Dapagliflozin

DRUG INFORMATION

  ADULT
    - (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
    - 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
    - (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

  CHILD
    - 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
    - • 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

  RENAL IMPAIRMENT
    - (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
    - 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
    - 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

  HEPATIC IMPAIRMENT
    - 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
    - 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

  PREGNANCY
    - 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
    - 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
    - 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

  BREASTFEEDING
    - (8.1) • Lactation: Not recommended when breastfeeding.
      Source: US FDA label for dapagliflozin (DAPAGLIFLOZIN), section 'use in specific
      populations', retrieved 2026-08-29
    - 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
    - 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