- Side Effects
- Drug Interactions
- Pregnancy & Breastfeeding
- What Else to Know
Generic Name: leflunomide
Brand Name: Arava
Drug Class: DMARDs, Other; Immunosuppressants
What is leflunomide, and what is it used for?
Leflunomide is an immunosuppressant medication used in the treatment of active rheumatoid arthritis (RA). RA is an autoimmune disease in which the body’s own immune system mistakenly attacks the joints, causing inflammation and damage to the joints.
Leflunomide is a disease modifying antirheumatic drug (DMARD) that modulates the immune system to reduce inflammation and slow down disease progression. Leflunomide is a prodrug that is converted to its active metabolite A77 1726 (referred to as M1) in the body.
Inflammation in active rheumatoid arthritis is characterized by high T-lymphocyte (T-cell) activity. Activated T-cells have a much higher requirement of pyrimidine nucleotide than T-cells that are at rest. Pyrimidine nucleotide is a chemical compound that is essential for DNA and RNA synthesis for T-cells to grow and proliferate. Leflunomide affects the activated T-cells more because the T-cells at rest use the salvage pathway to meet their pyrimidine requirement.
Leflunomide prevents the expansion of activated autoimmune lymphocytes by inhibiting dihydroorotate dehydrogenase, an enzyme essential for fresh (de novo) synthesis of pyrimidine. By inhibiting pyrimidine synthesis, leflunomide arrests the cell cycle progression of the activated T-cells, controlling T-cell mediated inflammation.
The uses of leflunomide include:
- Do not use in patients who are hypersensitive to leflunomide or any of its components.
- Do not use leflunomide in pregnant women, it may cause fetal harm.
- Do not initiate leflunomide therapy in women of reproductive potential without first excluding pregnancy.
- Advise women of child-bearing potential to use effective contraception during therapy. Do not use leflunomide in women who do not use reliable methods of contraception.
- Advise women to avoid pregnancy until they complete accelerated drug elimination procedure with cholestyramine, and leflunomide levels are verified to be undetectable.
- If pregnancy occurs during therapy, apprise the patient of the potential hazards to the fetus.
- Do not use leflunomide in patients receiving teriflunomide, an active metabolite of leflunomide.
- There have been reports of severe liver injury, including fatal liver failure.
- Using leflunomide concurrently with other medications that can damage the liver increases the risk for liver injury.
- Do not use leflunomide in patients with pre-existing liver disease and elevation of liver enzyme ALT two times more than the upper limit of normal (ULN).
- Monitor ALT levels regularly and if it increases more than 3 times ULN, interrupt therapy and investigate the probable cause. If leflunomide-induced, initiate cholestyramine or activated charcoal to accelerate elimination of leflunomide and monitor ALT level until it returns to normal range. If it is not leflunomide-induced, consider resuming therapy.
- Leflunomide can cause immunosuppression and bone marrow depression.
- Avoid use in patients with severe immunodeficiency, bone marrow dysplasia or severe uncontrolled infections.
- In case of serious infection, interrupt therapy and initiate accelerated drug elimination procedure.
- Monitor complete blood counts of patients and if there are signs of bone marrow depression, discontinue treatment and initiate cholestyramine.
- There are rare reports of severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis with leflunomide therapy. If a patient develops signs of skin reactions, discontinue leflunomide and initiate cholestyramine.
- There is a potential increased risk for malignancies, particularly lymphoproliferative disorders.
- Peripheral neuropathy has been reported, with persistent symptoms in some patients. Age older than 60 years, concomitant neurotoxic medications, and diabetes can increase the risk. If a patient develops symptoms, discontinue leflunomide and initiate drug elimination procedure.
- Interstitial lung disease has been reported with leflunomide treatment. If patient develops new onset or worsening of pulmonary symptoms, interrupt therapy, investigate cause, and if necessary, discontinue leflunomide and initiate drug elimination procedure.
- Screen patients for latent tuberculosis and if positive, treat tuberculosis with standard therapy before initiating leflunomide.
- Use with caution in patients with impaired kidney function.
- Do not administer live vaccines during leflunomide treatment and until the drug is undetectable in the serum.
- Check blood pressure before initiating leflunomide and monitor periodically thereafter.
What are the side effects of leflunomide?
