Generic Name: leflunomide, Oral tablet

Arava

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  • Arava
SECTION 1 of 4

Highlights for leflunomide

Oral tablet
1

Leflunomide is an oral medication used to treat active rheumatoid arthritis. It can help reduce the pain in your joints and help you perform daily tasks better.

2

Common side effects include diarrhea, hair loss, and rash. This medication may also increase your risk of getting infections.

3

If you’re pregnant or plan to become pregnant, you shouldn’t take this medication. It may cause harm to a fetus.

4

Leflunomide may cause liver damage or make liver damage worse. Your doctor may measure your liver function every 6 months while you take this drug. People with liver damage shouldn’t take this drug.

IMPORTANT INFORMATION

FDA Warning

This drug has a Black Box Warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients to potentially dangerous effects.

Pregnancy risk. You shouldn’t take this medication if you’re pregnant. You shouldn’t take it if you’re of childbearing age and not using effective birth control methods to prevent pregnancy. Avoid becoming pregnant while taking this medication. If you become pregnant, talk to your doctor.

Liver damage warning. Liver damage can occur in anyone taking this drug.  People with existing liver damage shouldn’t take this drug. Your doctor may do blood tests to measure liver function at least monthly for 6 months while you take this drug.

Infection warning

Leflunomide isn’t recommended if you have a weak immune system or serious infections. If you get a serious infection, such as pneumonia or tuberculosis, talk to your doctor to find out if you should stop taking this medication.

Nerve damage

This medication can damage the nerves in some people and cause numbness, tingling, or burning pain in the hands and feet. This can go away once the drug is stopped. However, some people continue to have symptoms.

May lower blood cell levels

Your doctor may monitor your blood cell levels regularly. Talk to your doctor if you experience fevers, unusual tiredness, frequent infections, or bruise or bleed easily.

Drug Features

Leflunomide is a prescription medication. It’s available in oral tablet form. It’s also available in a generic version. Generic drugs usually cost less. In some cases they may not be available in every strength or form as the brand. Talk to your healthcare provider to see if the generic will work for you.

Why It's Used

Leflunomide is used to treat active rheumatoid arthritis.

How It Works

Rheumatoid arthritis occurs when an overactive immune system attacks some parts of your body, such as the joints.

More Details

How It Works

Rheumatoid arthritis occurs when an overactive immune system attacks some parts of your body, such as the joints. Leflunomide works to block part of the immune system and proteins in the body that cause inflammation.

Leflunomide is a nonbiologic disease modifying anti-rheumatic drug.

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leflunomide Side Effects

Oral tablet

Most Common Side Effects

The most common side effects of leflunomide include:

  • diarrhea

  • hair loss

  • rash

  • worsening liver function

Serious Side Effects

If you experience any of these serious side effects, call your doctor right away. If your symptoms are potentially life threatening, or if you think you’re experiencing a medical emergency, call 9-1-1.

  • serious infections, including pneumonia, tuberculosis, and complications from infections

  • serious skin disorder. Symptoms may include:

    • flu-like symptoms
    • painful red or purple rash
    • blisters
  • low blood cell counts. Your doctor may monitor this through blood tests.

  • worsening lung function. Symptoms may include:

    • cough
    • difficulty breathing with or without fever
Pharmacist's Advice
Healthline Pharmacist Editorial Team

Leflunomide does not cause drowsiness.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
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leflunomide May Interact with Other Medications

Oral tablet

Leflunomide can interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Note: You can reduce your chances of drug interactions by having all of your prescriptions filled at the same pharmacy. That way, a pharmacist can check for possible drug interactions.

Medications That Might Interact with This Drug

Disease-modifying antirheumatic drug
  • methotrexate

Combining these drugs may increase your risk of liver damage.

Antibiotic
  • rifampin

Combining these drugs may cause higher levels of leflunomide in your body. This may increase side effects of leflunomide.

Live vaccines

Talk to your doctor or pharmacist before receiving live vaccinations. Leflunomide lowers immune function. This may increase your risk of getting the disease the vaccine is designed to prevent. Live vaccines include:

  • influenza nasal spray
  • measles, mumps, and rubella vaccine
  • chickenpox (varicella) vaccine

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

People with liver disease

If you have liver problems, using leflunomide may cause even more damage to your liver. This drug isn’t recommended if you have liver disease.

