{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "azathioprine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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",
        "cached_file": "labels/azathioprine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/azathioprine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/azathioprine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/azathioprine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/azathioprine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/azathioprine.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/azathioprine.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/azathioprine.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/azathioprine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/azathioprine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/azathioprine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/azathioprine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/azathioprine.json",
        "verbatim": true
      }
    ]
  }
}