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Drug Information For:


Ingredient Name:

LEFLUNOMIDE (le-FLOO-noh-mide)

Drug Manufacturer:


Common Uses:

This medicine is a pyrimidine synthesis inhibitor used to treat rheumatoid arthritis by reducing signs and symptoms, preventing the development of damage to the joints, and improving physical function.

Before Using This Medicine:

WARNING: This medicine may cause fetal harm (eg, birth defects) or fetal death. DO NOT take this medicine if you are pregnant or if you may become pregnant and are not using an effective form of birth control. You must make sure you are not pregnant before you start this medicine. DO NOT become pregnant while you take this medicine or for as long as any medicine remains in your body after you stop treatment. This medicine may stay in the body for 2 years or longer after you stop it. Women who may become pregnant must use effective birth control while they take this medicine and for as long as any medicine remains in the body. AFTER YOU STOP THIS MEDICINE, your doctor may prescribe other medicines to help remove this medicine from your body more quickly. Blood tests may also be performed to check if any medicine remains in the body. Talk with your doctor for more information and if you have questions about effective birth control. SERIOUS AND SOMETIMES FATAL LIVER PROBLEMS have been reported with this medicine. Your doctor will monitor your liver function while you use this medicine to check for liver problems. Do not take this medicine if you have liver problems or if you have abnormal liver function tests before taking this medicine. Ask your doctor if you are taking other medicines that may harm the liver. Contact your doctor right away if you develop symptoms of liver problems, such as dark urine, pale stools, yellowing of the skin or eyes, stomach pain, severe or persistent nausea or loss of appetite, or unusual tiredness. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking rifampin, anticoagulants (eg, warfarin), cholestyramine, medicines that may harm the liver (eg, acetaminophen, ketoconazole, isoniazid, certain medicines for HIV infection), or medicines that may cause nerve problems. Tell your doctor if you are currently taking or have recently taken methotrexate or another medicine that may suppress your immune system. Ask your doctor if you are unsure if any of your medicines might harm the liver, may suppress the immune system, or may cause nerve problems. DO NOT receive a live vaccine (eg, measles, mumps) while you are taking this medicine. Talk with your doctor before you receive any vaccine. Tell your doctor if you are taking medicine to treat or prevent malaria, or if you are taking another medicine to treat rheumatoid arthritis. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a weakened immune system, an infection, if you drink alcoholic beverages, allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history of lung problems,tuberculosis (TB) or a positive TB test, high blood pressure, blood or bone marrow problems, diabetes, liver problems, abnormal liver function tests, an infection that keeps coming back, or you have recently received a vaccination. Tell your doctor if you have or have a history of kidney problems or you are on dialysis. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have bone marrow problems; a severely weakened immune system; a severe, uncontrolled infection; liver problems (eg, hepatic insufficiency or failure); abnormal liver function tests prior to taking this medicine; or a history of hepatitis B or C infection. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are pregnant, planning to become pregnant, or breast-feeding, or if you may become pregnant and are not using effective birth control. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

How to Use This Medicine:

Follow the directions for using this medicine provided by your doctor. THIS MEDICINE CAN REMAIN IN THE BODY FOR UP TO 2 YEARS after you stop taking it. If your doctor decides that you are required to stop taking this medicine, a process exists that may help to remove the medicine from your body faster. Ask your doctor or pharmacist for more information. STORE THIS MEDICINE at room temperature below 77 degrees F (25 degrees C) in a tightly-closed container, away from heat and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do NOT take 2 doses at once.


DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS. Laboratory and/or medical tests may be done to monitor your progress or to check for side effects. This medicine may cause dizziness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Serious and sometimes fatal liver problems have been reported with this medicine. Alcohol also increases your risk for liver problems. Talk with your doctor before drinking alcohol while taking this medicine. A serious and sometimes fatal lung problem (interstitial lung disease) has been reported with this medicine. CONTACT YOUR DOCTOR RIGHT AWAY IF YOU DEVELOP NEW OR WORSENING BREATHING PROBLEMS such as cough or shortness of breath (with or without fever). THE SAFETY OF THIS MEDICINE in patients with inactive tuberculosis (TB) has not been confirmed. You may need to have a TB skin test before you start this medicine. SERIOUS AND SOMETIMES FATAL SKIN REACTIONS (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been rarely reported with this medicine. Contact your doctor right away if you develop a rash; red, swollen, blistered, or peeling skin; or blisters on the inside of eyes, nose, or mouth. THIS MEDICINE MAY LOWER YOUR RESISTANCE TO INFECTION. Contact your doctor immediately if you experience any sign of infection including fever, chills, rash, or sore throat. THIS MEDICINE MAY REDUCE THE NUMBER OF BLOOD CELLS THAT ARE NEEDED FOR CLOTTING. To prevent bleeding, avoid situations where bruising or injury may occur. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be more sensitive to the effects of this medicine, especially burning, numbness, or tingling. FOR MEN: It is unknown if this medicine may cause birth defects in children of men taking this medicine at the time of conception. Talk with your doctor or pharmacist about the use of effective birth control such as condoms while taking this medicine. IF YOU PLAN ON FATHERING A CHILD, talk with your doctor to discuss your treatment plan. FOR WOMEN: THIS MEDICINE CAN CAUSE SEVERE BIRTH DEFECTS OR FETAL DEATH. DO NOT USE THIS MEDICINE if you are pregnant. You must have a negative pregnancy test before starting this medicine. DO NOT BECOME PREGNANT while you are taking this medicine. Use a reliable form of birth control while taking this medicine and for 2 years after stopping this medicine. Ask your doctor or pharmacist if you have any questions abouteffective birth control options. IF YOU SUSPECT THAT YOU COULD BE PREGNANT or if your period is late, contact your doctor immediately. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking this medicine.

Possible Side Effects:

SIDE EFFECTS that may occur while taking this medicine include back pain; diarrhea; dizziness; hair loss; headache; indigestion; muscle aches; nausea; runny nose; weakness; or weight loss. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience blisters on the inside of eyes, nose, or mouth; burning, numbness, or tingling; chest pain; dark, tarry, or bloody stools; fast or irregular heartbeat; muscle cramps, including leg cramps; new or worsening breathing problems (eg, cough or shortness of breath, with or without fever); red, swollen, blistered, or peeling skin; severe or persistent vomiting; symptoms of high blood pressure (eg, severe or persistent headache or dizziness, vision changes); symptoms of infection (eg, fever, chills, sore throat, cough, increased or painful urination); symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes, stomach pain, severe or persistent nausea or loss of appetite); unusual or easy bruising or bleeding; unusual tiredness; or unusually pale skin. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


If overdose is suspected, contact your local poison control center or emergency room immediately.

Additional Information:

It may take 4 weeks or more to notice any improvement while taking this medicine. DO NOT STOP USING THIS MEDICINE without first checking with your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.

Copyright 2014 Wolters Kluwer Health, Inc.


- This information is not intended to substitute for professional medical advice. Be sure to contact your physician, pharmacist or other health care provider for more information about this medication. By searching these web site pages, you agree to our terms and conditions of use.