{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "fluorouracil",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "The recommended dose of fluorouracil, if administered in a bolus dosing regimen in combination with leucovorin, is 500 mg/m 2 by intravenous bolus on Days 1, 8, 15, 22, 29, and 36 in 8-week cycles. 2.3 Recommended Dosage for Adenocarcinoma of the Breast The recommended dose of fluorouracil, administered as a component of a cyclophosphamide-based multidrug regimen, is 500 mg/m 2 or 600 mg/m 2 intravenously on Days 1 and 8 every 28 days for 6 cycles.",
        "source": "US FDA label for fluorouracil (Fluorouracil), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fluorouracil.json",
        "verbatim": true
      },
      {
        "text": "for Adenocarcinoma of the Colon and Rectum The recommended dose of fluorouracil, administered in an infusional regimen in combination with leucovorin alone, or in combination with leucovorin and oxaliplatin or irinotecan, is 400 mg/m 2 by intravenous bolus on Day 1, followed by 2400 mg/m 2 to 3000 mg/m 2 intravenously as a continuous infusion over 46 hours every two weeks.",
        "source": "US FDA label for fluorouracil (Fluorouracil), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fluorouracil.json",
        "verbatim": true
      },
      {
        "text": "The recommended dose of fluorouracil, if administered in a bolus dosing regimen in combination with leucovorin, is 500 mg/m 2 by intravenous bolus on Days 1, 8, 15, 22, 29, and 36 in 8-week cycles.",
        "source": "US FDA label for fluorouracil (Fluorouracil), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fluorouracil.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness in pediatric patients have not been established.",
        "source": "US FDA label for fluorouracil (Fluorouracil), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/fluorouracil.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 fluorouracil (Fluorouracil), retrieved 2026-08-29",
        "cached_file": "labels/fluorouracil.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "The risks of resumption of fluorouracil in patients with cardiotoxicity that has resolved have not been established. 5.3 Hyperammonemic Encephalopathy Fluorouracil can cause hyperammonemic encephalopathy in the absence of liver disease or other identifiable cause, based on postmarketing reports.",
        "source": "US FDA label for fluorouracil (Fluorouracil), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/fluorouracil.json",
        "verbatim": true
      },
      {
        "text": "Hyperammonemic Encephalopathy Fluorouracil can cause hyperammonemic encephalopathy in the absence of liver disease or other identifiable cause, based on postmarketing reports.",
        "source": "US FDA label for fluorouracil (Fluorouracil), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/fluorouracil.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Category D Risk Summary There are no adequate and well-controlled studies with fluorouracil in pregnant women.",
        "source": "US FDA label for fluorouracil (Fluorouracil), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/fluorouracil.json",
        "verbatim": true
      },
      {
        "text": "Based on its mechanism of action, fluorouracil can cause fetal harm when administered to a pregnant woman.",
        "source": "US FDA label for fluorouracil (Fluorouracil), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/fluorouracil.json",
        "verbatim": true
      },
      {
        "text": "Administration of fluorouracil to rats and mice during selected periods of organogenesis, at doses lower than a human dose of 12 mg/kg, caused embryolethality and teratogenicity.",
        "source": "US FDA label for fluorouracil (Fluorouracil), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/fluorouracil.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "It is not known whether fluorouracil or its metabolites are present in human milk.",
        "source": "US FDA label for fluorouracil (Fluorouracil), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/fluorouracil.json",
        "verbatim": true
      },
      {
        "text": "Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from fluorouracil, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.",
        "source": "US FDA label for fluorouracil (Fluorouracil), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/fluorouracil.json",
        "verbatim": true
      },
      {
        "text": "•Nursing Mothers: Discontinue drug or discontinue nursing.",
        "source": "US FDA label for fluorouracil (Fluorouracil), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/fluorouracil.json",
        "verbatim": true
      }
    ]
  }
}