Arava is a brand-name prescription medication. It’s FDA-approved to treat active rheumatoid arthritis (RA) in adults.

RA is an autoimmune and inflammatory disease. It causes swelling, stiffness, damage, and pain in your joints. Autoimmune diseases are conditions that happen when your body’s immune system attacks your healthy tissues by mistake. With active RA, the condition is causing you to have RA symptoms.

For more information about Arava and how it’s used to treat RA, see the “Arava for rheumatoid arthritis” section below.

Drug details

Arava contains the drug leflunomide. After you take Arava, your body breaks down leflunomide into its active metabolite*, teriflunomide. Arava belongs to a class of medications called disease-modifying antirheumatic drugs (DMARDs). (Medication classes describe groups of drugs that act in similar ways.)

DMARDs change or suppress your body’s overactive immune system. And this helps to lower inflammation in your body. So Arava can help lower inflammation that’s caused by RA. The drug may also:

  • relieve RA symptoms
  • prevent new or worsening joint damage
  • allow you to stay physically active

Arava comes as tablets that you take by mouth. It’s typically taken once a day. Arava tablets are available in three strengths: 10 milligrams (mg), 20 mg, and 100 mg.

* An active metabolite is made when your body breaks down an ingredient in a drug. The active metabolite produces the intended effect of the drug in your body.

Effectiveness

For information about the effectiveness of Arava, see the “Arava for rheumatoid arthritis” section below.

Arava is a brand-name medication that contains the drug, leflunomide. After you take Arava, leflunomide is broken down by your body into its active metabolite*, teriflunomide.

Leflunomide is available as a generic medication in certain strengths. A generic medication is an exact copy of the drug and active ingredients contained in a brand-name medication. The generic is considered to be as safe and effective as the original drug. Generics tend to cost less than brand-name drugs.

If you’re interested in using a generic form of Arava, talk with your doctor. They can tell you if it comes in the right form and strength needed for your condition.

* An active metabolite is made when your body breaks down an ingredient in a drug. The active metabolite produces the intended effect of the drug in your body.

Arava can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Arava. These lists do not include all possible side effects.

For more information about the possible side effects of Arava, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

If you’re having certain side effects with Arava treatment, it’s possible your doctor may recommend that you stop taking Arava. In that case, your doctor will prescribe another treatment that works to remove Arava from your body faster than usual. For more information about this possible treatment, see the “How to take Arava” section below.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Arava, you can do so through MedWatch.

Mild side effects

Mild side effects* of Arava can include:

  • increased level of liver enzymes (certain proteins)
  • diarrhea
  • nausea and vomiting
  • headache
  • rash or itching
  • hair loss
  • weakness or low energy level
  • back pain
  • pain in your abdomen (belly) or digestive tract area
  • mouth ulcers
  • inflammation in your lungs or airways
  • runny or stuffy nose, or sneezing
  • dizziness

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Arava. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Arava’s prescribing information.

Serious side effects

Arava can cause serious side effects. Most of them aren’t common. But call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

* For more details about this side effect, see the “Arava precautions” section.
† For more information about this side effect, see the “Side effect details” section just below.
Arava has a boxed warning regarding this risk. A boxed warning is the strongest warning required by the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients about drug effects that may be dangerous. For information about liver problems, see the “Side effect details” section just below. And for more information about risks when used during pregnancy, see the “Arava and pregnancy” section below.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Arava.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth, swelling, or redness in your skin)

Keep in mind that these symptoms may also occur with other serious skin reactions* that are possible with Arava. If you have any of these symptoms, call your doctor right away.

In clinical studies, some people taking Arava had anaphylaxis (a severe, life-threatening allergic reaction). It’s not known for sure how many people had anaphylaxis during the studies. However, this wasn’t considered a common side effect of the drug. But it happened more often in people taking Arava than it did in people taking a placebo (treatment with no active drug).

Symptoms of anaphylaxis can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Arava, as it could become severe. But call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

* For details about these other serious skin reactions, see the “Serious side effects” list above.

Hair loss

Hair loss has been seen with Arava use. In clinical studies of people with rheumatoid arthritis (RA), hair loss occurred in:

  • 10% of people who received Arava
  • 1% of people who received a placebo (treatment with no active drug)
  • 6% of people who received sulfasalazine, another RA treatment
  • 6% to 10% of people who received methotrexate, another RA treatment

If you’re taking Arava and have hair loss, talk with your doctor. They’ll most likely:

  • change your RA therapy
  • prescribe treatment to help your body clear Arava faster than usual
  • prescribe treatment to help stimulate hair growth

Don’t stop taking Arava or change your dosage without your doctor’s instruction. And be sure to talk with your doctor before using any over-the-counter (OTC) products for hair growth.

Weight loss

Weight loss wasn’t reported by people taking Arava during clinical studies.

However, some people taking Arava in the studies reported having no appetite. Lack of appetite happened more in people taking Arava than in people taking a placebo (treatment with no active drug). But it’s not known exactly how many people experienced this side effect. Keep in mind that lack of appetite could lead to weight loss in some people.

It’s also possible that weight loss could be caused by liver damage. And Arava can cause severe liver damage* that may be fatal in some cases. In addition, other health conditions may also lead to weight loss.

So don’t ignore unexplained weight loss. Instead, talk with your doctor right away about it. They’ll check your overall health and ask about possible side effects that may be caused by Arava.

In any case, don’t stop taking Arava or change your dosage without your doctor’s instruction.

* Arava has a boxed warning regarding the risk of liver damage. A boxed warning is the strongest warning required by the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients about drug effects that may be dangerous. For information about liver problems, see the “Liver problems” section below.

Abdominal pain

Abdominal (belly) pain and other digestive system problems have been seen with Arava use. For example, in clinical studies that looked at Arava in adults with rheumatoid arthritis (RA), the following digestive system problems were reported:

In people taking AravaIn people taking a placebo*In people taking sulfasalazine†In people taking methotrexate†
Abdominal (belly) pain5% to 6%4%4% to 7%4% to 8%
Diarrhea17%12%10%10% to 20%
Nausea9%11%19%18%
Vomiting3%4%4%3%

* Placebo is treatment with no active drug.
† Sulfasalazine and methotrexate are other drugs used to treat RA.

Keep in mind that diarrhea and vomiting can cause abdominal (belly) pain. But belly pain may happen without any other symptoms.

