Consumer medicine information

GenRx Azathioprine Tablets

Contains the active ingredient, azathioprine (ay-za-THYE-oh-preen)

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before taking your medicine.

This leaflet answers some common questions about azathioprine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. Some more recent information on your medicine may be available.

Ask your doctor or pharmacist:

  • if there is anything you do not understand in this leaflet,
  • if you are worried about taking your medicine, or
  • to obtain the most up-to-date information.

You can also download the most up-to-date leaflet from

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

Keep this leaflet with your medicine. You may want to read it again.

What this medicine is used for

The name of your medicine is GenRx Azathioprine. It contains the active ingredient, azathioprine.

It is used to:

  • help prevent the body from rejecting transplanted organs (e.g. a heart or kidney)
  • treat other diseases called autoimmune diseases where your immune system is reacting against your own body. These include:
    – severe rheumatoid arthritis
    – systemic lupus erythematosus
    – chronic active hepatitis
    – certain skin, muscle, and blood diseases.

Azathioprine can be taken alone or in combination with other medicines such as corticosteroids or other immunosuppressants.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.

This medicine is available only with a doctor’s prescription.

How it works

This medicine belongs to a group of medicines called immunosuppressants.

It works by reducing the body’s immune responses.

Azathioprine helps prevent the rejection of a transplanted organ such as a kidney, liver or heart.

There is no known evidence to show that this medicine is addictive.

Before you take this medicine

When you must not take it

Do not take this medicine if:

  • You have had any of the following:
    rheumatoid arthritis previously treated with alkylating agents (medicines such as chlorambucil, melphalan or cyclophosphamide).
  • You are pregnant, you may be pregnant or you are likely to become pregnant in the near future.
    Azathioprine may affect your developing baby if you take it during pregnancy.
  • You are hypersensitive to, or have had an allergic reaction to, azathioprine, 6-mercaptopurine (Puri-Nethol) or any of the ingredients listed at the end of this leaflet.
    Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.
    If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
  • The expiry date (EXP) printed on the pack has passed.
  • The packaging is torn, shows signs of tampering or it does not look quite right.

Before you start to take it

Tell your doctor if:

  1. You have allergies to:
  • any other medicines
  • any other substances, such as foods, preservatives or dyes.
  1. You have or have had any medical conditions, especially the following:
  • kidney or liver disease
  • hypersplenism, an overactive spleen
  • a disease affecting the muscles called myasthenia gravis
  • chicken pox or shingles
  • Lesch-Nyhan Syndrome
  • a condition where your body produces too little of a natural chemical called thiopurine methyltransferase (TPMT)
  • Progressive Multifocal Leukoencephalopathy (PML) an infection caused by JC virus
  • hepatitis B
  • irritable bowel disease
  • and a history of cytomegalovirus disease.
  1. You are pregnant, you may be pregnant, you are likely to become pregnant in the near future or you are intending to father a child. Both you and your partner should take adequate contraceptive precautions while taking azathioprine.
  2. You are breastfeeding or plan to breastfeed. Use of this medicine during breastfeeding is not recommended.
  3. You have recently been vaccinated or immunised or plan to get a vaccination or immunisation.
  4. You are planning to have surgery or an anaesthetic.
  5. You are currently receiving or are planning to receive dental treatment. Tell your dentist that you are taking azathioprine. Dental work, whenever possible, should be completed before you start taking azathioprine or delayed until your blood cell counts are normal.
  6. You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Some medicines may interact with azathioprine. These include:

  • penicillamine, used in the treatment of rheumatoid arthritis
  • captopril, used in the treatment of high blood pressure and heart failure
  • cimetidine, used to treat stomach ulcers and indigestion
  • indomethacin, used as a painkiller and anti-inflammatory
  • co-trimoxazole, used to treat infections
  • allopurinol, oxipurinol or thiopurinol, used in the treatment of gout
  • tubocurarine, succinylcholine, used during anaesthesia
  • frusemide, may be used to reduce swelling caused by excess fluid
  • anticoagulants such as warfarin, used to prevent blood clots
  • mesalazine, olsalazine or sulphasalazine, used in the treatment of ulcerative colitis
  • phenytoin, phenobarbital, rifampicin, ketoconazole, erythromycin
  • methotrexate, used in the treatment of cancer
  • ribavirin, used to treat a type of respiratory infection.

If you are taking any of these you may need a different dose or you may need to take different medicines.

Other medicines not listed above may also interact with azathioprine.

How to take this medicine

Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.

How much to take

Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.

Do not stop taking your medicine or change your dosage without first checking with your doctor.

How to take it

Swallow the tablets whole with a full glass of water. Do not break, crush or chew the tablets.

Do not handle broken or damaged tablets. Provided that the film coating is undamaged, there is no risk in handling film-coated azathioprine tablets.

When to take it

Take this medicine at least one hour before or three hours after food or milk.

