Arava (Leflunomide) – Oral

Warning:

You should not use Arava (leflunomide) if you are pregnant or have severe liver disease. Arava can cause severe liver injury and fatal liver injury. If used during pregnancy, Arava can potentially be toxic to the embryo or fetus.

What Is Arava?

Arava (leflunomide) is a prescription medication that relieves rheumatoid arthritis (RA) symptoms. It belongs to a class known as disease-modifying antirheumatic drugs (DMARDs). DMARDs work by calming your body’s overactive immune system to help reduce inflammation. 

Arava is available in tablet form.

Drug Facts

Generic Name: Leflunomide

Brand Name: Arava

Drug Availability: Prescription

Administration Route: Oral

Therapeutic Classification: Immunosuppressant 

Available Generically: Yes

Controlled Substance: N/A

Active Ingredient: Leflunomide

Dosage Form: Tablet

What Is Arava Used For?

The Food and Drug Administration (FDA) approved Arava to treat adults with active RA. RA is an autoimmune disorder that causes symptoms such as swelling, pain, stiffness, and damage to your joints.

Arava carries a boxed warning, the FDA’s strictest warning label, advising against its use in people who are pregnant or have severe liver disease. According to the FDA, Arava can cause severe liver injury and fatal liver injury. If used during pregnancy, Arava can potentially be toxic to the embryo or fetus.

Arava ( Leflunomide ) Drug Information - Illustration by Zoe Hansen

Verywell / Zoe Hansen

How to Take Arava

Arava is available as an oral tablet. It is meant to be taken by mouth. You can take this medication with or without food.

Storage

Store Arava at a controlled room temperature, which is about 77 degrees Fahrenheit.

Always carry your medication with you. If you are flying, keep the original prescription-labeled bottle or box in your carry-on bag. Don’t leave this medication in your car, especially if the temperature is very cold or hot.

What Are the Side Effects of Arava?

Like most medications, Arava can cause mild or serious side effects. 

This is not a complete list of side effects and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

The most common side effects of Arava include:

  • Dizziness
  • Nausea or vomiting
  • Itching
  • Low energy level
  • Diarrhea
  • Hair loss
  • Mouth ulcers

Talk to your healthcare provider or pharmacist if any of these side effects don’t go away or become more severe.

Severe Side Effects

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include:

  • Severe allergic reactions, including trouble breathing, hives, and swelling of the tongue, lips, mouth, or throat
  • Nerve damage, including numbness, tingling, burning, sharp pain, and muscle weakness
  • Lung inflammation, including cough, shortness of breath, and wheezing
  • Drug reaction with eosinophilia and systemic symptoms (DRESS), including itchy, red skin and swollen lymph glands
  • High blood pressure, either an increase or a new onset of high blood pressure
  • Severe skin reactions, such as hair loss, eczema, Stevens-Johnson Syndrome (SJS, flu-like symptoms followed by a painful rash), or toxic epidermal necrolysis (TEN, life-threatening disorder of blistering and peeling of the skin)
  • Liver disease or failure, whose symptoms include tiredness, jaundice (yellowing of the skin and eyes), and abdominal pain
  • Lowered immunity

Report Side Effects

Arava may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much of Arava Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For rheumatoid arthritis:
      • Adults—
        • For patients who are at low-risk for liver disease and bone marrow problems caused by Arava®: At first, 100 milligrams (mg) once a day for 3 days, then 20 mg once a day. Your doctor may adjust the dose as needed. Your doctor may adjust your dose as needed and tolerated.
        • For patients who are at high-risk for liver disease and bone marrow problems caused by Arava®: 20 mg once a day. Your doctor may adjust your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of Arava, you should take the missed dose as soon as you remember. But if it is almost time for the next scheduled dose, you should skip the missed dose. Do not take extra to make up for the missed dose. Doing so can increase your risk for side effects.

Overdose: What Happens If I Take Too Much Arava?

If you take too much Arava, you may begin to experience:

  • Diarrhea
  • Stomach pain
  • Low level of red blood cells (anemia)
  • Low level of white blood cells (leukopenia)
  • Stomach pain
  • Increased liver enzymes

What Happens If I Overdose on Arava?

If you think you or someone else may have overdosed on Arava, call a healthcare provider or the Poison Control Center (800-222-1222). If someone collapses, has a seizure, has trouble breathing, or can’t wake up after taking too much Arava, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

You will need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Leflunomide may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Men taking leflunomide should use condoms as a form of birth control during sexual intercourse. A man intending to father a child should stop taking this medicine and check with his doctor right away.

Do not use this medicine if you are also using teriflunomide. Using these medicines together may cause unwanted serious side effects.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Leflunomide can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause drug reaction with eosinophilia and systemic reactions (DRESS), including serious skin reactions. Check with your doctor right away if you have any blistering, peeling, or loose skin, chills, itching, joint or muscle pain, red skin lesions, often with a purple center, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test.

Using this medicine may increase your risk of getting serious infections or cancer. Talk to your doctor if you have concerns about this risk.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Check with your doctor right away if you have a cough with or without a fever, shortness of breath, or any difficulty with breathing.

