Jardiance (empagliflozin)
Generic name: empagliflozin · Brand names: Jardiance, Glyxambi (empagliflozin and linagliptin), Synjardy (empagliflozin and metformin), Trijardy (empagliflozin, linagliptin, and metformin): combination products, NOT covered on this record
Quick facts
Drug class
Value
sodium-glucose co-transporter 2 (SGLT2) inhibitor
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display (Highlights: "JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated:"); https://medlineplus.gov/druginfo/meds/a614043.html
Rx or otc
Value
Rx
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display (package label: "Rx only"; Product Type HUMAN PRESCRIPTION DRUG)
Controlled schedule
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display
Forms and strengths
- 10 mg pale yellow, round, biconvex and bevel-edged, film-coated tablets debossed with "S 10" on one side and the Boehringer Ingelheim company symbol on the other side.
- 25 mg pale yellow, oval, biconvex, film-coated tablets debossed with "S 25" on one side and the Boehringer Ingelheim company symbol on the other side.
Forms source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display section 3
Generic available
Source
https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:EMPAGLIFLOZIN&limit=100 (openFDA Drugs@FDA data, fetched 2026-11-03); https://dailymed.nlm.nih.gov/dailymed/services/v2/spls.json?drug_name=empagliflozin
Common use one line
SGLT2 inhibitor used to lower the risk of heart failure hospitalization, kidney disease progression and cardiovascular death in certain adults, and to improve blood sugar control in adults and children aged 10 years and older with type 2 diabetes.
What it is used for
Jardiance lowers the risk of cardiovascular death and heart failure hospitalization in adults with heart failure. It lowers the risk of kidney function decline, end-stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease at risk of progression. It lowers the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. With diet and exercise it improves blood sugar control in adults and pediatric patients aged 10 years and older with type 2 diabetes. It is not recommended for blood sugar control in type 1 diabetes or when eGFR is less than 30 mL/min/1.73 m2.
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Section
1 INDICATIONS AND USAGE
Source text (exact source wording)
JARDIANCE is indicated:
to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.
to 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.
to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.
as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.
Limitations of Use
JARDIANCE is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.1)].
JARDIANCE is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m2. JARDIANCE is likely to be ineffective in this setting based upon its mechanism of action.
JARDIANCE is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of intravenous immunosuppressive therapy or greater than 45 mg of prednisone or equivalent for kidney disease [see Clinical Studies (14.5)]. JARDIANCE is not expected to be effective in these populations.
to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.
to 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.
to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.
as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.
Limitations of Use
JARDIANCE is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.1)].
JARDIANCE is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m2. JARDIANCE is likely to be ineffective in this setting based upon its mechanism of action.
JARDIANCE is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of intravenous immunosuppressive therapy or greater than 45 mg of prednisone or equivalent for kidney disease [see Clinical Studies (14.5)]. JARDIANCE is not expected to be effective in these populations.
How it works
Empagliflozin blocks SGLT2, the main transporter that moves glucose from the kidney filtrate back into the blood. This lowers the kidney threshold for glucose and increases glucose passed in urine. It also reduces sodium reabsorption.
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Section
12.1
Source text (exact source wording)
12.1 Mechanism of Action
Empagliflozin is an inhibitor of SGLT2, the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
Empagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule. This may influence several physiological functions including, but not restricted to, increasing tubuloglomerular feedback and reducing intraglomerular pressure, lowering both pre- and afterload of the heart and downregulating sympathetic activity.
Empagliflozin is an inhibitor of SGLT2, the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
Empagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule. This may influence several physiological functions including, but not restricted to, increasing tubuloglomerular feedback and reducing intraglomerular pressure, lowering both pre- and afterload of the heart and downregulating sympathetic activity.
Dosage: adults
The recommended dose is 10 mg once daily in the morning, with or without food. For additional blood sugar control, it may be increased to 25 mg once daily if 10 mg is tolerated. Check kidney function and volume status before starting. Hold for at least 3 days, if possible, before surgery or procedures with prolonged fasting.
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Section
2.1-2.3
Source text (exact source wording)
2.1 Testing Prior to Initiation of JARDIANCE
Assess renal function before initiating JARDIANCE and as clinically indicated [see Warnings and Precautions (5.2)].
Use for glycemic control is not recommended in patients with an eGFR less than 30 mL/min/1.73 m2 [see Use in Specific Populations (8.6)].
Assess volume status. In patients with volume depletion, correct this condition before initiating JARDIANCE [see Warnings and Precautions (5.2) and Use in Specific Populations (8.5, 8.6)].
2.2 Recommended Dosage
Table 1 presents the recommended dosage of JARDIANCE in adult and pediatric patients aged 10 years and older.
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.
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.
Reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus with established cardiovascular disease
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.
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. Resume JARDIANCE when the patient is clinically stable and has resumed oral intake [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2)].
Assess renal function before initiating JARDIANCE and as clinically indicated [see Warnings and Precautions (5.2)].
Use for glycemic control is not recommended in patients with an eGFR less than 30 mL/min/1.73 m2 [see Use in Specific Populations (8.6)].
Assess volume status. In patients with volume depletion, correct this condition before initiating JARDIANCE [see Warnings and Precautions (5.2) and Use in Specific Populations (8.5, 8.6)].
2.2 Recommended Dosage
Table 1 presents the recommended dosage of JARDIANCE in adult and pediatric patients aged 10 years and older.
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.
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.
Reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus with established cardiovascular disease
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.
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. Resume JARDIANCE when the patient is clinically stable and has resumed oral intake [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2)].
Dosage: children
For blood sugar control, pediatric patients aged 10 years and older take 10 mg once daily, and the dose may be raised to 25 mg once daily if tolerated. Safety and effectiveness have not been established in patients younger than 10 years.
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Section
2.2 Table 1; 8.4
Source text (exact source wording)
Table 1 (Section 2.2): 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.
8.4 Pediatric Use
The safety and effectiveness of JARDIANCE 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. Use of JARDIANCE for this indication is supported by evidence from a 26-week double-blind, placebo-controlled clinical trial, with a double-blind active treatment safety extension period of up to 52 weeks in 157 pediatric patients aged 10 to 17 years with type 2 diabetes mellitus and a pediatric pharmacokinetic study [see Clinical Pharmacology (12.3) and Clinical Studies (14.2)]. The safety profile of pediatric patients treated with JARDIANCE was similar to that observed in adults with type 2 diabetes mellitus, with the exception of hypoglycemia risk which was higher in pediatric patients treated with JARDIANCE regardless of concomitant insulin use [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)].
