Drug profile
Empagliflozin
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- ( 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
- ( 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
- 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
CHILD
- • 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
- 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
RENAL IMPAIRMENT
- ( 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
- 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
- ( 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
HEPATIC IMPAIRMENT
- 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
PREGNANCY
- 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
- 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
- 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
BREASTFEEDING
- ( 8.1 ) • Lactation: Not recommended when breastfeeding.
Source: US FDA label for empagliflozin (Jardiance), section 'use in specific
populations', retrieved 2026-08-29
- 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
- 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