While you are being treated with leflunomide, and after you stop using it, do not have any vaccinations without your doctor's approval. Live virus vaccines should not be given while receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What Are Reasons I Shouldn't Take Arava?

There are a few reasons why your healthcare provider may not choose Arava as part of your treatment plan.

You may not be able to take Arava if you:

  • Are allergic to leflunomide or any of its other ingredients
  • Are pregnant or trying to become pregnant
  • Have certain health conditions

Araxa can cause harm to the embryo or fetus during pregnancy. For this reason, you should not use Arava if you are pregnant or planning to become pregnant. Arava has a boxed warning about this risk. If you can conceive, you must use effective birth control before, during, and two years after taking Arava. It is best to talk to your healthcare provider if you are pregnant or plan to become pregnant so that they can decide the best option for you.

Arava can potentially harm a breastfed infant, but it is uncertain if the drug passes into breast milk. Talk with your provider if you are breastfeeding to discuss the best plan.

A person 65 years or older often processes drugs more slowly. If you are in this age group, you may need a lower dose or a different dosing schedule.

Your body may handle Arava differently if you have certain medical conditions. Inform your healthcare provider if you have the following health conditions:

What Other Medications Interact With Arava?

Arava can cause liver damage. This effect is increased when taken with the following medications:

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) such as Advil (ibuprofen), aspirin, or Aleve or Naprosyn (naproxen)
  • Birth control pills or hormone replacement therapy
  • Certain cholesterol-lowering medications or high blood pressure medications, such as Crestor (rosuvastatin), Vytorin (ezetimibe and simvastatin), Lipitor (atorvastatin), and others
  • Seizure medications, including Tegretol (carbamazepine) or Dilantin (phenytoin)
  • Antivirals or HIV (human immunodeficiency) medications
  • Antifungal medications

This list does not include all drugs that can interact with Arava. Before taking this medication, tell your healthcare provider about all of the prescription medications, over-the-counter (OTC) medications, vitamins, supplements, or herbs you are taking. This will help you avoid potential interactions. If you have any questions about drug interactions, speak with a healthcare practitioner or pharmacist.

What Medications Are Similar?

Arava is a medication known as a DMARD used to treat RA. 

Other medications that help manage RA symptoms include:

Humira

Humira is part of a class of medications known as biologics. Biologics work by decreasing inflammation. Humira is available as an injection. It is often prescribed to treat symptoms of inflammatory conditions such as RA, juvenile arthritis, and psoriatic arthritis, among others.

Xeljanz

Xeljanz is part of a class of medications known as JAK inhibitors. JAK inhibitors affect genes and immune cells to decrease inflammation and joint damage. Xeljanz is available as an oral tablet and extended-release oral tablet. It is often prescribed to treat RA, psoriatic arthritis, ulcerative colitis, and juvenile arthritis. 

Naprosyn 

Naprosyn is part of a class of medications known as NSAIDs. NSAIDs work by preventing inflammation. Naprosyn is available as an oral tablet. It helps treat RA, ankylosing spondylitis, osteoarthritis, and juvenile arthritis. 

This is a list of examples of medications used to treat symptoms of RA. It is not a list of drugs recommended to take with Arava. Ask your pharmacist or healthcare provider if you have any questions.

Frequently Asked Questions

  • What is Arava used for?

    Arava is part of a class of medications known as disease-modifying antirheumatic drugs (DMARDs). It works by decreasing inflammation caused by your immune system. It is often used to treat rheumatoid arthritis (RA).

  • What are the side effects of Arava?

    The most common side effects are dizziness, nausea, headache, hair loss, or low energy levels. Arava also has the potential for serious side effects such as an allergic reaction, lung inflammation, or nerve damage. If you are experiencing any serious side effects, call your healthcare provider right away. Call 911 if you are experiencing a medical emergency or life-threatening symptoms.

  • How do I stop taking Arava?

    If you stop taking Arava for any reason, your healthcare provider will prescribe treatment to remove teriflunomide, the active metabolite of Arava, from your body faster than normal. Teriflunomide can lead to serious health risks and may stay in your body for up to two years after you stop taking Arava.

How Do I Stay Healthy While Taking Arava?

Living with RA can be difficult and overwhelming at times. Arava can be a safe and effective medication for relief from the symptoms of RA when used correctly. Work with your healthcare team—which may include a primary healthcare provider, rheumatologist, and more—to find what treatment is best for you. 

While Arava does have the potential for serious side effects such as allergic reactions or lung inflammation, the most common side effects may be milder. Those include nausea, headache, dizziness, or low energy levels.

It is important to inform your healthcare provider of all of your other health conditions and any prescription medications, OTC medications, vitamins, supplements, or herbs you are taking. This way, your provider can make the best decision about what medication and what dose works best for you.

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare professional. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

4 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. U.S. Library of Medicine. DailyMed. Arava - leflunomide film coated tablets.

  2. U.S. Library of Medicine. DailyMed. Humira - adalimumab.

  3. U.S. Library of Medicine. DailyMed. Xeljanz tablet.

  4. U.S. Library of Medicine. DailyMed. Naprosyn-naproxen.

By Kaylea Swearingen, PharmD
Kaylea Swearingen is a registered pharmacist and health and wellness writer.