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Leflunomide oral tablet side effects: A detailed guide

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More common side effects Mild side effectsSerious side effectsFAQs CouponSide effects in detail Warnings Ask your doctor
Leflunomide oral tablet is prescribed for rheumatoid arthritis (RA) that’s causing symptoms in adults. It’s a disease-modifying antirheumatic drug that may cause mild or serious side effects. These include liver injury and pregnancy loss.
Medically reviewed by Alex Brewer, PharmD, MBA
Updated on

This article describes possible side effects of leflunomide oral tablet. You’ll also find information on cost savings and coupon options for leflunomide. You can explore this overview article to learn more about leflunomide oral tablet, including the drug’s uses and side effects, ways to save on cost, and more.

Leflunomide oral tablet is a generic version of the brand-name drug Arava.

Boxed warnings

Leflunomide has boxed warnings about the risk of harm if taken during pregnancy and the risk of liver damage. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

For details about the risk of liver damage, see the “Side effects of leflunomide in detail” section below. For more information about the risk of harm if taken during pregnancy, see the “Warnings for leflunomide” section below.

More common side effects of leflunomide

Leflunomide oral tablet may cause mild or serious side effects. Below are some of the more common side effects of this medication.

Commonly reported side effects of leflunomide oral tablet include:

* To learn more about this side effect, see the “Side effects of leflunomide in detail” section below.
Leflunomide oral tablet has a boxed warning for liver damage. A boxed warning is the most serious warning from the FDA. To learn more, see the “Side effects of leflunomide in detail” section below.

Mild side effects of leflunomide

Leflunomide may cause certain mild side effects. Most often, mild side effects are temporary and can be easily managed. Tell your doctor or pharmacist if you have side effects that don’t go away or become bothersome.

Mild side effects of leflunomide oral tablet that occurred in studies include:

* To learn more about this side effect, see the “Side effects of leflunomide in detail” section below.
Leflunomide oral tablet has a boxed warning for liver damage. A boxed warning is the most serious warning from the FDA. To learn more, see the “Side effects of leflunomide in detail” section below.

Leflunomide oral tablet may cause more mild side effects than those listed above. For details, see the drug’s prescribing information.

Serious side effects of leflunomide

Leflunomide may cause certain serious side effects. If you have any serious side effects from leflunomide oral tablet, call your doctor right away. But if you think you’re having a medical emergency or your side effects feel life threatening, take immediate action. Call 911 or a local emergency number, or go to the nearest emergency room.

After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Visit MedWatch’s website if you’d like to notify the FDA about a side effect you’ve had with leflunomide.

Serious side effects of leflunomide oral tablet that occurred in studies include:

* To learn more about this side effect, see the “Side effects of leflunomide in detail” section below.
Leflunomide oral tablet has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA.
‡ To learn more about this side effect, see the “Warnings for leflunomide” section below.

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Common questions about side effects of leflunomide

Here are answers to some common questions about side effects of leflunomide oral tablet. If you have other questions, talk with your doctor or pharmacist.

Are side effects of leflunomide similar to those of methotrexate?

Some side effects of leflunomide are similar to those of methotrexate. Both medications can cause:

These drugs can also cause different side effects. If you have concerns about certain side effects with either medication, talk with your doctor or pharmacist.

* To learn more about this side effect, see the “Side effects of leflunomide in detail” section below.
Leflunomide oral tablet has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA.

Will I experience certain side effects when stopping leflunomide?

No, it’s not likely. Leflunomide does not cause withdrawal symptoms when it’s stopped. However, your rheumatoid arthritis (RA) symptoms may come back or get worse if you stop taking leflunomide. (Keep in mind, the drug is prescribed to treat RA.)

Talk with your doctor if you want to discontinue leflunomide treatment.

How long do side effects of leflunomide typically last?

It’s not known how long side effects of leflunomide typically last. Some side effects are mild and may go away after a few days or weeks. Others may continue for as long as you take the drug. Some people may not experience any side effects from taking leflunomide.

If you have questions about side effects that are bothersome, talk with your doctor.

Does leflunomide cause long-term side effects?

Yes, in some cases leflunomide oral tablet may cause long-term side effects. These can occur if you take the drug for a long time. Some long-term side effects may continue after you stop taking leflunomide.

Examples of long-term side effects reported with leflunomide oral tablet include:

Talk with your doctor to learn more about these side effects and how to manage them. Ask your doctor for more information about how long these side effects of leflunomide oral tablet may last.

* To learn more about this side effect, see the “Side effects of leflunomide in detail” section below.
Leflunomide oral tablet has a boxed warning for liver damage. A boxed warning is the most serious warning from the FDA.

Coupon for leflunomide

Visit this page to access Optum Perks coupons and get price estimates for leflunomide when you use the coupons. These coupons can provide significant savings on your prescription costs. 

Note: Optum Perks coupons cannot be used with insurance copays or benefits.

Side effects of leflunomide in detail

Below you’ll find details on some of the side effects of leflunomide oral tablet.

