{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "cimetidine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "In a U.S. dose-ranging study of 400 mg at bedtime, 800 mg at bedtime and 1,600 mg at bedtime, a continuous dose-response relationship for ulcer healing was demonstrated.",
        "source": "US FDA label for cimetidine (Cimetidine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/cimetidine.json",
        "verbatim": true
      },
      {
        "text": "However, 800 mg at bedtime is the dose of choice for most patients, as it provides a high healing rate (the difference between 800 mg at bedtime and 1,600 mg at bedtime being small), maximal pain relief, a decreased potential for drug interactions (see PRECAUTIONS: Drug Interactions ) and maximal patient convenience.",
        "source": "US FDA label for cimetidine (Cimetidine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/cimetidine.json",
        "verbatim": true
      },
      {
        "text": "There is some evidence which suggests that more rapid healing can be achieved in this subpopulation with 1,600 mg of cimetidine tablets at bedtime.",
        "source": "US FDA label for cimetidine (Cimetidine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/cimetidine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Clinical experience in children is limited. Therefore, therapy with cimetidine cannot be recommended for children under 16, unless, in the judgement of the physician, anticipated benefits outweigh the potential risks. In very limited experience, doses of 20 mg/kg/day to 40 mg/kg/day have been used.",
        "source": "US FDA label for cimetidine (Cimetidine), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/cimetidine.json",
        "verbatim": true
      },
      {
        "text": "In very limited experience, doses of 20 mg/kg/day to 40 mg/kg/day have been used.",
        "source": "US FDA label for cimetidine (Cimetidine), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/cimetidine.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 cimetidine (Cimetidine), retrieved 2026-08-29",
        "cached_file": "labels/cimetidine.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "When liver impairment is also present, further reductions in dosage may be necessary.",
        "source": "US FDA label for cimetidine (Cimetidine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/cimetidine.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Reproduction studies have been performed in rats, rabbits and mice at doses up to 40 times the normal human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cimetidine.",
        "source": "US FDA label for cimetidine (Cimetidine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/cimetidine.json",
        "verbatim": true
      },
      {
        "text": "There are, however, no adequate and well-controlled studies in pregnant women.",
        "source": "US FDA label for cimetidine (Cimetidine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/cimetidine.json",
        "verbatim": true
      },
      {
        "text": "Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.",
        "source": "US FDA label for cimetidine (Cimetidine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/cimetidine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Cimetidine is secreted in human milk and, as a general rule, nursing should not be undertaken while a patient is on a drug.",
        "source": "US FDA label for cimetidine (Cimetidine), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/cimetidine.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'."
    }
  }
}