If you have new or worsening belly pain or other digestive problems while you’re taking Arava, call your doctor. They’ll recommend the best course of treatment for these problems. Don’t try and treat your symptoms with over-the-counter (OTC) drugs. And don’t stop taking Arava without your doctor’s instruction.

Liver problems

Severe and fatal liver problems have been seen in people taking Arava. But these side effects weren’t reported in initial clinical studies of Arava. Instead, these side effects were reported in people taking Arava after the drug was released onto the market. So it’s unclear how often these problems have occurred or if Arava caused them.

However, Arava has a boxed warning regarding the risk of liver problems. A boxed warning is the strongest warning required by the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients about drug effects that may be dangerous.

If you have severe liver disease, you shouldn’t take Arava. Doing so may worsen your liver condition.

To assess the health of your liver, your doctor will check your level of liver enzymes (certain proteins). These enzyme levels are increased if your liver is inflamed or damaged. Your liver enzyme levels will be checked:

  • before you start using Arava
  • then, monthly for 6 months after you start using Arava
  • then, once every 6 to 8 weeks while you’re using Arava

To help keep your liver healthy while you’re taking Arava, you should:

  • take the drug exactly as directed by your doctor
  • avoid consuming alcohol
  • avoid taking other drugs that harm your liver, unless they’re prescribed by your doctor and you’re being closely monitored
  • keep all appointments for labs and other medical tests
  • get checked for hepatitis C
  • monitor for symptoms of liver damage

If you’re concerned about your liver health with Arava treatment, talk with your doctor.

Increased liver enzymes

Two studies compared Arava with a placebo (treatment with no active drug) in people with rheumatoid arthritis (RA). In these studies, elevated liver enzymes occurred in:

  • 5% of people taking Arava
  • 2% of people taking the placebo
  • 4% of people taking sulfasalazine, another RA treatment
  • 10% to 17% of people taking methotrexate, another RA treatment

In the studies, most increased liver enzyme levels became normal when Arava was stopped. Very high liver enzyme levels were seen in 1.5% to 4.4% of people who took Arava. (A very high liver enzyme level is defined as having liver enzymes that are greater than three times the upper limit of normal for the level.)

If your liver enzyme levels are high, your doctor may lower your Arava dosage. Or they may have you stop taking the drug and prescribe a treatment for you that helps your body clear Arava faster than usual. (For more details, see the “How to take Arava” section below.)

Lowered immunity and serious infections

Arava may affect your immune system and cause it to not work properly. In this case, you may not be able to fight off infections like usual. And you could be more prone to developing serious infections.

Severe and life-threatening infections have been seen in people taking Arava. But these infections weren’t seen in clinical studies of Arava. Instead, they were reported in people taking Arava after the drug was released onto the market. So it’s unclear how often these infections have occurred or if Arava caused them.

Your risk for lowered immunity or serious infections may be increased if you’re also taking other drugs that affect your immune system. Having certain health conditions may also increase these risks. For instance, you shouldn’t take Arava if you currently have an infection or if your immune system is weakened.

As an example, tuberculosis (TB) is a possible serious lung infection that may develop with Arava use. TB was seen in people during clinical studies of teriflunomide. (Teriflunomide is the active metabolite* of leflunomide in Arava.) Because of this risk, you shouldn’t take Arava if you have active** or latent† TB infection.

Before you start taking Arava, your doctor will test you for TB. If you have TB, they’ll treat the infection until it’s cleared before having you start Arava. And your doctor will monitor you more closely during treatment to ensure the TB infection doesn’t come back while you’re taking Arava.

While using Arava, it’s important to take steps to avoid infections. These steps include:

  • washing your hands often
  • avoiding crowds during cold and flu season
  • staying up-to-date with vaccines‡
  • eating a healthy, well-balanced diet
  • keeping up with all doctor’s appointments
  • seeing your doctor if you have a fever or feel ill

Ask your doctor about your risk for lowered immunity and infection with Arava treatment. If you get a serious infection while using this drug, your doctor will have you stop taking Arava. They’ll also prescribe treatment to help your body clear Arava from your system more quickly than usual. And they’ll prescribe treatment to help treat the infection. (For more details, see the “How to take Arava” section below.)

* An active metabolite is made when your body breaks down an ingredient in a drug. The active metabolite produces the intended effect of the drug in your body.
** With active TB, you have symptoms of the condition.
† With latent TB, you have TB in your body, but it’s not causing symptoms.
‡ While taking Arava, you should only receive non-live vaccines per your doctor’s recommendation. For more information, see the “Arava interactions” section below.

Bone marrow problems

Serious blood disorders have been reported in people taking Arava. These blood disorders happen because your bone marrow is less active with Arava use. And your blood cells are made inside your bone marrow. The blood disorders seen with Arava affect your blood cell levels.

For example, in clinical studies of Arava, some people had:

It’s not known exactly how many people taking Arava had these blood disorders during clinical studies. But the disorders occurred more often in people taking Arava than in people taking a placebo (treatment with no active drug).

After Arava was released onto the market, people reported other blood disorders while using the drug. But because the other blood disorders weren’t seen during clinical studies, it’s unclear how often they’ve occurred or if Arava caused them. These other blood disorders include:

For Arava treatment, your doctor will order certain tests to check your blood cell levels. They’ll do this:

  • before you start taking Arava
  • then, monthly for 6 months after you start taking the drug
  • then, either:
    • once every 6 to 8 weeks while you’re taking Arava, or
    • once every month while you’re taking Arava, if you take other drugs that also affect your bone marrow

If you already have a blood disorder, you shouldn’t take Arava. Doing so may worsen your condition.

If you develop a blood disorder while you’re taking Arava, your doctor will have you stop taking the drug. They’ll also prescribe treatment to help your body clear Arava from your system faster than usual. (For more details, see the “How to take Arava” section below.)

The Arava dosage your doctor prescribes will depend on several factors. These include:

  • your risk for liver or bone marrow problems
  • how your body responds to Arava treatment
  • other medical conditions you may have

When you’re first starting Arava treatment, your doctor may have you start taking a dosage of the drug that’s higher than typical for the first 3 days. This is called a loading dose. It helps bring up Arava levels faster inside your body so that the drug can start working quickly.

Then, your doctor will lower your dosage to a daily dosage that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Arava comes as tablets that you take by mouth. It’s available in three strengths:

  • 10 milligrams (mg)
  • 20 mg
  • 100 mg

Dosage for rheumatoid arthritis

The usual dosage of Arava to treat rheumatoid arthritis (RA) in adults is 20 mg once daily. This is also the maximum recommended daily dose.

