{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "orlistat",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Doses above 120 mg three times a day have not been shown to provide additional benefit.",
        "source": "US FDA label for orlistat (ORLISTAT), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/orlistat.json",
        "verbatim": true
      },
      {
        "text": "One 120-mg capsule three times a day with each main meal containing fat (during or up to 1 hour after the meal). ( 2 ) Advise patients to take a nutritionally balanced, reduced-calorie diet that contains approximately 30% of calories from fat. ( 2 ) Distribute the daily intake of fat, carbohydrate, and protein over three main meals. ( 2 ) Advise patients to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition.",
        "source": "US FDA label for orlistat (ORLISTAT), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/orlistat.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "No child dose in this label. That usually means untested in children, not unsuitable - use a paediatric source.",
        "source": "Read and found silent: the US FDA label for orlistat (ORLISTAT), retrieved 2026-08-29",
        "cached_file": "labels/orlistat.json",
        "verbatim": false
      }
    ],
    "renal": [
      {
        "text": "Monitor renal function in patients at risk for renal insufficiency.",
        "source": "US FDA label for orlistat (ORLISTAT), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/orlistat.json",
        "verbatim": true
      },
      {
        "text": "Monitor renal function when prescribing ORLISTAT to patients at increased risk for oxalate nephropathy, including patients with renal impairment and in those with a history of hyperoxaluria or calcium oxalate nephrolithiasis.",
        "source": "US FDA label for orlistat (ORLISTAT), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/orlistat.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 orlistat (ORLISTAT), retrieved 2026-08-29",
        "cached_file": "labels/orlistat.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Category X ORLISTAT is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm.",
        "source": "US FDA label for orlistat (ORLISTAT), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/orlistat.json",
        "verbatim": true
      },
      {
        "text": "A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy.",
        "source": "US FDA label for orlistat (ORLISTAT), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/orlistat.json",
        "verbatim": true
      },
      {
        "text": "No embryotoxicity or teratogenicity was seen in animals that received orlistat at doses much higher than the recommended human dose.",
        "source": "US FDA label for orlistat (ORLISTAT), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/orlistat.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "It is not known if ORLISTAT is present in human milk.",
        "source": "US FDA label for orlistat (ORLISTAT), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/orlistat.json",
        "verbatim": true
      },
      {
        "text": "Caution should be exercised when ORLISTAT is administered to a nursing woman.",
        "source": "US FDA label for orlistat (ORLISTAT), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/orlistat.json",
        "verbatim": true
      },
      {
        "text": "Nursing Mothers: Caution should be exercised when administered to a nursing woman.",
        "source": "US FDA label for orlistat (ORLISTAT), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/orlistat.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "pregnancy": {
      "level": "avoid",
      "line": "The label says not to use it. Read the quote below before deciding.",
      "set_by": "Set from the label's own words, not from a reading of them: 'contraindicated during pregnan'."
    },
    "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 ORLISTAT is administered to a nursing'."
    }
  }
}