The safety and effectiveness of JARDIANCE have not been established in pediatric patients less than 10 years of age as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus.
The safety and effectiveness of JARDIANCE have not been established in pediatric patients to reduce the risk of: cardiovascular death and hospitalization for heart failure in patients with heart failure. sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in patients with chronic kidney disease at risk of progression. cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease.
8.4 Pediatric Use
The safety and effectiveness of JARDIANCE 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. Use of JARDIANCE for this indication is supported by evidence from a 26-week double-blind, placebo-controlled clinical trial, with a double-blind active treatment safety extension period of up to 52 weeks in 157 pediatric patients aged 10 to 17 years with type 2 diabetes mellitus and a pediatric pharmacokinetic study [see Clinical Pharmacology (12.3) and Clinical Studies (14.2)]. The safety profile of pediatric patients treated with JARDIANCE was similar to that observed in adults with type 2 diabetes mellitus, with the exception of hypoglycemia risk which was higher in pediatric patients treated with JARDIANCE regardless of concomitant insulin use [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)].
The safety and effectiveness of JARDIANCE have not been established in pediatric patients less than 10 years of age as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus.
The safety and effectiveness of JARDIANCE have not been established in pediatric patients to reduce the risk of: cardiovascular death and hospitalization for heart failure in patients with heart failure. sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in patients with chronic kidney disease at risk of progression. cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease.
Dosage adjustments
Drug interaction caps
Using Jardiance with insulin or an insulin secretagogue (such as a sulfonylurea) may call for lower dosages of those medicines to reduce the risk of low blood sugar.
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Section
7 Table 4
Source text (exact source wording)
Insulin or Insulin Secretagogues
Clinical Impact The risk of hypoglycemia is increased when JARDIANCE is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin.
Intervention Coadministration of JARDIANCE with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower dosages of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.
Clinical Impact The risk of hypoglycemia is increased when JARDIANCE is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin.
Intervention Coadministration of JARDIANCE with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower dosages of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.
Kidney
For blood sugar control, Jardiance is not recommended when eGFR is less than 30 mL/min/1.73 m2. The blood sugar lowering effect of the 25 mg dose decreased as kidney function worsened, and risks of volume depletion and urinary infections increased. Trials did not enroll adults with eGFR less than 20 mL/min/1.73 m2 or on dialysis.
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Section
2.1, 8.6
Source text (exact source wording)
2.1: Use for glycemic control is not recommended in patients with an eGFR less than 30 mL/min/1.73 m2 [see Use in Specific Populations (8.6)].
8.6 Renal Impairment
The efficacy and safety of JARDIANCE for glycemic control were evaluated in a trial of adult patients with type 2 diabetes mellitus with mild and moderate renal impairment (eGFR 30 to less than 90 mL/min/1.73 m2) [see Clinical Studies (14.1)]. The glucose lowering benefit of JARDIANCE 25 mg decreased in adult patients with worsening renal function. The risks of renal impairment, volume depletion adverse reactions and urinary tract infection-related adverse reactions increased with worsening renal function [see Warnings and Precautions (5.2)]. Use of JARDIANCE for glycemic control in patients without established cardiovascular disease or cardiovascular risk factors is not recommended when eGFR is less than 30 mL/min/1.73 m2.
Efficacy and safety trials with JARDIANCE did not enroll adult patients with an eGFR less than 20 mL/min/1.73 m2 or on dialysis.
8.6 Renal Impairment
The efficacy and safety of JARDIANCE for glycemic control were evaluated in a trial of adult patients with type 2 diabetes mellitus with mild and moderate renal impairment (eGFR 30 to less than 90 mL/min/1.73 m2) [see Clinical Studies (14.1)]. The glucose lowering benefit of JARDIANCE 25 mg decreased in adult patients with worsening renal function. The risks of renal impairment, volume depletion adverse reactions and urinary tract infection-related adverse reactions increased with worsening renal function [see Warnings and Precautions (5.2)]. Use of JARDIANCE for glycemic control in patients without established cardiovascular disease or cardiovascular risk factors is not recommended when eGFR is less than 30 mL/min/1.73 m2.
Efficacy and safety trials with JARDIANCE did not enroll adult patients with an eGFR less than 20 mL/min/1.73 m2 or on dialysis.
Liver
Jardiance may be used in patients with liver impairment.
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Section
8.7
Source text (exact source wording)
8.7 Hepatic Impairment
JARDIANCE may be used in patients with hepatic impairment [see Clinical Pharmacology (12.3)].
JARDIANCE may be used in patients with hepatic impairment [see Clinical Pharmacology (12.3)].
Elderly
In older adults, Jardiance is expected to have diminished blood sugar lowering in those with kidney impairment, and the risk of volume depletion and urinary tract infections increased in patients 75 years and older.
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Section
8.5
Source text (exact source wording)
8.5 Geriatric Use
In glycemic control trials in patients with type 2 diabetes mellitus, a total of 2,721 (32%) patients treated with JARDIANCE were 65 years of age and older, and 491 (6%) were 75 years of age and older. JARDIANCE is expected to have diminished glycemic efficacy in elderly patients with renal impairment [see Use in Specific Populations (8.6)]. The risk of volume depletion-related adverse reactions increased in patients who were 75 years of age and older to 2.1%, 2.3%, and 4.4% for placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg. The risk of urinary tract infections increased in patients who were 75 years of age and older to 10.5%, 15.7%, and 15.1% in patients randomized to placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].
In glycemic control trials in patients with type 2 diabetes mellitus, a total of 2,721 (32%) patients treated with JARDIANCE were 65 years of age and older, and 491 (6%) were 75 years of age and older. JARDIANCE is expected to have diminished glycemic efficacy in elderly patients with renal impairment [see Use in Specific Populations (8.6)]. The risk of volume depletion-related adverse reactions increased in patients who were 75 years of age and older to 2.1%, 2.3%, and 4.4% for placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg. The risk of urinary tract infections increased in patients who were 75 years of age and older to 10.5%, 15.7%, and 15.1% in patients randomized to placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].
Missed dose
Label
Take a missed dose as soon as you remember. If it is almost time for the next dose, skip it. Do not take two doses at the same time.
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Section
2.4; Patient Information
Source text (exact source wording)
2.4 Recommendations Regarding Missed Dose
If a dose is missed, instruct patients to take the dose as soon as possible.
Advise patients not to double up the next dose.
Patient Information: If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take two doses of JARDIANCE at the same time. Talk with your healthcare provider if you have questions about a missed dose.
