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Teriflunomide may cause serious or life-threatening liver damage. The risk of liver damage may be increased in people taking other medications known to cause liver damage, and in people who already have liver disease. Tell your doctor if you have liver disease. Your doctor may tell you not to take teriflunomide. Tell your doctor and pharmacist about all the medications you are taking so they can check whether any of your medications may increase the risk that you will develop liver damage during your treatment with teriflunomide. If you experience any of the following symptoms, call your doctor immediately: nausea, vomiting, extreme tiredness, unusual bleeding or bruising, lack of energy, loss of appetite, pain in the upper right part of the stomach, yellowing of the skin or eyes, dark-colored urine, or flu-like symptoms. If liver damage is suspected, your doctor may stop teriflunomide and may give you a treatment that will help to remove teriflunomide more quickly from your body.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before you begin your treatment and regularly during your treatment to check your body's response to teriflunomide.
Do not take teriflunomide if you are pregnant or plan to become pregnant. Teriflunomide may harm the fetus. You should not begin taking teriflunomide until you have taken a pregnancy test with negative results. You and your partner must use an effective method of birth control before you begin taking teriflunomide, during your treatment with teriflunomide, and for up to 2 years after treatment. If your period is late, you miss a period, or you think you may be pregnant during your treatment with teriflunomide or for 2 years after your treatment, call your doctor immediately. If you or your partner becomes pregnant, you should talk to your doctor about reporting the pregnancy to a pregnancy safety surveillance program. Or you can call the program directly at 1-800-745-4447.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with teriflunomide and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of taking teriflunomide.
WHY is this medicine prescribed?
Teriflunomide is used to treat certain types of multiple sclerosis (MS)(MS; a disease in which the nerves do not function properly). Teriflunomide is in a class of medications called immunomodulatory agents. It may work by decreasing inflammation and decreasing the action of immune cells that may cause nerve damage.
HOW should this medicine be used?
Teriflunomide comes as a tablet to take by mouth. Take terflunomide once a day with or without food. Take teriflunomide at around the same time every day. Follow the directions on your prescription label carefully. Ask your doctor or pharmacist to explain any part you do not understand. Do not take more or less of it or take it more often than prescribed by your doctor.
Teriflunomide may help to control the symptoms of multiple sclerosis, but does not cure it. Continue to take teriflunomide even if you feel well. Do not stop taking teriflunomide without talking to your doctor.
Are there OTHER USES for this medication?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking teriflunomide,
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Teriflunomide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop taking teriflunomide and call your doctor immediately or get emergency medical treatment:
Teriflunomide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.
What OTHER INFORMATION should I know?
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: February 15, 2025.