Empagliflozin is a once-daily oral drug that blocks sodium-glucose cotransporter 2 (SGLT2) in the kidney, so glucose that would normally be reabsorbed is passed in the urine. Boehringer Ingelheim sells it as Jardiance, in the US and the EU since 2014. It is also sold in fixed-dose combinations with metformin (Synjardy) and with linagliptin (Glyxambi, Trijardy XR).

Its defining result came from the EMPA-REG OUTCOME trial, where it cut cardiovascular death by 38% in people with type 2 diabetes and heart disease. Later trials led to approvals for heart failure and chronic kidney disease (CKD), with or without diabetes. For readers of this site, the key fact is that it raises hematocrit (the share of blood made up of red cells), and so does testosterone. The class as a whole is covered on the SGLT2 inhibitors page, and its closest relative on the dapagliflozin page. This page focuses on what is specific to empagliflozin.

This page summarizes what the FDA label and the major randomized trials report. It is for education only and is not medical advice.

Property	Detail
Drug class	Sodium-glucose cotransporter 2 (SGLT2) inhibitor (“gliflozin”)
Brands / approval	Jardiance (US initial approval 2014; EU authorization May 22, 2014); combinations Synjardy, Glyxambi, Trijardy XR
Route	Oral tablet, once daily in the morning, with or without food
Strengths	10 mg and 25 mg tablets
Labeled dose	10 mg once daily for all indications; may increase to 25 mg for blood sugar control
Half-life (label)	≈12.4 h (population pharmacokinetic estimate)
Key mechanism fact	≈64 g (10 mg) or ≈78 g (25 mg) of glucose lost in urine per day in type 2 diabetes
Boxed warning	None for Jardiance alone; metformin combinations carry metformin’s lactic acidosis boxed warning
US status	Prescription only; not a controlled substance
WADA status	Not named on the 2026 Prohibited List

What it is

Empagliflozin is a C-glucoside: a glucose-like ring joined by a carbon–carbon bond to a chlorinated diphenylmethane group that carries a tetrahydrofuranyl ether. Its formula is C₂₃H₂₇ClO₇ and its molecular weight is 450.9 g/mol (PubChem; FDA label). Unlike dapagliflozin, which is formulated as a propylene glycol co-crystal, Jardiance tablets contain empagliflozin as the free base.

SGLT2 is the main transporter that pulls filtered glucose back into the blood in the kidney’s proximal tubule. Blocking it lowers the kidney’s glucose threshold, so glucose spills into the urine. The label adds that empagliflozin also sends more sodium to the distal tubule. This may lower pressure inside the kidney’s filters, reduce the load on the heart before and after each beat, and turn down sympathetic nervous activity (FDA label). These effects do not depend on blood sugar, which is the usual explanation for the heart and kidney benefits in people without diabetes. The class mechanism is covered in more depth on the SGLT2 inhibitors page.

Pharmacokinetics

Parameter	Value (FDA label)
Time to peak	1.5 h
Effect of a high-fat meal (25 mg)	Total exposure down ≈16%, peak down ≈37%; not clinically relevant
Steady-state exposure	Dose-proportional; up to 22% accumulation with once-daily dosing
Protein binding	86.2%
Volume of distribution	73.8 L
Metabolism	Glucuronidation by UGT2B7, UGT1A3, UGT1A8 and UGT1A9; no major circulating metabolites; does not inhibit or induce CYP450 enzymes
Excretion	54.4% of a radiolabeled dose in urine, 41.2% in feces; about half of the urinary amount is unchanged drug
Terminal half-life	≈12.4 h; apparent oral clearance 10.6 L/h
Offset of effect	Urinary glucose loss approaches baseline about 3 days after a single dose

Reduced kidney function raises drug levels but blunts the effect. Exposure was about 18%, 20% and 66% higher in mild, moderate and severe kidney impairment. However, both the share of drug cleared unchanged in the urine and the amount of glucose excreted fell as eGFR (estimated glomerular filtration rate, a measure of kidney function) declined. In liver impairment, exposure rose by about 23%, 47% and 75% for mild, moderate and severe disease, and the label says empagliflozin may be used in these patients (FDA label).

