{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "rosuvastatin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "( 2.1 ) • Dose range: 5 to 40 mg once daily.",
        "source": "US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/rosuvastatin.json",
        "verbatim": true
      },
      {
        "text": "Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg.",
        "source": "US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/rosuvastatin.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) • Adult HoFH : Starting dose 20 mg/day.",
        "source": "US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/rosuvastatin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
        "source": "US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/rosuvastatin.json",
        "verbatim": true
      },
      {
        "text": "DOSAGE & ADMINISTRATION • Rosuvastatin tablets can be taken with or without food, at any time of day. ( 2.1 ) • Dose range: 5 to 40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg. ( 2.1 ) • Adult HoFH : Starting dose 20 mg/day. ( 2. 1) 2.1 General Dosing Information The dose range for rosuvastatin tablets in adults is 5 to 40 mg orally once daily. The usual starting dose is 10 to 20 mg once daily.",
        "source": "US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/rosuvastatin.json",
        "verbatim": true
      },
      {
        "text": "However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 2.3 Dosing in Asian Patients In Asian patients, consider initiation of rosuvastatin tablets therapy with 5 mg once daily due to increased rosuvastatin plasma concentrations.The increased systemic exposure should be taken into consideration when treating Asian patients not adequately controlled at doses up to 20 mg/day.",
        "source": "US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/rosuvastatin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "• Females of reproductive potential: Advise females of reproductive potential to use effective contraception during treatment with rosuvastatin tablets (8.3) • Severe renal impairment (not on hemodialysis) : Starting dose is 5 mg, not to exceed 10 mg.",
        "source": "US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/rosuvastatin.json",
        "verbatim": true
      },
      {
        "text": "Elderly patients are at higher risk of myopathy and rosuvastatin tablets should be prescribed with caution in the elderly [ see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ]. 8.6 Renal Impairment Rosuvastatin exposure is not influenced by mild to moderate renal impairment (CLcr ≥30 mL/min/1.73 m 2 ).",
        "source": "US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/rosuvastatin.json",
        "verbatim": true
      },
      {
        "text": "Exposure to rosuvastatin is increased to a clinically significant extent in patients with severe renal impairment (CL cr <30 mL/min/1.73 m 2 ) who are not receiving hemodialysis and dose adjustment is required [ see Dosage and Administration (2.5) , Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].",
        "source": "US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/rosuvastatin.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Exposure to rosuvastatin is increased to a clinically significant extent in patients with severe renal impairment (CL cr <30 mL/min/1.73 m 2 ) who are not receiving hemodialysis and dose adjustment is required [ see Dosage and Administration (2.5) , Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].",
        "source": "US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/rosuvastatin.json",
        "verbatim": true
      },
      {
        "text": "Chronic alcohol liver disease is known to increase rosuvastatin exposure; rosuvastatin tablets should be used with caution in these patients [ see Contraindications (4) , Warning and Precautions ( 5.3 ), and Clinical Pharmacology (12.3) ]. 8.8 Asian Patients Pharmacokinetic studies have demonstrated an approximate 2–fold increase in median exposure to rosuvastatin in Asian subjects when compared with Caucasian controls.",
        "source": "US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/rosuvastatin.json",
        "verbatim": true
      },
      {
        "text": "There were no cases of liver failure or irreversible liver disease in these trials.",
        "source": "US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/rosuvastatin.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Rosuvastatin tablets is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy with rosuvastatin tablets during pregnancy.",
        "source": "US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/rosuvastatin.json",
        "verbatim": true
      },
      {
        "text": "Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, rosuvastatin tablets may cause fetal harm when administered to pregnant women. rosuvastatin tablets should be discontinued as soon as pregnancy is recognized [see Contraindications (4) ] .",
        "source": "US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/rosuvastatin.json",
        "verbatim": true
      },
      {
        "text": "Limited published data on the use of rosuvastatin are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage.",
        "source": "US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/rosuvastatin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Contraception Rosuvastatin tablets may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].",
        "source": "US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/rosuvastatin.json",
        "verbatim": true
      },
      {
        "text": "Advise females of reproductive potential to use effective contraception during treatment with rosuvastatin tablets.",
        "source": "US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/rosuvastatin.json",
        "verbatim": true
      },
      {
        "text": "In pregnant rats given 2, 10 and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the MRHD of 40 mg/day based body surface area).",
        "source": "US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/rosuvastatin.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'."
    }
  }
}