SGLT2 Inhibitor Pregnancy: There are no data from the use of empagliflozin in pregnant women; animal studies show very limited placental transfer in late gestation and no direct or indirect harmful effects on early embryonic development, but adverse effects on postnatal development have been shown. As a precautionary measure it is preferable to avoid the use of empagliflozin during pregnancy. No human data are available on excretion into milk and empagliflozin is excreted in animal milk, so a risk to the newborn/infant cannot be excluded - empagliflozin should not be used during breast-feeding.

Empagliflozin (Heart Failure / CKD)

Brand names: Jardiance

This page covers empagliflozin used for chronic heart failure and chronic kidney disease, an SGLT2 inhibitor that improves cardiorenal outcomes independently of its glucose-lowering action.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 10 mg empagliflozin once daily - the recommended dose for heart failure, and the recommended dose for chronic kidney disease.

Route: Oral - tablets can be taken with or without food, swallowed whole with water

Frequency: Once daily

Max: The maximum daily dose is 25 mg, but the 25 mg dose applies to type 2 diabetes mellitus only (in patients tolerating 10 mg once daily who have an eGFR of 60 mL/min/1.73 m2 or above and need tighter glycaemic control). The SPC gives 10 mg once daily for heart failure and for chronic kidney disease with no uptitration.

Type 2 diabetes mellitus regimen, for reference only: recommended starting dose 10 mg once daily for monotherapy and for add-on combination therapy with other diabetes medicines; in patients tolerating 10 mg once daily who have an eGFR of 60 mL/min/1.73 m2 or above and need tighter glycaemic control the dose can be increased to 25 mg once daily. All indications: when empagliflozin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia. Missed dose: take it as soon as the patient remembers, but do not take a double dose on the same day. Hepatic impairment: no dose adjustment is required, but exposure is increased in severe hepatic impairment where therapeutic experience is limited and use is therefore not recommended. Elderly: no dose adjustment recommended based on age; in patients 75 years and older an increased risk of volume depletion should be taken into account. PAEDIATRIC: the SPC paediatric paragraph gives a recommended starting dose of 10 mg empagliflozin once daily, increasable to 25 mg once daily in patients tolerating 10 mg and requiring additional glycaemic control - this is a fixed dose (not per-kg) and it is a glycaemic-control dose. No data are available for children with an eGFR below 60 mL/min/1.73 m2 or below 10 years of age, and the safety and efficacy of empagliflozin for the treatment of HEART FAILURE or of CHRONIC KIDNEY DISEASE in children under 18 years have NOT been established (no data available) - so no paediatric dose exists for this page's indications. Verify any under-18 use against a children's formulary. Source: eMC SPC for Empagliflozin 10 mg film-coated tablets (previously known as Jardiance).

Dose adjustments

Renal

Due to limited experience, it is not recommended to initiate treatment with empagliflozin in patients with an eGFR below 20 mL/min/1.73 m2. In patients with an eGFR below 60 mL/min/1.73 m2 the daily dose of empagliflozin is 10 mg. In patients with type 2 diabetes mellitus the glucose-lowering efficacy is reduced when eGFR is below 45 mL/min/1.73 m2 and likely absent below 30 mL/min/1.73 m2, so if eGFR falls below 45 mL/min/1.73 m2 additional glucose-lowering treatment should be considered if needed.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients

Side effects

Genital infections - vaginal moniliasis, vulvovaginitis, balanitis and other genital infection (common)
Urinary tract infection, including pyelonephritis and urosepsis (common)
Hypoglycaemia when used with a sulphonylurea or insulin (very common in that combination); thirst (common)
Volume depletion (common) - the most frequent adverse reaction in the pooled EMPEROR-Reduced and EMPEROR-Preserved heart failure studies (empagliflozin 10 mg 11.4% vs placebo 9.7%)
Pruritus (generalised), rash (common); urticaria and angioedema (uncommon); constipation (common)
Diabetic ketoacidosis, including life-threatening and fatal cases, sometimes with only moderately raised blood glucose (rare); necrotising fasciitis of the perineum (Fournier's gangrene) (very rare)

Interactions

Sulphonylureas and insulin - when empagliflozin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (SPC section 4.2)
NOTE: SPC section 4.5 was not retrieved in this bundle - verify the full interactions section before publishing

Clinical monograph

How it works

It inhibits sodium-glucose co-transporter 2 in the proximal renal tubule, increasing urinary glucose and sodium excretion, which reduces preload, intraglomerular pressure and cardiac and renal stress.

Prescribing in practice

Counsel on the risk of euglycaemic diabetic ketoacidosis, which can occur with near-normal blood glucose, and advise withholding the drug during acute illness, dehydration or before surgery (sick-day guidance).
Increased risk of genital mycotic and urinary tract infections, including rare Fournier's gangrene of the perineum.
An expected small initial dip in renal function and an osmotic diuretic effect mean diuretic co-therapy may need review to avoid volume depletion.

Monitoring

Check renal function before starting and periodically thereafter, and reassess volume status, particularly when used alongside other diuretics.

Counselling the patient

Stop the medicine and seek urgent advice if you are unwell, vomiting or not eating, and know the symptoms of ketoacidosis even if blood sugar is normal.
Maintain good genital hygiene and report any genital or perineal pain, swelling or redness promptly.
This medicine protects your heart and kidneys even if you do not have diabetes.

Evidence & guidelines

The EMPEROR-Reduced, EMPEROR-Preserved and EMPA-KIDNEY trials demonstrated reductions in heart failure hospitalisation and chronic kidney disease progression, supporting NICE recommendations.

Reference: EMPEROR-Reduced (Packer et al. NEJM 2020); EMPEROR-Preserved (Anker et al. NEJM 2021); EMPA-KIDNEY (NEJM 2023); NICE TA679; MHRA SPC Jardiance; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

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