The label found no clinically relevant interactions with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, digoxin, hydrochlorothiazide, torsemide or oral contraceptives. Probenecid cut the share of empagliflozin excreted in urine by 30% without changing urinary glucose loss. The effect of UGT inducers such as rifampin has not been studied.

Approved medical use

The current FDA label (revised October 2025) lists four indications (FDA label):

to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure in adults with heart failure;
to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death and hospitalization in adults with CKD at risk of progression;
to reduce the risk of CV death in adults with type 2 diabetes and established CV disease;
as an add-on to diet and exercise to improve blood sugar control in adults and children aged 10 years and older with type 2 diabetes.

The CV death indication in type 2 diabetes sets empagliflozin apart from dapagliflozin, whose diabetes outcome indication covers heart failure hospitalization.

Indication	Labeled dosing	Notes
Heart failure, CKD, CV death risk in type 2 diabetes	10 mg once daily in the morning	Trials enrolled eGFR as low as 20; patients were not required to stop if eGFR fell below 20 or dialysis began
Blood sugar control, type 2 diabetes (adults and age 10+)	10 mg once daily; may increase to 25 mg if 10 mg is tolerated	Not recommended if eGFR under 30, where it is likely to be ineffective

Limitations of use in the label:

not recommended for blood sugar control in type 1 diabetes, where it may increase the risk of diabetic ketoacidosis;
not expected to work for CKD caused by polycystic kidney disease, or in people needing or recently given intravenous immunosuppression or more than 45 mg of prednisone (or equivalent) for kidney disease.

The label also says to assess kidney function and volume status before starting, correct dehydration first, and withhold the drug for at least 3 days, if possible, before surgery or procedures with prolonged fasting.

What the research shows

Blood sugar and body weight

In the label’s 24-week monotherapy trial (986 patients), empagliflozin lowered HbA1c (a 2–3 month average of blood sugar) from a baseline of 7.9% (FDA label):

Outcome at week 24	Empagliflozin 10 mg	Empagliflozin 25 mg	Placebo
HbA1c change	−0.7	−0.8	+0.1
Difference from placebo (97.5% CI)	−0.7 (−0.9 to −0.6)	−0.9 (−1.0 to −0.7)	—
Reached HbA1c under 7%	35%	44%	12%
Body weight change	−2.8%	−3.2%	−0.4%
Systolic blood pressure vs placebo	−2.6 mmHg	−3.4 mmHg	—

As an add-on to metformin, the placebo-adjusted HbA1c reduction was 0.6 percentage points for both doses. When started together with metformin in drug-naive patients (baseline HbA1c about 8.7%), the combination lowered HbA1c by 1.9–2.1 points over 24 weeks, more than either drug alone.

In a 104-week head-to-head trial in 1,545 patients on metformin, empagliflozin 25 mg was non-inferior to the sulfonylurea glimepiride for HbA1c. Body weight fell by 3.1 kg with empagliflozin and rose by 1.3 kg with glimepiride.

What the weight loss is made of matters to this site’s readers. The EMPA-ELDERLY trial randomized 129 Japanese adults aged 65 and older (mean age 74.1) with type 2 diabetes to empagliflozin 10 mg or placebo for 52 weeks (Yabe et al., Diabetes Obes Metab 2023):

Outcome at week 52	Placebo-adjusted change (95% CI)
HbA1c	−0.57 points (−0.78 to −0.36)
Body weight	−2.37 kg (−3.07 to −1.68)
Fat mass	−1.84 kg (−2.65 to −1.04)
Muscle mass	−0.61 kg (−1.61 to 0.39), not significant
Grip strength	−0.3 kg (−1.1 to 0.5), not significant

Most of the loss was fat, and muscle mass and strength were not significantly changed. The trial was small, so a modest loss of muscle cannot be ruled out.

