Evigrade

Empagliflozin

AEMPS

Sodium-glucose co-transporter 2 inhibitors (SGLT2i)

ATC code: A10BK03

Brand names: Jardiance

Updated · Methodology

Indications

A

Chronic kidney disease

First line

Per KDIGO 2024, SGLT2 inhibitors are recommended in CKD with eGFR ≥ 20 mL/min/1.73 m², with or without albuminuria. EMPA-KIDNEY (6,609 patients) showed a 28 % reduction in CKD progression or cardiovascular death. Benefit is similar with or without diabetes. Combined with maximally tolerated ACEi/ARB therapy.

ICD-10: N18 · ICD-11: GB61

A

Heart failure

First line

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Weight loss

Not recommended

International guidelines do not support empagliflozin for weight loss in non-diabetic patients without HF, CKD, or established CVD. The 2–3 kg weight reduction is modest and does not exceed lifestyle change. Drugs approved for obesity are GLP-1 agonists (semaglutide, liraglutide) and tirzepatide. Self-prescription of SGLT2 inhibitors «for weight loss» is unsafe: euglycemic ketoacidosis and genitourinary infections without a metabolic indication are unjustified.

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Selective reversible inhibitor of SGLT2 in the proximal renal tubules. Reduces glucose and sodium reabsorption, producing glycosuria and mild osmotic diuresis. Lowers by 0.5–1 %, body weight by 2–3 kg, and systolic BP by 4–5 mmHg. Cardioprotective and renoprotective effects extend beyond glucose-lowering and involve hemodynamic, metabolic, and anti-inflammatory mechanisms.

Safety

Contraindications

  • Hypersensitivity
  • Type 1 diabetes (ketoacidosis risk)
  • Severe renal impairment — eGFR below 20 mL/min/1.73 m² in most current labels
  • Pregnancy and breastfeeding

Serious adverse effects

  • Euglycemic diabetic ketoacidosis
  • Fournier gangrene (very rare)
  • Acute kidney injury (with hypovolemia)
  • Severe urinary tract infection, pyelonephritis

Common adverse effects

  • Genitourinary fungal infections (vulvovaginitis, balanitis)
  • Polyuria, nocturia
  • Thirst, mild dehydration
  • Hypoglycemia (only with insulin or sulfonylureas)

Pregnancy: can you take Empagliflozin?

EMA summary of product characteristics (section 4.6): there are no data on empagliflozin use in pregnant women. In animals, empagliflozin crossed the placenta to a very limited extent late in gestation and showed no direct or indirect harmful effects on early embryonic development, but animal studies did show adverse effects on postnatal development. As a precaution, it is preferable to avoid empagliflozin during pregnancy.

Breastfeeding: can you take Empagliflozin?

Breast milk transfer data are limited. The manufacturer label states a contraindication. Choose an alternative in breastfeeding patients.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Take once daily in the morning, with or without food. Morning dosing minimizes nocturnal polyuria. Maintain adequate hydration at initiation and during intercurrent illness with dehydration risk — glycosuric diuresis increases the risk of hypovolemia and AKI.

Monitoring

Before starting: eGFR, creatinine, electrolytes, ketones. At 4 weeks and every 6–12 months thereafter: eGFR, creatinine. Temporarily discontinue around surgery, fasting, and severe intercurrent illness — risk of euglycemic diabetic ketoacidosis. Counsel patients with risk factors for fungal infection on urogenital infection signs.

Special situations

Euglycemic diabetic ketoacidosis is rare but life-threatening and occurs at normal glucose levels. Triggers: fasting, low-carb diet, surgery, alcohol, infection. With nausea, vomiting, abdominal pain, or dyspnea, urgently check blood or urine ketones regardless of glucose. Fournier gangrene (necrotizing perineal fasciitis) has been reported as a rare severe complication — with pain, swelling, or erythema in the perineum, stop the drug and seek surgical evaluation immediately.

Drug–drug interactions

2 pairs found. Sorted from critical to minor.

ModerateAmlodipineCalcium channel blockers (dihydropyridines)

Mechanism

SGLT2 inhibitors (empagliflozin) cause osmotic diuresis and mild hypovolaemia. Combined with amlodipine: risk of hypotension and acute kidney injury in dehydration.

Symptoms

Lower blood pressure, postural dizziness, fatigue. Older patients: fall risk.

