Empagliflozin

updated

Empagliflozin is an FDA-approved SGLT2 inhibitor (JARDIANCE, 2014) for heart failure, chronic kidney disease and type 2 diabetes, backed by four large outcome trials. Sellers promote it on anabolic steroid cycles, but a PubMed search on 9 October 2026 found no human study in steroid users, and the one related record is a rat study with stanozolol.

Sodium-glucose co-transporter 2 (SGLT2) inhibitor

  • FDA approved JARDIANCE under NDA 204629 on 1 August 2014; the label lists four uses, none related to anabolic-androgenic steroids.
  • EMPEROR-Reduced (3730 adults with heart failure): cardiovascular death or heart failure hospitalization 19.4% versus 24.7% on placebo (hazard ratio 0.75).
  • EMPA-KIDNEY (6609 adults with chronic kidney disease): kidney disease progression or cardiovascular death 13.1% versus 16.9% (hazard ratio 0.72).
  • In label trials in type 2 diabetes, placebo-adjusted systolic blood pressure fell 2.6 to 4.8 mm Hg.
  • The label states empagliflozin causes an osmotic diuresis that may lead to intravascular volume contraction, and warns about ketoacidosis regardless of presenting blood glucose.
  • A PubMed search on 9 October 2026 returned 1 record pairing empagliflozin with an anabolic-androgenic steroid, a 54-rat stanozolol study; no human study and no trenbolone study was located.

What is empagliflozin approved to do?

FDA approved empagliflozin as JARDIANCE in 2014. It is labeled for heart failure, chronic kidney disease, cardiovascular death in type 2 diabetes with cardiovascular disease, and glycemic control in type 2 diabetes. None of the four uses relates to anabolic-androgenic steroids.

JARDIANCE is a sodium-glucose co-transporter 2 inhibitor labeled for four uses. It reduces the risk of cardiovascular death and heart failure hospitalization in adults with heart failure. It reduces the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease at risk of progression. It reduces the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. And it is an adjunct to diet and exercise for glycemic control in adults and children aged 10 and older with type 2 diabetes.

The label limits use in type 1 diabetes: it is not recommended for glycemic control there because it may increase diabetic ketoacidosis risk. FDA approved JARDIANCE under NDA 204629 on 1 August 2014. None of the four uses is prevention or management of harm from anabolic-androgenic steroids. Approvals outside the United States are not covered here.

Empagliflozin is C23H27ClO7 (450.9 g/mol, CAS 864070-44-0). Listed synonyms include JARDIANCE and the development code BI 10773.

JARDIANCE label, version effective 30 January 2026: indications, warnings, adverse reactions

FDA prescribing information

DailyMed, U.S. National Library of Medicine. JARDIANCE (empagliflozin) film-coated oral tablets, 10 and 25 mg, prescribing information, label version effective 30 January 2026. Set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565.

JARDIANCE is a sodium-glucose co-transporter 2 inhibitor labeled for four uses: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure; to reduce the risk of sustained eGFR decline, 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 and established cardiovascular disease; and as an adjunct to diet and exercise for glycemic control in adults and children aged 10 and older with type 2 diabetes. It is not recommended for glycemic control in type 1 diabetes because it may increase diabetic ketoacidosis risk. None of the four uses is prevention or management of harm from anabolic-androgenic steroids. Warnings cover diabetic ketoacidosis in type 1 diabetes and other ketoacidosis, with assessment for ketoacidosis regardless of presenting blood glucose; volume depletion; genitourinary infections including urosepsis, pyelonephritis, necrotizing fasciitis of the perineum (Fournier's gangrene) and genital mycotic infections; and hypoglycemia with insulin secretagogues or insulin, with a higher pediatric hypoglycemia risk regardless of insulin use. It is contraindicated in hypersensitivity to empagliflozin, with angioedema reported. In a pool of five placebo-controlled adult trials (placebo versus 10 mg versus 25 mg), urinary tract infection occurred in 7.6%, 9.3% and 7.6%; female genital mycotic infections in 1.5%, 5.4% and 6.4%; male genital mycotic infections in 0.4%, 3.1% and 1.6%; increased urination in 1.0%, 3.4% and 3.2%; thirst in 0%, 1.7% and 1.5%; and nocturia in 0.4%, 0.3% and 0.8%. Volume-depletion reactions, which include decreased blood pressure, dehydration, hypotension, hypovolemia, orthostatic hypotension and syncope, occurred in 0.3%, 0.5% and 0.3%. The label states that empagliflozin causes an osmotic diuresis that may lead to intravascular volume contraction and may increase hypotension risk in patients at risk for volume contraction.

Participants / model
Adults with heart failure, chronic kidney disease or type 2 diabetes; children 10 and older with type 2 diabetes; adults in five placebo-controlled trials and postmarketing reports
Treatment
JARDIANCE film-coated oral tablets, 10 and 25 mg
Follow-up
Label version effective 30 January 2026
Study design
FDA prescribing information
Funding
not stated in the source

The diuretic effect is described in the label as a hazard, not a benefit. Ketoacidosis is a label warning; this page gives no incidence figure for it.

Read the original source
Drugs@FDA: JARDIANCE approved 1 August 2014

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application record for NDA 204629 (JARDIANCE). Date read from the openFDA Drugs@FDA record.

FDA approved JARDIANCE under NDA 204629 on 1 August 2014.

Participants / model
Not a clinical population
Treatment
Drug application
Follow-up
Approval in 2014
Study design
FDA application record
Funding
not stated in the source

This record gives the approval date. Indications come from the product label.

Read the original source
PubChem: empagliflozin identity

Chemical identity record

National Library of Medicine. PubChem compound record CID 11949646 (empagliflozin).

Empagliflozin: C23H27ClO7, 450.9 g/mol, CAS 864070-44-0. Listed synonyms include JARDIANCE and the development code BI 10773.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined molecule
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

Identity record only; it says nothing about efficacy or safety.

Read the original source

What did the large outcome studies find?

Four large randomized trials each met their primary endpoint: fewer cardiovascular deaths or heart failure hospitalizations in heart failure, a lower cardiovascular composite in high-risk type 2 diabetes, and less kidney disease progression in chronic kidney disease.

EMPA-REG OUTCOME treated 7020 adults with type 2 diabetes at high cardiovascular risk for a median 3.1 years. The primary composite of cardiovascular death, nonfatal myocardial infarction or nonfatal stroke occurred in 10.5% versus 12.1% on placebo (hazard ratio 0.86, 95.02% CI 0.74 to 0.99, P=0.04 for superiority). Myocardial infarction and stroke rates did not differ significantly. Cardiovascular death was 3.7% versus 5.9%, hospitalization for heart failure 2.7% versus 4.1% and all-cause death 5.7% versus 8.3%.

EMPEROR-Reduced randomized 3730 adults with class II, III or IV heart failure and ejection fraction at or below 40%, on top of recommended therapy, for a median 16 months. Cardiovascular death or hospitalization for worsening heart failure occurred in 19.4% versus 24.7% (hazard ratio 0.75, 95% CI 0.65 to 0.86, P<0.001), consistent with and without diabetes. Annual eGFR decline was slower (-0.55 versus -2.28 mL/min/1.73 m2 per year).