If a dose is missed, instruct patients to take the dose as soon as possible.
Advise patients not to double up the next dose.
Patient Information: If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take two doses of JARDIANCE at the same time. Talk with your healthcare provider if you have questions about a missed dose.
Medlineplus
MedlinePlus gives the same advice: take it when you remember, skip it if the next dose is near, and do not double up.
Source
MedlinePlus Empagliflozin (https://medlineplus.gov/druginfo/meds/a614043.html), Last Revised - 07/15/2025
Section
MedlinePlus forget a dose
Source text (exact source wording)
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Overdose
In an overdose, consider calling the Poison Help line at 1-800-222-1222. If the person has collapsed, had a seizure, has trouble breathing, or cannot be awakened, call 911. Removal by hemodialysis has not been studied.
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display); MedlinePlus Empagliflozin (https://medlineplus.gov/druginfo/meds/a614043.html), Last Revised - 07/15/2025
Section
10; MedlinePlus
Source text (exact source wording)
10 OVERDOSAGE
In the event of an overdose with JARDIANCE, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Removal of empagliflozin by hemodialysis has not been studied.
MedlinePlus: In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
In the event of an overdose with JARDIANCE, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Removal of empagliflozin by hemodialysis has not been studied.
MedlinePlus: In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Storage
Store at 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F). This is the manufacturer label.
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Section
16
Source text (exact source wording)
16 HOW SUPPLIED/STORAGE AND HANDLING ... Dispense in a well-closed container as defined in the USP.
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Boxed warning
NONE (confirmed: the full printer-friendly label text, 123,375 characters, contains no BOXED WARNING heading and no 'WARNING:' box; Highlights go straight from the title to RECENT MAJOR CHANGES)Contraindications
Do not take Jardiance if you are allergic to empagliflozin or any ingredient in it. Reactions such as angioedema have occurred.
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Section
4
Source text (exact source wording)
JARDIANCE is contraindicated in patients:
with a hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred [see Warnings and Precautions (5.6)].
with a hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred [see Warnings and Precautions (5.6)].
Warnings and precautions
In type 1 diabetes, Jardiance significantly increases the risk of diabetic ketoacidosis, a life-threatening event. Type 2 diabetes and pancreatic disorders are also risk factors. If ketoacidosis is suspected, stop Jardiance and evaluate. Blood sugar may be less than 250 mg/dL when it happens.
Heading
5.1 Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Source text (exact source wording)
5.1 Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis
In patients with type 1 diabetes mellitus, JARDIANCE significantly increases the risk of diabetic ketoacidosis, a life-threatening event, beyond the background rate. In placebo-controlled trials of patients with type 1 diabetes mellitus, the risk of ketoacidosis was markedly increased in patients who received sodium glucose co-transporter 2 (SGLT2) inhibitors compared to patients who received placebo and fatal ketoacidosis has occurred with JARDIANCE. JARDIANCE is not indicated for glycemic control in patients with type 1 diabetes mellitus.
Type 2 diabetes mellitus and pancreatic disorders (e.g., history of pancreatitis or pancreatic surgery) are also risk factors for ketoacidosis. There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes mellitus using SGLT2 inhibitors, including JARDIANCE.
Precipitating conditions for diabetic ketoacidosis or other ketoacidosis include under-insulinization due to insulin dose reduction or missed insulin doses, acute febrile illness, reduced caloric intake, ketogenic diet, surgery, volume depletion, and alcohol abuse.
Signs and symptoms are consistent with dehydration and severe metabolic acidosis and include nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath. Blood glucose levels at presentation may be below those typically expected for diabetic ketoacidosis (e.g., less than 250 mg/dL). Ketoacidosis and glucosuria may persist longer than typically expected. Urinary glucose excretion persists for 3 days after discontinuing JARDIANCE [see Clinical Pharmacology (12.2)]; however, there have been postmarketing reports of ketoacidosis and/or glucosuria lasting greater than 6 days and some up to 2 weeks after discontinuation of SGLT2 inhibitors.
Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis if indicated by the clinical situation. Assess for ketoacidosis regardless of presenting blood glucose levels in patients who present with signs and symptoms consistent with severe metabolic acidosis. If ketoacidosis is suspected, discontinue JARDIANCE, promptly evaluate, and treat ketoacidosis, if confirmed. Monitor patients for resolution of ketoacidosis before restarting JARDIANCE.
Withhold JARDIANCE, if possible, in temporary clinical situations that could predispose patients to ketoacidosis. Resume JARDIANCE when the patient is clinically stable and has resumed oral intake [see Dosage and Administration (2.3)].
Educate all patients on the signs and symptoms of ketoacidosis and instruct patients to discontinue JARDIANCE and seek medical attention immediately if signs and symptoms occur.
In patients with type 1 diabetes mellitus, JARDIANCE significantly increases the risk of diabetic ketoacidosis, a life-threatening event, beyond the background rate. In placebo-controlled trials of patients with type 1 diabetes mellitus, the risk of ketoacidosis was markedly increased in patients who received sodium glucose co-transporter 2 (SGLT2) inhibitors compared to patients who received placebo and fatal ketoacidosis has occurred with JARDIANCE. JARDIANCE is not indicated for glycemic control in patients with type 1 diabetes mellitus.
Type 2 diabetes mellitus and pancreatic disorders (e.g., history of pancreatitis or pancreatic surgery) are also risk factors for ketoacidosis. There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes mellitus using SGLT2 inhibitors, including JARDIANCE.
Precipitating conditions for diabetic ketoacidosis or other ketoacidosis include under-insulinization due to insulin dose reduction or missed insulin doses, acute febrile illness, reduced caloric intake, ketogenic diet, surgery, volume depletion, and alcohol abuse.
Signs and symptoms are consistent with dehydration and severe metabolic acidosis and include nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath. Blood glucose levels at presentation may be below those typically expected for diabetic ketoacidosis (e.g., less than 250 mg/dL). Ketoacidosis and glucosuria may persist longer than typically expected. Urinary glucose excretion persists for 3 days after discontinuing JARDIANCE [see Clinical Pharmacology (12.2)]; however, there have been postmarketing reports of ketoacidosis and/or glucosuria lasting greater than 6 days and some up to 2 weeks after discontinuation of SGLT2 inhibitors.
Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis if indicated by the clinical situation. Assess for ketoacidosis regardless of presenting blood glucose levels in patients who present with signs and symptoms consistent with severe metabolic acidosis. If ketoacidosis is suspected, discontinue JARDIANCE, promptly evaluate, and treat ketoacidosis, if confirmed. Monitor patients for resolution of ketoacidosis before restarting JARDIANCE.