Take it at about the same time each day. Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take it.

How long to take it for

Continue taking your medicine for as long as your doctor tells you.

Patients with a transplant will need to take it continuously to reduce the risk of the body rejecting the transplanted organ.

Make sure you have enough to last over weekends and holidays.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed.

This may increase the chance of you getting an unwanted side effect.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively, go to the Accident and Emergency department at your nearest hospital.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much azathioprine, you may get an unexpected infection, ulcers in the throat, and bruising and bleeding.

While you are taking this medicine

Things you must do

Tell your doctor that you are taking this medicine if:

  • you are about to be started on any new medicine
  • you plan to have any vaccinations or immunisations
  • you are pregnant, planning to become pregnant or father a child
  • you are breastfeeding or are planning to breastfeed
  • you are about to have any blood tests
  • you are going to have surgery or an anaesthetic or are going into hospital.

Your doctor will perform blood tests every week for the first eight weeks, then at least once a month after that, while you are taking azathioprine.

Try to avoid contact with people who have infectious diseases (such as the ‘flu’).

Avoid contact with anyone suffering from chickenpox or shingles.

Tell your doctor immediately if you do come into contact with someone who has chickenpox or shingles.

Avoid contact sports or other situations where bruising or injury may occur. Be careful to avoid cutting yourself with sharp objects (e.g. razors).

Protect yourself from the sun while you are taking azathioprine. Azathioprine suppresses your immune system. Lowering your body’s immune defence system increases your risk of skin cancer, cervical cancer, lymphoma and other cancers.

Tell your doctor immediately if you notice new moles, changes in existing moles, lumps on your body or you feel unwell.

If you are female, tell your doctor if you notice unusual vaginal discharge or bleeding, and make sure to have regular Pap smears.

Things you must not do

Do not:

  • Give this medicine to anyone else, even if their symptoms seem similar to yours.
  • Take your medicine to treat any other condition unless your doctor tells you to.
  • Stop taking your medicine, or change the dosage, without first checking with your doctor.

Things to be careful of

Be careful while driving or operating machinery until you know how this medicine affects you. It may cause dizziness and tiredness in some people. If you have any of these symptoms, do not drive, or operate machinery or do anything else that is dangerous.

Possible side effects

Tell your doctor as soon as possible if you do not feel well while you are taking azathioprine or if you have any questions or concerns.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

Tell your doctor as soon as possible if you notice any of the following.

  • any infection or fever
  • you come into contact with anyone who is suffering from chickenpox or shingles
  • unexpected bruising or bleeding, black tarry stools or blood in the urine or stools
  • new marks on skin or any change to marks that may have been there previously
  • headache, stiff neck and extreme sensitivity to bright light
  • nausea and vomiting
  • tiredness, dizziness or generally unwell
  • irregular heart beat,sores in the mouth and on the lips
  • feeling of ants creeping in or under the skin
  • change in sense of smell or taste.

If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

These are very serious side effects and you may need urgent medical attention or hospitalisation:

  • muscle weakness, pain or stiffness
  • severe joint pain
  • kidney problems
  • feeling faint especially when standing up
  • severe abdominal pain
  • diarrhoea
  • jaundice, a yellow discoloration of the skin/eyes
  • serious skin reactions such as blistering or peeling.

Side effects reported particularly in organ transplant patients are:

  • viral, fungal and bacterial infections
  • hair loss (particularly following a kidney transplant)
  • diarrhoea, usually with blood and mucus
  • stomach pain with fever and vomiting.

Other side effects not listed above may occur in some patients.

Some of these side effects can only be found when your doctor does tests from time to time to check your progress (e.g. low blood cell count).

Allergic reactions

If you think you are having an allergic reaction to azathioprine, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

Symptoms of an allergic reaction may include some or all of the following:

  • cough, shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue, throat or other parts of the body
  • rash, itching or hives on the skin
  • fainting
  • hay fever-like symptoms.

Storage and Disposal


Keep your medicine in its original packaging until it is time to take it. If you take your medicine out of its original packaging it may not keep well.

Keep your medicine in a cool dry place where the temperature will stay below 30°C. Protect them from light and moisture.

Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.


If your doctor tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What it looks like

GenRx Azathioprine 50 mg tablets are round, pale yellow film-coated tablets, embossed with AZA, a break line, and 50 on one face. The other face is plain.

The tablets come in blister packs of 100.


Each tablet contains 50 mg of azathioprine as the active ingredient.

It also contains the following inactive ingredients:

  • microcrystalline cellulose
  • mannitol
  • povidone
  • maize starch
  • croscarmellose sodium
  • sodium stearyl fumarate
  • Opadry™ clear OY-7240 (macrogol 400 and hypromellose).

This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

GenRx Azathioprine 50 mg tablets:
Blister packs:
AUST R 80923


Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113

This leaflet was last updated in April 2015.

Published by MIMS August 2015