EMPEROR-Preserved randomized 5988 adults with heart failure and ejection fraction above 40% for a median 26.2 months. The same composite occurred in 13.8% versus 17.1% (hazard ratio 0.79, 95% CI 0.69 to 0.90, P<0.001), driven mainly by fewer heart failure hospitalizations (407 versus 541), consistent with and without diabetes.

EMPA-KIDNEY randomized 6609 adults with chronic kidney disease for a median 2.0 years. Kidney disease progression or cardiovascular death occurred in 13.1% versus 16.9% (hazard ratio 0.72, 95% CI 0.64 to 0.82, P<0.001), consistent with and without diabetes and across eGFR subgroups. All-cause hospitalization was lower (hazard ratio 0.86, 95% CI 0.78 to 0.95).

EMPA-REG OUTCOME: 7020 patients, median 3.1 years

Randomized controlled trial

Zinman B et al. N Engl J Med. 2015;373(22):2117-28. PMID 26378978.

The primary composite of cardiovascular death, nonfatal myocardial infarction or nonfatal stroke occurred in 10.5% versus 12.1% (hazard ratio 0.86, 95.02% CI 0.74 to 0.99, P=0.04 for superiority). Myocardial infarction and stroke rates did not differ significantly. Cardiovascular death was 3.7% versus 5.9% (38% relative risk reduction), hospitalization for heart failure 2.7% versus 4.1% (35% relative risk reduction) and all-cause death 5.7% versus 8.3% (32% relative risk reduction). Genital infection was more frequent on empagliflozin, with no increase in other adverse events.

Participants / model
7020 adults with type 2 diabetes at high cardiovascular risk
Treatment
Oral empagliflozin 10 or 25 mg once daily, or placebo
Follow-up
Median observation 3.1 years
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Applies to adults with type 2 diabetes at high cardiovascular risk, not to people using anabolic-androgenic steroids.

Read the original source
EMPEROR-Reduced: 3730 patients, median 16 months

Randomized controlled trial

Packer M et al. N Engl J Med. 2020;383(15):1413-1424. PMID 32865377.

The composite of cardiovascular death or hospitalization for worsening heart failure occurred in 19.4% versus 24.7% (hazard ratio 0.75, 95% CI 0.65 to 0.86, P<0.001), consistent with and without diabetes. Total heart failure hospitalizations were lower (hazard ratio 0.70, 95% CI 0.58 to 0.85, P<0.001), and annual eGFR decline was slower (-0.55 versus -2.28 mL/min/1.73 m2 per year, P<0.001). Uncomplicated genital tract infection was more frequent on empagliflozin.

Participants / model
3730 adults with class II, III or IV heart failure and ejection fraction at or below 40%
Treatment
Oral empagliflozin 10 mg or placebo, on top of recommended therapy
Follow-up
Median 16 months
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Applies to adults with heart failure and a reduced ejection fraction.

Read the original source
EMPEROR-Preserved: 5988 patients, median 26.2 months

Randomized controlled trial

Anker SD et al. N Engl J Med. 2021;385(16):1451-1461. PMID 34449189.

The composite of cardiovascular death or hospitalization for heart failure occurred in 13.8% versus 17.1% (hazard ratio 0.79, 95% CI 0.69 to 0.90, P<0.001), driven mainly by fewer heart failure hospitalizations (407 versus 541, hazard ratio 0.73, 95% CI 0.61 to 0.88, P<0.001), consistent with and without diabetes. Uncomplicated genital and urinary tract infections and hypotension were more frequent with empagliflozin.

Participants / model
5988 adults with class II to IV heart failure and ejection fraction above 40%
Treatment
Oral empagliflozin 10 mg or placebo
Follow-up
Median 26.2 months
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Applies to adults with heart failure and a preserved ejection fraction.

Read the original source
EMPA-KIDNEY: 6609 patients, median 2.0 years

Randomized controlled trial

Herrington WG et al. N Engl J Med. 2023;388(2):117-127. PMID 36331190.

The composite of kidney disease progression or cardiovascular death occurred in 13.1% versus 16.9% (hazard ratio 0.72, 95% CI 0.64 to 0.82, P<0.001), consistent with and without diabetes and across eGFR subgroups. All-cause hospitalization was lower (hazard ratio 0.86, 95% CI 0.78 to 0.95, P=0.003).

Participants / model
6609 adults with chronic kidney disease (eGFR 20 to below 45, or 45 to below 90 with a urinary albumin-to-creatinine ratio of at least 200)
Treatment
Oral empagliflozin 10 mg or placebo
Follow-up
Median 2.0 years
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Applies to adults with chronic kidney disease.

Read the original source

How much did blood pressure and weight change in people with diabetes?

In label trials in adults with type 2 diabetes, systolic blood pressure fell about 3 to 5 mm Hg more than on placebo, and body weight fell about 2.5 to 2.8% more than on placebo in the monotherapy trial.

In the 24-week placebo-controlled monotherapy trial, placebo-adjusted systolic pressure fell 2.6 mm Hg on 10 mg (p=0.0231) and 3.4 mm Hg on 25 mg (p=0.0028). Body weight fell 2.8% and 3.2% versus 0.4% on placebo, a placebo-adjusted 2.5% (95% CI -3.1 to -1.9) and 2.8% (95% CI -3.4 to -2.2).

In the add-on to metformin trial, 24-week placebo-corrected systolic reductions were 4.1 mm Hg on 10 mg and 4.8 mm Hg on 25 mg (both p<0.0001). Against glimepiride at 52 weeks, systolic change was -3.6 mm Hg versus +2.2 mm Hg (p<0.0001).

All of these results are in people with type 2 diabetes. None was measured in people using anabolic-androgenic steroids.

JARDIANCE label trials: systolic pressure down 2.6 to 4.8 mm Hg in type 2 diabetes

FDA prescribing information

DailyMed, U.S. National Library of Medicine. JARDIANCE (empagliflozin) film-coated oral tablets, prescribing information, clinical studies section, label version effective 30 January 2026. Set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565.

In the 24-week placebo-controlled monotherapy trial, placebo-adjusted systolic blood pressure fell by 2.6 mm Hg on 10 mg (p=0.0231) and 3.4 mm Hg on 25 mg (p=0.0028). Body weight fell by 2.8% and 3.2% versus 0.4% on placebo, placebo-adjusted 2.5% (95% CI -3.1 to -1.9) and 2.8% (95% CI -3.4 to -2.2). In the add-on to metformin trial, 24-week placebo-corrected systolic reductions were 4.1 mm Hg on 10 mg and 4.8 mm Hg on 25 mg (both p<0.0001). Against glimepiride at 52 weeks, systolic change was -3.6 mm Hg versus +2.2 mm Hg (p<0.0001). The blood pressure effect is on the order of 3 to 5 mm Hg systolic, in people with type 2 diabetes.

Participants / model
Adults with type 2 diabetes in the label's randomized trials
Treatment
Oral empagliflozin 10 or 25 mg
Follow-up
24 weeks (placebo-controlled trials) and 52 weeks (glimepiride comparison)
Study design
Label summary of randomized trials
Funding
not stated in the source

All blood pressure and weight results are in people with type 2 diabetes. They do not describe people using anabolic-androgenic steroids.