Withhold JARDIANCE, if possible, in temporary clinical situations that could predispose patients to ketoacidosis. Resume JARDIANCE when the patient is clinically stable and has resumed oral intake [see Dosage and Administration (2.3)].
Educate all patients on the signs and symptoms of ketoacidosis and instruct patients to discontinue JARDIANCE and seek medical attention immediately if signs and symptoms occur.
Jardiance can cause volume depletion, with low blood pressure or temporary changes in creatinine. Acute kidney injury has been reported after approval. Patients with eGFR less than 60 mL/min/1.73 m2, older patients and those on loop diuretics may be at higher risk.
Heading
5.2 Volume Depletion
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Source text (exact source wording)
5.2 Volume Depletion
JARDIANCE can cause intravascular volume depletion which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine [see Adverse Reactions (6.1)]. There have been post-marketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors, including JARDIANCE. Patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension. Before initiating JARDIANCE in patients with one or more of these characteristics, assess volume status and renal function. In patients with volume depletion, correct this condition before initiating JARDIANCE. Monitor for signs and symptoms of volume depletion, and renal function after initiating therapy.
JARDIANCE can cause intravascular volume depletion which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine [see Adverse Reactions (6.1)]. There have been post-marketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors, including JARDIANCE. Patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension. Before initiating JARDIANCE in patients with one or more of these characteristics, assess volume status and renal function. In patients with volume depletion, correct this condition before initiating JARDIANCE. Monitor for signs and symptoms of volume depletion, and renal function after initiating therapy.
Jardiance increases the risk of urinary tract and genital yeast infections in men and women. Serious infections including urosepsis, pyelonephritis and necrotizing fasciitis of the perineum (Fournier's gangrene) have occurred. Pain, tenderness, redness or swelling in the genital or perineal area with fever or malaise needs immediate evaluation.
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5.3 Genitourinary Infections...
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Source text (exact source wording)
5.3 Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier's Gangrene), and Genital Mycotic Infections
JARDIANCE increases urinary glucose excretion [see Clinical Pharmacology (12.2)] and increases the risk of genitourinary infections including urinary tract infections and genital mycotic infections in both male and female patients [see Adverse Reactions (6.1)].
Serious genitourinary infections, including urosepsis, pyelonephritis, and necrotizing fasciitis of the perineum (Fournier's gangrene, a rare life-threatening infection requiring urgent surgical intervention), have occurred in patients with and without diabetes mellitus receiving SGLT2 inhibitors, including JARDIANCE [see Adverse Reactions (6.2)]. Cases have required hospitalization. In patients with Fournier's gangrene, serious outcomes have included multiple surgeries and death.
Patients with a history of chronic or recurrent genitourinary infections are more likely to develop genitourinary infections when using JARDIANCE. Monitor patients for signs and symptoms of genitourinary infections and treat promptly, if indicated.
Immediately evaluate patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise, for necrotizing fasciitis. If suspected, discontinue JARDIANCE and promptly institute appropriate medical and/or surgical intervention.
JARDIANCE increases urinary glucose excretion [see Clinical Pharmacology (12.2)] and increases the risk of genitourinary infections including urinary tract infections and genital mycotic infections in both male and female patients [see Adverse Reactions (6.1)].
Serious genitourinary infections, including urosepsis, pyelonephritis, and necrotizing fasciitis of the perineum (Fournier's gangrene, a rare life-threatening infection requiring urgent surgical intervention), have occurred in patients with and without diabetes mellitus receiving SGLT2 inhibitors, including JARDIANCE [see Adverse Reactions (6.2)]. Cases have required hospitalization. In patients with Fournier's gangrene, serious outcomes have included multiple surgeries and death.
Patients with a history of chronic or recurrent genitourinary infections are more likely to develop genitourinary infections when using JARDIANCE. Monitor patients for signs and symptoms of genitourinary infections and treat promptly, if indicated.
Immediately evaluate patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise, for necrotizing fasciitis. If suspected, discontinue JARDIANCE and promptly institute appropriate medical and/or surgical intervention.
Low blood sugar risk may be higher when Jardiance is used with insulin or insulin secretagogues such as sulfonylureas. In pediatric patients aged 10 years and older the risk was higher regardless of insulin use.
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5.4 Hypoglycemia
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Source text (exact source wording)
5.4 Hypoglycemia
Insulin and insulin secretagogues are known to cause hypoglycemia. In adult patients, the risk of hypoglycemia may be increased when JARDIANCE is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin. In pediatric patients aged 10 years and older, the risk of hypoglycemia was higher with JARDIANCE regardless of insulin use [see Adverse Reactions (6.1)].
The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin. Inform patients using these concomitant medications and pediatric patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
Insulin and insulin secretagogues are known to cause hypoglycemia. In adult patients, the risk of hypoglycemia may be increased when JARDIANCE is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin. In pediatric patients aged 10 years and older, the risk of hypoglycemia was higher with JARDIANCE regardless of insulin use [see Adverse Reactions (6.1)].
The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin. Inform patients using these concomitant medications and pediatric patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
Some studies of SGLT2 inhibitors showed more lower limb amputations. Patients should get routine foot care and be monitored for foot infection, new pain or tenderness, sores or ulcers.
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5.5 Lower Limb Amputation
Source
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Source text (exact source wording)
5.5 Lower Limb Amputation
In some clinical studies with SGLT2 inhibitors an imbalance in the incidence of lower limb amputation has been observed. Across four JARDIANCE outcome trials, lower limb amputation event rates were 4.3 and 5.0 events per 1,000 patient-years in the placebo group and the JARDIANCE 10 mg or 25 mg dose group, respectively, with a HR of 1.05 (95 % CI) (0.81, 1.36).
In a long-term cardio-renal outcome trial [see Clinical Studies 14.5], in patients with chronic kidney disease, the occurrence of lower limb amputations was reported with event rates of 2.9, and 4.3 events per 1,000 patient-years in the placebo, and JARDIANCE 10 mg treatment arms, respectively. Amputation of the toe and mid-foot were most frequent (21 out of 28 JARDIANCE 10 mg treated patients with lower limb amputations), and some involving above and below the knee. Some patients had multiple amputations.
Peripheral artery disease, and diabetic foot infection (including osteomyelitis), were the most common precipitating medical events leading to the need for an amputation. The risk of amputation was highest in patients with a baseline history of diabetic foot, peripheral artery disease (including previous amputation) or diabetes.
