Leflunomide
Leflunomide (le FLOO noh mide) is a generic medication prescribed for rheumatoid arthritis in adults. Leflunomide belongs to a group of drugs called pyrimidine synthesis inhibitors. It’s a type of disease-modifying antirheumatic drug.
Leflunomide (le FLOO noh mide) is a generic medication prescribed for rheumatoid arthritis in adults. Leflunomide belongs to a group of drugs called pyrimidine synthesis inhibitors. It’s a type of disease-modifying antirheumatic drug.
- Generic
- • Tablet
- • 20mg
- • 30 Tablets
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Intro
Introduction
Written by Patricia Weiser, PharmD
Medically reviewed by Amber Watson, PharmD
Updated on August 17, 2023
Leflunomide (le FLOO noh mide) is a generic medication prescribed for rheumatoid arthritis in adults. Leflunomide belongs to a group of drugs called pyrimidine synthesis inhibitors. It’s a type of disease-modifying antirheumatic drug.
Disease-modifying antirheumatic drugs slow the progression of rheumatoid arthritis and ease symptoms.
Boxed warnings
Leflunomide has boxed warnings about the risks of fetal harm and liver damage. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).
For details, see the “Interactions and warnings for leflunomide” section.
Side effects
Side effects of leflunomide
Leflunomide may cause mild or serious side effects. More common mild side effects of leflunomide and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.
To learn more about leflunomide’s side effects, see this article or ask your doctor or pharmacist. You can also refer to the prescribing information for leflunomide listed in the “Resources” section.
Mild side effects
More common mild side effects reported with leflunomide are listed below.
This article doesn’t include all possible mild side effects of the drug. To learn more about leflunomide’s side effects, refer to the prescribing information for leflunomide listed in the “Resources” section.
With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects bother you, tell your doctor or pharmacist. They may be able to suggest ways to manage them.
Leflunomide oral tablet’s mild side effects include:
- diarrhea
- mild respiratory infection, such as bronchitis
- nausea
- headache
- mild allergic reaction*
* For details about this side effect, see the “Interactions and warnings for leflunomide” section.
Serious side effects
Serious side effects of leflunomide are listed below.
This article doesn’t include all possible serious side effects of the drug. To learn more about leflunomide’s side effects, refer to the prescribing information for leflunomide listed in the “Resources” section.
With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.
In general, leflunomide’s serious side effects include:
- increased blood pressure
- peripheral neuropathy (nerve damage in your hands and feet)
- risk of serious infection such as a certain type of pneumonia
- blood cell problems, such as low levels of platelets or white blood cells
- interstitial lung disease (scarring of the lungs)
- boxed warnings: risks of fetal harm and liver damage*
- severe allergic reaction,* including skin reactions
* For details about this side effect, see the “Interactions and warnings for leflunomide” section.
FAQs
Common questions about leflunomide
Below you’ll find answers to a few commonly asked questions about leflunomide.
What is leflunomide’s mechanism of action? How does the drug work?
Leflunomide works to treat rheumatoid arthritis (RA) by reducing inflammation. Specifically, it helps prevent your body from making a substance called pyrimidine. This substance plays an important role in how the body responds to inflammation. When there’s less pyrimidine, the level of inflammation goes down. This eases the symptoms of RA.
Leflunomide starts working to reduce symptoms of RA within a month of starting treatment. But individual results can vary.
If you’d like to know more about this, talk with your doctor or pharmacist. You can also ask your doctor what to expect with leflunomide treatment.
How does leflunomide compare with methotrexate?
Leflunomide and methotrexate (Otrexup, Rasuvo, Trexall, others) share some similarities but also some differences. Both drugs may be prescribed to treat RA. But methotrexate is approved to treat other conditions besides RA.
Leflunomide only comes as an oral tablet. Methotrexate comes as an oral tablet and as a liquid solution for injection.
Talk with your doctor to compare leflunomide versus methotrexate for treating your condition. They can help determine the treatment option that’s right for you.
Is it safe to take leflunomide with pain relievers?
Yes, it’s safe to take leflunomide with pain relievers, but certain types may be safer than others.
In general, nonsteroidal anti-inflammatory drugs (NSAIDs) are safe to take with leflunomide. Examples of NSAIDs are ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn). While acetaminophen (Tylenol) doesn’t directly interact with leflunomide, taking acetaminophen often may increase the risk of liver problems.
Before taking a pain reliever with leflunomide, talk with your doctor or pharmacist. They can help determine whether the drug will be safe and effective for you.
Can leflunomide cause weight loss?
Possibly. But weight loss wasn’t specifically reported as a side effect of leflunomide in studies of the drug.
However, nausea was a common side effect of leflunomide in the drug’s studies. Loss of appetite also occurred. If you experience these side effects while taking leflunomide, you may not eat as much food as usual. This may lead to weight loss in some people. To learn about other side effects, you can refer to the “Side effects of leflunomide” section or this article.
Talk with your doctor about any unexplained weight loss while taking leflunomide. They can help identify the cause and suggest ways to address it.