Read the original source

Does empagliflozin help people using anabolic steroids?

No study in people supports it. A PubMed search on 9 October 2026 returned 1 record pairing empagliflozin with an anabolic-androgenic steroid, a rat study with stanozolol. No human study and no study with trenbolone in any species was located.

Sellers promote empagliflozin on anabolic-androgenic steroid cycles, trenbolone in particular, to counter insulin resistance, lower blood pressure, reduce cardiac load and reduce fluid retention. Three of those four effects have a counterpart in the label and trial records, but each was measured in a different population: blood pressure in type 2 diabetes, cardiac load in heart failure, and diuresis described as a hazard. None of the studies summarized here measured insulin sensitivity.

A PubMed search on 9 October 2026 for empagliflozin or SGLT2 inhibitors with anabolic steroid, anabolic-androgenic, trenbolone, bodybuilder or bodybuilding terms returned 1 record. On ClinicalTrials.gov the same day, queries for empagliflozin with anabolic androgenic steroid, and for SGLT2 inhibitors with bodybuilder or androgen users, each returned no studies. No human study of empagliflozin in anabolic-androgenic steroid users, and no study of empagliflozin with trenbolone in any species, was located.

PubMed search, 9 October 2026: 1 record, a rat study; no human study

PubMed search record

PubMed search run on 9 October 2026: (empagliflozin OR SGLT2 inhibitor OR sodium-glucose cotransporter 2) AND (anabolic steroid OR anabolic-androgenic OR trenbolone OR bodybuilder OR bodybuilding). 1 record returned. ClinicalTrials.gov queries the same day for empagliflozin with anabolic androgenic steroid, and for SGLT2 inhibitor with bodybuilder or androgen users, each returned no studies.

The search returned 1 record, the rat stanozolol study. On ClinicalTrials.gov the same day, queries for empagliflozin and anabolic androgenic steroid, and for SGLT2 inhibitor with bodybuilder or androgen users, each returned no studies. No human study of empagliflozin in anabolic-androgenic steroid users, and no study of empagliflozin with trenbolone in any species, was located.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Search run on 9 October 2026
Study design
Literature and registry search
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists.

Read the original source
JARDIANCE label, version effective 30 January 2026: indications, warnings, adverse reactions

FDA prescribing information

DailyMed, U.S. National Library of Medicine. JARDIANCE (empagliflozin) film-coated oral tablets, 10 and 25 mg, prescribing information, label version effective 30 January 2026. Set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565.

JARDIANCE is a sodium-glucose co-transporter 2 inhibitor labeled for four uses: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure; to reduce the risk of sustained eGFR decline, 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 and established cardiovascular disease; and as an adjunct to diet and exercise for glycemic control in adults and children aged 10 and older with type 2 diabetes. It is not recommended for glycemic control in type 1 diabetes because it may increase diabetic ketoacidosis risk. None of the four uses is prevention or management of harm from anabolic-androgenic steroids. Warnings cover diabetic ketoacidosis in type 1 diabetes and other ketoacidosis, with assessment for ketoacidosis regardless of presenting blood glucose; volume depletion; genitourinary infections including urosepsis, pyelonephritis, necrotizing fasciitis of the perineum (Fournier's gangrene) and genital mycotic infections; and hypoglycemia with insulin secretagogues or insulin, with a higher pediatric hypoglycemia risk regardless of insulin use. It is contraindicated in hypersensitivity to empagliflozin, with angioedema reported. In a pool of five placebo-controlled adult trials (placebo versus 10 mg versus 25 mg), urinary tract infection occurred in 7.6%, 9.3% and 7.6%; female genital mycotic infections in 1.5%, 5.4% and 6.4%; male genital mycotic infections in 0.4%, 3.1% and 1.6%; increased urination in 1.0%, 3.4% and 3.2%; thirst in 0%, 1.7% and 1.5%; and nocturia in 0.4%, 0.3% and 0.8%. Volume-depletion reactions, which include decreased blood pressure, dehydration, hypotension, hypovolemia, orthostatic hypotension and syncope, occurred in 0.3%, 0.5% and 0.3%. The label states that empagliflozin causes an osmotic diuresis that may lead to intravascular volume contraction and may increase hypotension risk in patients at risk for volume contraction.

Participants / model
Adults with heart failure, chronic kidney disease or type 2 diabetes; children 10 and older with type 2 diabetes; adults in five placebo-controlled trials and postmarketing reports
Treatment
JARDIANCE film-coated oral tablets, 10 and 25 mg
Follow-up
Label version effective 30 January 2026
Study design
FDA prescribing information
Funding
not stated in the source

The diuretic effect is described in the label as a hazard, not a benefit. Ketoacidosis is a label warning; this page gives no incidence figure for it.

Read the original source
JARDIANCE label trials: systolic pressure down 2.6 to 4.8 mm Hg in type 2 diabetes

FDA prescribing information

DailyMed, U.S. National Library of Medicine. JARDIANCE (empagliflozin) film-coated oral tablets, prescribing information, clinical studies section, label version effective 30 January 2026. Set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565.

In the 24-week placebo-controlled monotherapy trial, placebo-adjusted systolic blood pressure fell by 2.6 mm Hg on 10 mg (p=0.0231) and 3.4 mm Hg on 25 mg (p=0.0028). Body weight fell by 2.8% and 3.2% versus 0.4% on placebo, placebo-adjusted 2.5% (95% CI -3.1 to -1.9) and 2.8% (95% CI -3.4 to -2.2). In the add-on to metformin trial, 24-week placebo-corrected systolic reductions were 4.1 mm Hg on 10 mg and 4.8 mm Hg on 25 mg (both p<0.0001). Against glimepiride at 52 weeks, systolic change was -3.6 mm Hg versus +2.2 mm Hg (p<0.0001). The blood pressure effect is on the order of 3 to 5 mm Hg systolic, in people with type 2 diabetes.

Participants / model
Adults with type 2 diabetes in the label's randomized trials
Treatment
Oral empagliflozin 10 or 25 mg
Follow-up
24 weeks (placebo-controlled trials) and 52 weeks (glimepiride comparison)
Study design
Label summary of randomized trials
Funding
not stated in the source

All blood pressure and weight results are in people with type 2 diabetes. They do not describe people using anabolic-androgenic steroids.

Read the original source

What did the one rat study with an anabolic steroid find?

In 54 rats, stanozolol injured the heart muscle, and empagliflozin or platelet-rich plasma improved the measures. The steroid was stanozolol, not trenbolone, and the result is not evidence of benefit in a person.

Fifty-four albino rats were randomized to six groups: control, empagliflozin, platelet-rich plasma, stanozolol, stanozolol plus empagliflozin, and stanozolol plus platelet-rich plasma. Stanozolol produced myocardial injury with raised MDA, reduced GSH and catalase, increased IL-1 beta and NF-kB/P65 expression, caspase-3 immunoreactivity, left ventricular hypertrophy and functional impairment. Heart tissue, heart function and antioxidant measures improved with either empagliflozin or platelet-rich plasma.