People with kidney disease

Talk to your doctor about using leflunomide if you have kidney problems. Higher levels of the drug may stay in your body if your kidneys don’t work well. It’s unknown if this would cause more side effects.

People with serious infection

Leflunomide isn’t recommended if you have a weak immune system or serious infections. If you get a serious infection, such as pneumonia or tuberculosis, talk to your doctor to find out if you should stop taking this medication.

Pregnant women

Leflunomide is a pregnancy category X drug. Category X drugs should never be used during pregnancy.

If you’re a man, it isn’t known if this drug can pass into your sperm. Taking this drug during conception could harm the development of the fetus.

Women who are nursing

It isn’t known if this drug passes through breast milk. It isn’t recommended for women to breastfeed while using leflunomide. You and your doctor may need to decide whether you’ll breastfeed or take this drug.

For Children

This drug is not approved for people under the age of 18 years.

Allergies

Leflunomide can cause a severe allergic reaction. Symptoms may include:

  • trouble breathing
  • swelling of your throat or tongue
  • hives

Don’t take this medication again if you’ve ever had an allergic reaction to leflunomide or teriflunomide. Taking it again could be fatal.

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How to Take leflunomide (Dosage)

Oral tablet

All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

What Are You Taking This Medication For?

Active rheumatoid arthritis
Form: Oral Tablet
Strength: 10 mg, 20 mg, and 100 mg
Adult Dosage (ages 18 years and older)
  • Some people receive a starting dose of one 100-mg tablet per day for 3 days. This is called a “loading dose.”
  • The recommended daily dose for continuing treatment is 20 mg. If you’re unable to tolerate this dose, your doctor may lower it to 10 mg per day.
  • Doses higher than 20 mg per day are not recommended.
Child Dosage (ages 0-17 years)

Dosage for people younger than 18 years hasn’t been established.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.
Pharmacist's Advice
Healthline Pharmacist Editorial Team

Leflunomide comes with risks if you don’t take it as prescribed by your doctor.

If You Don’t Take It at All

Rheumatoid arthritis can cause severe pain and affect other organs in your body, especially if left untreated.

If You Stop

It’s important to continue taking your medication as directed by your doctor, even if you feel better. This will give you the best chance of managing rheumatoid arthritis and improving your quality of life.

If You Take Too Much

If you take too much, you may experience more side effects, including diarrhea, stomach pain, and changes in your blood cell levels and liver function. You may need to take another medication to help get rid of excess leflunomide in your body more quickly. If you take or think you’ve taken too much leflunomide, get medical help right away.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you can. If it’s close to time for your next dose, skip the missed dose and take the next dose at the usual time. Don’t take more than one dose at a time or extra doses. Doing so could lead to more side effects or toxicity.

How to Tell If the Drug is Working

You may be able to tell if this drug is working if you have less joint pain and are able to perform your daily tasks better.

This is a long-term treatment.

Don’t cut or crush the oral tablet

This drug is considered a hazardous material and shouldn’t be broken apart and handled.

Store this medication at 77°F (25°C)

Keep it away from light.

Keep your drugs away from areas where they could get wet, such as bathrooms. Store them away from moisture and damp locations.

Travel

When traveling with your medication:

  • Always carry it with you or in your carry-on bag.
  • Don’t worry about airport X-ray machines. They can’t hurt this medication.
  • You may need to show your pharmacy’s preprinted label to identify the medication. Keep the original prescription-labeled box with you when traveling.

Clinical Monitoring

Leflunomide may affect your liver function and blood levels in your body. Your doctor may order blood tests when starting treatment, 6 months later, and then every 6–8 weeks after that. 

A pregnancy test is required before starting leflunomide. If you think you’re pregnant while taking leflunomide, tell your doctor immediately. You may need to take another pregnancy test.

Insurance

Many insurance companies will require a prior authorization before they approve the prescription and pay for leflunomide.

What does the pill look like?

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Are There Any Alternatives?

There are other drugs available to treat your condition. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.


Show Sources

Content developed in collaboration with University of Illinois-Chicago, Drug Information Group

Medically reviewed by Creighton University, Center for Drug Information and Evidence-Based Practice on May 19, 2015

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Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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