Fenofibrate

DRUG INFORMATION

  ADULT
    - 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
    - Primary hyperlipidemia : 145 mg orally once daily ( 2.2 ).
      Source: US FDA label for fenofibrate (Fenofibrate), section 'dosage and
      administration', retrieved 2026-08-29
    - 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

  CHILD
    - 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

  RENAL IMPAIRMENT
    - 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
    - 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
    - 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

  HEPATIC IMPAIRMENT
    - 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
    - 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
    - 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

  PREGNANCY
    - 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
    - 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
    - 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

  BREASTFEEDING
    - 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
    - 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
    - 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