EMPA-REG OUTCOME: cardiovascular death in type 2 diabetes

EMPA-REG OUTCOME treated 7,020 adults with type 2 diabetes and established atherosclerotic CV disease with empagliflozin 10 mg, 25 mg or placebo, on top of standard care, for a median of 3.1 years (Zinman et al., NEJM 2015). The two doses were pooled as planned.

Outcome	Empagliflozin	Placebo	Hazard ratio (95% CI)
MACE (CV death, nonfatal heart attack, nonfatal stroke)	10.5%	12.1%	0.86 (0.74–0.99)
CV death	3.7%	5.9%	0.62 (0.49–0.77)
Nonfatal heart attack	4.5%	5.2%	0.87 (0.70–1.09)
Nonfatal stroke	3.2%	2.6%	1.24 (0.92–1.67)
Hospitalization for heart failure	2.7%	4.1%	35% relative reduction
Death from any cause	5.7%	8.3%	32% relative reduction

Data from the label and the trial paper (FDA label). The MACE benefit came entirely from fewer CV deaths; heart attacks and strokes did not change. Results for 10 mg and 25 mg were consistent. Genital infections were more common with empagliflozin, with no increase in other adverse events.

This differs from dapagliflozin’s outcome trial in type 2 diabetes (DECLARE-TIMI 58), which reduced heart failure hospitalization but not CV death (HR 0.98, 95% CI 0.82–1.17) (Wiviott et al., NEJM 2019). The two trials enrolled different populations: all EMPA-REG patients had established CV disease, while most DECLARE patients did not. One proposed explanation for the CV death effect is discussed under hematocrit below.

EMPEROR-Reduced and EMPEROR-Preserved: heart failure

Both trials gave empagliflozin 10 mg or placebo on top of usual heart failure therapy to adults with and without diabetes (Packer et al., NEJM 2020; Anker et al., NEJM 2021). Ejection fraction is the share of blood the left ventricle pumps out with each beat.

Outcome	EMPEROR-Reduced (n = 3,730; EF 40% or less; median 16 months)	EMPEROR-Preserved (n = 5,988; EF over 40%; median 26 months)
CV death or heart failure hospitalization (primary)	19.4% vs 24.7%; HR 0.75 (0.65–0.86)	13.8% vs 17.1%; HR 0.79 (0.69–0.90)
First heart failure hospitalization	HR 0.69 (0.59–0.81)	HR 0.71 (0.60–0.83)
Total heart failure hospitalizations	HR 0.70 (0.58–0.85)	HR 0.73 (0.61–0.88)
CV death alone	HR 0.92 (0.75–1.12)	HR 0.91 (0.76–1.09)

In both trials the benefit came mostly from fewer heart failure hospitalizations, and it was similar with and without diabetes. In EMPEROR-Reduced, eGFR declined more slowly with empagliflozin (−0.55 vs −2.28 mL/min/1.73 m² per year). In EMPEROR-Preserved, uncomplicated genital and urinary infections and low blood pressure were more common on empagliflozin.

EMPA-KIDNEY: chronic kidney disease

EMPA-KIDNEY randomized 6,609 adults with CKD to empagliflozin 10 mg or placebo, with a median follow-up of 2 years (EMPA-KIDNEY Collaborative Group, NEJM 2023). It enrolled people with an eGFR of 20–44, or 45–89 with significant albumin in the urine. It reached a broader population than dapagliflozin’s DAPA-CKD trial, which required an eGFR of 25–75 and albuminuria (Heerspink et al., NEJM 2020). In EMPA-KIDNEY, mean eGFR was 37, 35% of patients had an eGFR under 30, 20% had a urine albumin-to-creatinine ratio under 30 mg/g (normal or near-normal), and only 44% had type 2 diabetes (FDA label).

