{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "empagliflozin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "( 2.1 ) • Recommended dosage is 10 mg orally once daily in the morning, taken with or without food.",
        "source": "US FDA label for empagliflozin (Jardiance), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/empagliflozin.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 ) • For additional glycemic control, dosage may be increased to 25 mg orally once daily in patients tolerating JARDIANCE.",
        "source": "US FDA label for empagliflozin (Jardiance), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/empagliflozin.json",
        "verbatim": true
      },
      {
        "text": "Table 1 Recommended Dosage of JARDIANCE Population Indication Recommended Dosage Adults Reduce the risk of cardiovascular death and hospitalization in patients with heart failure • 10 mg orally once daily in the morning, taken with or without food.",
        "source": "This line points to a numbered table that this card does not show - read that table in the label before you dose. US FDA label for empagliflozin (Jardiance), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/empagliflozin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "• Assess renal function before initiating and as clinically indicated. Assess volume status and correct volume depletion before initiating. ( 2.1 ) • Recommended dosage is 10 mg orally once daily in the morning, taken with or without food. ( 2.2 ) • For additional glycemic control, dosage may be increased to 25 mg orally once daily in patients tolerating JARDIANCE.",
        "source": "US FDA label for empagliflozin (Jardiance), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/empagliflozin.json",
        "verbatim": true
      },
      {
        "text": "Pediatric patients aged 10 years and older Glycemic control in type 2 diabetes mellitus • 10 mg orally once daily in the morning, taken with or without food. • For additional glycemic control, may increase to 25 mg orally once daily in patients tolerating 10 mg once daily. 2.3 Temporary Interruption for Surgery Withhold JARDIANCE for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting.",
        "source": "US FDA label for empagliflozin (Jardiance), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/empagliflozin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "( 2.3 ) 2.1 Testing Prior to Initiation of JARDIANCE • Assess renal function before initiating JARDIANCE and as clinically indicated [see Warnings and Precautions (5.2) ] . o Use for glycemic control is not recommended in patients with an eGFR less than 30 mL/min/1.73 m 2 [see Use in Specific Populations (8.6) ]. • Assess volume status.",
        "source": "US FDA label for empagliflozin (Jardiance), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/empagliflozin.json",
        "verbatim": true
      },
      {
        "text": "Reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression.",
        "source": "US FDA label for empagliflozin (Jardiance), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/empagliflozin.json",
        "verbatim": true
      },
      {
        "text": "( 8.5 ) • Renal Impairment: Higher incidence of adverse reactions related to reduced renal function.",
        "source": "US FDA label for empagliflozin (Jardiance), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/empagliflozin.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Once enrolled, adult patients in the EMPA-REG OUTCOME, EMPEROR-Reduced, EMPEROR-Preserved, and EMPA-KIDNEY trials were not required to discontinue therapy for worsening of eGFR to less than 20 mL/min/1.73 m 2 or initiation of dialysis [see Clinical Studies (14.3 , 14.4 , 14.5) ]. 8.7 Hepatic Impairment JARDIANCE may be used in patients with hepatic impairment [see Clinical Pharmacology (12.3) ] .",
        "source": "US FDA label for empagliflozin (Jardiance), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/empagliflozin.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Based on animal data showing adverse renal effects, JARDIANCE is not recommended during the second and third trimesters of pregnancy.",
        "source": "US FDA label for empagliflozin (Jardiance), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/empagliflozin.json",
        "verbatim": true
      },
      {
        "text": "The limited available data with JARDIANCE in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage.",
        "source": "US FDA label for empagliflozin (Jardiance), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/empagliflozin.json",
        "verbatim": true
      },
      {
        "text": "There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations ] .",
        "source": "US FDA label for empagliflozin (Jardiance), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/empagliflozin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "( 8.1 ) • Lactation: Not recommended when breastfeeding.",
        "source": "US FDA label for empagliflozin (Jardiance), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/empagliflozin.json",
        "verbatim": true
      },
      {
        "text": "In pre- and postnatal development studies in pregnant rats, empagliflozin was administered from gestation day 6 through to lactation day 20 (weaning) at up to 100 mg/kg/day (approximately 16-times the 25 mg maximum clinical dose) without maternal toxicity.",
        "source": "US FDA label for empagliflozin (Jardiance), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/empagliflozin.json",
        "verbatim": true
      },
      {
        "text": "Reduced body weight was observed in the offspring at greater than or equal to 30 mg/kg/day (approximately 4-times the 25 mg maximum clinical dose). 8.2 Lactation Risk Summary There is limited information regarding the presence of JARDIANCE in human milk, the effects of JARDIANCE on the breastfed infant or the effects on milk production.",
        "source": "US FDA label for empagliflozin (Jardiance), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/empagliflozin.json",
        "verbatim": true
      }
    ]
  }
}