Linezolid

DRUG INFORMATION

  ADULT
    - No adult dose in this label - read the full label before dosing.
      Source: Read and found silent: the US FDA label for linezolid (Linezolid),
      retrieved 2026-08-29

  CHILD
    - Consequently, preterm neonates < 7 days of age may need an alternative linezolid
      dosing regimen of 10 mg/kg every 12 hours [ see Dosage and Administration (2.1)
      and Clinical Pharmacology (12.3) ].
      Source: US FDA label for linezolid (Linezolid), section 'pediatric use', retrieved
      2026-08-29
    - These neonates should be initiated with a dosing regimen of 10 mg/kg every 12
      hours.
      Source: US FDA label for linezolid (Linezolid), section 'dosage and
      administration', retrieved 2026-08-29
    - Consideration may be given to the use of 10 mg/kg every 8 hours regimen in
      neonates with a sub-optimal clinical response.
      Source: US FDA label for linezolid (Linezolid), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for linezolid (Linezolid),
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for linezolid (Linezolid),
      retrieved 2026-08-29

  PREGNANCY
    - Teratogenic Effects – Pregnancy Category C Linezolid was not teratogenic in mice,
      rats, or rabbits at exposure levels 6.5-fold (in mice), equivalent to (in rats),
      or 0.06-fold (in rabbits) the expected human exposure level, based on AUCs.
      Source: US FDA label for linezolid (Linezolid), section 'pregnancy', retrieved
      2026-08-29
    - However, embryo and fetal toxicities were seen (see Non-teratogenic Effects).
      Source: US FDA label for linezolid (Linezolid), section 'pregnancy', retrieved
      2026-08-29
    - There are no adequate and well-controlled studies in pregnant women.
      Source: US FDA label for linezolid (Linezolid), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Linezolid and its metabolites are excreted in the milk of lactating rats.
      Source: US FDA label for linezolid (Linezolid), section 'nursing mothers',
      retrieved 2026-08-29
    - Concentrations in milk were similar to those in maternal plasma.
      Source: US FDA label for linezolid (Linezolid), section 'nursing mothers',
      retrieved 2026-08-29
    - It is not known whether linezolid is excreted in human milk.
      Source: US FDA label for linezolid (Linezolid), section 'nursing mothers',
      retrieved 2026-08-29