Counsel patients about the importance of routine preventative foot care. Monitor patients receiving JARDIANCE for signs and symptoms of diabetic foot infection (including osteomyelitis), new pain or tenderness, sores or ulcers involving the lower limbs, and institute appropriate treatment.
In some clinical studies with SGLT2 inhibitors an imbalance in the incidence of lower limb amputation has been observed. Across four JARDIANCE outcome trials, lower limb amputation event rates were 4.3 and 5.0 events per 1,000 patient-years in the placebo group and the JARDIANCE 10 mg or 25 mg dose group, respectively, with a HR of 1.05 (95 % CI) (0.81, 1.36).
In a long-term cardio-renal outcome trial [see Clinical Studies 14.5], in patients with chronic kidney disease, the occurrence of lower limb amputations was reported with event rates of 2.9, and 4.3 events per 1,000 patient-years in the placebo, and JARDIANCE 10 mg treatment arms, respectively. Amputation of the toe and mid-foot were most frequent (21 out of 28 JARDIANCE 10 mg treated patients with lower limb amputations), and some involving above and below the knee. Some patients had multiple amputations.
Peripheral artery disease, and diabetic foot infection (including osteomyelitis), were the most common precipitating medical events leading to the need for an amputation. The risk of amputation was highest in patients with a baseline history of diabetic foot, peripheral artery disease (including previous amputation) or diabetes.
Counsel patients about the importance of routine preventative foot care. Monitor patients receiving JARDIANCE for signs and symptoms of diabetic foot infection (including osteomyelitis), new pain or tenderness, sores or ulcers involving the lower limbs, and institute appropriate treatment.
Serious allergic reactions such as angioedema have been reported. If one occurs, stop Jardiance and treat promptly.
Heading
5.6 Hypersensitivity Reactions
Source
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Source text (exact source wording)
5.6 Hypersensitivity Reactions
There have been postmarketing reports of serious hypersensitivity reactions (e.g., angioedema) in patients treated with JARDIANCE. If a hypersensitivity reaction occurs, discontinue JARDIANCE; treat promptly per standard of care, and monitor until signs and symptoms resolve. JARDIANCE is contraindicated in patients with hypersensitivity to empagliflozin or any of the excipients in JARDIANCE [see Contraindications (4)].
There have been postmarketing reports of serious hypersensitivity reactions (e.g., angioedema) in patients treated with JARDIANCE. If a hypersensitivity reaction occurs, discontinue JARDIANCE; treat promptly per standard of care, and monitor until signs and symptoms resolve. JARDIANCE is contraindicated in patients with hypersensitivity to empagliflozin or any of the excipients in JARDIANCE [see Contraindications (4)].
Pregnancy and breastfeeding
Based on animal data showing adverse kidney effects, Jardiance is not recommended during the second and third trimesters of pregnancy. Poorly controlled diabetes in pregnancy carries risks. It is not recommended while breastfeeding because of potential effects on the infant's developing kidneys.
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display); MedlinePlus Empagliflozin (https://medlineplus.gov/druginfo/meds/a614043.html), Last Revised - 07/15/2025
Section
8.1, 8.2; MedlinePlus
Source text (exact source wording)
8.1 Pregnancy
Risk Summary
Based on animal data showing adverse renal effects, JARDIANCE is not recommended during the second and third trimesters of pregnancy.
The limited available data with JARDIANCE in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations].
In animal studies, adverse renal changes were observed in rats when empagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. Doses approximately 13-times the maximum clinical dose caused renal pelvic and tubule dilatations that were reversible [see Data].
The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20% to 25% in women with HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations
Disease-associated maternal and/or embryo/fetal risk
Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.
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. Empagliflozin is present in the milk of lactating rats [see Data]. Since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney.
Because of the potential for serious adverse reactions in a breastfed infant, including the potential for empagliflozin to affect postnatal renal development, advise patients that use of JARDIANCE is not recommended while breastfeeding.
MedlinePlus: tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Do not breastfeed while you are taking empagliflozin. If you become pregnant while taking empagliflozin, call your doctor.
Risk Summary
Based on animal data showing adverse renal effects, JARDIANCE is not recommended during the second and third trimesters of pregnancy.
The limited available data with JARDIANCE in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations].
In animal studies, adverse renal changes were observed in rats when empagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. Doses approximately 13-times the maximum clinical dose caused renal pelvic and tubule dilatations that were reversible [see Data].
The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20% to 25% in women with HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations
Disease-associated maternal and/or embryo/fetal risk
Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.
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. Empagliflozin is present in the milk of lactating rats [see Data]. Since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney.
Because of the potential for serious adverse reactions in a breastfed infant, including the potential for empagliflozin to affect postnatal renal development, advise patients that use of JARDIANCE is not recommended while breastfeeding.
MedlinePlus: tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Do not breastfeed while you are taking empagliflozin. If you become pregnant while taking empagliflozin, call your doctor.
Side effects
Common
The most common side effects (5% or greater incidence) were urinary tract infections and female genital mycotic infections.
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Section
Highlights (the 6.1 text has no separate most-common list)
Threshold
5% or greater incidence
Source text (exact source wording)
Highlights: Most common adverse reactions (5% or greater incidence) were urinary tract infections and female genital mycotic infections (6.1)
Less common
In the blood sugar trials, urinary tract infection occurred in 9.3% on 10 mg and 7.6% on 25 mg (7.6% on placebo). Female genital yeast infections were 5.4% and 6.4% versus 1.5%. Upper respiratory infection, increased urination, dyslipidemia, arthralgia, male genital yeast infections and nausea were each reported in at least 2% in the table, as shown in the source text.
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Section
6.1 Table 2
Source text (exact source wording)
Table 2 Adverse Reactions Reported in ≥2% of Adults with Type 2 Diabetes Mellitus Treated with JARDIANCE and Greater than Placebo in Pooled Placebo-Controlled Clinical Trials of JARDIANCE Monotherapy or Combination Therapy
Adverse Reactions Placebo (%) N=995 JARDIANCE 10 mg (%) N=999 JARDIANCE 25 mg (%) N=977
Urinary tract infection(a) 7.6 9.3 7.6
Female genital mycotic infections(b) 1.5 5.4 6.4
Upper respiratory tract infection 3.8 3.1 4.0
Increased urination(c) 1.0 3.4 3.2
Dyslipidemia 3.4 3.9 2.9
Arthralgia 2.2 2.4 2.3
Male genital mycotic infections(d) 0.4 3.1 1.6
Nausea 1.4 2.3 1.1
Thirst (including polydipsia) was reported in 0%, 1.7%, and 1.5% for placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively.