This is the only record located anywhere that pairs empagliflozin with an anabolic-androgenic steroid. It is a rat model, the endpoints are tissue biomarkers and histology, and the authors say more work is needed. It does not show benefit in a person using anabolic-androgenic steroids.

Rat study: 54 rats, stanozolol with empagliflozin or platelet-rich plasma

Animal study

Hafez SM et al. BMC Pharmacol Toxicol. 2026;27(1). PMID 41731624.

Fifty-four albino rats were randomized to six groups: control, empagliflozin, platelet-rich plasma, stanozolol, stanozolol plus empagliflozin, and stanozolol plus platelet-rich plasma. Stanozolol produced myocardial injury with raised MDA, reduced GSH and catalase, increased IL-1 beta and NF-kB/P65 expression, caspase-3 immunoreactivity, left ventricular hypertrophy and functional impairment. Heart tissue, heart function and antioxidant measures improved with either empagliflozin or platelet-rich plasma. The authors say more work is needed.

Participants / model
54 albino rats across six groups
Treatment
Stanozolol with or without empagliflozin; animal dosing not stated in the source
Follow-up
not stated in the source
Study design
Randomized animal experiment
Funding
not stated in the source

This is a rat model, the steroid is stanozolol and not trenbolone, and the endpoints are tissue biomarkers and histology. It is not evidence of benefit in a person using anabolic-androgenic steroids.

Read the original source

How does empagliflozin work, and does it do what sellers say?

Empagliflozin is a sodium-glucose co-transporter 2 inhibitor that causes an osmotic diuresis. Blood pressure, heart and kidney effects are measured in diabetes, heart failure and kidney disease, and no source reviewed measured insulin sensitivity.

JARDIANCE is a sodium-glucose co-transporter 2 inhibitor. The label states that empagliflozin causes an osmotic diuresis that may lead to intravascular volume contraction and may increase hypotension risk in patients at risk for volume contraction. The label treats this as a hazard to monitor, not as a treatment for fluid retention.

On blood pressure, systolic pressure fell about 3 to 5 mm Hg in people with type 2 diabetes. On cardiac load, the benefit was shown in people with diagnosed heart failure. On kidney outcomes, it was shown in chronic kidney disease. None of the studies summarized here measured insulin sensitivity, so this page makes no insulin-resistance claim.

JARDIANCE label, version effective 30 January 2026: indications, warnings, adverse reactions

FDA prescribing information

DailyMed, U.S. National Library of Medicine. JARDIANCE (empagliflozin) film-coated oral tablets, 10 and 25 mg, prescribing information, label version effective 30 January 2026. Set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565.

JARDIANCE is a sodium-glucose co-transporter 2 inhibitor labeled for four uses: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure; to reduce the risk of sustained eGFR decline, 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 and established cardiovascular disease; and as an adjunct to diet and exercise for glycemic control in adults and children aged 10 and older with type 2 diabetes. It is not recommended for glycemic control in type 1 diabetes because it may increase diabetic ketoacidosis risk. None of the four uses is prevention or management of harm from anabolic-androgenic steroids. Warnings cover diabetic ketoacidosis in type 1 diabetes and other ketoacidosis, with assessment for ketoacidosis regardless of presenting blood glucose; volume depletion; genitourinary infections including urosepsis, pyelonephritis, necrotizing fasciitis of the perineum (Fournier's gangrene) and genital mycotic infections; and hypoglycemia with insulin secretagogues or insulin, with a higher pediatric hypoglycemia risk regardless of insulin use. It is contraindicated in hypersensitivity to empagliflozin, with angioedema reported. In a pool of five placebo-controlled adult trials (placebo versus 10 mg versus 25 mg), urinary tract infection occurred in 7.6%, 9.3% and 7.6%; female genital mycotic infections in 1.5%, 5.4% and 6.4%; male genital mycotic infections in 0.4%, 3.1% and 1.6%; increased urination in 1.0%, 3.4% and 3.2%; thirst in 0%, 1.7% and 1.5%; and nocturia in 0.4%, 0.3% and 0.8%. Volume-depletion reactions, which include decreased blood pressure, dehydration, hypotension, hypovolemia, orthostatic hypotension and syncope, occurred in 0.3%, 0.5% and 0.3%. The label states that empagliflozin causes an osmotic diuresis that may lead to intravascular volume contraction and may increase hypotension risk in patients at risk for volume contraction.

Participants / model
Adults with heart failure, chronic kidney disease or type 2 diabetes; children 10 and older with type 2 diabetes; adults in five placebo-controlled trials and postmarketing reports
Treatment
JARDIANCE film-coated oral tablets, 10 and 25 mg
Follow-up
Label version effective 30 January 2026
Study design
FDA prescribing information
Funding
not stated in the source

The diuretic effect is described in the label as a hazard, not a benefit. Ketoacidosis is a label warning; this page gives no incidence figure for it.

Read the original source
JARDIANCE label trials: systolic pressure down 2.6 to 4.8 mm Hg in type 2 diabetes

FDA prescribing information

DailyMed, U.S. National Library of Medicine. JARDIANCE (empagliflozin) film-coated oral tablets, prescribing information, clinical studies section, label version effective 30 January 2026. Set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565.

In the 24-week placebo-controlled monotherapy trial, placebo-adjusted systolic blood pressure fell by 2.6 mm Hg on 10 mg (p=0.0231) and 3.4 mm Hg on 25 mg (p=0.0028). Body weight fell by 2.8% and 3.2% versus 0.4% on placebo, placebo-adjusted 2.5% (95% CI -3.1 to -1.9) and 2.8% (95% CI -3.4 to -2.2). In the add-on to metformin trial, 24-week placebo-corrected systolic reductions were 4.1 mm Hg on 10 mg and 4.8 mm Hg on 25 mg (both p<0.0001). Against glimepiride at 52 weeks, systolic change was -3.6 mm Hg versus +2.2 mm Hg (p<0.0001). The blood pressure effect is on the order of 3 to 5 mm Hg systolic, in people with type 2 diabetes.

Participants / model
Adults with type 2 diabetes in the label's randomized trials
Treatment
Oral empagliflozin 10 or 25 mg
Follow-up
24 weeks (placebo-controlled trials) and 52 weeks (glimepiride comparison)
Study design
Label summary of randomized trials
Funding
not stated in the source

All blood pressure and weight results are in people with type 2 diabetes. They do not describe people using anabolic-androgenic steroids.

Read the original source
EMPEROR-Reduced: 3730 patients, median 16 months

Randomized controlled trial

Packer M et al. N Engl J Med. 2020;383(15):1413-1424. PMID 32865377.

The composite of cardiovascular death or hospitalization for worsening heart failure occurred in 19.4% versus 24.7% (hazard ratio 0.75, 95% CI 0.65 to 0.86, P<0.001), consistent with and without diabetes. Total heart failure hospitalizations were lower (hazard ratio 0.70, 95% CI 0.58 to 0.85, P<0.001), and annual eGFR decline was slower (-0.55 versus -2.28 mL/min/1.73 m2 per year, P<0.001). Uncomplicated genital tract infection was more frequent on empagliflozin.

