{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "linezolid",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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",
        "cached_file": "labels/linezolid.json",
        "verbatim": false
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/linezolid.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/linezolid.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/linezolid.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/linezolid.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/linezolid.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/linezolid.json",
        "verbatim": true
      },
      {
        "text": "However, embryo and fetal toxicities were seen (see Non-teratogenic Effects).",
        "source": "US FDA label for linezolid (Linezolid), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/linezolid.json",
        "verbatim": true
      },
      {
        "text": "There are no adequate and well-controlled studies in pregnant women.",
        "source": "US FDA label for linezolid (Linezolid), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/linezolid.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/linezolid.json",
        "verbatim": true
      },
      {
        "text": "Concentrations in milk were similar to those in maternal plasma.",
        "source": "US FDA label for linezolid (Linezolid), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/linezolid.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/linezolid.json",
        "verbatim": true
      }
    ]
  }
}