SGLT2 Inhibitor Pregnancy: Not recommended during the second and third trimesters of pregnancy — there are no data in pregnant women and rat studies show toxicity to the developing kidney in the period corresponding to the human second and third trimesters. Treatment should be discontinued when pregnancy is detected. Dapagliflozin should not be used while breast-feeding (animal data show excretion in milk and pharmacologically mediated effects in nursing offspring; a risk to the newborn/infant cannot be excluded).

Dapagliflozin

Brand names: Forxiga

Dapagliflozin is an SGLT2 inhibitor used in type 2 diabetes and, independently of diabetes, in heart failure and chronic kidney disease, where it has cardiovascular and renal benefits.

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

Route: Oral — tablets swallowed whole, with or without food, at any time of day

Frequency: Once daily

The same 10 mg once-daily dose applies to all three licensed indications in the fetched UK SPC §4.2: type 2 diabetes mellitus, heart failure, and chronic kidney disease. COMBINATION CAUTION: when dapagliflozin is used with insulin or an insulin secretagogue such as a sulphonylurea, a lower dose of the insulin or secretagogue may be considered to reduce the risk of hypoglycaemia. HEPATIC IMPAIRMENT: no dose adjustment in mild or moderate impairment; in severe hepatic impairment a starting dose of 5 mg is recommended, increased to 10 mg if well tolerated. ELDERLY (65 years and over): no dose adjustment recommended based on age. DIABETIC KETOACIDOSIS: rare cases, including life-threatening and fatal cases and cases with only moderately raised blood glucose below 14 mmol/L (250 mg/dL), have been reported with SGLT2 inhibitors — assess for ketoacidosis immediately if non-specific symptoms occur regardless of blood glucose, stop dapagliflozin if DKA is suspected or diagnosed, and interrupt treatment in patients hospitalised for major surgery or acute serious medical illness (the US label advises withholding for at least 3 days, if possible, before surgery or procedures with prolonged fasting, and resuming when clinically stable with oral intake resumed). VOLUME STATUS: dapagliflozin increases diuresis and modestly lowers blood pressure — use caution in patients on antihypertensives, with a history of hypotension, or elderly patients, and interrupt treatment temporarily in patients who develop volume depletion until corrected. US LABELLING DIFFERS FOR GLYCAEMIC CONTROL: FARXIGA is started at 5 mg once daily to improve glycaemic control, increased to 10 mg once daily if additional control is needed; 10 mg once daily for all other indications. PAEDIATRIC: no dose adjustment is required for the treatment of type 2 diabetes mellitus in children aged 10 years and above; no data are available below 10 years; safety and efficacy for heart failure or chronic kidney disease in children under 18 have not been established. Verify any paediatric use against a children's formulary.

Dose adjustments

Renal

No dose adjustment is required based on renal function. It is not recommended to initiate treatment in patients with an eGFR below 15 mL/min/1.73m2. In type 2 diabetes the glucose-lowering efficacy is reduced when eGFR is below 45 mL/min/1.73m2 and is likely absent in severe renal impairment, so additional glucose-lowering treatment should be considered if eGFR falls below 45 mL/min/1.73m2. (US label: do not use for glycaemic control if eGFR is below 45 mL/min/1.73m2; for non-glycaemic indications do not initiate below eGFR 25 mL/min/1.73m2, but patients already on treatment may continue 10 mg once daily if eGFR falls below 25.)

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

US labelling (FDA)

Reference — US labelling, may differ from UK

• Assess volume status and correct volume depletion before initiating. (2.1) eGFR (mL/min/1.73 m 2 ) Recommended Dose eGFR 45 or greater To improve glycemic control, the recommended starting dose is 5 mg orally once daily. Dose can be increased to 10 mg orally once daily for additional glycemic control. For all other indications, the recommended starting dose is 10 mg orally once daily. eGFR 25 to less than 45 10 mg orally once daily eGFR less than 25 Initiation is not recommended; however, patients may continue 10 mg orally once daily to reduce the risk of eGFR decline, ESKD, CV death and hHF. • Withhold FARXIGA for at least 3 days, if possible, prior to major surgery or procedures …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2023-12-12. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

Hypersensitivity to dapagliflozin or to any of the excipients (the US label specifies a history of serious hypersensitivity reaction, including reported anaphylaxis and angioedema)

Side effects

Genital infections (genital mycotic infections) — the most frequently reported adverse reactions across the clinical studies
Urinary tract infections; nasopharyngitis (US label: 5% or greater incidence)
Volume depletion and hypotension, particularly in the elderly, in renal impairment, at low systolic blood pressure and on diuretics
Diabetic ketoacidosis — rare, including life-threatening and fatal cases, and may present with only moderately raised blood glucose
Hypoglycaemia when used with insulin or an insulin secretagogue
Necrotising fasciitis of the perineum (Fournier's gangrene), urosepsis and pyelonephritis; increased parathyroid hormone and hypotension were more frequent in moderate renal impairment (eGFR < 60 mL/min/1.73m2)

Interactions

Insulin and insulin secretagogues (e.g. sulphonylureas) — increased risk of hypoglycaemia; a lower dose of the insulin or secretagogue may be required
Lithium — concomitant use of an SGLT2 inhibitor may decrease serum lithium concentrations; monitor lithium levels more frequently on initiation and dose changes
Diuretics and antihypertensives — additive volume depletion/hypotension risk; assess and correct volume status before initiating
Urine glucose tests — SGLT2 inhibitors increase urinary glucose excretion and cause positive results; do not use urine glucose to monitor glycaemic control
1,5-anhydroglucitol (1,5-AG) assay — unreliable for assessing glycaemic control in patients taking SGLT2 inhibitors

Clinical monograph

How it works

It blocks the sodium-glucose co-transporter 2 in the proximal renal tubule, increasing urinary glucose and sodium excretion; its heart-failure and kidney benefits are only partly explained by glucose lowering.

Prescribing in practice

There is a risk of diabetic ketoacidosis, which can occur with near-normal glucose — withhold during acute illness, fasting or surgery (sick-day rules) and counsel on warning symptoms.
Genital and urinary infections and volume depletion can occur, especially with diuretics; a small early dip in eGFR is expected and not a reason to stop.
It is not relied upon for glucose lowering at low eGFR, though cardiorenal indications extend to lower eGFR thresholds.

Monitoring

Monitor renal function and volume status; remain alert to ketoacidosis symptoms regardless of blood glucose.

Counselling the patient

Follow sick-day rules — stop temporarily if you are acutely unwell, vomiting, or not eating, and seek advice.
Maintain genital hygiene and report symptoms of infection.
Seek urgent help for nausea, vomiting, abdominal pain or breathlessness even if your sugar is normal.

Evidence & guidelines

SGLT2 inhibitors are recommended in HFrEF and in CKD (e.g. DAPA-HF, DAPA-CKD) and in type 2 diabetes with cardiovascular risk, per NICE guidance.

Reference: NICE TA679; NICE TA775; DAPA-HF Trial (NEJM 2019); DELIVER Trial (NEJM 2022); 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).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Drugs

Pathways