{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "resmetirom",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "For patients weighing: o <100 kg, the recommended dosage is 80 mg orally once daily. o ≥100 kg, the recommended dosage is 100 mg orally once daily.",
        "source": "US FDA label for resmetirom (REZDIFFRA), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/resmetirom.json",
        "verbatim": true
      },
      {
        "text": "For patients weighing: <100 kg, the recommended dosage is 80 mg orally once daily. ≥100 kg, the recommended dosage is 100 mg orally once daily.",
        "source": "US FDA label for resmetirom (REZDIFFRA), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/resmetirom.json",
        "verbatim": true
      },
      {
        "text": "If REZDIFFRA is used concomitantly with a moderate CYP2C8 inhibitor (e.g., clopidogrel) [see Drug Interactions (7.1) ] , reduce the dosage of REZDIFFRA: <100 kg, reduce the dosage of REZDIFFRA to 60 mg once daily. ≥100 kg, reduce the dosage of REZDIFFRA to 80 mg once daily.",
        "source": "US FDA label for resmetirom (REZDIFFRA), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/resmetirom.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "No child dose in this label. That usually means untested in children, not unsuitable - use a paediatric source.",
        "source": "Read and found silent: the US FDA label for resmetirom (REZDIFFRA), retrieved 2026-08-29",
        "cached_file": "labels/resmetirom.json",
        "verbatim": false
      }
    ],
    "renal": [
      {
        "text": "No overall differences in effectiveness but numerically higher incidence of adverse reactions have been observed in patients 65 years of age and older compared to younger adult patients. 8.6 Renal Impairment The recommended dosage of REZDIFFRA in patients with mild, moderate, or severe renal impairment is the same as in patients with normal kidney function [see Clinical Pharmacology (12.3) ] .",
        "source": "US FDA label for resmetirom (REZDIFFRA), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/resmetirom.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Hepatic Impairment: Avoid use of REZDIFFRA in patients with moderate to severe hepatic impairment (Child-Pugh Class B or C).",
        "source": "US FDA label for resmetirom (REZDIFFRA), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/resmetirom.json",
        "verbatim": true
      },
      {
        "text": "No overall differences in effectiveness but numerically higher incidence of adverse reactions have been observed in patients 65 years of age and older compared to younger adult patients. 8.6 Renal Impairment The recommended dosage of REZDIFFRA in patients with mild, moderate, or severe renal impairment is the same as in patients with normal kidney function [see Clinical Pharmacology (12.3) ] .",
        "source": "US FDA label for resmetirom (REZDIFFRA), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/resmetirom.json",
        "verbatim": true
      },
      {
        "text": "Moderate or severe hepatic impairment (Child-Pugh Class B or C) increases resmetirom C max and AUC [see Clinical Pharmacology (12.3 ) ], which may increase the risk of adverse reactions.",
        "source": "US FDA label for resmetirom (REZDIFFRA), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/resmetirom.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Nothing on pregnancy in this label. Treat as unknown, not as safe.",
        "source": "Read and found silent: the US FDA label for resmetirom (REZDIFFRA), retrieved 2026-08-29",
        "cached_file": "labels/resmetirom.json",
        "verbatim": false
      }
    ],
    "lactation": [
      {
        "text": "A pre- and postnatal development study in rats with maternal dosing of resmetirom during organogenesis through lactation showed a decrease in birthweight and increased incidence of stillbirths and mortality (postnatal days 1-4) at 37 times the maximum recommended dose (see Data ) .",
        "source": "US FDA label for resmetirom (REZDIFFRA), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/resmetirom.json",
        "verbatim": true
      },
      {
        "text": "A pre- and postnatal development study was performed using oral administration of 3, 30, or 100 mg/kg/day in female rats during organogenesis through lactation.",
        "source": "US FDA label for resmetirom (REZDIFFRA), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/resmetirom.json",
        "verbatim": true
      },
      {
        "text": "No effects were observed in pregnant rats treated orally with up to 100 mg/kg/day MGL-3623 (4.7 times the maximum recommended dose based on AUC for MGL-3623) during the period of organogenesis. 8.2 Lactation Risk Summary There is no information regarding the presence of REZDIFFRA in human or animal milk, the effects on the breast-fed infant, or the effects on milk production.",
        "source": "US FDA label for resmetirom (REZDIFFRA), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/resmetirom.json",
        "verbatim": true
      }
    ]
  }
}