API- Azathioprine

Packaging- 10 Tablets

Strength- 50 mg

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Azathioprine is in the purine analogue and antimetabolite family of medication, is indicated for used alone or in combination with other immunosuppressive therapy in order to prevent rejection following organ transplantation and to treat an array of autoimmune diseases, including rheumatoid arthritis, pemphigus, systemic lupus erythematosus, Behcet’s disease, and other forms of vasculitis, autoimmune hepatitis, atopic dermatitis, myasthenia gravis, neuromyelitis optica (Devic’s disease), restrictive lung disease, and others.

Apart from this, it is also an important therapy and steroid-sparing agent for inflammatory bowel disease (such as Crohn’s disease and ulcerative colitis) and for multiple sclerosis.

Dosage and Side Effects

Azathioprine 50 mg should be taken orally at about the same time each day, either with or without food. Azathioprine tablets should be swallowed whole with water. The tablets should not be opened, broken, or chewed.

Most common side effects of Azathioprine include dizziness, diarrhea, fatigue, skin rashes, hair loss, acute pancreatitis, nausea, and vomiting.

Warning 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.


Is Azathioprine 50 mg tablet FDA approved?

Yes, it is approved by the Food and Drug Administration (FDA) for use in kidney transplantation from human donors, and for rheumatoid arthritis.
Is Azathioprine a steroid?
Azathioprine is a steroid-sparing agent or immunosuppression medicine. Azathioprine keeps the dose of steroids at a minimum level and eventually stops the use of steroids.
Is Imuran the same as Azathioprine?
Imuran is the brand name under which Azathioprine is sold. Healthcare professionals use it to treat patients who have organ transplants to prevent rejection of the organ and treat an array of autoimmune diseases.
What are the ingredients in the medicine Azathioprine?
Azathioprine is the active ingredient in the medicine, and lactose, magnesium stearate, potato starch, povidone, and stearic acid are the inactive ingredients in the drug.
What are the most common side-effects of the medicine Azathioprine?
Dizziness, diarrhea, fatigue, skin rashes, hair loss, acute pancreatitis, nausea, and vomiting are the most common side effects.