Adverse Reactions Placebo (%) N=995 JARDIANCE 10 mg (%) N=999 JARDIANCE 25 mg (%) N=977
Urinary tract infection(a) 7.6 9.3 7.6
Female genital mycotic infections(b) 1.5 5.4 6.4
Upper respiratory tract infection 3.8 3.1 4.0
Increased urination(c) 1.0 3.4 3.2
Dyslipidemia 3.4 3.9 2.9
Arthralgia 2.2 2.4 2.3
Male genital mycotic infections(d) 0.4 3.1 1.6
Nausea 1.4 2.3 1.1
Thirst (including polydipsia) was reported in 0%, 1.7%, and 1.5% for placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively.
Serious
Label
Serious reactions reported after approval include ketoacidosis, Fournier's gangrene, urosepsis, pyelonephritis, acute kidney injury and angioedema.
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Section
5, 6.2
Source text (exact source wording)
6.2 Postmarketing Experience
Additional adverse reactions have been identified during postapproval use of JARDIANCE. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: Constipation
Infections: Necrotizing fasciitis of the perineum (Fournier's gangrene), urosepsis and pyelonephritis
Metabolism and Nutrition Disorders: Ketoacidosis
Renal and Urinary Disorders: Acute kidney injury
Skin and Subcutaneous Tissue Disorders: Angioedema, skin reactions (e.g., rash, urticaria)
See 5.1 to 5.6 above.
Additional adverse reactions have been identified during postapproval use of JARDIANCE. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: Constipation
Infections: Necrotizing fasciitis of the perineum (Fournier's gangrene), urosepsis and pyelonephritis
Metabolism and Nutrition Disorders: Ketoacidosis
Renal and Urinary Disorders: Acute kidney injury
Skin and Subcutaneous Tissue Disorders: Angioedema, skin reactions (e.g., rash, urticaria)
See 5.1 to 5.6 above.
Medlineplus
MedlinePlus lists urinary and genital infection symptoms and signs of ketoacidosis or allergic reaction as reasons to call the doctor or get emergency care.
Source
MedlinePlus Empagliflozin (https://medlineplus.gov/druginfo/meds/a614043.html), Last Revised - 07/15/2025
Section
MedlinePlus side effects
Source text (exact source wording)
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
frequent, urgent, burning, or painful urination; decrease in amount of urine; urine that is cloudy, red, pink, or brown; strong smelling urine; pelvic or rectal pain; or fever, back pain, nausea, or vomiting
(in women) vaginal odor, white or yellowish vaginal discharge (may be lumpy or look like cottage cheese), or vaginal itching
(in men) redness, itching, or swelling of the penis; rash on the penis; foul smelling discharge from the penis; or pain in the skin around the penis
feeling tired, weak, or uncomfortable; along with a fever and pain, tenderness, redness, and swelling of the genitals or the area between the genitals and the rectum
If you experience any of the following symptoms, stop taking empagliflozin and call your doctor immediately or get emergency medical treatment:
rash; hives; itching; difficulty breathing or swallowing; swelling of the face, throat, tongue, lips, mouth, or eyes; or hoarseness
If you experience any of the following symptoms of ketoacidosis, stop taking empagliflozin and call your doctor immediately or get emergency medical treatment. If possible, check for ketones in your urine if you have these symptoms, even if your blood sugar is less than 250 mg/dL:
nausea, vomiting, stomach-area pain, tiredness, or difficulty breathing
frequent, urgent, burning, or painful urination; decrease in amount of urine; urine that is cloudy, red, pink, or brown; strong smelling urine; pelvic or rectal pain; or fever, back pain, nausea, or vomiting
(in women) vaginal odor, white or yellowish vaginal discharge (may be lumpy or look like cottage cheese), or vaginal itching
(in men) redness, itching, or swelling of the penis; rash on the penis; foul smelling discharge from the penis; or pain in the skin around the penis
feeling tired, weak, or uncomfortable; along with a fever and pain, tenderness, redness, and swelling of the genitals or the area between the genitals and the rectum
If you experience any of the following symptoms, stop taking empagliflozin and call your doctor immediately or get emergency medical treatment:
rash; hives; itching; difficulty breathing or swallowing; swelling of the face, throat, tongue, lips, mouth, or eyes; or hoarseness
If you experience any of the following symptoms of ketoacidosis, stop taking empagliflozin and call your doctor immediately or get emergency medical treatment. If possible, check for ketones in your urine if you have these symptoms, even if your blood sugar is less than 250 mg/dL:
nausea, vomiting, stomach-area pain, tiredness, or difficulty breathing
Led to discontinuation
In the trials, few patients stopped because of genital infection (0.2% on either dose versus 0% on placebo) or urinary tract infection (0.1%, 0.2% and 0.1% for placebo, 10 mg and 25 mg).
Source
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Section
6.1 Other adverse reactions (excerpts; ellipses mark omitted text)
Source text (exact source wording)
Genital Mycotic Infections: ... Discontinuation from trial due to genital infection occurred in 0% of placebo-treated patients and 0.2% of patients treated with either JARDIANCE 10 mg or 25 mg.
Urinary Tract Infections: ... The rate of treatment discontinuation due to urinary tract infections was 0.1%, 0.2%, and 0.1% for placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively.
Urinary Tract Infections: ... The rate of treatment discontinuation due to urinary tract infections was 0.1%, 0.2%, and 0.1% for placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively.
Interactions
Drugs
Diuretics with empagliflozin increased urine volume and frequency of voids, which might enhance the potential for volume depletion. Assess volume status and kidney function before starting.
Name
Diuretics
Section
7
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Source text (exact source wording)
Diuretics
Clinical Impact Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
Intervention Before initiating JARDIANCE, assess volume status and renal function. In patients with volume depletion, correct this condition before initiating JARDIANCE. Monitor for signs and symptoms of volume depletion, and renal function after initiating therapy.
Clinical Impact Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
Intervention Before initiating JARDIANCE, assess volume status and renal function. In patients with volume depletion, correct this condition before initiating JARDIANCE. Monitor for signs and symptoms of volume depletion, and renal function after initiating therapy.
The risk of low blood sugar is increased with insulin or insulin secretagogues (such as sulfonylureas); lower dosages of those may be needed.
Name
Insulin or Insulin Secretagogues
Section
7
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Source text (exact source wording)
Insulin or Insulin Secretagogues
Clinical Impact The risk of hypoglycemia is increased when JARDIANCE is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin.
