angina, depression, diabetes that affects blood flow, diseased arteries in the brain, eye or eyesight problems, heart disease, heart attack, high blood pressure, itching all over the body, liver disease, liver tumor, stroke, severe headaches or migraines, severe stomach pain, or yellow skin or eyes.
  • If you have had any of these health problems: Endometrial cancer, cancer of the cervix or vagina, or vaginal bleeding where the cause is not known.
  • If you have ever had a cancer where hormones make it grow.
  • If you have had a health problem that led to loss of hearing (otosclerosis) during a past pregnancy.
  • If you turned yellow while pregnant or with estrogen use like hormonal birth control.
  • If you have taken ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks.
  • If you are taking aminocaproic acid.
  • If you are pregnant or may be pregnant. Do not take this drug if you are pregnant.
  • If you are breast-feeding or plan to breast-feed.

Children:

  • If your child has not started having menstrual periods.

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

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

What are some things I need to know or do while I take this drug?

  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. This drug may need to be stopped before certain types of surgery as your doctor has told you. If this drug is stopped, your doctor will tell you when to start taking this drug again after your surgery or procedure.
  • Use care if you have risks for heart disease (high blood pressure, high cholesterol, overweight, high blood sugar or diabetes, cigarette smoking, male older than 40 years of age, other family members with early heart disease, female after menopause). Talk with your doctor.
  • Blood clots have happened with this drug. Sometimes, blood clots like heart attack and stroke have been deadly. Talk with the doctor.
  • Talk with your doctor if you 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 your chance of blood clots.
  • Call your doctor right away if you have signs of a blood clot like chest, arm, back, or jaw pain or pressure; coughing up blood; numbness or weakness on one side of your body; trouble speaking or thinking; change in balance; drooping on one side of your face; change in eyesight; trouble breathing; anxiety; abnormal sweating; fast or abnormal heartbeat; upset stomach, vomiting, or heartburn; choking feeling; dizziness or passing out; weakness; or swelling, warmth, numbness, change of color, or pain in the leg or arm.
  • High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
  • Talk with your doctor before you drink alcohol.
  • This drug does not stop the spread of diseases like HIV or hepatitis that are passed through having sex. Do not have any kind of sex without using a latex or polyurethane condom. If you have questions, talk with your doctor.
  • This drug may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
  • 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.
  • This drug is not approved for use if you are going through or have been through menopause.
  • If you have not taken this drug as you have been told, you may need to use a non-hormone type of birth control like condoms to prevent pregnancy. Talk with your doctor.
  • If you want to get pregnant after stopping this drug, talk with your doctor. You may need to prevent pregnancy until you have at least 1 monthly period (menstrual) cycle. Talk with your doctor about what kind of birth control to use.
  • This drug may cause harm to an unborn baby. A pregnancy test will be done before you start this drug to show that you are NOT pregnant.

What are some side effects that I need to call my 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 doctor or get medical help right away if you have 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 gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; change in stools; dark urine or yellow skin or eyes; or fever with chills.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Fast breathing.
  • Anxiety.
  • Depression or other mood changes.
  • Severe stomach pain.
  • Eyesight changes or loss, bulging eyes, or change in how contact lenses feel.
  • A lump in the breast or breast soreness.
  • Vaginal bleeding that is not normal.
  • Change in sex interest.
  • Vaginal itching or discharge.
  • Trouble controlling body movements.
  • Change in color of fingers or toes.
  • Change in hearing.
  • This drug may cause you to swell or keep fluid in your body. Tell your doctor if you have swelling, weight gain, or trouble breathing.

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 doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Stomach pain or cramps.
  • Headache.
  • Feeling nervous and excitable.
  • Weight gain or loss.
  • Appetite changes.
  • Runny or stuffy nose.
  • Period (menstrual) changes. These include lots of bleeding, spotting, or bleeding between cycles.
  • Change in hair growth.

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

You may report side effects to your national health agency.

How is this drug best taken?

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take this drug at the same time of day.
  • If your period is delayed for more than 7 days, talk with your doctor. Do not start a new pack.
  • If you throw up or have diarrhea, this drug may not work as well to prevent pregnancy. Use an extra form of birth control, like condoms, until you check with your doctor.
  • Be sure to have regular breast exams and gynecology check-ups. You will also need to do breast self-exams as you have been told.
  • Certain drugs, herbal products, or health problems may cause hormone-based birth control to not work as well. Be sure your doctor knows about all of your drugs and health problems. You will need to see if you also need to use a non-hormone form of birth control like condoms.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it has been 12 hours or more since the missed dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

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 symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this drug, please talk with your 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

2023-11-20

Copyright

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Last Updated

Monday, December 12, 2022