If you have certain side effects from the drug, your doctor will lower your dosage to 10 mg each day.

Depending on your risk for serious side effects, your doctor may start you on a higher dose for the first 3 days of treatment. Doing this helps bring up your Arava levels faster so the drug can begin working quickly.

Then, your doctor will lower your daily dosage to one that’s right for you. For more information about lab tests your doctor may order to check your risk for serious side effects, see the “Common questions about Arava” section below.

Dosage for people with a low-risk of serious side effects

If your risk for liver problems or bone marrow problems is low, the recommended Arava dosage is as follows:

  • a starting dose of 100 mg daily for 3 days
  • a maintenance dose of 20 mg daily going forward

Dosage for people with a high-risk of serious side effects

If your risk for liver problems or bone marrow problems is high, the recommended Arava dosage is 20 mg daily. In this case, there isn’t a higher starting dosage of the drug.

Dosage questions

Below, some common questions about Arava’s dosage are answered.

What if I miss a dose?

If you forget to take Arava, take it as soon as you remember. But if it’s almost time for your next dose, skip the missed dose. Then, get back on your regular schedule. Don’t double up or make up for any missed doses. And call your doctor if you’re concerned about missing doses of the drug.

To help make sure that you don’t forget a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Will I need to use this drug long term?

Arava is meant to be used as a long-term treatment. If you and your doctor determine that Arava is safe and effective for you, you’ll likely take it long term.

What if I need to stop Arava due to side effects?

If you need to stop taking Arava due to serious side effects, your doctor may prescribe another treatment for you. This other treatment works to remove Arava’s active metabolite*, teriflunomide, from your body faster than usual. (See the “How to take Arava” section for more details.)

Teriflunomide has serious health risks. So, without this treatment to help your body clear it faster, it may stay in your body for up to 2 years after stopping Arava.

* An active metabolite is made when your body breaks down an ingredient in a drug. The active metabolite produces the intended effect of the drug in your body.

As with all medications, the cost of Arava can vary. To find current prices for Arava in your area, check out GoodRx.com.

The cost you find on GoodRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of Arava. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, talk with your doctor or your insurance company.

Before approving coverage for Arava, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Arava, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Arava, help may be available.

Medicine Assistance Tool’s site lists programs that may lower the cost of Arava. For more information and to find out if you’re eligible for support, visit their website.

Mail-order pharmacies

Arava may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Arava, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor and your insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Arava is available in a generic form called leflunomide in certain strengths. A generic medication is an exact copy of the drug and active ingredients in a brand-name medication. The generic is considered to be as safe and effective as the original drug. And generics tend to cost less than brand-name drugs. To find out how the cost of leflunomide compares to the cost of Arava, visit GoodRx.com.

If your doctor has prescribed Arava and you’re interested in using leflunomide instead, talk with your doctor. They may prefer one version over the other. You’ll also need to check your insurance plan to see which medication is covered.

You may wonder how Arava compares with other medications that are prescribed for similar uses. Here we look at how Arava and methotrexate are alike and different.

Ingredients

Arava contains the drug leflunomide that’s broken down by your body into the active metabolite*, teriflunomide. A generic form of leflunomide is also available. (A generic drug is an exact copy of the drug and active ingredients in a brand-name medication.)

Methotrexate, on the other hand, is an active ingredient that’s available as a generic drug. In addition, it’s also available as these brand-name drugs:

* An active metabolite is made when your body breaks down an ingredient in a drug. The active metabolite produces the intended effect of the drug in your body.

Uses

Here’s a list of conditions that the Food and Drug Administration (FDA) has approved Arava and methotrexate to treat.

* For these conditions, methotrexate is approved for use when given in combination with other drugs.

Drug forms and administration

Both Arava and methotrexate come as tablets that are taken by mouth. Brand-name forms of methotrexate are available as follows:

  • Trexall comes as tablets you take by mouth.
  • Rasuvo, RediTrex, and Otrexup each come as solutions that are injected under your skin.
  • Xatmep comes as a liquid that children take by mouth.

For managing RA in adults:

  • Arava is taken once a day.
  • Methotrexate is either taken by mouth once a week or injected under the skin once a week.

Your doctor will prescribe the dosage and form of either drug that’s best for your condition.

Side effects and risks

Arava and methotrexate both work by changing and suppressing the activity of your immune system. So these medications can cause very similar side effects but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with either Arava or methotrexate, as well as mild side effects that both drugs may share.

  • Can occur with Arava:
    • back pain
  • Can occur with methotrexate:
    • fever or chills
    • stomatitis (inflammation in the mouth that can make it hard to talk or eat)
    • anemia (low level of red blood cells)
  • Can occur with both Arava and methotrexate:

Serious side effects

These lists contain examples of serious side effects that can occur with either Arava or methotrexate, as well as serious side effects that both drugs may share.

* Arava and methotrexate both have a boxed warning regarding the risk of this side effect. A boxed warning is the strongest warning required by the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients about drug effects that may be dangerous.
Methotrexate has a boxed warning regarding the risk of this side effect.

Effectiveness

The only condition both Arava and methotrexate are FDA-approved to manage is rheumatoid arthritis (RA) in adults.

The American College of Rheumatology recommends both drugs for managing RA in certain people. But in people who’ve never taken a DMARD*, methotrexate is preferred.

* Disease-modifying antirheumatic drugs (DMARDs) are a group of drugs that work by changing or suppressing your body’s overactive immune system to help lower inflammation.

Costs

According to estimates on GoodRx.com, Arava and methotrexate generally cost about the same. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Arava is a brand-name medication that has generic forms in some strengths. (A generic medication is an exact copy of the drug and active ingredients in a brand-name medication.) Methotrexate is a generic medication that also comes as brand-name drugs. In general, brand-name medications usually cost more than generics do.

The Food and Drug Administration (FDA) approves prescription drugs such as Arava to treat certain conditions. Arava is FDA-approved to treat active rheumatoid arthritis (RA) in adults.

About RA

RA is an autoimmune disease that causes inflammation in your body. Autoimmune diseases are conditions that happen when your body’s immune system attacks your healthy tissues by mistake. With RA, your immune system attacks the lining of your joints.

Common RA symptoms include swelling, stiffness, tenderness, and pain in your joints. Smaller joints are usually affected first.