Participants / model
3730 adults with class II, III or IV heart failure and ejection fraction at or below 40%
Treatment
Oral empagliflozin 10 mg or placebo, on top of recommended therapy
Follow-up
Median 16 months
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Applies to adults with heart failure and a reduced ejection fraction.

Read the original source
EMPEROR-Preserved: 5988 patients, median 26.2 months

Randomized controlled trial

Anker SD et al. N Engl J Med. 2021;385(16):1451-1461. PMID 34449189.

The composite of cardiovascular death or hospitalization for heart failure occurred in 13.8% versus 17.1% (hazard ratio 0.79, 95% CI 0.69 to 0.90, P<0.001), driven mainly by fewer heart failure hospitalizations (407 versus 541, hazard ratio 0.73, 95% CI 0.61 to 0.88, P<0.001), consistent with and without diabetes. Uncomplicated genital and urinary tract infections and hypotension were more frequent with empagliflozin.

Participants / model
5988 adults with class II to IV heart failure and ejection fraction above 40%
Treatment
Oral empagliflozin 10 mg or placebo
Follow-up
Median 26.2 months
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Applies to adults with heart failure and a preserved ejection fraction.

Read the original source
EMPA-KIDNEY: 6609 patients, median 2.0 years

Randomized controlled trial

Herrington WG et al. N Engl J Med. 2023;388(2):117-127. PMID 36331190.

The composite of kidney disease progression or cardiovascular death occurred in 13.1% versus 16.9% (hazard ratio 0.72, 95% CI 0.64 to 0.82, P<0.001), consistent with and without diabetes and across eGFR subgroups. All-cause hospitalization was lower (hazard ratio 0.86, 95% CI 0.78 to 0.95, P=0.003).

Participants / model
6609 adults with chronic kidney disease (eGFR 20 to below 45, or 45 to below 90 with a urinary albumin-to-creatinine ratio of at least 200)
Treatment
Oral empagliflozin 10 mg or placebo
Follow-up
Median 2.0 years
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Applies to adults with chronic kidney disease.

Read the original source

What warnings and side effects does the label report?

The label warns about ketoacidosis, with assessment regardless of presenting blood glucose, as well as volume depletion, genitourinary infections including Fournier's gangrene, and hypoglycemia with insulin or insulin secretagogues. It contraindicates use in hypersensitivity.

The JARDIANCE label warns about diabetic ketoacidosis in type 1 diabetes and other ketoacidosis, and instructs assessment for ketoacidosis regardless of presenting blood glucose. This page gives no incidence figure for it. The label also warns about volume depletion, with volume status and renal function assessed before starting in patients with impaired renal function, elderly patients or patients on loop diuretics.

Genitourinary warnings cover urosepsis, pyelonephritis, necrotizing fasciitis of the perineum (Fournier's gangrene) and genital mycotic infections. The label also warns about hypoglycemia with insulin secretagogues or insulin, and a higher pediatric hypoglycemia risk regardless of insulin use. It is contraindicated in hypersensitivity to empagliflozin, with angioedema reported.

In a pool of five placebo-controlled adult trials (placebo versus 10 mg versus 25 mg), urinary tract infection occurred in 7.6%, 9.3% and 7.6%, female genital mycotic infections in 1.5%, 5.4% and 6.4%, male genital mycotic infections in 0.4%, 3.1% and 1.6%, increased urination in 1.0%, 3.4% and 3.2%, and volume-depletion reactions in 0.3%, 0.5% and 0.3%. Genital infection was also more frequent on empagliflozin in EMPA-REG OUTCOME, and hypotension was more frequent in EMPEROR-Preserved.

No trial tested empagliflozin in people using anabolic-androgenic steroids, so benefit and harm in that population are unmeasured.

JARDIANCE label, version effective 30 January 2026: indications, warnings, adverse reactions

FDA prescribing information

DailyMed, U.S. National Library of Medicine. JARDIANCE (empagliflozin) film-coated oral tablets, 10 and 25 mg, prescribing information, label version effective 30 January 2026. Set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565.

JARDIANCE is a sodium-glucose co-transporter 2 inhibitor labeled for four uses: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure; to reduce the risk of sustained eGFR decline, 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 and established cardiovascular disease; and as an adjunct to diet and exercise for glycemic control in adults and children aged 10 and older with type 2 diabetes. It is not recommended for glycemic control in type 1 diabetes because it may increase diabetic ketoacidosis risk. None of the four uses is prevention or management of harm from anabolic-androgenic steroids. Warnings cover diabetic ketoacidosis in type 1 diabetes and other ketoacidosis, with assessment for ketoacidosis regardless of presenting blood glucose; volume depletion; genitourinary infections including urosepsis, pyelonephritis, necrotizing fasciitis of the perineum (Fournier's gangrene) and genital mycotic infections; and hypoglycemia with insulin secretagogues or insulin, with a higher pediatric hypoglycemia risk regardless of insulin use. It is contraindicated in hypersensitivity to empagliflozin, with angioedema reported. In a pool of five placebo-controlled adult trials (placebo versus 10 mg versus 25 mg), urinary tract infection occurred in 7.6%, 9.3% and 7.6%; female genital mycotic infections in 1.5%, 5.4% and 6.4%; male genital mycotic infections in 0.4%, 3.1% and 1.6%; increased urination in 1.0%, 3.4% and 3.2%; thirst in 0%, 1.7% and 1.5%; and nocturia in 0.4%, 0.3% and 0.8%. Volume-depletion reactions, which include decreased blood pressure, dehydration, hypotension, hypovolemia, orthostatic hypotension and syncope, occurred in 0.3%, 0.5% and 0.3%. The label states that empagliflozin causes an osmotic diuresis that may lead to intravascular volume contraction and may increase hypotension risk in patients at risk for volume contraction.

Participants / model
Adults with heart failure, chronic kidney disease or type 2 diabetes; children 10 and older with type 2 diabetes; adults in five placebo-controlled trials and postmarketing reports
Treatment
JARDIANCE film-coated oral tablets, 10 and 25 mg
Follow-up
Label version effective 30 January 2026
Study design
FDA prescribing information
Funding
not stated in the source

The diuretic effect is described in the label as a hazard, not a benefit. Ketoacidosis is a label warning; this page gives no incidence figure for it.

Read the original source
EMPA-REG OUTCOME: 7020 patients, median 3.1 years

Randomized controlled trial

Zinman B et al. N Engl J Med. 2015;373(22):2117-28. PMID 26378978.

The primary composite of cardiovascular death, nonfatal myocardial infarction or nonfatal stroke occurred in 10.5% versus 12.1% (hazard ratio 0.86, 95.02% CI 0.74 to 0.99, P=0.04 for superiority). Myocardial infarction and stroke rates did not differ significantly. Cardiovascular death was 3.7% versus 5.9% (38% relative risk reduction), hospitalization for heart failure 2.7% versus 4.1% (35% relative risk reduction) and all-cause death 5.7% versus 8.3% (32% relative risk reduction). Genital infection was more frequent on empagliflozin, with no increase in other adverse events.