Outcome (EMPA-KIDNEY)	Empagliflozin	Placebo	Hazard ratio (95% CI)
Kidney disease progression or CV death (primary)	13.1%	16.9%	0.72 (0.64–0.82)
Sustained eGFR decline of 40% or more	10.9%	14.3%	0.70 (0.61–0.81)
End-stage kidney disease or eGFR under 10	4.8%	6.7%	0.69 (0.56–0.84)
CV death	1.8%	2.1%	0.84 (0.60–1.19)
First and recurrent hospitalization, any cause	—	—	0.86 (0.78–0.95)
Death from any cause	4.5%	5.1%	Not significant

Results were consistent with and without diabetes and across eGFR ranges. The label notes that the benefit was not evident in patients with very low albuminuria, although they had few events.

After the trial ended, 4,891 patients were followed for 2 more years without study drug (EMPA-KIDNEY Collaborative Group, NEJM 2025). Over the combined periods, the primary outcome occurred in 26.2% of the original empagliflozin group versus 30.3% of the placebo group (HR 0.79, 95% CI 0.72–0.87). The authors concluded that benefit persisted for up to 12 months after stopping.

Where empagliflozin did not help

EMPACT-MI randomized 6,522 patients hospitalized for a heart attack and at risk of heart failure to empagliflozin 10 mg or placebo within 14 days of admission (Butler et al., NEJM 2024). Over a median of 17.9 months, the primary outcome of first heart failure hospitalization or death from any cause was not significantly reduced (8.2% vs 9.1%; HR 0.90, 95% CI 0.76–1.06). First heart failure hospitalization alone was lower (HR 0.77, 95% CI 0.60–0.98), but death was not (HR 0.96). Empagliflozin is not approved for use after a heart attack.

Hematocrit and red blood cells

The rise in hematocrit is a labeled effect. In a pool of four placebo-controlled trials, median hematocrit rose by 2.8% with both empagliflozin 10 mg and 25 mg, versus a 1.3% fall with placebo. Among patients who started within the normal range, 2.7% (10 mg) and 3.5% (25 mg) ended above the upper limit of normal, versus 0.6% on placebo (FDA label).

Several empagliflozin trials show this is more than fluid loss concentrating the blood:

Type 2 diabetes. In a 3-month randomized placebo-controlled study of 44 patients on empagliflozin 10 mg, urine volume rose from day 1, but hematocrit (40.6% to 42.2%) and hemoglobin (136 to 142 g/L) rose only by month 3. Red cell count rose, while ferritin and transferrin saturation fell, consistent with new red cell production using up iron stores (Thiele et al., Diabetes Obes Metab 2021).
Heart failure (Empire HF). In 190 patients with reduced ejection fraction, 12 weeks of empagliflozin raised erythropoietin, the kidney hormone that drives red cell production (adjusted difference 2.6 IU/L, 95% CI 0.8–4.4), and lowered hepcidin, a hormone that restricts iron supply to the bone marrow (Fuchs Andersen et al., Eur J Heart Fail 2023).
EMPEROR program. In 1,139 patients with biomarker data, empagliflozin raised hemoglobin by 0.6–0.9 g/dL versus placebo at 12 weeks, raised erythroferrone (a red cell precursor signal) by more than 40%, and lowered hepcidin and transferrin saturation (Ferreira et al., JACC 2025).
Anemia. In EMPEROR-Reduced, hematocrit rose as early as week 4, and new-onset anemia occurred in 12.3% on empagliflozin versus 22.6% on placebo (HR 0.49, 95% CI 0.41–0.59) (Ferreira et al., Eur J Heart Fail 2022).

The hematocrit rise may also be part of how the drug works. In an exploratory mediation analysis of EMPA-REG OUTCOME, changes in hematocrit and hemoglobin statistically explained 51.8% and 48.9% of the reduction in CV death, more than glucose, HbA1c or uric acid (Inzucchi et al., Diabetes Care 2018). The authors read hematocrit mainly as a marker of plasma volume. A mediation analysis cannot prove cause.