Management

Standard combination in type 2 diabetes with hypertension. In hypovolaemia (dehydration, vomiting, diarrhoea), temporarily stop empagliflozin. Check blood pressure and creatinine 2 weeks after start.

Pair details →Amlodipine →

ModerateBisoprololSelective beta-adrenergic blockers

Mechanism

Empagliflozin (SGLT2 inhibitor) causes osmotic diuresis and mild hypovolaemia. Combined with a beta-blocker: additive orthostatic hypotension risk, especially in the first weeks.

Symptoms

Lower blood pressure, postural dizziness, fatigue. Older patients: fall risk. With additional antihypertensives: bradycardia (pulse below 60/min).

Management

The combination is part of guideline-directed therapy in heart failure with reduced ejection fraction and type 2 diabetes. In hypovolaemia (dehydration, vomiting, diarrhoea), temporarily stop empagliflozin. Check blood pressure and creatinine 2 weeks after start.

Pair details →Bisoprolol →

Label mentions26 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • Majorinsulinclass named in the label
    «DRUG INTERACTIONS: 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…»

    FDA, section 7 · Open on DailyMed

  • «No se ha estudiado el efecto de la inducción de la UGT (p. ej., inducción por rifampicina o por fenitoína) sobre empagliflozina. No se recomienda el tratamiento concomitante con inductores de las…»

    AEMPS, section 4.5 · Open on CIMA

  • «No se ha estudiado el efecto de la inducción de la UGT (p. ej., inducción por rifampicina o por fenitoína) sobre empagliflozina. No se recomienda el tratamiento concomitante con inductores de las…»

    AEMPS, section 4.5 · Open on CIMA

  • Majorsulfonylureasclass named in the label
    «DRUG INTERACTIONS: 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…»

    FDA, section 7 · Open on DailyMed

  • ModerateLithium
    «Empagliflozina puede aumentar la excreción renal de litio y reducir así los niveles sanguíneos de litio. Se debe monitorizar la concentración sérica de litio con mayor frecuencia después del inicio…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateLithium
    «DRUG INTERACTIONS: Intervention Monitor serum lithium concentration more frequently during JARDIANCE initiation and dosage changes.»

    FDA, section 7 · Open on DailyMed

  • anticonceptivos hormonalesclass named in the label
    «Los estudios de interacciones realizados en voluntarios sanos sugieren que empagliflozina no tuvo ningún efecto clínicamente relevante sobre la farmacocinética de metformina, glimepirida…»

    AEMPS, section 4.5 · Open on CIMA

  • «Empagliflozina no inhibe la gp ‑ P a dosis terapéuticas. En base a los estudios in vitro , se considera improbable que empagliflozina provoque interacciones con principios activos que sean sustratos…»

    AEMPS, section 4.5 · Open on CIMA

  • diuréticosclass named in the label
    «Diuréticos: Empagliflozina puede aumentar el efecto diurético de las tiazidas y de los diuréticos del asa y puede aumentar el riesgo de deshidratación e hipotensión (ver sección 4.4).»

    AEMPS, section 4.5 · Open on CIMA

  • diuréticos del asaclass named in the label
    «Diuréticos: Empagliflozina puede aumentar el efecto diurético de las tiazidas y de los diuréticos del asa y puede aumentar el riesgo de deshidratación e hipotensión (ver sección 4.4).»

    AEMPS, section 4.5 · Open on CIMA

  • diureticsclass named in the label
    «DRUG INTERACTIONS: Diuretics»

    FDA, section 7 · Open on DailyMed

  • «Un estudio de interacción con gemfibrozilo, un inhibidor in vitro de los transportadores OAT3 y OATP1B1/1B3, mostró que la C max de empagliflozina aumentaba en un 15 % y el AUC aumentaba en un 59 %…»

    AEMPS, section 4.5 · Open on CIMA

  • «Los estudios de interacciones sugieren que la farmacocinética de empagliflozina no se vio influida por la administración conjunta de metformina, glimepirida, pioglitazona, sitagliptina, linagliptina…»

    AEMPS, section 4.5 · Open on CIMA

  • «Los estudios de interacciones sugieren que la farmacocinética de empagliflozina no se vio influida por la administración conjunta de metformina, glimepirida, pioglitazona, sitagliptina, linagliptina…»

    AEMPS, section 4.5 · Open on CIMA

  • «Los estudios de interacciones sugieren que la farmacocinética de empagliflozina no se vio influida por la administración conjunta de metformina, glimepirida, pioglitazona, sitagliptina, linagliptina…»