Participants / model
7020 adults with type 2 diabetes at high cardiovascular risk
Treatment
Oral empagliflozin 10 or 25 mg once daily, or placebo
Follow-up
Median observation 3.1 years
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Applies to adults with type 2 diabetes at high cardiovascular risk, not to people using anabolic-androgenic steroids.

Read the original source
EMPEROR-Preserved: 5988 patients, median 26.2 months

Randomized controlled trial

Anker SD et al. N Engl J Med. 2021;385(16):1451-1461. PMID 34449189.

The composite of cardiovascular death or hospitalization for heart failure occurred in 13.8% versus 17.1% (hazard ratio 0.79, 95% CI 0.69 to 0.90, P<0.001), driven mainly by fewer heart failure hospitalizations (407 versus 541, hazard ratio 0.73, 95% CI 0.61 to 0.88, P<0.001), consistent with and without diabetes. Uncomplicated genital and urinary tract infections and hypotension were more frequent with empagliflozin.

Participants / model
5988 adults with class II to IV heart failure and ejection fraction above 40%
Treatment
Oral empagliflozin 10 mg or placebo
Follow-up
Median 26.2 months
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Applies to adults with heart failure and a preserved ejection fraction.

Read the original source
PubMed search, 9 October 2026: 1 record, a rat study; no human study

PubMed search record

PubMed search run on 9 October 2026: (empagliflozin OR SGLT2 inhibitor OR sodium-glucose cotransporter 2) AND (anabolic steroid OR anabolic-androgenic OR trenbolone OR bodybuilder OR bodybuilding). 1 record returned. ClinicalTrials.gov queries the same day for empagliflozin with anabolic androgenic steroid, and for SGLT2 inhibitor with bodybuilder or androgen users, each returned no studies.

The search returned 1 record, the rat stanozolol study. On ClinicalTrials.gov the same day, queries for empagliflozin and anabolic androgenic steroid, and for SGLT2 inhibitor with bodybuilder or androgen users, each returned no studies. No human study of empagliflozin in anabolic-androgenic steroid users, and no study of empagliflozin with trenbolone in any species, was located.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Search run on 9 October 2026
Study design
Literature and registry search
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists.

Read the original source

Why does empagliflozin sit in A tier?

Four labeled uses and four large outcome trials support the A for the approved populations. The supplier's use on anabolic steroid cycles sits outside every trial, and the only related record is a rat study.

Empagliflozin is a well-studied approved medicine, with trials on hard outcomes including death, hospitalization and kidney failure. The A reflects that an approved drug is being promoted for a use outside its label.

The supplier's use sits outside every trial population. Blood pressure fell 2.6 to 4.8 mm Hg in people with type 2 diabetes, the cardiac benefit was shown in people with diagnosed heart failure, and the label describes the diuretic effect as a hazard, not a treatment for fluid retention. No human study in anabolic-androgenic steroid users was located, and the only related record is a 54-rat stanozolol experiment.

JARDIANCE label, version effective 30 January 2026: indications, warnings, adverse reactions

FDA prescribing information

DailyMed, U.S. National Library of Medicine. JARDIANCE (empagliflozin) film-coated oral tablets, 10 and 25 mg, prescribing information, label version effective 30 January 2026. Set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565.

JARDIANCE is a sodium-glucose co-transporter 2 inhibitor labeled for four uses: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure; to reduce the risk of sustained eGFR decline, 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 and established cardiovascular disease; and as an adjunct to diet and exercise for glycemic control in adults and children aged 10 and older with type 2 diabetes. It is not recommended for glycemic control in type 1 diabetes because it may increase diabetic ketoacidosis risk. None of the four uses is prevention or management of harm from anabolic-androgenic steroids. Warnings cover diabetic ketoacidosis in type 1 diabetes and other ketoacidosis, with assessment for ketoacidosis regardless of presenting blood glucose; volume depletion; genitourinary infections including urosepsis, pyelonephritis, necrotizing fasciitis of the perineum (Fournier's gangrene) and genital mycotic infections; and hypoglycemia with insulin secretagogues or insulin, with a higher pediatric hypoglycemia risk regardless of insulin use. It is contraindicated in hypersensitivity to empagliflozin, with angioedema reported. In a pool of five placebo-controlled adult trials (placebo versus 10 mg versus 25 mg), urinary tract infection occurred in 7.6%, 9.3% and 7.6%; female genital mycotic infections in 1.5%, 5.4% and 6.4%; male genital mycotic infections in 0.4%, 3.1% and 1.6%; increased urination in 1.0%, 3.4% and 3.2%; thirst in 0%, 1.7% and 1.5%; and nocturia in 0.4%, 0.3% and 0.8%. Volume-depletion reactions, which include decreased blood pressure, dehydration, hypotension, hypovolemia, orthostatic hypotension and syncope, occurred in 0.3%, 0.5% and 0.3%. The label states that empagliflozin causes an osmotic diuresis that may lead to intravascular volume contraction and may increase hypotension risk in patients at risk for volume contraction.

Participants / model
Adults with heart failure, chronic kidney disease or type 2 diabetes; children 10 and older with type 2 diabetes; adults in five placebo-controlled trials and postmarketing reports
Treatment
JARDIANCE film-coated oral tablets, 10 and 25 mg
Follow-up
Label version effective 30 January 2026
Study design
FDA prescribing information
Funding
not stated in the source

The diuretic effect is described in the label as a hazard, not a benefit. Ketoacidosis is a label warning; this page gives no incidence figure for it.

Read the original source
EMPA-REG OUTCOME: 7020 patients, median 3.1 years

Randomized controlled trial

Zinman B et al. N Engl J Med. 2015;373(22):2117-28. PMID 26378978.

The primary composite of cardiovascular death, nonfatal myocardial infarction or nonfatal stroke occurred in 10.5% versus 12.1% (hazard ratio 0.86, 95.02% CI 0.74 to 0.99, P=0.04 for superiority). Myocardial infarction and stroke rates did not differ significantly. Cardiovascular death was 3.7% versus 5.9% (38% relative risk reduction), hospitalization for heart failure 2.7% versus 4.1% (35% relative risk reduction) and all-cause death 5.7% versus 8.3% (32% relative risk reduction). Genital infection was more frequent on empagliflozin, with no increase in other adverse events.

Participants / model
7020 adults with type 2 diabetes at high cardiovascular risk
Treatment
Oral empagliflozin 10 or 25 mg once daily, or placebo
Follow-up
Median observation 3.1 years
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Applies to adults with type 2 diabetes at high cardiovascular risk, not to people using anabolic-androgenic steroids.

Read the original source
EMPEROR-Reduced: 3730 patients, median 16 months

Randomized controlled trial

Packer M et al. N Engl J Med. 2020;383(15):1413-1424. PMID 32865377.

The composite of cardiovascular death or hospitalization for worsening heart failure occurred in 19.4% versus 24.7% (hazard ratio 0.75, 95% CI 0.65 to 0.86, P<0.001), consistent with and without diabetes. Total heart failure hospitalizations were lower (hazard ratio 0.70, 95% CI 0.58 to 0.85, P<0.001), and annual eGFR decline was slower (-0.55 versus -2.28 mL/min/1.73 m2 per year, P<0.001). Uncomplicated genital tract infection was more frequent on empagliflozin.

