{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "sucralfate",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Active Duodenal Ulcer The recommended adult oral dosage for duodenal ulcer is 1 g four times per day on an empty stomach.",
        "source": "US FDA label for sucralfate (Sucralfate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/sucralfate.json",
        "verbatim": true
      },
      {
        "text": "Maintenance Therapy The recommended adult oral dosage is 1 g twice a day.",
        "source": "US FDA label for sucralfate (Sucralfate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/sucralfate.json",
        "verbatim": true
      },
      {
        "text": "Active Duodenal Ulcer The recommended adult oral dosage for duodenal ulcer is 1 g four times per day on an empty stomach. Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after sucralfate. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.",
        "source": "US FDA label for sucralfate (Sucralfate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/sucralfate.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness in pediatric patients have not been established.",
        "source": "US FDA label for sucralfate (Sucralfate), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/sucralfate.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Special Populations Chronic Renal Failure and Dialysis Patients When sucralfate is administered orally, small amounts of aluminum are absorbed from the gastrointestinal tract.",
        "source": "US FDA label for sucralfate (Sucralfate), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/sucralfate.json",
        "verbatim": true
      },
      {
        "text": "Patients with chronic renal failure or those receiving dialysis have impaired excretion of absorbed aluminum.",
        "source": "US FDA label for sucralfate (Sucralfate), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/sucralfate.json",
        "verbatim": true
      },
      {
        "text": "In addition, aluminum does not cross dialysis membranes because it is bound to albumin and transferrin plasma proteins.",
        "source": "US FDA label for sucralfate (Sucralfate), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/sucralfate.json",
        "verbatim": true
      }
    ],
    "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 sucralfate (Sucralfate), retrieved 2026-08-29",
        "cached_file": "labels/sucralfate.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Teratogenic Effects Pregnancy category B Teratogenicity studies have been performed in mice, rats, and rabbits at doses up to 50 times the human dose and have revealed no evidence of harm to the fetus due to sucralfate.",
        "source": "US FDA label for sucralfate (Sucralfate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/sucralfate.json",
        "verbatim": true
      },
      {
        "text": "There are, however, no adequate and well-controlled studies in pregnant women.",
        "source": "US FDA label for sucralfate (Sucralfate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/sucralfate.json",
        "verbatim": true
      },
      {
        "text": "Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.",
        "source": "US FDA label for sucralfate (Sucralfate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/sucralfate.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "It is not known whether this drug is excreted in human milk.",
        "source": "US FDA label for sucralfate (Sucralfate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/sucralfate.json",
        "verbatim": true
      },
      {
        "text": "Because many drugs are excreted in human milk, caution should be exercised when sucralfate is administered to a nursing woman.",
        "source": "US FDA label for sucralfate (Sucralfate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/sucralfate.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "pregnancy": {
      "level": "caution",
      "line": "The label allows it only when the benefit is judged to outweigh the risk. Read the quote below.",
      "set_by": "Set from the label's own words, not from a reading of them: 'should be used during pregnancy only if'."
    },
    "lactation": {
      "level": "caution",
      "line": "The label allows it only when the benefit is judged to outweigh the risk. Read the quote below.",
      "set_by": "Set from the label's own words, not from a reading of them: 'caution should be exercised when sucralfate is administered to a nursing'."
    }
  }
}