Over time, RA may cause your joints to become damaged or deformed. RA inflammation can damage other body parts, too, including your heart, eyes, and lungs. In addition, you may have other symptoms or health problems from RA, such as low-grade fever or severe fatigue (lack of energy).

RA symptoms often come and go. You may have periods of flares, during which you have active RA symptoms. Or you may have periods of remission, during which you don’t have any RA symptoms.

About RA treatment

RA treatment includes:

  • lifestyle changes, such as increased rest and doing low-impact exercise
  • medication to treat the underlying disease
  • medication to help relieve symptoms

The key drugs that manage the underlying disease of RA are called disease-modifying antirheumatic drugs (DMARDs). DMARDs change or suppress your body’s overactive immune system to help reduce inflammation. There are many traditional DMARDs made from chemicals, such as Arava. And now, there are DMARDs called biologics that are more targeted therapies made from living cells.

Taking DMARDs, such as Arava, may help lower inflammation caused by RA. And less inflammation may help:

  • relieve your RA symptoms
  • prevent new or worse joint damage
  • keep you active and able to do your daily tasks

Effectiveness of Arava for RA

In two large clinical studies, Arava was effective in treating RA in adults. In the studies, people were given either Arava, sulfasalazine, methotrexate, or a placebo. Sulfasalazine and methotrexate are other RA treatments. And a placebo is a treatment with no active drug. For people taking Arava, they took:

  • 100 milligrams (mg) of Arava once a day for the first 3 days of treatment
  • 20 mg once a day after the first 3 days of treatment

In this study, the effectiveness of treatment was measured with the following outcomes:

  • Improved RA symptoms. This was measured using the American College of Rheumatology (ACR) 20 Responder Index. ACR 20 is a group of tests and questionnaires that helps doctors assess if your RA symptoms have improved. If you’re an “ACR 20 Responder,” you’ve had more than 20% reduction in tender and swollen joints plus certain other improvements in your RA.
  • Improved physical function. This was measured using the Health Assessment Questionnaire Disability Index (HAQ DI) and Medical Outcomes Survey Short Form (SF-36).
  • Prevention of joint damage. This was measured with the Sharp Score. It’s tallied using X-rays that show the amount of bone loss and joint-space narrowing in your hand, wrist, and foot joints.

At the end of these studies, the following percentages of people were considered ACR 20 Responders:

  • 40.7% to 48.5% of people taking Arava
  • 18.6% to 28.6% of people taking the placebo
  • 44.7% of people taking sulfasalazine
  • 35.0% to 56.6 of people taking methotrexate

In both studies, Arava was markedly better than placebo in improving physical function.* For example:

  • Arava was better at improving all HAQ DI parameters. These included dressing, arising, eating, walking, maintaining hygiene, reaching, gripping, and doing certain activities.
  • Arava was also better at improving overall health-related quality of life on the SF-36 scale.

Lastly, in both studies, Arava was markedly better than the placebo in preventing joint damage, as measured by the change in Sharp Score.*

* These results were based on the difference in values taken prior to the study and those taken at the end of the study.

Arava and children

Arava is only approved for use in adults. It’s not approved for use in children.

In addition to treating rheumatoid arthritis (RA), which is discussed just above, Arava may also be used off-label for other conditions. Off-label drug use is when a drug that’s approved for one use is given for another use that it’s not approved for. Below, we describe two examples of off-label uses for Arava.

Arava for other types of arthritis

With arthritis, you have swelling, tenderness, or pain in your joints. Arthritis includes a variety of conditions that cause these symptoms, including inflammatory conditions such as RA.

Arava is a disease-modifying antirheumatic drug (DMARD). DMARDs are used to treat many autoimmune and inflammatory conditions. This is because DMARDs change or suppress the immune system, reducing damaging inflammation.

Arava is only approved to treat active RA* in adults. But the drug may be used off-label for other conditions when:

  • other DMARDs don’t work, or
  • people can’t tolerate other DMARDs

For example, Arava may be used off-label to manage psoriatic arthritis or juvenile idiopathic arthritis. Below, we describe the drug’s off-label use for these conditions.

* With active RA, the condition is causing RA symptoms.

Arava for psoriatic arthritis (off-label use)

Psoriatic arthritis is a type of arthritis that affects both the skin and the joints. It usually starts in early adulthood. Similar to RA, psoriatic arthritis is an autoimmune disease.

Some symptoms of psoriatic arthritis include:

  • itchy, painful, and scaly patches of skin
  • cracked, pitted, or discolored nails
  • joint pain, swelling, stiffness, warmth, and tenderness
  • low-grade fever and fatigue (lack of energy)

Like other autoimmune and inflammatory conditions, psoriatic arthritis is managed with DMARDs.

A 24-week study done in 2004 looked at leflunomide’s* effectiveness in treating psoriatic arthritis in adults. People were given either a placebo (treatment with no active drug) or leflunomide. At the end of the study, overall improvement in people’s psoriatic arthritis was seen in:

  • about 59% of people taking leflunomide
  • about 30% of people taking the placebo

If you’d like to know more about using Arava for psoriatic arthritis, talk with your doctor.

* Leflunomide is the active drug in Arava.

Arava for JIA (off-label use)

The most common type of arthritis in children is called juvenile idiopathic arthritis (JIA). (Idiopathic means the cause of the condition is unknown.)

Like RA that affects adults, JIA is an autoimmune and inflammatory disease. And children with JIA may have symptoms similar to those of RA, such as joint swelling or pain. But JIA isn’t the same condition as RA. In fact, there are six types of JIA that are each based on the specific symptoms a child is having. For example, with polyarticular JIA, five or more joints on both sides of a child’s body are affected.

JIA treatment focuses on managing the underlying disease to lower inflammation and help relieve symptoms. The key medications used to lower inflammation in JIA are DMARDs.

Arava is a DMARD; however, it’s not approved for treating JIA. But doctors may try different DMARDs to treat JIA if approved treatments for JIA don’t improve the condition or children don’t tolerate them.

A 2005 study looked at Arava’s effectiveness in managing polyarticular JIA. Children ages 3 to 17 years took Arava or another DMARD called methotrexate for 16 weeks. Compared with prior to treatment, researchers reported that:

  • Arava wasn’t markedly better than methotrexate in treating JIA.
  • Arava didn’t markedly improve JIA symptoms.

More research is needed to prove the effectiveness of Arava for JIA or other types of arthritis in children. If you have questions about using Arava for JIA, talk with your or your child’s doctor.

Other drugs are available that can treat rheumatoid arthritis (RA). Some may be a better fit for you than others. Some medications are used alone or used in combination with other drugs.