    AEMPS, section 4.5 · Open on CIMA

  • «Los estudios de interacciones sugieren que la farmacocinética de empagliflozina no se vio influida por la administración conjunta de metformina, glimepirida, pioglitazona, sitagliptina, linagliptina…»

    AEMPS, section 4.5 · Open on CIMA

  • «Los estudios de interacciones sugieren que la farmacocinética de empagliflozina no se vio influida por la administración conjunta de metformina, glimepirida, pioglitazona, sitagliptina, linagliptina…»

    AEMPS, section 4.5 · Open on CIMA

  • «Los estudios de interacciones sugieren que la farmacocinética de empagliflozina no se vio influida por la administración conjunta de metformina, glimepirida, pioglitazona, sitagliptina, linagliptina…»

    AEMPS, section 4.5 · Open on CIMA

  • «Los estudios de interacciones sugieren que la farmacocinética de empagliflozina no se vio influida por la administración conjunta de metformina, glimepirida, pioglitazona, sitagliptina, linagliptina…»

    AEMPS, section 4.5 · Open on CIMA

  • «Los estudios de interacciones sugieren que la farmacocinética de empagliflozina no se vio influida por la administración conjunta de metformina, glimepirida, pioglitazona, sitagliptina, linagliptina…»

    AEMPS, section 4.5 · Open on CIMA

  • sulfonilureasclass named in the label
    «Insulina y secretagogos de insulina: La insulina y los secretagogos de insulina, como las sulfonilureas, pueden aumentar el riesgo de hipoglucemia. Por lo tanto, puede necesitarse una dosis más baja…»

    AEMPS, section 4.5 · Open on CIMA

  • tiazidasclass named in the label
    «Diuréticos: Empagliflozina puede aumentar el efecto diurético de las tiazidas y de los diuréticos del asa y puede aumentar el riesgo de deshidratación e hipotensión (ver sección 4.4).»

    AEMPS, section 4.5 · Open on CIMA

  • «Los estudios de interacciones sugieren que la farmacocinética de empagliflozina no se vio influida por la administración conjunta de metformina, glimepirida, pioglitazona, sitagliptina, linagliptina…»

    AEMPS, section 4.5 · Open on CIMA

  • «La exposición a empagliflozina fue similar con y sin la administración conjunta de verapamilo, un inhibidor de la gp ‑ P, lo que indica que la inhibición de la gp ‑ P no tiene un efecto clínicamente…»

    AEMPS, section 4.5 · Open on CIMA

  • «Los estudios de interacciones sugieren que la farmacocinética de empagliflozina no se vio influida por la administración conjunta de metformina, glimepirida, pioglitazona, sitagliptina, linagliptina…»

    AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

  • «Interacciones que disminuyen los niveles de litio: Empagliflozina»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Empagliflozin used for?

Empagliflozin is evaluated for the following indications with varying evidence strength: Heart failure (evidence tier A), Type 2 diabetes mellitus (evidence tier A), Chronic kidney disease (evidence tier A). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Empagliflozin?

Common side effects of Empagliflozin (≥ 1 in 100): Genitourinary fungal infections (vulvovaginitis, balanitis), Polyuria, nocturia, Thirst, mild dehydration, Hypoglycemia (only with insulin or sulfonylureas). See the Safety section for uncommon and serious reactions.

Is Empagliflozin safe during pregnancy?

EMA summary of product characteristics (section 4.6): there are no data on empagliflozin use in pregnant women. In animals, empagliflozin crossed the placenta to a very limited extent late in gestation and showed no direct or indirect harmful effects on early embryonic development, but animal studies did show adverse effects on postnatal development. As a precaution, it is preferable to avoid empagliflozin during pregnancy.

Is Empagliflozin compatible with breastfeeding?

Breast milk transfer data are limited. The manufacturer label states a contraindication. Choose an alternative in breastfeeding patients.

Can you drink alcohol while taking Empagliflozin?

Triggers: fasting, low-carb diet, surgery, alcohol, infection.

Who should not take Empagliflozin?

Empagliflozin is contraindicated in: Hypersensitivity; Type 1 diabetes (ketoacidosis risk); Severe renal impairment — eGFR below 20 mL/min/1.73 m² in most current labels; Pregnancy and breastfeeding. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Glibenclamide, Gliclazide, Glimepiride, Insulin, Insulin glulisine, Metformin, Sitagliptin + Metformin, Insulin aspart