Intervention Coadministration of JARDIANCE with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower dosages of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.
Clinical Impact The risk of hypoglycemia is increased when JARDIANCE is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin.
Intervention Coadministration of JARDIANCE with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower dosages of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.
An SGLT2 inhibitor with lithium may decrease serum lithium concentrations, so lithium levels should be monitored more often when starting Jardiance and after dose changes.
Name
Lithium
Section
7
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Source text (exact source wording)
Lithium
Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations.
Intervention Monitor serum lithium concentration more frequently during JARDIANCE initiation and dosage changes.
Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations.
Intervention Monitor serum lithium concentration more frequently during JARDIANCE initiation and dosage changes.
Jardiance will lead to positive urine glucose tests, so urine glucose tests should not be used to monitor blood sugar control.
Name
Positive Urine Glucose Test
Section
7
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Source text (exact source wording)
Positive Urine Glucose Test
Clinical Impact SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests.
Intervention Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
Clinical Impact SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests.
Intervention Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
1,5-AG measurements are unreliable for judging blood sugar control while taking Jardiance, so other methods should be used.
Name
Interference with 1,5-anhydroglucitol (1,5-AG) Assay
Section
7
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Source text (exact source wording)
Interference with 1,5-anhydroglucitol (1,5-AG) Assay
Clinical Impact Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors.
Intervention Monitoring glycemic control with 1,5-AG assay is not recommended. Use alternative methods to monitor glycemic control.
Clinical Impact Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors.
Intervention Monitoring glycemic control with 1,5-AG assay is not recommended. Use alternative methods to monitor glycemic control.
Food and alcohol
Take Jardiance in the morning, with or without food.
Name
Food
Section
2.2
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Source text (exact source wording)
10 mg orally once daily in the morning, taken with or without food.
MedlinePlus says empagliflozin can cause dehydration and it is important to drink plenty of water.
Name
Fluids / dehydration
Section
MedlinePlus
Source
MedlinePlus Empagliflozin (https://medlineplus.gov/druginfo/meds/a614043.html), Last Revised - 07/15/2025
Source text (exact source wording)
Empagliflozin can cause dehydration. It is important that you drink plenty of water while taking empagliflozin. Talk to your doctor or pharmacist about the right amount of water to drink to prevent dehydration while taking empagliflozin.
Alcohol may change blood sugar, and alcohol abuse can raise the risk of ketoacidosis. Ask your doctor about safe use of alcohol.
Name
Alcohol
Section
MedlinePlus; Medication Guide; 5.1
Source
MedlinePlus Empagliflozin (https://medlineplus.gov/druginfo/meds/a614043.html), Last Revised - 07/15/2025; DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Source text (exact source wording)
alcohol may cause a change in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are taking empagliflozin. (Medication Guide also lists: drink alcohol very often or drink a lot of alcohol in the short term ("binge" drinking) among conditions to tell your provider about; Section 5.1 lists alcohol abuse as a precipitating condition for ketoacidosis.)
Patient tips
Label medication guide
The Medication Guide says to take Jardiance exactly as prescribed, once in the morning with or without food, and to stop it and get medical help right away for signs of ketoacidosis. It warns about dehydration, genital and urinary infections, low blood sugar, amputations and allergic reactions. If you miss a dose take it when you remember, but do not take two doses at the same time.
Source
Medication Guide (Patient Information) in DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Section
Patient Information
Source text (exact source wording)
What is the most important information I should know about JARDIANCE?
JARDIANCE can cause serious side effects, including:
Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 and other ketoacidosis. JARDIANCE can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis.
Stop taking JARDIANCE and call your healthcare provider or get medical help right away if you get any of the following. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL: nausea; vomiting; stomach-area (abdominal) pain; tiredness; trouble breathing; ketones in your urine or blood
Dehydration. JARDIANCE can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden worsening of kidney function in people who are taking JARDIANCE. You may be at higher risk of dehydration if you: take medicines to lower your blood pressure, including diuretics (water pills); are on low sodium (salt) diet; have kidney problems; are 65 years of age or older
Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, for example if you are sick or you cannot eat, or start to lose liquids from your body, for example from vomiting, diarrhea or being in the sun too long.
How should I take JARDIANCE?
Take JARDIANCE exactly as your healthcare provider tells you to take it.
Take JARDIANCE by mouth 1 time in the morning each day, with or without food.
Your healthcare provider will tell you how much JARDIANCE to take and when to take it. Your healthcare provider may change your dose if needed.
Your healthcare provider may tell you to take JARDIANCE along with other diabetes medicines. Low blood sugar can happen more often when JARDIANCE is taken with certain other diabetes medicines. See "What are the possible side effects of JARDIANCE?"
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take two doses of JARDIANCE at the same time. Talk with your healthcare provider if you have questions about a missed dose.
If you take too much JARDIANCE, call your healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room right away.
When taking JARDIANCE, you may have sugar in your urine, which will show up on a urine test.
When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change. Tell your healthcare provider right away if you have any of these conditions and follow your healthcare provider's instructions.
Your healthcare provider may do certain blood tests before you start JARDIANCE and during treatment as needed.
Who should not take JARDIANCE?
Do not take JARDIANCE if you: are allergic to empagliflozin or any of the ingredients in JARDIANCE. ... Symptoms of a serious allergic reaction to JARDIANCE may include: rash; raised, red areas on your skin (hives); swelling of your face, lips, mouth, and throat that may cause difficulty in breathing or swallowing
If you have any of these symptoms, stop taking JARDIANCE and call your healthcare provider right away or go to the nearest hospital emergency room.
The most common side effects of JARDIANCE include: urinary tract infections; yeast infections in females
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store JARDIANCE?
Store JARDIANCE at room temperature between 68°F to 77°F (20°C to 25°C).
Keep JARDIANCE and all medicines out of the reach of children.
JARDIANCE can cause serious side effects, including:
Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 and other ketoacidosis. JARDIANCE can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis.
Stop taking JARDIANCE and call your healthcare provider or get medical help right away if you get any of the following. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL: nausea; vomiting; stomach-area (abdominal) pain; tiredness; trouble breathing; ketones in your urine or blood
Dehydration. JARDIANCE can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden worsening of kidney function in people who are taking JARDIANCE. You may be at higher risk of dehydration if you: take medicines to lower your blood pressure, including diuretics (water pills); are on low sodium (salt) diet; have kidney problems; are 65 years of age or older
Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, for example if you are sick or you cannot eat, or start to lose liquids from your body, for example from vomiting, diarrhea or being in the sun too long.