Combined with testosterone

Testosterone also stimulates red cell production (see testosterone cypionate). No randomized trial has tested empagliflozin together with testosterone. The evidence is observational:

Empagliflozin case series. Five consecutive men on long-term testosterone developed erythrocytosis (an abnormally high red cell count) after empagliflozin was added for diabetes. It resolved after testosterone was stopped or reduced, or with phlebotomy. Four of the five carried one copy of the H63D hemochromatosis gene variant, which the authors suggested might add to the risk (Schumacher & Gosmanov, J Investig Med High Impact Case Rep 2022).
Class-level cohorts. In 53,971 US veterans with type 2 diabetes, men on an SGLT2 inhibitor plus testosterone had higher adjusted odds of a new hematocrit over 54% than those on an SGLT2 inhibitor alone (OR 3.80, 95% CI 2.27–6.11) or testosterone alone (OR 2.49, 95% CI 1.51–3.59) (Gosmanov et al., J Endocrinol Invest 2024). An Israeli cohort of 5,235 men with diabetes and hypogonadism found similar results (OR 4.85, 95% CI 3.06–7.69) (Kabha et al., Endocrinol Diabetes Metab 2025). Neither study reported results for empagliflozin separately.

The dapagliflozin page covers this class evidence and its management in more detail.

Side effects and risks

Jardiance has no boxed warning. Its only contraindication is serious hypersensitivity to empagliflozin or the tablet’s ingredients; angioedema has been reported. The label states that the safety profile was generally consistent across type 2 diabetes, heart failure and CKD, and no new adverse reactions appeared in the EMPEROR trials (FDA label).

Common adverse reactions

From the label’s pool of five placebo-controlled trials in adults with type 2 diabetes (about 23 weeks of exposure):

Adverse reaction	Placebo	10 mg	25 mg
Urinary tract infection	7.6%	9.3%	7.6%
Genital fungal infection, women	1.5%	5.4%	6.4%
Genital fungal infection, men	0.4%	3.1%	1.6%
Increased urination	1.0%	3.4%	3.2%
Thirst	0%	1.7%	1.5%
Nausea	1.4%	2.3%	1.1%

Urinary tract infections were far more common in women (16.6% placebo, 18.4% on 10 mg) than in men (3.2% and 3.6%). In patients aged 75 and older, urinary tract infections rose to 15.7% on 10 mg versus 10.5% on placebo.

Class warnings

Empagliflozin shares the class warnings described on the SGLT2 inhibitors page. In brief, from the Jardiance label:

Ketoacidosis. It can occur with blood sugar only mildly raised (for example, under 250 mg/dL). Fatal cases have occurred in type 1 and type 2 diabetes. Triggers include missed insulin, acute illness, reduced calorie intake or a ketogenic diet, surgery, dehydration and alcohol abuse. A history of pancreatitis or pancreatic surgery is also a risk factor. Glucose loss lasts about 3 days after stopping, but ketoacidosis or glucosuria lasting up to 2 weeks has been reported.
Volume depletion and kidney injury. Acute kidney injury, some needing dialysis, has been reported. Risk is higher with eGFR under 60, in older adults and with loop diuretics. A small rise in creatinine in the first weeks is expected; in a long-term trial the eGFR dip generally did not exceed 9 mL/min/1.73 m² at week 4 and reversed after stopping.
Serious genital and urinary infections, including urosepsis, kidney infection and Fournier’s gangrene (a rare, life-threatening infection of the perineum that has required multiple surgeries and caused deaths).

Lower limb amputation

Across four Jardiance outcome trials, amputation rates were 5.0 versus 4.3 events per 1,000 patient-years (HR 1.05, 95% CI 0.81–1.36). In EMPA-KIDNEY, however, rates were 4.3 on empagliflozin versus 2.9 on placebo. Most were toe or midfoot amputations, and risk was highest in people with prior diabetic foot problems, peripheral artery disease or diabetes. The label carries an amputation warning and advises routine preventive foot care (FDA label).

Hypoglycemia

On its own or with metformin, empagliflozin rarely caused low blood sugar (glucose 70 mg/dL or less in 0.4–1.8% of patients; no severe episodes). With metformin plus a sulfonylurea, the rate was 16.1% on 10 mg versus 8.4% on placebo, and with basal insulin it was 28.4% on 25 mg versus 20.6%. In children aged 10–17, hypoglycemia (glucose under 54 mg/dL) occurred in 19.2% on empagliflozin versus 7.5% on placebo, regardless of insulin use.