Common side effects of leflunomide include:
- Indigestion (dyspepsia)
- Abdominal pain
- Gastrointestinal pain
- Mouth ulcer
- Gum inflammation (gingivitis)
- Oral inflammation (stomatitis)
- Salivary gland enlargement
- Dry mouth (xerostomia)
- Oral Candida yeast infection (moniliasis/candidiasis)
- Inflammation of the esophagus (esophagitis)
- Colon inflammation (colitis)
- Gas (flatulence)
- Tarry black stools (melena)
- Loss of appetite (anorexia)
- Elevated levels of liver enzymes ALT and AST
- Gallstones (cholelithiasis)
- Hair loss (alopecia)
- Itching (pruritus)
- Dry skin
- High blood pressure (hypertension)
- Chest pain
- Chest pain related to coronary artery disease (angina pectoris)
- Rapid heart rate (tachycardia)
- Varicose veins
- Dilation of blood vessels (vasodilation)
- Blood vessel inflammation (vasculitis)
- Upper respiratory tract infection
- Increased cough
- Bronchial inflammation (bronchitis)
- Sinus inflammation (sinusitis)
- Throat inflammation (pharyngitis)
- Nasal inflammation (rhinitis)
- Nasal bleeding (epistaxis)
- Shortness of breath (dyspnea)
- Lung disorder
- Urinary tract infection
- Bladder inflammation (cystitis)
- Albumin in urine (albuminuria)
- Painful urination (dysuria)
- Blood in urine (hematuria)
- Urinary frequency
- Prostate disorder
- Menstrual disorder
- Vaginal candidiasis
- Skin tingling and numbness (paresthesia)
- Joint disorder
- Inflammation of membrane around tendons (tenosynovitis)
- Inflammation of the connective tissue that lines joints (synovitis)
- Inflammation of the fluid-filled sacs that cushion joints (bursitis)
- Joint pain (arthralgia)
- Joint degeneration (arthrosis)
- Bone tissue death (necrosis)
- Bone pain
- Tendon rupture
- Muscle cramps
- Muscle pain (myalgia)
- Leg cramps
- Back pain
- Neck pain
- Pelvic pain
- Weakness (asthenia)
- Flu syndrome
- Injury accident
- Feeling unwell (malaise)
- Allergic reaction
- Weight loss
- Low blood potassium levels (hypokalemia)
- High blood glucose levels (hyperglycemia)
- High blood fats (hyperlipidemia)
- Increase in creatine phosphokinase
- Swelling of extremities (peripheral edema)
- Diabetes mellitus
- Overactive thyroid (hyperthyroidism)
- Low red blood cell count (anemia)
- Skin reactions including:
- Contact dermatitis
- Fungal dermatitis
- Flat and raised skin lesions (maculopapular rash)
- Bleeding under the skin (hematoma)
- Discoloration of skin from bleeding underneath (ecchymosis)
- Skin and subcutaneous nodules
- Skin ulcers
- Skin disorders
- Nail disorders
- Herpes simplex
- Herpes zoster
- Hair discoloration
- Sleep disorder
- Sleeplessness (insomnia)
- Nerve inflammation (neuritis)
- Nerve pain (neuralgia)
- Increased sweating
- Eye disorder
- Blurred vision
- Inflammation of conjunctiva, the membrane over the eye whites and inner eyelid surfaces (conjunctivitis)
- Taste perversion
Less common and rare side effects of leflunomide include:
- Opportunistic and severe infections including sepsis
- Hypersensitivity reactions including:
- Serious skin reactions including:
- Blood disorders including:
- Inflammation of the pancreas (pancreatitis)
- Liver inflammation (hepatitis)
- Impaired bile flow (cholestasis)
- Severe liver damage including hepatic failure and necrosis
- Lung scarring diseases (interstitial lung disease) such as:
- Peripheral nerve disease (neuropathy)
Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:
- Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
- Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
- Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
- Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.
What are the dosages of leflunomide?
- 10 mg
- 20 mg
- 100 mg
- 100 mg orally once daily for 3 days initially, THEN 10-20 mg orally once daily
- No dosage adjustment provided by the manufacturer; use with caution
- Preexisting liver disease: Not recommended
- Baseline ALT more than 2 times ULN: Not recommended
- Severe hepatic impairment: Contraindicated
- Hepatotoxicity following administration: Discontinue therapy and determine cause; if leflunomide induced, discontinue treatment and initiate accelerated drug elimination process
- Drug elimination process recommended to achieve nondetectable plasma levels (i.e., below 0.02 mg/L) after discontinuation
- Step 1: Administer cholestyramine 8 g orally thrice daily for 11 days; the 11 days do not need to be consecutive unless there is a need to lower the plasma level rapidly
- Step 2: Verify whether plasma levels are below 0.02 mg/L by 2 separate tests at least 14 days apart; if plasma levels are above 0.02 mg/L, consider additional cholestyramine treatment
- Without the drug elimination procedure, it may take up to 2 years to reach plasma M1 metabolite levels below 0.02 mg/L due to individual variation in drug clearance
- Safety and efficacy not established
What drugs interact with leflunomide?
Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.
- Leflunomide has no known severe interactions with other drugs.
- Leflunomide has serious interactions with at least 74 different drugs.
- Leflunomide has moderate interactions with at least 60 different drugs.
- Mild interactions of leflunomide include:
The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.
It is important to always tell your doctor, pharmacist, or healthcare provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.
Pregnancy and breastfeeding
- Do not use leflunomide in pregnant women, it may cause fetal harm. There are no adequate and well-controlled studies in pregnant women, however animal studies show leflunomide may increase the risk of fetal malformation and fetal death.
- Do not initiate leflunomide therapy in women of reproductive potential without first excluding pregnancy. Women of pregnancy potential should use effective contraception during therapy.
- Women wishing to become pregnant must discontinue leflunomide therapy, undergo accelerated drug elimination procedure with cholestyramine, and avoid pregnancy until leflunomide levels are verified to be undetectable. Without the accelerated drug elimination procedure, it may take up to 2 years for leflunomide to be eliminated.
- Available information does not indicate leflunomide therapy for men is associated with fetal risks, however, to minimize risks, men wishing to father a child should consider first discontinuing leflunomide and undergoing drug elimination procedure.
- It is not known if leflunomide is present in breast milk, however, many drugs are excreted in breast milk. Leflunomide should not be used in nursing mothers because of the potential for serious adverse reactions in the breastfed infant. Decision to continue nursing or initiate leflunomide therapy should be taken based on the importance of the treatment to the mother.
- A pregnancy exposure registry monitors pregnancy outcomes in women exposed to therapy during pregnancy. Health care providers and patients are encouraged to report pregnancies by calling 1-877-311-8972.
What else should I know about leflunomide?
- Take leflunomide exactly as prescribed.
- You will need periodic tests while on leflunomide therapy. Do not miss your appointments.
- Notify your physician immediately if you experience:
- Any skin reactions
- Liver injury symptoms such as abdominal pain, jaundice, or unusual tiredness
- Onset or worsening of lung disease symptoms such as cough or shortness of breath
- Symptoms of immunosuppression and bone marrow depression such as easy bruising or bleeding, recurrent infections, fever, paleness or unusual tiredness.
- Symptoms of peripheral neuropathy such as numbness, pain, or tingling in extremities
- Do not take live vaccines while on leflunomide therapy.
- Store safely out of reach of children.
- In case of overdose, seek medical help or contact Poison Control.
Leflunomide is an immunosuppressant medication used in the treatment of active rheumatoid arthritis (RA). Do not use leflunomide in pregnant women, as it may cause fetal harm. Common side effects of leflunomide include diarrhea, nausea, vomiting, indigestion (dyspepsia), abdominal pain, gastrointestinal pain, mouth ulcer, gum inflammation (gingivitis), oral inflammation (stomatitis), salivary gland enlargement, dry mouth (xerostomia), oral Candida yeast infection (moniliasis/candidiasis), gastroenteritis, inflammation of the esophagus (esophagitis), gastritis, colon inflammation (colitis), gas (flatulence), constipation, tarry black stools (melena), loss of appetite (anorexia), elevated levels of liver enzymes ALT and AST, gallstones (cholelithiasis), and others.
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Myositis can result from several causes, such as presenting as a rare side effect of severe rheumatoid arthritis. Check out the center below for more medical references on rheumatoid arthritis, including multimedia (slideshows, images, and quizzes), related disease conditions, treatment and diagnosis, medications, and prevention or wellness.
What Are the Differences Between Tendonitis and Arthritis?
While tendonitis and arthritis occur in similar sites on the body and share symptoms, there are differences between these two rheumatic disorders. Check out the center below for more medical references on tendonitis and arthritis, including multimedia (slideshows, images, and quizzes), related disease conditions, treatment and diagnosis, medications, and prevention or wellness.
Can Rheumatoid Arthritis Cause Carpal Tunnel?
Carpal tunnel syndrome is one of the common complications of rheumatoid arthritis. Learn the symptoms, causes, diagnosis, and treatment of carpal tunnel syndrome.