If you’re interested in finding an alternative to Arava, talk with your doctor. They can tell you about other medications that may work well for your RA.

Examples of other drugs that may be used for RA include:

* Traditional DMARDs are made with chemicals.
† Biologic DMARDs are made from living cells.

Arava doesn’t interact with alcohol. However, alcohol can damage your liver. And Arava can cause serious or even fatal liver damage.*

To help keep your liver as healthy as possible, you should avoid drinking alcohol while taking Arava. If you have questions about alcohol use while you’re taking Arava, talk with your doctor.

* Arava has a boxed warning regarding the risk of liver damage. A boxed warning is the strongest warning required by the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients about drug effects that may be dangerous. For information about liver problems, see the “Arava side effects” section above.

Arava can interact with several other medications. Arava could interact with vitamins, herbs, supplements, or foods. But none of these interactions have been reported.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Arava and other medications

Below, medications that can interact with Arava are described. This article doesn’t include all the drugs that may interact with Arava.

Before taking Arava, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Arava and warfarin

Taking Arava with the blood thinner warfarin (Coumadin, Jantoven) may decrease your international normalized ratio (INR). Specifically, taking these drugs together could lower your INR by about 25%.

INR measures how fast your blood can form clots. So a decreased INR means your blood will clot faster than usual. And this could be dangerous to your health.

If you take warfarin and Arava together, your doctor or pharmacist will closely monitor your INR.

Arava and oral contraceptives

Taking Arava with certain oral contraceptives (birth control pills) may cause higher levels of certain hormones in your body. And this may cause unwanted effects or health risks. Specifically, this interaction can happen with oral contraceptives that contain:

To help prevent this interaction, your doctor may change your oral contraceptive dose or product. But keep in mind that all women of childbearing age who take Arava must use effective birth control. So be sure to ask your doctor which birth control option is right for you.

Arava and methotrexate

Taking Arava with methotrexate (Trexall, Rasuvo, RediTrex, Otrexup) may increase levels of methotrexate in your body. This is because Arava may interfere with your body’s metabolism (break down) of methotrexate. And this could increase your risk for serious side effects from methotrexate.

Keep in mind, methotrexate and Arava are both used to treat rheumatoid arthritis (RA). And these drugs may sometimes be used together. If you’re taking both drugs, tell your doctor about any new or worsening side effects.

To help prevent this interaction, your doctor may lower your methotrexate dosage, and they’ll monitor you during treatment.

Arava and rifampin

Taking Arava with the antibiotic rifampin can increase the level of Arava’s active metabolite*, teriflunomide.

In fact, this interaction can raise the level of teriflunomide in your blood by 40%. And increased teriflunomide levels could raise your risk for serious side effects, such as liver damage or even liver failure.

To help avoid this interaction, Arava and rifampin shouldn’t be used together. But if you need to take both drugs, your doctor will monitor you closely during treatment.

On the other hand, Arava may raise levels of rifampin in your blood by interfering with your body’s metabolism (break down) of rifampin. To help prevent this interaction, your doctor may lower your rifampin dosage if you need to take the drugs together. But again, using Arava with rifampin isn’t recommended unless the benefits of doing so outweigh the risks.

* An active metabolite is made when your body breaks down an ingredient in a drug. The active metabolite produces the intended effect of the drug in your body.

Arava and certain type 2 diabetes drugs

Taking Arava with certain drugs used for type 2 diabetes may increase levels of the diabetes drugs in your body. This is because Arava may interfere with your body’s metabolism (break down) of the diabetes medications. And this could cause low blood sugar levels or other problems.

Examples of diabetes medications that may be affected by Arava include:

  • pioglitazone (Actos, Duetact, Oseni)
  • rosiglitazone (Avandia)
  • nateglinide
  • repaglinide

To help prevent this interaction, your doctor may adjust the dosage of your diabetes medication if you’re taking Arava.

Arava and paclitaxel

Taking Arava with the cancer drug paclitaxel (Abraxane) may increase levels of paclitaxel in your body. This is because Arava may interfere with your body’s metabolism (break down) of paclitaxel. And this could increase your risk for side effects from paclitaxel. To help prevent this interaction, your doctor may adjust your paclitaxel dosage. And they’ll monitor you during treatment.

Arava and certain antibiotics

Taking Arava with certain antibiotics may raise the levels of the antibiotics in your body. This is because Arava may interfere with your body’s metabolism (break down) of antibiotics. And this could increase your risk for side effects. Examples of these antibiotics include:

  • cefaclor
  • ciprofloxacin (Cipro)
  • penicillin G (Bicillin C-R, Bicillin L-A, Pfizerpen)

To help prevent this interaction, your doctor may adjust your antibiotic dosage. And they’ll monitor you during treatment.

Arava and statin medications

Taking Arava with statins (drugs used to treat high cholesterol) may prevent your body from breaking down the statin drugs. This could cause higher statin levels in your body which may increase your risk for side effects from the statins. Example of statins include:

To help prevent this interaction, you shouldn’t take more than 10 milligrams (mg) of rosuvastatin each day. If you take a different statin, your doctor may lower your statin dosage. And they’ll monitor you during treatment.

Arava and cimetidine

Taking Arava with the antacid cimetidine (Tagamet) may raise cimetidine levels in your body. This is because Arava may interfere with your body’s metabolism (break down) of cimetidine. And this may increase your risk for side effects. To help prevent this interaction, your doctor may adjust your cimetidine dosage. And they’ll monitor you during treatment.

Arava and furosemide

Taking Arava with the diuretic furosemide (Lasix) may raise furosemide levels in your body. This is because Arava may interfere with your body’s metabolism (breaking down) of furosemide. And this may increase your risk for side effects. To help prevent this interaction, your doctor may adjust your furosemide dosage. And they’ll monitor you during treatment.

Arava and ketoprofen

Taking Arava with the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen may raise ketoprofen levels in your body. This is because Arava may interfere with your body’s metabolism (break down) of ketoprofen. And this may increase your risk for side effects. To help prevent this interaction, your doctor may adjust your ketoprofen dosage. And they’ll monitor you during treatment.

Arava and alosetron

Taking Arava with the irritable bowel syndrome (IBS) drug alosetron (Lotronex) may lower alosetron levels in your body. This is because Arava may increase your body’s metabolism (break down) of alostron. And this may make alosetron less effective. To help prevent this interaction, your doctor may adjust your alosetron dosage. And they’ll monitor you during treatment.

