Febuxostat

DRUG INFORMATION

  ADULT
    - Recommended febuxostat dosage is 40 mg or 80 mg once daily.
      Source: US FDA label for febuxostat (Febuxostat), section 'dosage and
      administration', retrieved 2026-08-29
    - The recommended starting dose is 40 mg once daily.
      Source: US FDA label for febuxostat (Febuxostat), section 'dosage and
      administration', retrieved 2026-08-29
    - For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after 2
      weeks, the recommended dosage is 80 mg once daily.
      Source: US FDA label for febuxostat (Febuxostat), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness in pediatric patients have not been established.
      Source: US FDA label for febuxostat (Febuxostat), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - ( 2.1 ) Limit the dosage of febuxostat tablet to 40 mg once daily in patients with
      severe renal impairment.
      Source: US FDA label for febuxostat (Febuxostat), section 'dosage and
      administration', retrieved 2026-08-29
    - Febuxostat tablets can be taken without regard to food or antacid use [see
      Clinical Pharmacology ( 12.3) ]. 2.2 Dosage Recommendations in Patients with Renal
      Impairment and Hepatic Impairment No dose adjustment is necessary when
      administering febuxostat tablets in patients with mild or moderate renal
      impairment.
      Source: US FDA label for febuxostat (Febuxostat), section 'dosage and
      administration', retrieved 2026-08-29
    - The recommended dosage of febuxostat tablet is limited to 40 mg once daily in
      patients with severe renal impairment [see Use in Specific Populations ( 8.6 ) and
      Clinical Pharmacology ( 12.3 ) ].
      Source: US FDA label for febuxostat (Febuxostat), section 'dosage and
      administration', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Febuxostat tablets can be taken without regard to food or antacid use [see
      Clinical Pharmacology ( 12.3) ]. 2.2 Dosage Recommendations in Patients with Renal
      Impairment and Hepatic Impairment No dose adjustment is necessary when
      administering febuxostat tablets in patients with mild or moderate renal
      impairment.
      Source: US FDA label for febuxostat (Febuxostat), section 'dosage and
      administration', retrieved 2026-08-29
    - No dose adjustment is necessary in patients with mild to moderate hepatic
      impairment [see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology (
      12.3 ) ]. 2.3 Uric Acid Level Testing for the target serum uric acid level of less
      than 6 mg/dL may be performed as early as two weeks after initiating febuxostat
      therapy.
      Source: US FDA label for febuxostat (Febuxostat), section 'dosage and
      administration', retrieved 2026-08-29
    - No studies have been conducted in patients with severe hepatic impairment.
      Source: US FDA label for febuxostat (Febuxostat), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Limited available data with febuxostat use in pregnant women are
      insufficient to inform a drug associated risk of adverse developmental outcomes.
      Source: US FDA label for febuxostat (Febuxostat), section 'pregnancy', retrieved
      2026-08-29
    - No adverse developmental effects were observed in embryo-fetal development studies
      with oral administration of febuxostat to pregnant rats and rabbits during
      organogenesis at doses that produced maternal exposures up to 40 and 51 times,
      respectively, the exposure at the maximum recommended human dose (MRHD).
      Source: US FDA label for febuxostat (Febuxostat), section 'pregnancy', retrieved
      2026-08-29
    - No adverse developmental effects were observed in a pre- and postnatal development
      study with administration of febuxostat to pregnant rats from organogenesis
      through lactation at an exposure approximately 11 times the MRHD (see Data).
      Source: US FDA label for febuxostat (Febuxostat), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Risk Summary There are no data on the presence of febuxostat in human milk, the
      effects on the breastfed infant, or the effects on milk production.
      Source: US FDA label for febuxostat (Febuxostat), section 'nursing mothers',
      retrieved 2026-08-29
    - The developmental and health benefits of breastfeeding should be considered along
      with the mother’s clinical need for febuxostat and any potential adverse effects
      on the breastfed child from febuxostat or from the underlying maternal condition.
      Source: US FDA label for febuxostat (Febuxostat), section 'nursing mothers',
      retrieved 2026-08-29
    - Data Animal Data Orally administered febuxostat was detected in the milk of
      lactating rats at up to approximately 7 times the plasma concentration.
      Source: US FDA label for febuxostat (Febuxostat), section 'nursing mothers',
      retrieved 2026-08-29