Participants / model
3730 adults with class II, III or IV heart failure and ejection fraction at or below 40%
Treatment
Oral empagliflozin 10 mg or placebo, on top of recommended therapy
Follow-up
Median 16 months
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Applies to adults with heart failure and a reduced ejection fraction.

Read the original source
EMPEROR-Preserved: 5988 patients, median 26.2 months

Randomized controlled trial

Anker SD et al. N Engl J Med. 2021;385(16):1451-1461. PMID 34449189.

The composite of cardiovascular death or hospitalization for heart failure occurred in 13.8% versus 17.1% (hazard ratio 0.79, 95% CI 0.69 to 0.90, P<0.001), driven mainly by fewer heart failure hospitalizations (407 versus 541, hazard ratio 0.73, 95% CI 0.61 to 0.88, P<0.001), consistent with and without diabetes. Uncomplicated genital and urinary tract infections and hypotension were more frequent with empagliflozin.

Participants / model
5988 adults with class II to IV heart failure and ejection fraction above 40%
Treatment
Oral empagliflozin 10 mg or placebo
Follow-up
Median 26.2 months
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Applies to adults with heart failure and a preserved ejection fraction.

Read the original source
EMPA-KIDNEY: 6609 patients, median 2.0 years

Randomized controlled trial

Herrington WG et al. N Engl J Med. 2023;388(2):117-127. PMID 36331190.

The composite of kidney disease progression or cardiovascular death occurred in 13.1% versus 16.9% (hazard ratio 0.72, 95% CI 0.64 to 0.82, P<0.001), consistent with and without diabetes and across eGFR subgroups. All-cause hospitalization was lower (hazard ratio 0.86, 95% CI 0.78 to 0.95, P=0.003).

Participants / model
6609 adults with chronic kidney disease (eGFR 20 to below 45, or 45 to below 90 with a urinary albumin-to-creatinine ratio of at least 200)
Treatment
Oral empagliflozin 10 mg or placebo
Follow-up
Median 2.0 years
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Applies to adults with chronic kidney disease.

Read the original source
PubMed search, 9 October 2026: 1 record, a rat study; no human study

PubMed search record

PubMed search run on 9 October 2026: (empagliflozin OR SGLT2 inhibitor OR sodium-glucose cotransporter 2) AND (anabolic steroid OR anabolic-androgenic OR trenbolone OR bodybuilder OR bodybuilding). 1 record returned. ClinicalTrials.gov queries the same day for empagliflozin with anabolic androgenic steroid, and for SGLT2 inhibitor with bodybuilder or androgen users, each returned no studies.

The search returned 1 record, the rat stanozolol study. On ClinicalTrials.gov the same day, queries for empagliflozin and anabolic androgenic steroid, and for SGLT2 inhibitor with bodybuilder or androgen users, each returned no studies. No human study of empagliflozin in anabolic-androgenic steroid users, and no study of empagliflozin with trenbolone in any species, was located.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Search run on 9 October 2026
Study design
Literature and registry search
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists.

Read the original source
Rat study: 54 rats, stanozolol with empagliflozin or platelet-rich plasma

Animal study

Hafez SM et al. BMC Pharmacol Toxicol. 2026;27(1). PMID 41731624.

Fifty-four albino rats were randomized to six groups: control, empagliflozin, platelet-rich plasma, stanozolol, stanozolol plus empagliflozin, and stanozolol plus platelet-rich plasma. Stanozolol produced myocardial injury with raised MDA, reduced GSH and catalase, increased IL-1 beta and NF-kB/P65 expression, caspase-3 immunoreactivity, left ventricular hypertrophy and functional impairment. Heart tissue, heart function and antioxidant measures improved with either empagliflozin or platelet-rich plasma. The authors say more work is needed.

Participants / model
54 albino rats across six groups
Treatment
Stanozolol with or without empagliflozin; animal dosing not stated in the source
Follow-up
not stated in the source
Study design
Randomized animal experiment
Funding
not stated in the source

This is a rat model, the steroid is stanozolol and not trenbolone, and the endpoints are tissue biomarkers and histology. It is not evidence of benefit in a person using anabolic-androgenic steroids.

Read the original source

Studies and sources

PubChem: empagliflozin identity

Chemical identity record

National Library of Medicine. PubChem compound record CID 11949646 (empagliflozin).

Empagliflozin: C23H27ClO7, 450.9 g/mol, CAS 864070-44-0. Listed synonyms include JARDIANCE and the development code BI 10773.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined molecule
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

Identity record only; it says nothing about efficacy or safety.

Read the original source
JARDIANCE label, version effective 30 January 2026: indications, warnings, adverse reactions

FDA prescribing information

DailyMed, U.S. National Library of Medicine. JARDIANCE (empagliflozin) film-coated oral tablets, 10 and 25 mg, prescribing information, label version effective 30 January 2026. Set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565.

JARDIANCE is a sodium-glucose co-transporter 2 inhibitor labeled for four uses: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure; to reduce the risk of sustained eGFR decline, 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 and established cardiovascular disease; and as an adjunct to diet and exercise for glycemic control in adults and children aged 10 and older with type 2 diabetes. It is not recommended for glycemic control in type 1 diabetes because it may increase diabetic ketoacidosis risk. None of the four uses is prevention or management of harm from anabolic-androgenic steroids. Warnings cover diabetic ketoacidosis in type 1 diabetes and other ketoacidosis, with assessment for ketoacidosis regardless of presenting blood glucose; volume depletion; genitourinary infections including urosepsis, pyelonephritis, necrotizing fasciitis of the perineum (Fournier's gangrene) and genital mycotic infections; and hypoglycemia with insulin secretagogues or insulin, with a higher pediatric hypoglycemia risk regardless of insulin use. It is contraindicated in hypersensitivity to empagliflozin, with angioedema reported. In a pool of five placebo-controlled adult trials (placebo versus 10 mg versus 25 mg), urinary tract infection occurred in 7.6%, 9.3% and 7.6%; female genital mycotic infections in 1.5%, 5.4% and 6.4%; male genital mycotic infections in 0.4%, 3.1% and 1.6%; increased urination in 1.0%, 3.4% and 3.2%; thirst in 0%, 1.7% and 1.5%; and nocturia in 0.4%, 0.3% and 0.8%. Volume-depletion reactions, which include decreased blood pressure, dehydration, hypotension, hypovolemia, orthostatic hypotension and syncope, occurred in 0.3%, 0.5% and 0.3%. The label states that empagliflozin causes an osmotic diuresis that may lead to intravascular volume contraction and may increase hypotension risk in patients at risk for volume contraction.

Participants / model
Adults with heart failure, chronic kidney disease or type 2 diabetes; children 10 and older with type 2 diabetes; adults in five placebo-controlled trials and postmarketing reports
Treatment
JARDIANCE film-coated oral tablets, 10 and 25 mg
Follow-up
Label version effective 30 January 2026
Study design
FDA prescribing information
Funding
not stated in the source

The diuretic effect is described in the label as a hazard, not a benefit. Ketoacidosis is a label warning; this page gives no incidence figure for it.