Risk of liver damage

In studies, liver damage was reported in people taking leflunomide oral tablet. This side effect may be serious. In fact, leflunomide oral tablet has a boxed warning about the risk of liver damage. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

With liver damage, your liver doesn’t work like it should. Symptoms may include:

Certain factors can increase the risk of liver damage with leflunomide oral tablet. These include already having liver problems or taking certain medications that may damage the liver.

Ways to manage

Your doctor will likely recommend checking your liver function before and during treatment with leflunomide. They will tell you how often they’ll order liver function tests for you while you’re taking leflunomide.

Let your doctor know right away if you think you have symptoms of liver damage while taking leflunomide. They can decide the best way to treat your symptoms, and whether it’s safe for you to continue taking leflunomide.

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Diarrhea

In studies, diarrhea was common in people taking leflunomide oral tablet. This side effect is usually mild.

With diarrhea, you have frequent loose stools. Symptoms may include abdominal cramps, bloating, and an urgent need to have a bowel movement.

Certain factors can increase the risk of diarrhea with leflunomide oral tablet. These may include certain foods, drinks, medications, or other health conditions you may have.

Ways to manage

If you experience symptoms of diarrhea, tell your doctor. They’ll likely recommend eating a bland diet and making sure that you get enough fluids. If diarrhea becomes severe, they may recommend certain medications to help manage it.

Serious skin reactions

In studies, serious skin reactions were rare in people taking leflunomide oral tablet. This side effect may be serious. Possible skin reactions include:

With these serious skin reactions, you may experience a painful red or discolored rash. Other symptoms may include:

  • blisters on the skin, eyes, nose, mouth, and genitals
  • facial swelling
  • swelling of the lips
  • fever
  • skin that is broken, raw, or shedding

Certain factors can increase the risk of serious skin reactions with leflunomide oral tablet. These include having certain health conditions or having a family history of serious skin reactions.

Ways to manage

If you experience symptoms of serious skin reactions described above, seek immediate medical help. This includes going to the closest emergency room or calling 911 or your local emergency number. These skin reactions are severe, life threatening emergencies that require immediate treatment.

Allergic reaction

For some people, leflunomide oral tablet can cause an allergic reaction.

Symptoms can be mild or serious, and they may include:

  • itchiness
  • skin rash
  • swelling under the skin, usually affecting eyelids, lips, hands, or feet
  • swelling of the mouth, tongue, or throat, which can make it hard to breathe
  • flushing (temporary warmth, redness, or deepening of skin color)

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know if you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to leflunomide oral tablet, your doctor may recommend taking a different medication instead.

Warnings for leflunomide

Below are some factors you may want to discuss with your doctor before taking leflunomide oral tablet.

Boxed warnings

This drug has boxed warnings about the risk of harm if taken during pregnancy and the risk of liver damage. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

For details about the risk of liver damage, see the “Side effects of leflunomide in detail” section above. For more information about the risk of harm if taken during pregnancy, see the “Leflunomide and pregnancy” section below.

Other warnings

It may not be safe for you to take leflunomide oral tablet if you have specific health conditions. These are sometimes called drug-condition interactions. Other things may also affect whether leflunomide oral tablet is a safe treatment option for you.

Before taking leflunomide oral tablet, tell your doctor about your health and medications you take. Things to consider include:

Leflunomide and pregnancy

Leflunomide oral tablet should not be taken during pregnancy.

Risk of harm if taken during pregnancy

Leflunomide has a boxed warning about the risk of harm if taken during pregnancy. A boxed warning is the most serious warning from the FDA. Leflunomide oral tablet may cause pregnancy loss or congenital anomalies (also called birth defects) if taken during pregnancy.

If you can become pregnant, your doctor may order a pregnancy test before you start taking leflunomide. If you take leflunomide, use an effective birth control method during treatment.

Tell your doctor if you become pregnant while taking leflunomide. Follow your doctor’s instructions for stopping leflunomide oral tablet.

Leflunomide and breastfeeding

Leflunomide oral tablet should not be taken while breastfeeding. If you’re breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor may recommend other ways to feed your child during treatment with leflunomide.

Leflunomide and alcohol

Leflunomide oral tablet is not known to interact with alcohol. However, leflunomide oral tablet can cause serious liver damage. It has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. For more details, see the “Side effects of leflunomide in detail” section above.

Because alcohol can damage the liver, it’s recommended that you do not drink alcohol while taking leflunomide oral tablet.

If you drink alcohol, talk with your doctor if you have questions about drinking it during your treatment with leflunomide oral tablet.

What to ask your doctor

This article describes common and serious side effects of leflunomide oral tablet. If your doctor prescribes this medication, they can discuss possible side effects with you. Let your doctor know if you have concerns or questions about treatment with this medication.

Here’s a list of some possible questions you may want to ask your doctor:

  • Am I at higher risk of side effects than others?
  • Is my risk of diarrhea higher when I first start treatment?
  • Does my risk of liver damage depend on the dosage you prescribe?

Disclaimer: Optum Perks 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 another 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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