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Azasan

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Azasan

Azasan

Azasan Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Azasan (azathioprine) is used to prevent the body from rejecting a transplanted kidney. It is also used to treat symptoms of rheumatoid arthritis. It is an immunosuppressive antimetabolite that lowers the body's immune system. This medication is available in generic form. Many people using this medication do not have serious side effects. Side effects may include stomach/intestinal symptoms such as nausea, vomiting, diarrhea, or loss of appetite.

The dose of Azasan required to prevent rejection and minimize toxicity varies. The initial dose is usually 3 to 5 mg/kg daily, beginning at the time of transplant. It is usually given as a single daily dose on the day of, and in some cases 1 to 3 days before, transplantation. Azasan may interact with allopurinol, mercaptopurine, methotrexate, blood thinners, cyclosporine, olsalazine, sulfasalazine, sulfamethoxasole, trimethoprim, or ACE inhibitors. Tell your doctor all medications and supplements you use. Azasan is not recommended for use during pregnancy. It may harm a fetus. Men and women should use two forms of birth control (e.g., condoms, birth control pill) while taking this medication. Azasan can decrease the effectiveness of intrauterine devices (IUDs). Consult your doctor about birth control. This medication passes into breast milk and may have undesirable effects on a nursing infant. Breastfeeding while using this drug is not recommended.

Our Azasan (azathioprine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Azasan in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

  • fever, night sweats, weight loss, tiredness;
  • feeling full after eating only a small amount;
  • pain in your upper stomach that may spread to your shoulder;
  • easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Stop using azathioprine and call your doctor at once if you have any of these other serious side effects:

  • signs of infection (fever, chills, sore throat, body aches, weakness, muscle pain, flu symptoms);
  • severe nausea, vomiting, or diarrhea;
  • pain or burning with urination; or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

  • mild upset stomach, nausea, diarrhea, loss of appetite;
  • hair loss; or
  • skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Azasan (azathioprine) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Azasan FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The principal and potentially serious toxic effects of AZASAN® (azathioprine) are hematologic and gastrointestinal. The risks of secondary infection and neoplasia are also significant (see WARNINGS). The frequency and severity of adverse reactions depend on the dose and duration of AZASAN® (azathioprine) as well as on the patient's underlying disease or concomitant therapies. The incidence of hematologic toxicities and neoplasia encountered in groups of renal homograft recipients is significantly higher than that in studies employing AZASAN® (azathioprine) for rheumatoid arthritis. The relative incidences in clinical studies are summarized below:

Toxicity Renal Homograft Rheumatoid Arthritis
Leukopenia
  Any Degree > 50% 28%
< 2500 cells/mm 316% 5.3%
Infections 20% < 1%
Neoplasia   *
  Lymphoma 0.5%  
  Others 2.8%  
*Data on the rate and risk of neoplasia among persons with rheumatoid arthritis treated with azathioprine are limited. The incidence of lymphoproliferative disease in patients with RA appears to be significantly higher than that in the general population. In one completed study, the rate of lymphoproliferative disease in RA patients receiving higher than recommended doses of azathioprine (5 mg/kg/day) was 1.8 cases per 1000 patient-years of follow-up, compared with 0.8 cases per 1000 patient-years of follow-up in those not receiving azathioprine. However, the proportion of the increased risk attributable to the azathioprine dosage or to other therapies (i.e., alkylating agents) received by patients treated with azathioprine cannot be determined.

Hematologic

Leukopenia and/or thrombocytopenia are dose dependent and may occur late in the course of therapy with AZASAN® (azathioprine) . Dose reduction or temporary withdrawal may result in reversal of these toxicities. Infection may occur as a secondary manifestation of bone marrow suppression or leukopenia, but the incidence of infection in renal homotransplantation is 30 to 60 times that in rheumatoid arthritis. Macrocytic anemia and/or bleeding have been reported.

TPMT genotyping or phenotyping can help identify patients with low or absent TPMT activity (homozygous for nonfunctional alleles) who are at increased risk for severe, life-threatening myelosuppression from AZASAN®. See CLINICAL PHARMACOLOGY, WARNINGS and PRECAUTIONS: Laboratory Tests. Death associated with pancytopenia has been reported in patients with absent TPMT activity receiving azathioprine. 6, 20

Gastrointestinal

Nausea and vomiting may occur within the first few months of therapy with AZASAN® (azathioprine) , and occurred in approximately 12% of 676 rheumatoid arthritis patients. The frequency of gastric disturbance often can be reduced by administration of the drug in

divided doses and/or after meals. However, in some patients, nausea and vomiting may be severe and may be accompanied by symptoms such as diarrhea, fever, malaise, and myalgias (see PRECAUTIONS). Vomiting with abdominal pain may occur rarely with a hypersensitivity pancreatitis. Hepatotoxicity manifest by elevation of serum alkaline phosphatase, bilirubin, and/or serum transaminases is known to occur following azathioprine use, primarily in allograft recipients. Hepatotoxicity has been uncommon (less than 1%) in rheumatoid arthritis patients. Hepatotoxicity following transplantation most often occurs within 6 months of transplantation and is generally reversible after interruption of AZASAN® (azathioprine) . A rare, but life-threatening hepatic veno-occlusive disease associated with chronic administration of azathioprine has been described in transplant patients and in one patient receiving azathioprine for panuveitis.21, 22, 23 Periodic measurement of serum transaminases, alkaline phosphatase, and bilirubin is indicated for early detection of hepatotoxicity. If hepatic veno-occlusive disease is clinically suspected, AZASAN® (azathioprine) should be permanently withdrawn.

Others

Additional side effects of low frequency have been reported. These include skin rashes, alopecia, fever, arthralgias, diarrhea, steatorrhea, negative nitrogen balance, and reversible interstitial pneumonitis.

REFERENCES

6. Data on file, Prometheus Laboratories Inc.

20. Schutz E, Gummert J, Mohr F, Oellerich M. Azathioprine-induced myelosuppression in thiopurine methyltransferase deficient heart transplant patients. Lancet. 1993; 341:436.

21. Read AE, Wiesner RH, LaBrecque DR, et al. Hepatic venoocclusive disease associated with renal transplantation and azathioprine therapy. Ann Intern Med. 1986; 104:651-655.

22. Katzka DA, Saul SH, Jorkasky D, et al. Azathioprine and hepatic veno-occlusive disease in renal transplant patients. Gastroenterology. 1986; 90:446-454.

23. Weitz H, Gokel JM, Loeshke K, et al. Veno-occlusive disease of the liver in patients receiving immunosuppressive therapy. Virchows Arch A Pathol Anat Histol. 1982; 395:245-256.

Read the entire FDA prescribing information for Azasan (azathioprine) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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