How Is Psoriatic Arthritis Diagnosed?
Psoriatic arthritis is a painful joint condition associated with psoriasis that is diagnosed through imaging and blood tests when accompanying symptoms are present.
How Do You Treat Rheumatoid Arthritis (RA) Rash?
Treatment for a rheumatoid arthritis rash focuses on treating the underlying condition and may include topical antibiotics and ointments. Check out the center below for more medical references on rheumatoid arthritis, including multimedia (slideshows, images, and quizzes), related disease conditions, treatment and diagnosis, medications, and prevention or wellness.
Can Osteoarthritis Be Cured?
Osteoarthritis cannot be cured or reversed; however, effective treatment can reduce its progression and slow down complications.
Can Rheumatoid Arthritis (RA) Cause Inflammation of the Brain?
Rheumatoid meningitis is a rare complication of RA that can affect the way the brain functions, leading to further symptoms such as brain fog. Check out the center below for more medical references on rheumatoid arthritis, including multimedia (slideshows, images, and quizzes), related disease conditions, treatment and diagnosis, medications, and prevention or wellness.
Early Signs of Arthritis in the Wrist
Wrist arthritis is inflammation (swelling) of one or more joints of the wrist. Wrist arthritis is long-lasting or permanent and eventually causes severe joint damage. The early signs of arthritis in the wrist include morning stiffness, redness, tenderness, pain, swelling, weakness, warmth and other symptoms.
Rheumatoid Arthritis vs. Gout
Although gout is often mistaken for rheumatoid arthritis, learn the differences associated with the causes, symptoms, and treatments below.
Rheumatoid Arthritis vs. Psoriatic Arthritis
Here are the differences between rheumatoid arthritis and psoriatic arthritis.
Early Signs and Symptoms of Arthritis in Thumb
The earliest sign and symptom of thumb arthritis is pain, swelling, and tenderness with activities that involve pinching action. The pain may be dull, achy, or sharp at the base of the thumb. The pain can occur when we grip, grasp, or pinch an object or use the thumb to apply force.
Is There a Genetic Marker for Rheumatoid Arthritis?
Genes and family history can predispose a person to develop rheumatoid arthritis (RA). Check out the center below for more medical references on rheumatoid arthritis, including multimedia (slideshows, images, and quizzes), related disease conditions, treatment and diagnosis, medications, and prevention or wellness.
Can Rheumatoid Arthritis Affect Your Elbows?
Since rheumatoid arthritis affects the joints, many people with RA experience elbow pain. Check out the center below for more medical references on rheumatoid arthritis, including multimedia (slideshows, images, and quizzes), related disease conditions, treatment and diagnosis, medications, and prevention or wellness.
Can Rheumatoid Arthritis Affect the Cervical Spine?
The cervical spine and neck are the third most commonly affected sites of rheumatoid arthritis (RA). Check out the center below for more medical references on rheumatoid arthritis, including multimedia (slideshows, images, and quizzes), related disease conditions, treatment and diagnosis, medications, and prevention or wellness.
How Can I Improve My Grip Strength With Rheumatoid Arthritis?
Rheumatoid arthritis (RA) is an autoimmune disorder characterized by gradual joint inflammation and degeneration. Here are five exercises that reduce muscle stiffness and improve pain due to RA.
How Do I Know If I Have Rheumatoid Arthritis in My Thumb?
Rheumatoid arthritis (RA) in the thumb results in severe pain and swelling that leads to a decrease in range of motion and makes performing simple tasks difficult. Check out the center below for more medical references on rheumatoid arthritis, including multimedia (slideshows, images, and quizzes), related disease conditions, treatment and diagnosis, medications, and prevention or wellness.
What Are the 4 Signs of Osteoarthritis?
The signs and symptoms of osteoarthritis may vary depending on the severity of the condition. Learn four signs, two types, and other associated conditions.
Quackery of Arthritis
Arthritis patients are sometimes vulnerable to quackery (the business of promoting unproven remedies). These "quick fix" treatments are promoted as cure-alls, but they really have no right to such claims. Consumers should be wary of products that have marketing claims like "will cure," "ancient remedy," "has no side effects," and "revolutionary new scientific breakthrough." Read about arthritis remedies and tests that have no scientific proof of benefits.
Rheumatoid Arthritis vs. Juvenile Arthritis
Rheumatoid arthritis and juvenile arthritis are both types of inflammatory arthritis; however, learn their differences below.
