{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "atorvastatin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Dose range: 10 to 80 mg once daily ( 2.1 ).",
        "source": "US FDA label for atorvastatin (Atorvastatin calcium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/atorvastatin.json",
        "verbatim": true
      },
      {
        "text": "Recommended start dose: 10 or 20 mg once daily ( 2.1 ).",
        "source": "US FDA label for atorvastatin (Atorvastatin calcium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/atorvastatin.json",
        "verbatim": true
      },
      {
        "text": "Patients requiring large LDL-C reduction (>45%) may start at 40 mg once daily ( 2.1 ).",
        "source": "US FDA label for atorvastatin (Atorvastatin calcium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/atorvastatin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Dose range: 10 to 80 mg once daily ( 2.1 ). Recommended start dose: 10 or 20 mg once daily ( 2.1 ). Patients requiring large LDL-C reduction (>45%) may start at 40 mg once daily ( 2.1 ). Pediatric patients with HeFH: starting dose: 10 mg once daily; dose range: 10 to 20 mg/day for patients 10 years to 17 years of age ( 2.2 ). 2.1 Hyperlipidemia and Mixed Dyslipidemia The recommended starting dose of atorvastatin calcium tablets are 10 or 20 mg once daily.",
        "source": "US FDA label for atorvastatin (Atorvastatin calcium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/atorvastatin.json",
        "verbatim": true
      },
      {
        "text": "Homozygous Familial Hypercholesterolemia (HoFH) Clinical efficacy of atorvastatin calcium with dosages up to 80 mg/day for 1 year was evaluated in an uncontrolled study of patients with HoFH including 8 pediatric patients [ see Clinical Studies (14.5) ].",
        "source": "US FDA label for atorvastatin (Atorvastatin calcium), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/atorvastatin.json",
        "verbatim": true
      },
      {
        "text": "Pediatric patients with HeFH: starting dose: 10 mg once daily; dose range: 10 to 20 mg/day for patients 10 years to 17 years of age ( 2.2 ). 2.1 Hyperlipidemia and Mixed Dyslipidemia The recommended starting dose of atorvastatin calcium tablets are 10 or 20 mg once daily.",
        "source": "US FDA label for atorvastatin (Atorvastatin calcium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/atorvastatin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Predisposing factors include advanced age (> 65), uncontrolled hypothyroidism, and renal impairment.",
        "source": "US FDA label for atorvastatin (Atorvastatin calcium), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/atorvastatin.json",
        "verbatim": true
      },
      {
        "text": "Risk Factors for Myopathy Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher atorvastatin dosage [see Drug Interactions (7.1) ].",
        "source": "US FDA label for atorvastatin (Atorvastatin calcium), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/atorvastatin.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Hepatic impairment: Plasma concentrations markedly increased in patients with chronic alcoholic liver disease ( 8.6 , 12.3 ).",
        "source": "US FDA label for atorvastatin (Atorvastatin calcium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/atorvastatin.json",
        "verbatim": true
      },
      {
        "text": "Since advanced age (≥65 years) is a predisposing factor for myopathy, atorvastatin calcium should be prescribed with caution in the elderly. 8.6 Hepatic Impairment Atorvastatin calcium is contraindicated in patients with active liver disease which may include unexplained persistent elevations in hepatic transaminase levels [ see Contraindications (4) and Clinical Pharmacology (12.3) ].",
        "source": "US FDA label for atorvastatin (Atorvastatin calcium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/atorvastatin.json",
        "verbatim": true
      },
      {
        "text": "Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.",
        "source": "US FDA label for atorvastatin (Atorvastatin calcium), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/atorvastatin.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Atorvastatin calcium is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit of lipid lowering drugs during pregnancy.",
        "source": "US FDA label for atorvastatin (Atorvastatin calcium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/atorvastatin.json",
        "verbatim": true
      },
      {
        "text": "Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, atorvastatin may cause fetal harm when administered to a pregnant woman.",
        "source": "US FDA label for atorvastatin (Atorvastatin calcium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/atorvastatin.json",
        "verbatim": true
      },
      {
        "text": "Atorvastatin calcium should be discontinued as soon as pregnancy is recognized [ see Contraindications (4) ] .",
        "source": "US FDA label for atorvastatin (Atorvastatin calcium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/atorvastatin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "In rats administered atorvastatin during gestation and lactation, decreased postnatal growth and development was observed at doses ≥ 6 times the MRHD (see Data).",
        "source": "US FDA label for atorvastatin (Atorvastatin calcium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/atorvastatin.json",
        "verbatim": true
      },
      {
        "text": "In a study in pregnant rats administered 20, 100, or 225 mg/kg/day from gestation day 7 through to lactation day 20 (weaning), there was decreased survival at birth, postnatal day 4, weaning, and post-weaning in pups of mothers dosed with 225 mg/kg/day, a dose at which maternal toxicity was observed.",
        "source": "US FDA label for atorvastatin (Atorvastatin calcium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/atorvastatin.json",
        "verbatim": true
      },
      {
        "text": "These doses correspond to 6 times (100 mg/kg) and 22 times (225 mg/kg) the human exposure at the MRHD, based on AUC. 8.2 Lactation Risk Summary Atorvastatin calcium use is contraindicated during breastfeeding [ see Contraindications (4) ].",
        "source": "US FDA label for atorvastatin (Atorvastatin calcium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/atorvastatin.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "pregnancy": {
      "level": "avoid",
      "line": "The label says not to use it. Read the quote below before deciding.",
      "set_by": "Set from the label's own words, not from a reading of them: 'contraindicated for use in pregnan'."
    },
    "lactation": {
      "level": "avoid",
      "line": "The label says not to use it. Read the quote below before deciding.",
      "set_by": "Set from the label's own words, not from a reading of them: 'contraindicated during breast'."
    }
  }
}