WARNINGS AND PRECAUTIONS

• Females of childbearing potential must be advised to avoid pregnancy while on Azathioprine.
• Hair loss is often seen in transplant patients receiving the drug, but rarely occurs under other indications.
• Azathioprine 50 mg may suppress the bone marrow, patients may develop anaemia and will be more susceptible in order to get infection. Therefore, regular monitoring of the blood count is recommended during the entire treatment.
• Acute pancreatitis can also occur, especially in patients with Crohn’s disease.
• People who have previously been treated with an alkylating agent may have an excessive risk of cancers if treated with azathioprine.
• The use of immunosuppressive medication including azathioprine in organ transplantation has been linked to increased rates of developing skin cancer.
• Breastfeeding should be avoided whilst taking azathioprine 50 mg tablet.
• Renal transplant patients are known to have an increased risk of malignancy, predominantly skin cancer, and reticulum cell or lymphomatous tumors.
• The probability of the risk of post-transplant lymphomas can be increased in those patients who take aggressive treatment with immunosuppressive drugs, including azapure. So immunosuppressive drug therapy needs to be maintained at the lowest effective levels.
• Patients with TPMT activity (intermediate thiopurine S-Methyl Transferase) more often at an increased risk of myelotoxicity if they are taking conventional doses of azapure (azathioprine).
• A gastrointestinal hypersensitivity reaction characterized by severe nausea and vomiting has been reported. These symptoms may also be accompanied by diarrhea, rash, fever, malaise, myalgias, elevations in liver enzymes, and occasionally, hypotension.
• Efficacy, as well as safety of azathioprine in pediatric patients, have not been specified.