Arava and duloxetine

Taking Arava with the antidepressant duloxetine (Cymbalta, Drizalma Sprinkle) may lower duloxetine levels in your body. This is because Arava may increase your body’s metabolism (break down) of duloxetine. And this may make duloxetine less effective. To help prevent this interaction, your doctor may adjust your duloxetine dosage. And they’ll monitor you during treatment.

Arava and theophylline

Taking Arava with the asthma drug theophylline (Elixophyllin SR, Theochron, Theo-24) may lower levels of theophylline in your body. This is because Arava may increase your body’s metabolism (break down) of theophylline. And this may make this drug less effective. To help prevent this interaction, your doctor may adjust your theophylline dosage. And they’ll monitor you during treatment.

Arava and tizanidine

Taking Arava with the muscle-relaxant drug, tizanidine (Zanaflex) may lower levels of tizanidine in your body. This is because Arava may increase your body’s metabolism (break down) of tizanidine. And this may make tizanidine less effective. To help prevent this interaction, your doctor may adjust your tizanidine dosage. And they’ll monitor you during treatment.

Arava and zidovudine

Taking Arava with the HIV drug zidovudine (Retrovir, Combivir, Trizivir) may increase levels of zidovudine in your body. This is because Arava may increase your body’s metabolism (breaking down) of zidovudine. And this may increase your risk for side effects from zidovudine. To help prevent this interaction, your doctor may adjust your zidovudine dosage, and they’ll monitor you during treatment.

Arava and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Arava. However, you should still talk with your doctor or pharmacist before using any of these products while taking Arava.

Arava and foods

There aren’t any foods that have been specifically reported to interact with Arava. If you have any questions about eating certain foods with Arava, talk with your doctor.

Arava and lab tests

Arava shouldn’t affect the results of any lab test. Both before and during Arava treatment, your doctor may order lab tests to check your liver health and blood cell levels. And after stopping treatment with Arava, your doctor may order tests to see how well Arava is being cleared from your body.

If you have questions about whether Arava will affect any lab tests you’re having, talk with your doctor.

Arava and vaccines

Arava can affect how well your immune system works. So don’t get any vaccines without first talking with your doctor. And while you’re taking Arava, don’t get any live vaccines. (Live vaccines contain a live, but weakened, form of the germ they’re used to protect you from.)

Keep in mind that Arava’s active metabolite*, teriflunomide, may stay in your body for 2 years after you’ve stopped treatment. So talk with your doctor before getting a live vaccine or any other immunizations during this period of time.

If have any questions about vaccinations and Arava therapy, talk with your doctor or pharmacist.

Note: It’s important to know that the injectable influenza (flu) vaccine is not a live vaccine. Talk with your doctor about getting your yearly flu vaccine.

* An active metabolite is made when your body breaks down an ingredient in a drug. The active metabolite produces the intended effect of the drug in your body.

Arava is approved to treat active rheumatoid arthritis (RA) in adults. (With active RA, the condition is causing symptoms.) For more information about RA, see the “Arava for rheumatoid arthritis” section above.

How does RA affect the body?

With RA, your body’s immune system attacks your joints and other healthy tissues by mistake and causes inflammation. Over time, the inflammation can damage your tissues and cause RA symptoms.

How does Arava help treat RA?

The key medications that manage the underlying disease with RA are called disease-modifying anti-rheumatic drugs (DMARDs). DMARDs change or suppress your body’s overactive immune system to help lower damaging inflammation. There are many traditional DMARDs made from chemicals, such as Arava. And now, there are DMARDs called biologics that are more targeted therapies made from living cells.

Taking DMARDs, such as Arava, may help lower inflammation caused by RA. And less inflammation may help:

  • relieve your RA symptoms
  • prevent new or worse joint damage
  • keep you active and able to do your daily tasks

How long does it take Arava to work?

Once you start taking the drug, it may take many weeks or months to feel the benefits of Arava. Arava and other DMARDs aren’t meant to give fast relief of pain or other RA symptoms. Instead, DMARDs are meant to work over time to manage the underlying disease and reduce RA symptoms. Ask your doctor about ways to manage RA symptoms until Arava has started working.

How quickly does your body clear Arava?

Your body breaks down Arava and removes it from your system through your urine and stool. This drug has a half-life of about 18 to 19 days. This means, after you take a dose of Arava, it takes 18 to 19 days for your body to clear half of that dose. So it can take quite a while for a full dose of Arava to be fully cleared from your body.

Arava should never be used during pregnancy or while you’re trying to conceive. The drug is unsafe when used during these periods of time, and it may cause serious harm to a developing fetus. In fact, Arava has a boxed warning for this risk. A boxed warning is the strongest warning required by the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Both before and during treatment with Arava, you must use effective birth control to prevent pregnancy. And you should continue to use it for 2 years after you’ve stopped taking Arava. In addition, you shouldn’t start taking Arava until you’ve had a negative pregnancy test that’s confirmed by your doctor.

If Arava is used during pregnancy or if you become pregnant within 2 years of stopping the drug, your doctor will prescribe another treatment for you that helps clear Arava’s active metabolite*, teriflunomide, from your body faster than usual. And if you’re currently taking Arava, your doctor will have you stop taking it right away.

* An active metabolite is made when your body breaks down an ingredient in a drug. The active metabolite produces the intended effect of the drug in your body.

Arava’s pregnancy registry

If Arava is used during pregnancy, you and your doctor should report it to the pregnancy exposure registry. The registry follows the health of mothers, fetuses, and infants who were affected by Arava use during pregnancy. Pregnancy registries gather information that can be used to help other doctors and patients understand the risks and benefits of using certain drugs during pregnancy.

To learn more or enroll in the registry, call 877-311-8972 or visit the pregnancy exposure registry.

Arava and fertility

It’s unclear whether Arava affects people’s fertility (the ability to reproduce). However, Arava isn’t safe for use in females who are trying to conceive or in males who are trying to father a child.

See the “Arava and pregnancy ” and “Arava and birth control” sections for more details.

If you’re planning a pregnancy, talk with your doctor right away about Arava use and your reproductive desires.

Arava isn’t safe to take during pregnancy. It may cause serious harm to a developing pregnancy. (See the “Arava and pregnancy” section above for details.) For this reason, it’s recommended that you use birth control before, during, and for a period of time after Arava treatment.

Below, birth control recommendations for both females and males using the drug are described.

For females using Arava

If you’re a female of childbearing age, you shouldn’t start taking Arava until you’ve had a negative pregnancy test that’s confirmed by your doctor. And you must use effective birth control before starting Arava, during treatment, and for 2 years after stopping the drug. Call your doctor right away if you think you might be pregnant during this time.

If you’re planning to become pregnant within the 2 years after stopping Arava, your doctor can prescribe a treatment that helps remove Arava’s active metabolite*, teriflunomide, from your body faster than usual. But keep using birth control during this time, until your doctor confirms the level of teriflunomide is low and safe enough for pregnancy.

* An active metabolite is made when your body breaks down an ingredient in a drug. The active metabolite produces the intended effect of the drug in your body.

For males using Arava

It’s unknown if Arava use affects fertility, reproductive health, or offspring of males using the drug. And studies of males who’ve fathered children while using Arava aren’t available.

However, Arava’s active metabolite*, teriflunomide, has been found in semen. So be sure to talk with your doctor about these situations and general recommendations:

  • If you don’t want to father a child. You and your female partner should use effective birth control.
  • If you do want to father a child. Talk with your doctor about wanting to stop taking Arava. Then, your doctor will prescribe a treatment that helps clear the drug from your body faster than usual. You’ll take this treatment until your Arava levels are low and safe enough for pregnancy.

* An active metabolite is made when your body breaks down an ingredient in a drug. The active metabolite produces the intended effect of the drug in your body.

It isn’t known if Arava will:

  • pass into human breast milk
  • affect a child who’s breastfed
  • affect how your body makes breast milk

However, it’s possible that Arava may cause serious harm to a child who’s breastfed. So you shouldn’t breastfeed while taking this drug.

If you’re currently breastfeeding or planning to breastfeed while using Arava, talk with your doctor. They can recommend safe and healthy ways to feed your child.

Here are answers to some frequently asked questions about Arava.

Is there anything important to know about coming off of or stopping Arava?

Yes, there is. If you stop taking Arava for any reason, including having a serious side effect, your doctor will prescribe another treatment for you. This other treatment works to remove Arava’s active metabolite*, teriflunomide, from your body faster than usual.

This other treatment is needed because teriflunomide has serious health risks. And it may stay in your body for up to 2 years after stopping if you don’t use treatment to clear it faster.

After stopping treatment, your doctor will check your body’s teriflunomide levels. If the levels aren’t low enough, your doctor will advise you that you can repeat the removal treatment course.

Keep in mind that the symptoms of the condition you’re using Arava to treat may return during or after this process.

It’s also important to note that after stopping Arava, you may need to continue using birth control for a while. Specifically, if you’re a woman of childbearing age, you must use effective birth control until teriflunomide levels in your body are low and safe. (For more information, see the “Arava and pregnancy” section above.)

* An active metabolite is made when your body breaks down an ingredient in a drug. The active metabolite produces the intended effect of the drug in your body.

Will Arava cure my rheumatoid arthritis?

No. Arava doesn’t cure rheumatoid arthritis (RA). However, Arava helps to treat active RA. With RA, your immune system attacks your joints or other body parts by mistake and causes damaging inflammation. With active RA, you’re having symptoms of the condition. (Active RA is also known as an RA flare.)

Arava may help lower the number or severity of RA flares. The drug may also help you reach remission. During remission, you don’t have any symptoms of active RA.

So Arava treatment may:

  • relieve RA symptoms
  • stop new or worsening joint damage
  • help you function better

You must keep taking Arava as directed by your doctor to get the drug’s benefits. Once you stop taking Arava, your RA may flare up again.

If you have questions about Arava treatment, talk with your doctor.

Will I need to have tests or monitoring done while I’m taking Arava?

Yes, you will. In fact, your doctor will order certain lab tests for you before, during, and possibly, after Arava treatment.

Before starting, possible recommended tests include:

  • tuberculosis (TB) test to check for active* or latent† TB infection
  • lab tests to check your liver health and your blood cell levels
  • a pregnancy test, if you’re a woman of childbearing age
  • blood pressure screening to check for high blood pressure

During treatment, possible recommended tests include:

  • lab tests to check your liver health and your blood cell levels
  • blood pressure screening to check for high blood pressure

After treatment, the tests may include:

  • blood tests to check your levels of teriflunomide (the active metabolite‡ in Arava)
  • lab tests to check your liver health, blood cell levels, and overall health

* With active TB, you have symptoms of the condition.
† With latent TB, you have TB in your body, but it’s not causing symptoms.
‡ An active metabolite is made when your body breaks down an ingredient in a drug. The active metabolite produces the intended effect of the drug in your body.

Can older people take Arava?

Yes, in general they can. No differences in Arava’s safety or effectiveness have been reported in older people compared with younger people. So the recommended Arava dosages are the same for both age groups.

But still, doctors should monitor Arava use and dosages in people older than 65 years of age. This is because people in this age group may be more sensitive to drugs than younger people are.

Can I take Arava if I have liver damage?

Maybe. People with known severe liver disease can’t take Arava. This is because Arava can cause severe or even fatal liver problems.*

Before starting Arava, your doctor will order lab tests to check your liver health. If your liver is healthy enough to take Arava, your doctor will prescribe a starting dosage for you that’s based on certain risk factors.

And your doctor will monitor your liver health closely for the first 6 months of treatment. Then, they’ll continue to monitor it but less often.

If you have liver damage while you’re taking Arava, your doctor will have you stop taking the drug. And they’ll prescribe another treatment for you that works to remove Arava’s active metabolite†, teriflunomide, from your body faster than usual.

Before starting Arava, tell your doctor about:

  • any current or past liver problems, including hepatitis C
  • any alcohol use
  • other medications you’re taking that can damage your liver, such acetaminophen (Tylenol)

* Arava has a boxed warning regarding the risk of liver damage. A boxed warning is the strongest warning required by the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients about drug effects that may be dangerous. For information about liver problems, see the “Arava side effects” section above.
† An active metabolite is made when your body breaks down an ingredient in a drug. The active metabolite produces the intended effect of the drug in your body.

Does Arava increase the risk of cancer?

It’s unclear if Arava increases the risk of cancer.

Cancers weren’t reported during clinical studies of Arava. But certain cancers, including lymphomas (cancer of the lymphatic system), have been reported with other drugs that suppress the immune system. And Arava can also suppress the immune system.

More research is needed to determine this risk of cancer with Arava use. Before starting this drug, tell your doctor if you currently have cancer or have had it in the past.

