Leflunomide

Leflunomide is prescribed by specialist doctors.

It may take several weeks before you start to feel the benefit of this treatment. This is normal.

Do not drink alcohol whilst you are taking leflunomide - it will increase the risk of damage to your liver.

Leflunomide may harm an unborn baby - use suitable contraception so that you do not become pregnant or father a child.

Type of medicine Immunosuppressant (a medicine which affects your body's immune response)
Used for Treatment of rheumatoid arthritis or psoriatic arthritis (in adults)
Also called Arava®
Available as Tablets

Rheumatoid arthritis (RA) is thought to be an autoimmune disease. The immune system normally makes antibodies (small proteins) to attack bacteria, viruses, and other germs. In people with autoimmune diseases, the immune system makes antibodies against tissues of the body. In people with RA, antibodies are formed against the tissues that surround the joints. This causes inflammation, pain, and swelling around the affected joints. Over time, it causes damage. Medicines called disease-modifying antirheumatic drugs (DMARDs) are prescribed to suppress the inflammation.

Psoriatic arthritis is a particular type of arthritis that develops in some people who also have a skin condition called psoriasis.

Leflunomide is a disease-modifying antirheumatic medicine. It eases the symptoms mentioned above, but also reduces the damaging effect of the disease on the joints. It works by blocking the way inflammation develops in the joints.

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking leflunomide it is important that your doctor or pharmacist knows:

  • If you are pregnant, trying for a baby or breast-feeding.
  • If you have liver or kidney problems.
  • If you currently have an infection, or if you have ever had tuberculosis (TB).
  • If you have been told by a doctor that you have low numbers of proteins in your blood.
  • If you know you have a blood or bone marrow disorder.
  • If you have a problem which affects your immune system, such as AIDS.
  • If you have ever had an allergic reaction to a medicine.
  • If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
  • Before you start this treatment, read the manufacturer's printed information leaflet from inside your pack. The leaflet will give you more information about leflunomide, how to take it, and a full list of side-effects which you may experience from taking it.
  • If you have recently taken another DMARD, your doctor will want to make sure that all of this medicine has gone from your bloodstream before you start taking leflunomide. This is called a washout procedure. It is important that you follow any directions that you are given to do this.
  • Take leflunomide exactly as your doctor tells you to. It is taken once a day. Your doctor is likely to recommend that you start treatment on a high-strength (100 mg) tablet for three days. After this, the strength of your tablets will be reduced to 10 mg or 20 mg.
  • Take the tablets with a drink of water. You can take them before or after meals. Swallow them whole - do not chew or break the tablets.
  • Try to take your doses at the same time each day, as this will help you to remember to take them. If you do forget to take a dose, take it as soon as you remember. If you do not remember until the following day, skip the missed dose. Do not take two doses together to make up for a forgotten dose.
  • Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress. Your doctor will want to do some blood tests before and during this treatment.
  • Leflunomide may have no immediate effect on pain or inflammation. It can take several weeks before you notice any effect, and several months before you notice the full benefit. It is, however, important that you keep taking it as prescribed, even if it does not seem to be working at first.
  • It is likely that your doctor will recommend that you do not drink alcohol while you are on leflunomide. This is because it will increase the risk of side-effects, such as liver problems.
  • This medicine may harm an unborn baby:
    • If you are female, you must not get pregnant while you are taking leflunomide. Make sure you have discussed with your doctor what contraception is suitable for you and your partner. If you wish to have a baby after finishing treatment, you should discuss this with your doctor also, as the medicine may continue in your bloodstream for up to two years.
    • If you are male you must not get a woman pregnant while you are taking leflunomide. Ask your doctor about suitable contraception. If you wish to become a father, you should discuss this with your doctor. It is important that it is confirmed that leflunomide has been sufficiently removed from your body before you father a child.
  • Your doctor will discuss with you the possibility of unwanted side-effects, such as that you could become more susceptible to infections. Also, that there is a slightly increased risk of cancer associated with this medicine. If you have any concerns about your general health, discuss these with your doctor straightaway.
  • While you are taking leflunomide, do not have any immunisations (vaccinations) without talking to your doctor first. Leflunomide lowers your body's resistance and there is a chance that you may get an infection from the vaccine. Also, some vaccines may be less effective.
  • Before having any kind of medical treatment, tell the doctor, dentist or surgeon that you are taking leflunomide.
  • Treatment with leflunomide is usually long-term unless you experience an adverse effect. Continue to take the tablets unless you are advised otherwise.

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. These usually improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following side-effects continue or become troublesome.

Common leflunomide side-effects - these affect less than 1 in 10 people who take this medicine What can I do if I experience this?
Increased susceptibility to infections Contact your doctor if you feel unwell
Diarrhoea Drink plenty of water to replace lost fluids
Feeling or being sick, abdominal discomfort Stick to simple foods - avoid rich or spicy meals. Try taking the tablets after meals
Feeling dizzy or tired Getting up or moving more slowly may help. If you begin to feel faint, sit down for a few moments before standing
Headache Ask your pharmacist to recommend a suitable painkiller
Increased blood pressure, loss of appetite, mouth ulcers, tingling feelings, tendon inflammation, increased hair loss, itchy skin rash, dry skin If any of these become troublesome, discuss them with your doctor

Important: if you experience any of the following possibly serious symptoms, contact your doctor for advice straightaway. These may be signs that your liver is not working as it should.

  • Dark urine, pale stools, jaundice (yellowing of your skin or the whites of your eyes), pain in the upper part of your abdomen, and feeling unusually tired.
  • Keep all medicines out of the reach and sight of children.
  • Store in a cool, dry place, away from direct heat and light.

Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.

This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.

If you buy any medicines, check with a pharmacist that they are safe to take with your other medicines.

Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.

If you have any questions about this medicine ask your pharmacist.

Further reading & references

  • Manufacturer's PIL, Arava® 10 mg tablets; Sanofi, The electronic Medicines Compendium. Dated March 2012.
  • British National Formulary; 64th Edition (Sep 2012) British Medical Association and Royal Pharmaceutical Society of Great Britain, London

Disclaimer: This article is for information only and should not be used for the diagnosis or treatment of medical conditions. EMIS has used all reasonable care in compiling the information but make no warranty as to its accuracy. Consult a doctor or other health care professional for diagnosis and treatment of medical conditions. For details see our conditions.

Original Author:
Helen Allen
Current Version:
Peer Reviewer:
Dr Adrian Bonsall
Last Checked:
05/02/2013
Document ID:
3788 (v25)
© EMIS
The Information Standard - certified member