What Are the Symptoms of Rheumatoid Arthritis in the Knees?
Symptoms of rheumatoid arthritis (RA) in the knees include pain and swelling and weakness of the joint. Check out the center below for more medical references on rheumatoid arthritis, including multimedia (slideshows, images, and quizzes), related disease conditions, treatment and diagnosis, medications, and prevention or wellness.
What Is the Main Cause of Osteoarthritis?
Osteoarthritis (OA) is a chronic degenerative disease of the joints affecting middle-aged and elderly people. It involves the breakdown of cartilage and associated inflammatory changes in the adjacent bone. It is a leading cause of chronic disability, affecting 30 million people in the United States alone.
Can Rheumatoid Arthritis Cause Pleuritis?
Rheumatoid arthritis (RA) can result in pleuritis, which is inflammation of the pleura. Check out the center below for more medical references on rheumatoid arthritis, including multimedia (slideshows, images, and quizzes), related disease conditions, treatment and diagnosis, medications, and prevention or wellness.
Does Rheumatoid Arthritis Increase Cardiovascular Risk?
Rheumatoid arthritis (RA) is an autoimmune and inflammatory disease, which usually affects joints, and can increase the risk of cardiovascular diseases.
What Are the 3 Common Types of Arthritis?
The 3 most common types of arthritis include osteoarthritis, rheumatoid arthritis, and gout.
Osteoarthritis and Treatment
Painful swelling of the joints due to wear and tear over many years is called osteoarthritis. Osteoarthritis may develop in any joint that includes the fingers, hips, and knees. There are many treatment options available to curb the complications of arthritis.
What Are 5 Common Risk Factors to Rheumatoid Arthritis?
Rheumatoid arthritis (RA) is an autoimmune disorder (the body's immune system mistakenly attacks its own cells). Certain factors increase the risk of RA.
Do Anti-Inflammatories Help Rheumatoid Arthritis?
Rheumatoid arthritis is a chronic inflammatory disorder. Anti-inflammatory medications can help address symptoms of rheumatoid arthritis.
Are Psoriasis and Psoriatic Arthritis the Same?
Psoriatic arthritis is a type of inflammatory arthritis that occurs due to joint inflammation in people with psoriasis; however, not every person with psoriasis gets psoriatic arthritis.
Can Psoriasis Lead to Psoriatic Arthritis?
It is well established that both psoriatic arthritis and psoriasis are linked. Nearly 30 percent of people with psoriasis develop psoriatic arthritis.
Treatment & Diagnosis
- Rheumatoid Arthritis FAQs
- Rheumatoid Arthritis (RA): 17 Warning Signs of Serious Complications
- Will Rheumatoid Arthritis Nodules Go Away?
- What if I get COVID-19 with Rheumatoid Arthritis?
- Is Inflammatory Arthritis the Same as Rheumatoid Arthritis?
- Living With Rheumatoid Arthritis
- Rheumatoid Arthritis vs. Osteoarthritis
- Why Does Pregnancy Affect the Course of Rheumatoid Arthritis (RA)?
- Can Rituximab Be Taken By Breastfeeding Women With Rheumatoid Arthritis?
- Are Corticosteroids Safe for Pregnant and Nursing Women with Rheumatoid Arthritis?
- How Does Pregnancy Affect the Course of Rheumatoid Arthritis (RA)?
- 5 Surprising Facts About Rheumatoid Arthritis
- Arthritis or Injury: Ice or Heat - Which To Apply
- Kineret (anakinra) for Rheumatoid Arthritis
- Celebrex - New Arthritis Drug
- Arthritis Roller Coaster
- Arthritis Medications
- What Not to Eat When You Have Arthritis
- How Do Arthritis Symptoms Start?
- Ultrasound Imaging of Joints in Rheumatoid Arthritis (RA)
- Can You Be Too Young for a Knee Replacement?
- Can Fifth Disease Cause Arthritis Pain?
- What Are the Side Effects of Remicade for Rheumatoid Arthritis?
- What Are the Side Effects of Glucosamine?
- Can You Get a Cartilage Transplant?
- Can Milk Allergy Cause Rheumatoid Arthritis?
- Can Glucosamine Treat Arthritis?
- Are Hidradenitis and Rheumatoid Arthritis Related?
- How Is Arthritis Diagnosed?
- Can My Diet Improve Arthritis?
- What's the Rheumatoid Arthritis Prognosis?
- What Are Home Remedies for Rheumatoid Arthritis?
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.