{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "ticagrelor",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "ACS or History of MI Initiate treatment with 180 mg oral loading dose of ticagrelor tablets.",
        "source": "US FDA label for ticagrelor (Ticagrelor), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/ticagrelor.json",
        "verbatim": true
      },
      {
        "text": "Then administer 90 mg twice daily during the first year.",
        "source": "US FDA label for ticagrelor (Ticagrelor), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/ticagrelor.json",
        "verbatim": true
      },
      {
        "text": "After one year, administer 60 mg twice daily.",
        "source": "US FDA label for ticagrelor (Ticagrelor), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/ticagrelor.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of ticagrelor have not been established in pediatric patients. Effectiveness was not demonstrated in an adequate and well-controlled study conducted in 101 ticagrelor-treated pediatric patients, aged 2 to <18 for reducing the rate of vaso-occlusive crises in sickle cell disease.",
        "source": "US FDA label for ticagrelor (Ticagrelor), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/ticagrelor.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No dosage adjustment is needed in patients with mild hepatic impairment [see Warnings and Precautions ( 5.5 ) and Clinical Pharmacology ( 12.3 )] . 8.7 Renal Impairment No dosage adjustment is needed in patients with renal impairment [see Clinical Pharmacology ( 12.3 )] .",
        "source": "US FDA label for ticagrelor (Ticagrelor), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/ticagrelor.json",
        "verbatim": true
      },
      {
        "text": "Patients with End-Stage Renal Disease on dialysis Clinical efficacy and safety studies with ticagrelor did not enroll patients with end-stage renal disease (ESRD) on dialysis.",
        "source": "US FDA label for ticagrelor (Ticagrelor), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/ticagrelor.json",
        "verbatim": true
      },
      {
        "text": "It is not known whether these concentrations will lead to similar efficacy and safety in patients with ESRD on dialysis as were seen in PLATO, PEGASUS, THEMIS and THALES.",
        "source": "US FDA label for ticagrelor (Ticagrelor), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/ticagrelor.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "No overall differences in safety or effectiveness were observed between elderly and younger patients. 8.6 Hepatic Impairment Ticagrelor is metabolized by the liver and impaired hepatic function can increase risks for bleeding and other adverse events.",
        "source": "US FDA label for ticagrelor (Ticagrelor), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/ticagrelor.json",
        "verbatim": true
      },
      {
        "text": "Avoid use of ticagrelor in patients with severe hepatic impairment.",
        "source": "US FDA label for ticagrelor (Ticagrelor), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/ticagrelor.json",
        "verbatim": true
      },
      {
        "text": "There is limited experience with ticagrelor in patients with moderate hepatic impairment; consider the risks and benefits of treatment, noting the probable increase in exposure to ticagrelor.",
        "source": "US FDA label for ticagrelor (Ticagrelor), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/ticagrelor.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Available data from case reports with ticagrelor use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.",
        "source": "US FDA label for ticagrelor (Ticagrelor), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ticagrelor.json",
        "verbatim": true
      },
      {
        "text": "Ticagrelor given to pregnant rats and pregnant rabbits during organogenesis caused structural abnormalities in the offspring at maternal doses about 5 to 7 times the maximum recommended human dose (MRHD) based on body surface area.",
        "source": "US FDA label for ticagrelor (Ticagrelor), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ticagrelor.json",
        "verbatim": true
      },
      {
        "text": "When ticagrelor was given to rats during late gestation and lactation, pup death and effects on pup growth were seen at approximately 10 times the MRHD ( see Data).",
        "source": "US FDA label for ticagrelor (Ticagrelor), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ticagrelor.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary There are no data on the presence of ticagrelor or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.",
        "source": "US FDA label for ticagrelor (Ticagrelor), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/ticagrelor.json",
        "verbatim": true
      },
      {
        "text": "Ticagrelor and its metabolites were present in rat milk at higher concentrations than in maternal plasma.",
        "source": "US FDA label for ticagrelor (Ticagrelor), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/ticagrelor.json",
        "verbatim": true
      },
      {
        "text": "When a drug is present in animal milk, it is likely that the drug will be present in human milk.",
        "source": "US FDA label for ticagrelor (Ticagrelor), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/ticagrelor.json",
        "verbatim": true
      }
    ]
  }
}