Uses
Uses of leflunomide
The Food and Drug Administration (FDA) approves prescription drugs such as leflunomide for certain conditions. Approved uses for leflunomide are described below.
Use for rheumatoid arthritis
Doctors may prescribe leflunomide oral tablet for treating rheumatoid arthritis (RA). It’s used for this purpose in adults. It’s usually prescribed as a long-term treatment.
With RA, your immune system mistakenly attacks the tissue inside your joints. This leads to symptoms, such as swelling, pain, and stiffness in your joints. Leflunomide treatment limits your immune system and reduces RA symptoms. To learn more, see “What is leflunomide’s mechanism of action? How does the drug work?” in the “Common questions about leflunomide” section.
Interactions and warnings
Interactions and warnings for leflunomide
Below, you’ll find information about leflunomide’s possible interactions and warnings.
Interactions of leflunomide
Certain things may affect how a drug works. These include getting vaccines, consuming alcohol or certain foods, or taking the drug with other medications. This effect is called a drug interaction.
Before you take leflunomide, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:
- prescription or over-the-counter drugs
- vitamins, herbs, or supplements
To learn about drug-condition interactions, see the “Warnings for leflunomide” section below.
Warnings for leflunomide
Some people should not take leflunomide, and others should take it cautiously.
Boxed warnings
Leflunomide has boxed warnings about the risk of fetal harm and liver damage. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).
To learn more about these warnings, read below. You can also talk with your doctor or pharmacist.
Risk of fetal harm. To learn more about this risk, see the “Pregnancy or breastfeeding and leflunomide” section below.
Risk of liver damage. With leflunomide treatment, you may experience increased liver enzymes, liver damage, or liver failure. This side effect was rarely reported in studies of leflunomide.
Symptoms of liver damage or liver failure may include:
- abdominal pain
- dark urine
- fatigue (low energy)
- jaundice (yellowing of the skin or eyes)
- unexplained weight loss
If you have concerns about the effects of leflunomide on your liver, tell your doctor. They’ll likely monitor the health of your liver before and during leflunomide treatment. They may also recommend avoiding alcohol and other medications that can cause liver problems while taking leflunomide.
Other warnings
Leflunomide could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether leflunomide is a safe option for you.
Ask your doctor about specific warnings for leflunomide, and be sure to tell your doctor about your:
- current health, including any allergies to medications
- past health conditions or surgeries
Allergic reaction
Leflunomide can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.
If you’ve had an allergic reaction to leflunomide or any of its ingredients, your doctor will likely not prescribe leflunomide. They can tell you about medications that are safer options for you.
A mild allergic reaction may cause the following symptoms:
A severe allergic reaction may cause the following symptoms:
- swelling under your skin, usually in your hands, feet, eyelids, or lips
- swelling of your mouth, throat, or tongue, which can cause breathing problems
If you have an allergic reaction to leflunomide, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.
Overdose of leflunomide
You should not take more leflunomide than your doctor prescribes. For some drugs, doing so may lead to harmful effects or overdose.
If you think you’ve taken too much leflunomide, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.
Pregnancy or breastfeeding and leflunomide
Information about leflunomide and pregnancy and breastfeeding is described below.
Leflunomide and pregnancy
Leflunomide should not be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication. Your doctor may suggest birth control options to use during treatment with leflunomide.
Boxed warning: risk of fetal harm
Leflunomide should not be taken during pregnancy due to the risk of fetal harm. This risk was found in animal studies in which the drug was shown to cause pregnancy loss (death of embryos and fetuses) in animals.
If you’re able to become pregnant, your doctor will have you take a pregnancy test before starting leflunomide. This is because they need to confirm you aren’t pregnant before you take the drug. Your doctor will likely suggest birth control to help prevent pregnancy during treatment with leflunomide.
If you become pregnant while taking leflunomide, tell your doctor right away. They’ll likely recommend stopping leflunomide. They can also prescribe certain medications to help clear leflunomide from your system.
If you become pregnant during leflunomide treatment, you can consider participating in the pregnancy registry for the drug. A registry collects information about the use of medications during pregnancy. You can learn more on the registry website or by calling 877-311-8972.
Talk with your doctor or pharmacist if you would like to know more about safe treatment options for rheumatoid arthritis during pregnancy.
Leflunomide and breastfeeding
Leflunomide should not be taken while breastfeeding. If you’re currently 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.
Ask your doctor
What to ask your doctor
Let your doctor know whether you have questions about leflunomide or would like more details about it.
Here’s a list of some possible questions you may want to ask your doctor:
- How long will I need to take leflunomide?
- How does leflunomide compare with other medications that treat my condition?
- What are some ways to reduce my risk of side effects with leflunomide?
- What do I do if I miss a dose of leflunomide?
- Does my birth control interact with leflunomide?
Resources
Resources
- Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
- Leflunomide tablet, film coated. (2022). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/eb85de02-2964-453b-978a-26451cd1c97a/spl-doc
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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