{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "fenofibrate",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Severe hypertriglyceridemia : 48 to 145 mg orally once daily; the dosage should be adjusted according to patient response ( 2.2 ).",
        "source": "US FDA label for fenofibrate (Fenofibrate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fenofibrate.json",
        "verbatim": true
      },
      {
        "text": "Primary hyperlipidemia : 145 mg orally once daily ( 2.2 ).",
        "source": "US FDA label for fenofibrate (Fenofibrate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fenofibrate.json",
        "verbatim": true
      },
      {
        "text": "In patients with diabetes and fasting chylomicronemia, improve glycemic control prior to considering starting fenofibrate tablets. 2.2 Recommended Dosage and Administration Severe hypertriglyceridemia: The recommended dosage of fenofibrate tablets is 48 mg or 145 mg orally once daily.",
        "source": "US FDA label for fenofibrate (Fenofibrate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fenofibrate.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of fenofibrate have not been established in pediatric patients with severe hypertriglyceridemia or primary hyperlipidemia.",
        "source": "US FDA label for fenofibrate (Fenofibrate), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/fenofibrate.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Renal impairment : Initial dosage of 48 mg orally once daily ( 2.3 ).",
        "source": "US FDA label for fenofibrate (Fenofibrate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fenofibrate.json",
        "verbatim": true
      },
      {
        "text": "Advise patients to take fenofibrate tablets at least 1 hour before or 4 hours to 6 hours after a bile acid binding resin to avoid impeding its absorption. 2.3 Recommended Dosage in Patients with Renal Impairment Assess renal function prior to initiation of fenofibrate tablets and periodically thereafter [see Warnings and Precautions (5.4) ].",
        "source": "US FDA label for fenofibrate (Fenofibrate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fenofibrate.json",
        "verbatim": true
      },
      {
        "text": "Treatment with fenofibrate tablets should be initiated at a dosage of 48 mg orally once daily in patients with mild to moderately impaired renal function (eGFR 30 to < 60 mL/min/1.73m 2 ), and increased only after evaluation of the effects on renal function and TG levels at this dosage.",
        "source": "US FDA label for fenofibrate (Fenofibrate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fenofibrate.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Renal impairment is a risk factor for myopathy and rhabdomyolysis [see Warnings and Precautions (5.3 , 5.4) and Clinical Pharmacology (12.3) ] . 8.7 Hepatic Impairment The use of fenofibrate has not been evaluated in patients with hepatic impairment.",
        "source": "US FDA label for fenofibrate (Fenofibrate), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/fenofibrate.json",
        "verbatim": true
      },
      {
        "text": "Fenofibrate is contraindicated in patients with active liver disease, including those with unexplained persistent liver function abnormalities [see Clinical Pharmacology (12.3) ] .",
        "source": "US FDA label for fenofibrate (Fenofibrate), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/fenofibrate.json",
        "verbatim": true
      },
      {
        "text": "Fenofibrate tablets are contraindicated in patients with active liver disease, including those with unexplained persistent liver function abnormalities.",
        "source": "US FDA label for fenofibrate (Fenofibrate), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/fenofibrate.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.",
        "source": "US FDA label for fenofibrate (Fenofibrate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/fenofibrate.json",
        "verbatim": true
      },
      {
        "text": "In animal reproduction studies, no evidence of embryo-fetal toxicity was observed with oral administration of fenofibrate in rats and rabbits during organogenesis at doses less than or comparable to the maximum recommended clinical dosage of 145 mg of fenofibrate daily, based on body surface area (mg/m 2 ).",
        "source": "US FDA label for fenofibrate (Fenofibrate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/fenofibrate.json",
        "verbatim": true
      },
      {
        "text": "Adverse reproductive outcomes occurred at higher doses in the presence of maternal toxicity (see Data).",
        "source": "US FDA label for fenofibrate (Fenofibrate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/fenofibrate.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary There is no available information on the presence of fenofibrate in human milk, effects of the drug on the breastfed infant, or the effects on milk production.",
        "source": "US FDA label for fenofibrate (Fenofibrate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/fenofibrate.json",
        "verbatim": true
      },
      {
        "text": "Fenofibrate is present in the milk of rats, and is therefore likely to be present in human milk.",
        "source": "US FDA label for fenofibrate (Fenofibrate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/fenofibrate.json",
        "verbatim": true
      },
      {
        "text": "Because of the potential for serious adverse reactions in breastfed infants, such as disruption of infant lipid metabolism, women should not breastfeed during treatment with fenofibrate and for 5 days after the final dose.",
        "source": "US FDA label for fenofibrate (Fenofibrate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/fenofibrate.json",
        "verbatim": true
      }
    ]
  }
}