Drugs A - Z

Azathioprine Sodium Solution for injection

It is used to prevent organ rejection after a transplant

Generic Name: azathioprine

Brand Names: Azasan, Imuran

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 04/14/2011] ISSUE: FDA continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL, primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factors (TNF) blockers, as well as with azathioprine, and/or mercaptopurine. TNF blockers include infliximab (Remicade), etancercept (Enbrel), adalimumab (Humira), certolizumab pegol (Cimzia) and golimumab (Simponi).

BACKGROUND: HSTCL is an aggressive (fast-growing) cancer and is usually fatal. The majority of cases reported were in patients being treated for Crohn’s disease or ulcerative colitis, but also included a patient being treated for psoriasis and two patients being treated for rheumatoid arthritis. FDA is now updating the number of reported cases of HSTCL.

Although most reported cases of HSTCL occurred in patients treated with a combination of medicines known to suppress the immune system, including the TNF blockers, azathioprine, and/or mercaptopurine, there have been cases reported in patients receiving azathioprine or mercaptopurine alone.

  • Educate patients and caregivers about the signs and symptoms of malignancies such as HSTCL so that they are aware of and can seek evaluation and treatment of any signs or symptoms. These may include splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, and weight loss.
  • Monitor for the emergence of malignancies when a patient has been treated with TNF blockers, azathioprine, and/or mercaptopurine.
  • Know that people with rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis may be more likely to develop lymphoma than the general U.S. population. Therefore, it may be difficult to measure the added risk of TNF blockers, azathioprine, and/or meracaptopurine.

Read the Drug Safety Communications for other specific recommendations for Healthcare Professionals and Patients and the Data Summary for additional information. For more information visit the FDA website at: [Web] and [Web].

What is this medicine?

AZATHIOPRINE (ay za THYE oh preen) suppresses the immune system. It is used to prevent organ rejection after a transplant. It is also used to treat rheumatoid arthritis. The injection is given only when the medicine can not be taken by mouth.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • infection
  • kidney disease
  • liver disease
  • an unusual or allergic reaction to azathioprine, other medicines, lactose, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast feeding

How should I use this medicine?

This medicine is for injection or infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • mercaptopurine

This medicine may also interact with the following medications:

  • allopurinol
  • aminosalicylates like sulfasalazine, mesalamine, balsalazide, and olsalazine
  • leflunomide
  • medicines called ACE inhibitors like benazepril, captopril, enalapril, fosinopril, quinapril, lisinopril, ramipril, and trandolapril
  • mycophenolate
  • sulfamethoxazole; trimethoprim
  • vaccines
  • warfarin

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.

This medicine may increase your risk of getting an infection. Stay away from people who are sick. See your doctor if you get an infection.

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

Men may have a reduced sperm count while they are taking this medicine. Talk to your health care professional for more information.

This medicine may increase your risk of getting certain kinds of cancer. Talk to your doctor about healthy lifestyle choices, important screenings, and your risk.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • fever, chills, or any other sign of infection
  • severe stomach pain
  • unusual bleeding, bruising
  • unusually weak or tired
  • vomiting
  • yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • hair loss
  • nausea

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Last Updated: March 11, 2009
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