{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "gemfibrozil",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY ).",
        "source": "US FDA label for gemfibrozil (Gemfibrozil), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/gemfibrozil.json",
        "verbatim": true
      },
      {
        "text": "The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY ). OVERDOSAGE There have been reported cases of overdosage with gemfibrozil. In one case, a 7-year-old child recovered after ingesting up to 9 grams of gemfibrozil.",
        "source": "US FDA label for gemfibrozil (Gemfibrozil), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/gemfibrozil.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "10. Pediatric Use Safety and efficacy in pediatric patients have not been established.",
        "source": "US FDA label for gemfibrozil (Gemfibrozil), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/gemfibrozil.json",
        "verbatim": true
      },
      {
        "text": "The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY ). OVERDOSAGE There have been reported cases of overdosage with gemfibrozil. In one case, a 7-year-old child recovered after ingesting up to 9 grams of gemfibrozil.",
        "source": "US FDA label for gemfibrozil (Gemfibrozil), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/gemfibrozil.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 gemfibrozil (Gemfibrozil), retrieved 2026-08-29",
        "cached_file": "labels/gemfibrozil.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 gemfibrozil (Gemfibrozil), retrieved 2026-08-29",
        "cached_file": "labels/gemfibrozil.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Gemfibrozil has been shown to produce adverse effects in rats and rabbits at doses between 0.5 and 3 times the human dose (based on surface area).",
        "source": "US FDA label for gemfibrozil (Gemfibrozil), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/gemfibrozil.json",
        "verbatim": true
      },
      {
        "text": "There are no adequate and well-controlled studies in pregnant women.",
        "source": "US FDA label for gemfibrozil (Gemfibrozil), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/gemfibrozil.json",
        "verbatim": true
      },
      {
        "text": "Gemfibrozil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.",
        "source": "US FDA label for gemfibrozil (Gemfibrozil), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/gemfibrozil.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Nursing Mothers It is not known whether this drug is excreted in human milk.",
        "source": "US FDA label for gemfibrozil (Gemfibrozil), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/gemfibrozil.json",
        "verbatim": true
      },
      {
        "text": "Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for gemfibrozil in animal studies, 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. 7.",
        "source": "US FDA label for gemfibrozil (Gemfibrozil), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/gemfibrozil.json",
        "verbatim": true
      },
      {
        "text": "Hematologic Changes Mild hemoglobin, hematocrit, and white blood cell decreases have been observed in occasional patients following initiation of gemfibrozil therapy.",
        "source": "US FDA label for gemfibrozil (Gemfibrozil), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/gemfibrozil.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'."
    }
  }
}