Side Effects of Imuran (Azathioprine)

Imuran (azathioprine) is a type of immunosuppressive antimetabolite drug. Imuran may be prescribed to treat conditions such as inflammatory bowel disease (IBD) or rheumatoid arthritis. It might also be used in patients who have had an organ transplant, in order to prevent the body from rejecting the organ. This drug suppresses the immune system. In most cases, Imuran is used to treat IBD after other drugs have not worked. It might also be used at the same time as steroids.

Medications that affect the immune system might increase the risk of developing an infection, and precautions might need to be taken to protect against infections. People taking Imuran should not receive any live vaccines. It might also be necessary to avoid people who are sick and any sign of infection should be discussed with a doctor right away.

Imuran tablets contain a black box warning related to the possibility of developing a specific kind of cancer. This is related in particular to people who take the drug and also have IBD. The risk of developing cancer should be weighed against the risk of not treating the IBD with this drug.

Cancer risks in people with IBD are still an ongoing topic for debate and study, so it is important to take a common sense approach when considering the risks. Some studies have shown a risk, but others have not. Be sure to discuss this potential adverse effect with your physicians so that you can understand your individual risk.

"Chronic immunosuppression with IMURAN, a purine antimetabolite increases risk of malignancy in humans. Reports of malignancy include post-transplant lymphoma and hepatosplenic T-cell lymphoma (HSTCL) in patients with inflammatory bowel disease. Physicians using this drug should be very familiar with this risk as well as with the mutagenic potential to both men and women and with possible hematologic toxicities. Physicians should inform patients of the risk of malignancy with IMURAN."

Check with your doctor if any of the following side effects continue or are bothersome:

• Loss of appetite
• Nausea or vomiting

Check with your doctor if any of the following side effects continue or are bothersome:

• Skin rash

More common

• Cough, hoarseness
• Fever or chills
• Lower back or side pain
• Painful or difficult urination
• Unusual tiredness, weakness

Less Common

• Black, tarry stools
• Blood in urine or stools
• Pinpoint red spots on the skin
• Unusual bleeding or bruising

Less Common or Rare

• Fast heartbeat
• Fever (sudden)
• Muscle or joint pain
• Nausea, vomiting, and diarrhea (severe)
• Redness or blisters on the skin
• Shortness of breath
• Sores in the mouth, on lips
• Stomach pain
• Swelling of feet or lower legs
• A feeling of discomfort or illness (sudden)

Other Notes:

Your doctor will watch for any liver problems this medicine may cause.

Because of the way this medicine acts on the body, there is a chance that it might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia, lymphoma, or skin cancer. The risk of cancer is lower in people taking azathioprine for arthritis, and you should discuss these possible effects with your doctor.

After you stop this medicine, there may still be some side effects. During this time notify your doctor as soon as possible if you notice any of the following:

• Black, tarry stools
• Blood in urine
• Cough or hoarseness
• Fever or chills
• Lower back or side pain
• Painful or difficult urination
• Pinpoint red spots on the skin
• Unusual bleeding or bruising

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor. This information is meant only as a guideline - always consult a physician or pharmacist for complete information about prescription medications.