- Follow up with the doctor as you have been told.
- Very bad infections, bleeding, or other problems may rarely happen after any type of abortion. This includes after using this drug to end pregnancy. Sometimes, these problems may be deadly.
- Be sure you know who to call and what do if you have an emergency. This includes going to an ER (emergency room) if you cannot reach your doctor. Call your doctor right away if you have a fever that does not go away, very bad belly pain, fast heartbeat, a lot of vaginal bleeding that does not go away, or passing out.
- If you are going to an ER (emergency room) or some other doctor, take your patient information card with you.
- If this drug does not work in 2 days, your doctor may give you another drug. Call your doctor right away if you have belly pain, weakness, upset stomach or throwing up, or loose stools (diarrhea) more than 24 hours after taking the other drug.
- Once you start taking this drug, be sure to finish both steps. Both mifepristone and misoprostol can cause birth defects if you are still pregnant.
- If this drug does not cause a full abortion, surgery may be needed. Make sure that you know about this drug, what it is for, how to use it, and when to go back to your doctor. You must agree to the abortion and surgery if needed. You must read the patient medication information leaflet and patient information card and sign a consent.
- You can get pregnant again right after your pregnancy ends. If you do not want to get pregnant again, start using birth control that you can trust to prevent pregnancy as soon as your pregnancy ends or before you start having sex again.
- If you want to get pregnant again, talk with your doctor. To lower the chance of birth defects, avoid getting pregnant again before your next period. Use birth control to prevent pregnancy for 1 month after taking this drug.
- It is used to end a pregnancy.
- You may only get this drug through a special program. Talk with your doctor.
- If you have an allergy to this drug or any part of this drug.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have any of these health problems: Adrenal gland problems, asthma, bleeding problems, blood vessel problems, diabetes, heart disease, high blood pressure, kidney or liver problems, poor nutrition, or porphyria.
- If you are a heavy smoker (more than 15 cigarettes per day) and older than 35 years of age.
- If you have a pregnancy that is not inside the uterus (ectopic pregnancy).
- If you have an IUD (intrauterine device) in place.
- If you are not able to follow what your doctor tells you for treatment to end your pregnancy or you are not able to get to an ER (emergency room) if you need one.
- If you are not sure how long you have been pregnant.
- If you are not able to learn or follow the Patient-Physician contract.
- If you are taking a blood thinner or are on a long-term steroid, such as prednisone.
- If you are breast-feeding. Do not breast-feed while you take this drug.
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.
- Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
- Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
- It is normal to have vaginal bleeding after taking this drug. Most of the time, bleeding lasts for about 11 days. It is also normal for vaginal bleeding to be heavier than normal for 2 to 3 days. Call your doctor right away if vaginal bleeding continues, if you have heavy vaginal bleeding that does not go away, or if you are worried about your vaginal bleeding.
- This drug is not for regular use to prevent pregnancy.
- This drug is not approved for use in women who are going through or have been through the change of life (menopause). Talk with your doctor.
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 infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Bleeding a lot (soaking 2 pads per hour).
- Vaginal bleeding that does not stop or go back to normal.
- Very bad vaginal irritation.
- Pelvic pain.
- Dizziness or passing out.
- Feeling confused.
- Fast breathing.
- Very bad headache.
- Shortness of breath.
- Feeling very tired or weak.
- A fast heartbeat.
- Change in how much urine is passed.
- Dry mouth.
- More thirst.
- Very upset stomach or throwing up.
- Very bad belly pain.
- Very loose stools (diarrhea).
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:
- Vaginal bleeding.
- Feeling tired or weak.
- Stomach pain.
- Loose stools (diarrhea).
- Upset stomach or throwing up.
- Stomach cramps.
- Tender breasts.
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.
Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Follow how to take this drug as you have been told by your doctor. Do not use more than you were told to use.
- Be sure you know when and how to take misoprostol after you have taken the mifepristone. Check with your doctor or pharmacist if you have questions.
- Most women will pass the pregnancy within 2 to 24 hours after taking misoprostol. During this time, you will have bleeding and cramping that will most likely be heavier than your normal period. Be sure that you take the misoprostol in a proper place so you are ready. Talk with your doctor.
- Follow up with the doctor as you have been told.
- Call your doctor to find out what to do.
- If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
- 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.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- 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.
- 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.
- 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.
This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
© 2018 Wolters Kluwer Clinical Drug Information, Inc. and its affiliates and/or licensors. All rights reserved.