Read the original source
JARDIANCE label trials: systolic pressure down 2.6 to 4.8 mm Hg in type 2 diabetes

FDA prescribing information

DailyMed, U.S. National Library of Medicine. JARDIANCE (empagliflozin) film-coated oral tablets, prescribing information, clinical studies section, label version effective 30 January 2026. Set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565.

In the 24-week placebo-controlled monotherapy trial, placebo-adjusted systolic blood pressure fell by 2.6 mm Hg on 10 mg (p=0.0231) and 3.4 mm Hg on 25 mg (p=0.0028). Body weight fell by 2.8% and 3.2% versus 0.4% on placebo, placebo-adjusted 2.5% (95% CI -3.1 to -1.9) and 2.8% (95% CI -3.4 to -2.2). In the add-on to metformin trial, 24-week placebo-corrected systolic reductions were 4.1 mm Hg on 10 mg and 4.8 mm Hg on 25 mg (both p<0.0001). Against glimepiride at 52 weeks, systolic change was -3.6 mm Hg versus +2.2 mm Hg (p<0.0001). The blood pressure effect is on the order of 3 to 5 mm Hg systolic, in people with type 2 diabetes.

Participants / model
Adults with type 2 diabetes in the label's randomized trials
Treatment
Oral empagliflozin 10 or 25 mg
Follow-up
24 weeks (placebo-controlled trials) and 52 weeks (glimepiride comparison)
Study design
Label summary of randomized trials
Funding
not stated in the source

All blood pressure and weight results are in people with type 2 diabetes. They do not describe people using anabolic-androgenic steroids.

Read the original source
Drugs@FDA: JARDIANCE approved 1 August 2014

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application record for NDA 204629 (JARDIANCE). Date read from the openFDA Drugs@FDA record.

FDA approved JARDIANCE under NDA 204629 on 1 August 2014.

Participants / model
Not a clinical population
Treatment
Drug application
Follow-up
Approval in 2014
Study design
FDA application record
Funding
not stated in the source

This record gives the approval date. Indications come from the product label.

Read the original source
EMPA-REG OUTCOME: 7020 patients, median 3.1 years

Randomized controlled trial

Zinman B et al. N Engl J Med. 2015;373(22):2117-28. PMID 26378978.

The primary composite of cardiovascular death, nonfatal myocardial infarction or nonfatal stroke occurred in 10.5% versus 12.1% (hazard ratio 0.86, 95.02% CI 0.74 to 0.99, P=0.04 for superiority). Myocardial infarction and stroke rates did not differ significantly. Cardiovascular death was 3.7% versus 5.9% (38% relative risk reduction), hospitalization for heart failure 2.7% versus 4.1% (35% relative risk reduction) and all-cause death 5.7% versus 8.3% (32% relative risk reduction). Genital infection was more frequent on empagliflozin, with no increase in other adverse events.

Participants / model
7020 adults with type 2 diabetes at high cardiovascular risk
Treatment
Oral empagliflozin 10 or 25 mg once daily, or placebo
Follow-up
Median observation 3.1 years
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Applies to adults with type 2 diabetes at high cardiovascular risk, not to people using anabolic-androgenic steroids.

Read the original source
EMPEROR-Reduced: 3730 patients, median 16 months

Randomized controlled trial

Packer M et al. N Engl J Med. 2020;383(15):1413-1424. PMID 32865377.

The composite of cardiovascular death or hospitalization for worsening heart failure occurred in 19.4% versus 24.7% (hazard ratio 0.75, 95% CI 0.65 to 0.86, P<0.001), consistent with and without diabetes. Total heart failure hospitalizations were lower (hazard ratio 0.70, 95% CI 0.58 to 0.85, P<0.001), and annual eGFR decline was slower (-0.55 versus -2.28 mL/min/1.73 m2 per year, P<0.001). Uncomplicated genital tract infection was more frequent on empagliflozin.

Participants / model
3730 adults with class II, III or IV heart failure and ejection fraction at or below 40%
Treatment
Oral empagliflozin 10 mg or placebo, on top of recommended therapy
Follow-up
Median 16 months
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Applies to adults with heart failure and a reduced ejection fraction.

Read the original source
EMPEROR-Preserved: 5988 patients, median 26.2 months

Randomized controlled trial

Anker SD et al. N Engl J Med. 2021;385(16):1451-1461. PMID 34449189.

The composite of cardiovascular death or hospitalization for heart failure occurred in 13.8% versus 17.1% (hazard ratio 0.79, 95% CI 0.69 to 0.90, P<0.001), driven mainly by fewer heart failure hospitalizations (407 versus 541, hazard ratio 0.73, 95% CI 0.61 to 0.88, P<0.001), consistent with and without diabetes. Uncomplicated genital and urinary tract infections and hypotension were more frequent with empagliflozin.

Participants / model
5988 adults with class II to IV heart failure and ejection fraction above 40%
Treatment
Oral empagliflozin 10 mg or placebo
Follow-up
Median 26.2 months
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Applies to adults with heart failure and a preserved ejection fraction.

Read the original source
EMPA-KIDNEY: 6609 patients, median 2.0 years

Randomized controlled trial

Herrington WG et al. N Engl J Med. 2023;388(2):117-127. PMID 36331190.

The composite of kidney disease progression or cardiovascular death occurred in 13.1% versus 16.9% (hazard ratio 0.72, 95% CI 0.64 to 0.82, P<0.001), consistent with and without diabetes and across eGFR subgroups. All-cause hospitalization was lower (hazard ratio 0.86, 95% CI 0.78 to 0.95, P=0.003).

Participants / model
6609 adults with chronic kidney disease (eGFR 20 to below 45, or 45 to below 90 with a urinary albumin-to-creatinine ratio of at least 200)
Treatment
Oral empagliflozin 10 mg or placebo
Follow-up
Median 2.0 years
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Applies to adults with chronic kidney disease.

Read the original source
Rat study: 54 rats, stanozolol with empagliflozin or platelet-rich plasma

Animal study

Hafez SM et al. BMC Pharmacol Toxicol. 2026;27(1). PMID 41731624.

Fifty-four albino rats were randomized to six groups: control, empagliflozin, platelet-rich plasma, stanozolol, stanozolol plus empagliflozin, and stanozolol plus platelet-rich plasma. Stanozolol produced myocardial injury with raised MDA, reduced GSH and catalase, increased IL-1 beta and NF-kB/P65 expression, caspase-3 immunoreactivity, left ventricular hypertrophy and functional impairment. Heart tissue, heart function and antioxidant measures improved with either empagliflozin or platelet-rich plasma. The authors say more work is needed.

Participants / model
54 albino rats across six groups
Treatment
Stanozolol with or without empagliflozin; animal dosing not stated in the source
Follow-up
not stated in the source
Study design
Randomized animal experiment
Funding
not stated in the source

This is a rat model, the steroid is stanozolol and not trenbolone, and the endpoints are tissue biomarkers and histology. It is not evidence of benefit in a person using anabolic-androgenic steroids.

Read the original source

Why is Empagliflozin in A tier?

A fits an approved medicine with four labeled uses and four large outcome trials that is promoted for an off-label use. The use sold, countering the effects of anabolic steroid cycles, sits outside every trial population, and nothing in people tests it.