Take Arava according to your doctor’s or healthcare provider’s instructions.

When to take

You should take your prescribed dose of Arava once every day. This drug can be taken at any time of day, unless your doctor recommends a specific time. But try to take it at about the same time each day.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Taking Arava with food

You can take Arava with or without food.

Can Arava be crushed, split, or chewed?

In general, you shouldn’t crush, split, or chew Arava tablets. Instead, swallow the tablets whole.

If you have trouble swallowing whole tablets, ask your doctor or pharmacist how to take Arava.

Treatment for faster drug removal when stopping Arava

If you stop Arava therapy for any reason, including a serious side effect, your doctor will prescribe treatment to remove Arava’s active metabolite*, teriflunomide, from your body faster than usual. This is because teriflunomide has serious health risks, and it may stay in your body for up to 2 years after stopping Arava.

Recommended treatments for teriflunomide removal include either:

After you’ve completed this drug removal treatment, your doctor will check your teriflunomide levels. If they aren’t low enough, you can repeat the removal treatment. Keep in mind the symptoms of the condition you’re using Arava to treat may return during or after this process.

* An active metabolite is made when your body breaks down an ingredient in a drug. The active metabolite produces the intended effect of the drug in your body.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings, which are described below. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Fetal harm if used during pregnancy

Arava can cause serious harm if it’s used during pregnancy. If you’re pregnant or planning to become pregnant, don’t take Arava. And you shouldn’t start taking Arava until you’ve had a negative pregnancy test that’s confirmed by your doctor. In addition, you must use effective birth control before starting Arava, during treatment, and for 2 more years after stopping the drug.

For more information, see the “Arava and pregnancy” and “Arava and birth control” sections below.

Liver problems

Arava can cause severe liver problems that may be fatal. This risk is higher if you also take other drugs that cause liver damage. Tell your doctor if you take other drugs that can harm your liver, such as acetaminophen (Tylenol). And don’t take Arava if you already have severe liver disease.

Before you start taking Arava, your doctor will check your liver health with certain blood tests. And after you’ve started taking the drug, your doctor will monitor your liver for damage.

Tell your doctor about any new or worsening symptoms of liver damage. These can include nausea, unusual bleeding or bruising, low energy level, and pain in the upper right part of your belly. It’s also possible to have yellowing of your skin or the whites of your eyes, dark urine, or flu-like symptoms.

If you have liver problems while taking Arava, your doctor will have you stop the drug. And they’ll prescribe a treatment that helps remove Arava’s active metabolite*, teriflunomide, from your body faster than usual.

* An active metabolite is made when your body breaks down an ingredient in a drug. The active metabolite produces the intended effect of the drug in your body.

Other precautions

Before taking Arava, talk with your doctor about your health history. Arava may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Lowered immunity, bone marrow problems, and severe infections. With lowered immunity, you may not be able to fight off infections like usual. And with certain bone marrow problems, you may have blood cells that aren’t normal. Your body needs different blood cells to prevent bleeds, carry oxygen throughout your body, and help fight off infections. Other health conditions may lead to severe infections, too. Taking Arava with any of these conditions or an active infection puts you at even higher risk for having certain severe infections. Tell your doctor if you look pale, have active* or latent† tuberculosis (TB) infection, have other recurrent infections, or have unusual bruising, bleeding, or fatigue (lack of energy). In some cases, you may have an increased risk for serious lung infections or blood disorders.
  • Lung inflammation or scarring. Arava may cause new or worsened inflammation or scarring in the lungs (interstitial lung disease) that can sometimes be fatal. This scarring can make it harder for you to breath and get enough oxygen. Before starting Arava, tell your doctor if you have any past or present lung disease. While taking Arava, tell your doctor about any new or worsening lung symptoms, such as cough or shortness of breath, whether or not you have a fever. Your doctor will check your lungs and may have you stop taking Arava. They may also prescribe another treatment that works to remove Arava’s active metabolite‡, teriflunomide, from your body faster than usual.
  • High blood pressure. High blood pressure (hypertension) has been reported with Arava use. Your doctor should check your blood pressure before starting Arava and during treatment. (For more details, see the “Arava side effects” section above.)
  • Cancer. Certain cancers, including immune system cancers such as lymphoma (cancer of the lymph system), have been reported with other drugs that suppress the immune system. And Arava can also suppress the immune system. Cancer wasn’t reported during clinical studies of Arava. However, before starting Arava, tell your doctor if you currently have cancer or have had it in the past.
  • Allergic reaction. If you’ve had an allergic reaction to Arava or any of its ingredients, you shouldn’t take Arava. Ask your doctor what other medications are better options for you.
  • Pregnancy. Arava should not be used during pregnancy. See the section above called “FDA warnings” for details.
  • Breastfeeding. Arava hasn’t been studied in people who are breastfeeding. But the drug may cause serious harm to a child who’s breastfed. So you shouldn’t breastfeed while taking it. For more information, see the “Arava and breastfeeding” section above.

Note: For more information about the potential negative effects of Arava, see the “Arava side effects” section above.

* With active TB, you have symptoms of the condition.
† With latent TB, you have TB in your body, but it’s not causing symptoms.
‡ An active metabolite is made when your body breaks down an ingredient in a drug. The active metabolite produces the intended effect of the drug in your body.

Using more than the recommended dosage of Arava can lead to serious side effects. Don’t use more Arava than your doctor recommends.

Overdose symptoms

Symptoms* of an Arava overdose can include:

  • diarrhea
  • abdominal (belly) pain
  • leukopenia (low level of white blood cells)
  • anemia (low level of red blood cells)
  • increased level of liver enzymes (certain proteins)

* The symptoms listed here are also common side effects of Arava. (For more information, see the “Arava side effects” section above.) Because of this, tell your doctor if you’re having any of these symptoms. They can help you determine if you’ve taken too much Arava or if your symptoms are common side effects from treatment.

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. If needed, your doctor will prescribe another treatment* to remove Arava’s active metabolite†, teriflunomide, from your body faster than usual.

You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

* See the “How to take Arava” section above for more details about this other treatment.
† An active metabolite is made when your body breaks down an ingredient in a drug. The active metabolite produces the intended effect of the drug in your body.

When you get Arava from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Arava tablets should be stored at room temperature (77°F/25°C). They should be kept in a tightly sealed container away from light.

Disposal

If you no longer need to take Arava and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.

Disclaimer: Medical News Today 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.