Azathioprine

DRUG INFORMATION

  ADULT
    - The initial dose is usually 3 to 5 mg/kg daily, beginning at the time of
      transplant.
      Source: US FDA label for azathioprine (Azathioprine Sodium), section 'dosage and
      administration', retrieved 2026-08-29
    - Dose reduction to maintenance levels of 1 to 3 mg/kg daily is usually possible.
      Source: US FDA label for azathioprine (Azathioprine Sodium), section 'dosage and
      administration', retrieved 2026-08-29
    - The initial dose should be approximately 1 mg/kg (50 to 100 mg) given as a single
      dose or on a twice-daily schedule.
      Source: US FDA label for azathioprine (Azathioprine Sodium), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and efficacy of azathioprine in pediatric patients have not been
      established.
      Source: US FDA label for azathioprine (Azathioprine Sodium), section 'pediatric
      use', retrieved 2026-08-29
    - Renal Homotransplantation The dose of azathioprine required to prevent rejection
      and minimize toxicity will vary with individual patients; this necessitates
      careful management. The initial dose is usually 3 to 5 mg/kg daily, beginning at
      the time of transplant. Azathioprine is usually given as a single daily dose on
      the day of, and in a minority of cases 1 to 3 days before, transplantation.
      Source: US FDA label for azathioprine (Azathioprine Sodium), section 'dosage and
      administration', retrieved 2026-08-29
    - The initial dose is usually 3 to 5 mg/kg daily, beginning at the time of
      transplant.
      Source: US FDA label for azathioprine (Azathioprine Sodium), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for azathioprine (Azathioprine
      Sodium), retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for azathioprine (Azathioprine
      Sodium), retrieved 2026-08-29

  PREGNANCY
    - Azathioprine can cause fetal harm when administered to a pregnant woman.
      Source: US FDA label for azathioprine (Azathioprine Sodium), section 'pregnancy',
      retrieved 2026-08-29
    - Azathioprine should not be given during pregnancy without careful weighing of risk
      versus benefit.
      Source: US FDA label for azathioprine (Azathioprine Sodium), section 'pregnancy',
      retrieved 2026-08-29
    - Whenever possible, use of azathioprine in pregnant patients should be avoided.
      Source: US FDA label for azathioprine (Azathioprine Sodium), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - The use of azathioprine in nursing mothers is not recommended.
      Source: US FDA label for azathioprine (Azathioprine Sodium), section 'nursing
      mothers', retrieved 2026-08-29
    - Azathioprine or its metabolites are transferred at low levels, both
      transplacentally and in breast milk. 8, 9, 10 Because of the potential for
      tumorigenicity shown for azathioprine, a decision should be made whether to
      discontinue nursing or discontinue the drug, taking into account the importance of
      the drug to the mother.
      Source: US FDA label for azathioprine (Azathioprine Sodium), section 'nursing
      mothers', retrieved 2026-08-29