{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "dapagliflozin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "(2.1) • To improve glycemic control, the recommended starting dosage is 5 mg orally once daily.",
        "source": "US FDA label for dapagliflozin (DAPAGLIFLOZIN), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/dapagliflozin.json",
        "verbatim": true
      },
      {
        "text": "Dosage can be increased to 10 mg orally once daily for additional glycemic control.",
        "source": "US FDA label for dapagliflozin (DAPAGLIFLOZIN), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/dapagliflozin.json",
        "verbatim": true
      },
      {
        "text": "(2.2) • For all other indications, the recommended dosage is 10 mg orally once daily.",
        "source": "US FDA label for dapagliflozin (DAPAGLIFLOZIN), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/dapagliflozin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of DAPAGLIFLOZIN TABLETS as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established in pediatric patients aged 10 years and older.",
        "source": "US FDA label for dapagliflozin (DAPAGLIFLOZIN), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/dapagliflozin.json",
        "verbatim": true
      },
      {
        "text": "• Assess renal function prior to initiation and then as clinically indicated. Assess volume status and correct volume depletion before initiating. (2.1) • To improve glycemic control, the recommended starting dosage is 5 mg orally once daily. Dosage can be increased to 10 mg orally once daily for additional glycemic control. (2.2) • For all other indications, the recommended dosage is 10 mg orally once daily.",
        "source": "US FDA label for dapagliflozin (DAPAGLIFLOZIN), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/dapagliflozin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "(2.3) • See full prescribing information for dosage recommendations in patients with renal impairment.",
        "source": "US FDA label for dapagliflozin (DAPAGLIFLOZIN), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/dapagliflozin.json",
        "verbatim": true
      },
      {
        "text": "For Adult and Pediatric Patients with Type 2 Diabetes Mellitus and Renal Impairment: • The recommended dosage for DAPAGLIFLOZIN TABLETS in patients with an eGFR greater than or equal to 45 mL/min/1.73 m 2 is the same as the recommended dosage in patients with normal renal function. • DAPAGLIFLOZIN TABLETS are not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 .",
        "source": "US FDA label for dapagliflozin (DAPAGLIFLOZIN), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/dapagliflozin.json",
        "verbatim": true
      },
      {
        "text": "For Adults with Renal Impairment Receiving DAPAGLIFLOZIN TABLETS for Indications Other than Glycemic Control: • The recommended dosage of DAPAGLIFLOZIN TABLETS in patients with an eGFR greater than or equal to 25 mL/min/1.73 m 2 is the same as the recommended dosage in patients with normal renal function. • Initiation with DAPAGLIFLOZIN TABLETS is not recommended in patients with an eGFR less than 25 mL/min/1.73 m 2 .",
        "source": "US FDA label for dapagliflozin (DAPAGLIFLOZIN), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/dapagliflozin.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Once enrolled in the DAPA-HF trial, adult patients were not required to discontinue therapy if eGFR fell below 30 mL/min/1.73 m 2 or if dialysis was initiated [see Dosage and Administration (2.3) and Clinical Studies (14.4 , 14.5 )]. 8.7 Hepatic Impairment No dose adjustment is recommended for patients with mild, moderate, or severe hepatic impairment.",
        "source": "US FDA label for dapagliflozin (DAPAGLIFLOZIN), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/dapagliflozin.json",
        "verbatim": true
      },
      {
        "text": "However, the benefit-risk for the use of dapagliflozin in patients with severe hepatic impairment should be individually assessed since the safety and efficacy of dapagliflozin have not been specifically studied in this population [see Clinical Pharmacology (12.3) ] .",
        "source": "US FDA label for dapagliflozin (DAPAGLIFLOZIN), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/dapagliflozin.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Based on animal data showing adverse renal effects, DAPAGLIFLOZIN TABLETS are not recommended during the second and third trimesters of pregnancy.",
        "source": "US FDA label for dapagliflozin (DAPAGLIFLOZIN), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/dapagliflozin.json",
        "verbatim": true
      },
      {
        "text": "Limited data with dapagliflozin in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage.",
        "source": "US FDA label for dapagliflozin (DAPAGLIFLOZIN), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/dapagliflozin.json",
        "verbatim": true
      },
      {
        "text": "There are risks to the mother and fetus associated with poorly controlled diabetes and untreated heart failure in pregnancy (see Clinical Considerations ) .",
        "source": "US FDA label for dapagliflozin (DAPAGLIFLOZIN), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/dapagliflozin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "(8.1) • Lactation: Not recommended when breastfeeding.",
        "source": "US FDA label for dapagliflozin (DAPAGLIFLOZIN), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/dapagliflozin.json",
        "verbatim": true
      },
      {
        "text": "In a prenatal and postnatal development study, dapagliflozin was administered to maternal rats from gestation day 6 through lactation day 21 at doses of 1, 15, or 75 mg/kg/day, and pups were indirectly exposed in utero and throughout lactation.",
        "source": "US FDA label for dapagliflozin (DAPAGLIFLOZIN), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/dapagliflozin.json",
        "verbatim": true
      },
      {
        "text": "No developmental toxicities were observed in rabbits at doses up to 180 mg/kg/day (1191-times the 10 mg clinical dose, based on AUC). 8.2 Lactation Risk Summary There is no information regarding the presence of dapagliflozin in human milk, the effects on the breastfed infant, or the effects on milk production.",
        "source": "US FDA label for dapagliflozin (DAPAGLIFLOZIN), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/dapagliflozin.json",
        "verbatim": true
      }
    ]
  }
}