Lipids and lab tests

LDL cholesterol rose in a dose-related way: 4.6% (10 mg) and 6.5% (25 mg) versus 2.3% with placebo. The label also notes:

urine glucose tests will be positive and cannot be used to monitor blood sugar;
the 1,5-anhydroglucitol (1,5-AG) blood test is unreliable on SGLT2 inhibitors.

Interactions and special populations

Insulin and sulfonylureas. Lower doses may be needed to avoid hypoglycemia (see insulin).
Diuretics. Adding empagliflozin increases urine volume and the risk of volume depletion.
Lithium. SGLT2 inhibitors may lower lithium levels; the label advises more frequent monitoring.
Testosterone. Not a labeled interaction, but both raise hematocrit (see above).
Pregnancy. Not recommended in the second and third trimesters. In rats, about 13 times the maximum human exposure during kidney development caused reversible kidney dilatation.
Breastfeeding. Not recommended.

Monitoring

The label and the studies above point to these checks:

What	Why
Kidney function (eGFR)	Before starting and as clinically indicated; an early small dip is expected
Volume status and blood pressure	Before starting, especially in older adults and people on diuretics
Ketones when ill, fasting or around surgery	Ketoacidosis can occur with near-normal glucose
Feet, genital and urinary symptoms	Amputation warning; genital infections are common and rarely severe
Hematocrit, if also on testosterone	Observational data link the combination to hematocrit over 54%

Legal status and use outside medicine

In the US, empagliflozin is a prescription drug and is not a controlled substance. It is not named on the WADA 2026 Prohibited List. Section S5 bans named diuretics and masking agents “and other substances with a similar chemical structure or similar biological effect(s)”; SGLT2 inhibitors are not among the named examples, and the list does not address them.

Interest outside approved uses usually centers on fat loss. In trials, weight loss was about 2–3 kg more than placebo, and the outcome benefits were shown in people with diabetes, heart failure or CKD, not in healthy or athletic people.

Key takeaways

The SGLT2 inhibitor with a CV death indication. In EMPA-REG OUTCOME, empagliflozin cut CV death by 38% (HR 0.62) in people with type 2 diabetes and heart disease. Heart attacks and strokes did not change.
Broad heart and kidney evidence. It reduced CV death or heart failure hospitalization in EMPEROR-Reduced (HR 0.75) and EMPEROR-Preserved (HR 0.79), and kidney progression or CV death in EMPA-KIDNEY (HR 0.72), with or without diabetes. It did not significantly help after a heart attack (EMPACT-MI).
Simple dosing. 10 mg once daily for all indications, 25 mg only for extra blood sugar control. Half-life is about 12 hours, and it is cleared mainly by glucuronidation, not CYP enzymes.
Hematocrit rises through real red cell production. Median hematocrit rose 2.8% in the label pool, and trials show higher erythropoietin and lower hepcidin. Case reports and cohorts link SGLT2 inhibitors plus testosterone to erythrocytosis.
Infections and ketoacidosis are the key risks. Genital yeast infections are common; Fournier’s gangrene and ketoacidosis at near-normal blood sugar are rare but serious.
Weight loss is modest and mostly fat. About 2–3 kg more than placebo; in older adults, muscle mass and grip strength were not significantly reduced.

Sources

Boehringer Ingelheim. Jardiance (empagliflozin) tablets, prescribing information, revised 10/2025. DailyMed.
Boehringer Ingelheim. Synjardy (empagliflozin and metformin hydrochloride), Glyxambi (empagliflozin and linagliptin) and Trijardy XR (empagliflozin, linagliptin and metformin) prescribing information. DailyMed: Synjardy; DailyMed: Glyxambi; DailyMed: Trijardy XR.
European Medicines Agency. Jardiance (empagliflozin): EPAR. EMA.
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World Anti-Doping Agency. 2026 Prohibited List. WADA.

Empagliflozin (Jardiance)