How should I take JARDIANCE?
Take JARDIANCE exactly as your healthcare provider tells you to take it.
Take JARDIANCE by mouth 1 time in the morning each day, with or without food.
Your healthcare provider will tell you how much JARDIANCE to take and when to take it. Your healthcare provider may change your dose if needed.
Your healthcare provider may tell you to take JARDIANCE along with other diabetes medicines. Low blood sugar can happen more often when JARDIANCE is taken with certain other diabetes medicines. See "What are the possible side effects of JARDIANCE?"
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take two doses of JARDIANCE at the same time. Talk with your healthcare provider if you have questions about a missed dose.
If you take too much JARDIANCE, call your healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room right away.
When taking JARDIANCE, you may have sugar in your urine, which will show up on a urine test.
When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change. Tell your healthcare provider right away if you have any of these conditions and follow your healthcare provider's instructions.
Your healthcare provider may do certain blood tests before you start JARDIANCE and during treatment as needed.
Who should not take JARDIANCE?
Do not take JARDIANCE if you: are allergic to empagliflozin or any of the ingredients in JARDIANCE. ... Symptoms of a serious allergic reaction to JARDIANCE may include: rash; raised, red areas on your skin (hives); swelling of your face, lips, mouth, and throat that may cause difficulty in breathing or swallowing
If you have any of these symptoms, stop taking JARDIANCE and call your healthcare provider right away or go to the nearest hospital emergency room.
The most common side effects of JARDIANCE include: urinary tract infections; yeast infections in females
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store JARDIANCE?
Store JARDIANCE at room temperature between 68°F to 77°F (20°C to 25°C).
Keep JARDIANCE and all medicines out of the reach of children.
Medlineplus
MedlinePlus says to take it once a day in the morning, continue taking it even when you feel well, and not stop without talking to your doctor.
Source
MedlinePlus Empagliflozin (https://medlineplus.gov/druginfo/meds/a614043.html), Last Revised - 07/15/2025
Section
MedlinePlus
Source text (exact source wording)
Empagliflozin comes as a tablet to take by mouth. It is usually taken once a day in the morning with or without food. Take empagliflozin at around the same time every day.
Take empagliflozin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may start you on a low dose of empagliflozin and increase your dose as needed.
Empagliflozin helps to control your condition, but does not cure it. Continue to take empagliflozin even if you feel well. Do not stop taking empagliflozin without talking to your doctor.
Empagliflozin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
urinating a lot, including at night
increased thirst
Take empagliflozin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may start you on a low dose of empagliflozin and increase your dose as needed.
Empagliflozin helps to control your condition, but does not cure it. Continue to take empagliflozin even if you feel well. Do not stop taking empagliflozin without talking to your doctor.
Empagliflozin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
urinating a lot, including at night
increased thirst
When to call doctor
See the Medication Guide stop-and-call list and MedlinePlus serious side effect lists in side effects above.
Alternatives
Class source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display (Highlights: SGLT2 inhibitor) and https://medlineplus.gov/druginfo/meds/a614043.html
Indication source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display section 1
Note
No recommendation of one over another.
Frequently asked questions
Question
What is Jardiance used for?
Answer
Jardiance lowers the risk of cardiovascular death and heart failure hospitalization in adults with heart failure, lowers the risk of kidney function decline in adults with chronic kidney disease, lowers the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and improves blood sugar control in adults and pediatric patients aged 10 years and older with type 2 diabetes.
Source section
1
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Question
When and how do I take Jardiance?
Answer
The recommended dose is 10 mg once daily in the morning, with or without food. For additional blood sugar control it may be increased to 25 mg once daily if 10 mg is tolerated.
Source section
2.2
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Question
What if I miss a dose?
Answer
Take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time.
Source section
Patient Information
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Question
What are the most common side effects?
Answer
The most common side effects (5% or greater incidence) were urinary tract infections and female genital mycotic infections.
Source section
Highlights
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Question
Is there a generic Jardiance?
Answer
No generic label is listed on DailyMed. FDA records show a generic application with status Prescription (ANDA212330) and others that are tentatively approved or discontinued, so availability on the market could not be confirmed.
Source section
openFDA Drugs@FDA; DailyMed search
Source
https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:EMPAGLIFLOZIN&limit=100
Question
Do I need to stop Jardiance before surgery?
Answer
The label says to withhold Jardiance for at least 3 days, if possible, before surgery or procedures with prolonged fasting, and to resume when clinically stable and eating again.
Source section
2.3
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Question
Can I drink alcohol on Jardiance?
Answer
MedlinePlus says alcohol may cause a change in blood sugar and to ask your doctor about safe use. The label lists alcohol abuse as a risk for ketoacidosis.
Source section
MedlinePlus; 5.1
Source
MedlinePlus Empagliflozin (https://medlineplus.gov/druginfo/meds/a614043.html), Last Revised - 07/15/2025; DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Question
Is Jardiance safe during pregnancy or breastfeeding?
Answer
Based on animal data showing adverse kidney effects, the label does not recommend Jardiance during the second and third trimesters. It is not recommended while breastfeeding.
Source section
8.1, 8.2
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Question
What should I not combine with Jardiance?
Answer
Diuretics can add to fluid loss. Insulin or insulin secretagogues such as sulfonylureas raise the risk of low blood sugar and may need lower doses. Lithium levels may decrease. Urine glucose tests will be positive.
Source section
7
Source
DailyMed printer-friendly label JARDIANCE (Boehringer Ingelheim Pharmaceuticals, Inc.), set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565, Revised: 1/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=display)
Sources
- DailyMed printer-friendly label, JARDIANCE (Boehringer Ingelheim) - CHOSEN (brand-only)
Set id: faf3dd6a-9cd0-39c2-0d2e-232cb3f67565 · Label effective or revised date: Revised: 1/2026 · Dailymed version date: Feb 02, 2026 (DailyMed list publish date) · Fetched at: 2026-11-03 · Sections used: Highlights, 1,2,3,4,5,6.1,6.2,7,8.1,8.2,8.4,8.5,8.6,8.7,10,12.1,16, Medication Guide (read from full text via get_page_text) - MedlinePlus Empagliflozin
Label effective or revised date: Last Revised - 07/15/2025 · Fetched at: 2026-11-03 · Sections used: full page - openFDA Drugs@FDA data (empagliflozin)
Fetched at: 2026-11-03 · Sections used: application numbers, sponsors, marketing status - DailyMed SPL list (empagliflozin)
Fetched at: 2026-11-02 · Sections used: 13 entries, none generic
Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug