Ezetimibe

DRUG INFORMATION

  ADULT
    - The recommended dose of ezetimibe tablets is 10 mg orally once daily, administered
      with or without food.
      Source: US FDA label for ezetimibe (Ezetimibe), section 'dosage and
      administration', retrieved 2026-08-29
    - The recommended dose of ezetimibe tablets is 10 mg orally once daily, administered
      with or without food. If as dose is missed, take the missed dose as soon as
      possible. Do not double the next dose. Assess LDL-C when clinically appropriate,
      as early as 4 weeks after initiating ezetimibe tablets.
      Source: US FDA label for ezetimibe (Ezetimibe), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of ezetimibe in combination with a statin as an
      adjunct to diet to reduce LDL-C have been established in pediatric patients 10
      years of age and older with HeFH. Use of ezetimibe for this indication is based on
      a double-blind, placebo-controlled clinical trial in 248 pediatric patients (142
      males and 106 postmenarchal females) 10 years of age and older with HeFH [see
      Clinical Studies ( 14 )] .
      Source: US FDA label for ezetimibe (Ezetimibe), section 'pediatric use', retrieved
      2026-08-29

  RENAL IMPAIRMENT
    - No clinically meaningful differences in the pharmacokinetics of ezetimibe were
      observed in geriatric patients compared to younger adult patients [see Clinical
      Pharmacology ( 12.3 )] . 8.6 Renal Impairment No dosage adjustment of ezetimibe is
      necessary in patients with renal impairment.
      Source: US FDA label for ezetimibe (Ezetimibe), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No clinically meaningful differences in the pharmacokinetics of ezetimibe were
      observed in geriatric patients compared to younger adult patients [see Clinical
      Pharmacology ( 12.3 )] . 8.6 Renal Impairment No dosage adjustment of ezetimibe is
      necessary in patients with renal impairment.
      Source: US FDA label for ezetimibe (Ezetimibe), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - Risk Summary There are insufficient data on ezetimibe use in pregnant women to
      evaluate for a drug-associated risk of major birth defects, miscarriage or adverse
      maternal or fetal outcomes.
      Source: US FDA label for ezetimibe (Ezetimibe), section 'pregnancy', retrieved
      2026-08-29
    - In animal reproduction studies, no adverse developmental effects were observed in
      pregnant rats and rabbits orally administered ezetimibe during the period of
      organogenesis at doses that resulted in up to 10 and 150 times, respectively, the
      human exposure at the MRHD, based on AUC (see Data) .
      Source: US FDA label for ezetimibe (Ezetimibe), section 'pregnancy', retrieved
      2026-08-29
    - Ezetimibe should be used during pregnancy only if the potential benefit justifies
      the potential risk to the fetus.
      Source: US FDA label for ezetimibe (Ezetimibe), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - The effect of ezetimibe on prenatal and postnatal development and maternal
      function was evaluated in pregnant rats at doses of 100, 300 or 1,000 mg/kg/day
      from gestation day 6 through lactation day 21.
      Source: US FDA label for ezetimibe (Ezetimibe), section 'use in specific
      populations', retrieved 2026-08-29
    - Reproductive findings occurred at lower doses in combination therapy compared to
      monotherapy. 8.2 Lactation Risk Summary There is no information about the presence
      of ezetimibe in human milk.
      Source: US FDA label for ezetimibe (Ezetimibe), section 'use in specific
      populations', retrieved 2026-08-29
    - When a drug is present in animal milk, it is likely that the drug will be present
      in human milk.
      Source: US FDA label for ezetimibe (Ezetimibe), section 'use in specific
      populations', retrieved 2026-08-29