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This page describes the most common side effects and addresses key safety considerations regarding the use of dapagliflozin, an SGLT2 inhibitor, in patients.
Dapagliflozin is a generally well-tolerated drug, however, as with any medication, there are risks and side effects which need to be considered.
The common side effects of dapagliflozin include:1
This is not an exhaustive list. Please read below for further information on the side effects for dapagliflozin and consult the Summary of Product Characteristics for a full list of adverse reactions before prescribing.
Dapagliflozin may add to the diuretic effect of thiazide and loop diuretics, and may increase the risk of dehydration and hypotension.1
SGLT2 inhibitors can lead to a modest decrease in blood pressure so caution should be exercised in patients for where this could pose a risk such as patients on antihypertensive therapy. In case of intercurrent conditions that may lead to volume depletion, careful monitoring of volume is recommended.
Patients at risk of volume depletion and hypotension include:
Temporary interruption of treatment with dapagliflozin is recommended for patients who develop volume depletion until the depletion is corrected.
It is not recommended to initiate treatment with dapagliflozin in patients with eGFR <15 mL/min/1.73m2.
There is limited experience with initiating treatment with dapagliflozin in patients with eGFR <25 mL/min/1.73m2.
In patients with moderate renal impairment (eGFR <60 mL/min/1.73m2), a higher proportion of patients treated with dapagliflozin had adverse reactions of increase in parathyroid hormone and hypotension, compared with placebo.
The glucose lowering efficacy of dapagliflozin is dependent on renal function, and is reduced in patients with eGFR <45 mL/min/1.73m2 and is likely absent in patients with severe renal impairment.1 Therefore, if eGFR falls below 45 mL/min/1.73m2, additional glucose lowering treatment should be considered in patients with T2D.
Dapagliflozin exposure is increased in patients with severe hepatic impairment. A reduced dapagliflozin starting dose of 5 mg once daily is recommended in patients with severe hepatic impairment; if tolerated, this may be increased to 10 mg.1
Experience with dapagliflozin in NYHA class IV is limited.1
Increased haematocrit has been observed with dapagliflozin treatment. Patients with pronounced elevations in haematocrit should be monitored and investigated for underlying haematological disease.1
Dapagliflozin tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
The following safety information and considerations should be taken into account.
There are no data from the use of dapagliflozin in pregnant women therefore, its use is not recommended during the second and third trimesters of pregnancy.
When pregnancy is detected, treatment with dapagliflozin should be discontinued.
It is unknown whether dapagliflozin and/or its metabolites are excreted in human milk so the risk to the newborns/infants cannot be excluded. Dapagliflozin should not be used while breast-feeding.
Dapagliflozin has no or negligible influence on the ability to drive or use machinery. Patients should however be alerted to the risk of hypoglycaemia when dapagliflozin is used in combination with a sulphonylurea or insulin - this may cause vision problems affecting a patient’s ability to operate machines.
The elderly are at a greater risk for volume depletion and impaired renal function. They are more likely to be treated with diuretics and antihypertensive medicinal products that may cause changes in renal function (e.g., angiotensin-converting enzyme inhibitors [ACEi] and angiotensin II type 1 receptor blockers [ARB]).
The same recommendations for renal function apply to elderly patients as to all patients. Please refer to the SmPC for full dosing information.
Dapagliflozin was well-tolerated with fewer patients discontinuing, and fewer serious adverse events (AEs) vs placebo.2
Please refer to the Summary of Product Characteristics for a full list of adverse events before prescribing.
Serious Adverse Event
Select adverse events (AEs) | DECLARE (CV Outcomes Trial [CVOT] in T2D) | |
|---|---|---|
| Dapagliflozin 10 mg (n=8,574) | Placebo (n=8,569) | |
| Serious adverse event | 34.1% | 36.2% |
| Adverse event leading to discontinuation of trial regime | 8.1% | 6.9% |
| Fracture | 5.3% | 5.1% |
| Volume depletion | 2.5% | 2.4% |
| Amputation | 1.4% | 1.3% |
| Major hypoglycaemia* | 0.7% | 1.0% |
| Diabetic ketoacidosis† | 0.3% | 0.1% |
| Urinary tract infection | 1.5% | 1.6% |
| Genital infection | 0.9% | 0.1% |
| Cancer Bladder cancer Breast cancer | 5.6% 0.3% 0.4% | 5.7% 0.5% 0.4% |
| Hypersensitivity | 0.4% | 0.4% |
| Fournier's gangrene | 0.01% | 0.06% |
| Acute kidney injury | 1.5% | 2.0% |
| Hepatic event | 1.0% | 1.0% |
Not all AEs are included in the table, see Wiviott SD et al2 for the full list.
*Major hypoglycemia defined as symptomatic events requiring external assistance due to severe impairment of conciseness with prompt recovery after glucose or glucagon administration.2 †Adjudicated.
DECLARE - Dapagliflozin Effect on Cardiovascular Events
In rare cases, SGLT2 inhibitors have been reported to cause euglycemic DKA in patients. The presentation of DKA is normally atypical in patients taking dapagliflozin, with only moderately increased blood glucose levels, less than 14 mmol/L (250mg/dL). If DKA is suspected, dapagliflozin should be stopped. If dapagliflozin leads to a marked reduction of insulin need, discontinuation of FORXIGA should be considered to avoid high risk of DKA.
In the event of non-specific symptoms (for example: nausea, abdominal pain, excessive thirst, difficulty breathing, unusual fatigue or sleep problems) patients should be assessed for DKA immediately, regardless of blood glucose level. Restarting dapagliflozin/SGLT2 inhibitor treatment in patients experiencing DKA is not recommended unless another clear precipitating factor is identified and resolved.
Risk factors that need to be considered prior to initiating SGLT2 inhibitors like dapagliflozin which may predispose a patient to DKA:
Please refer to the SmPC for further information.
FORXIGA was generally well tolerated in the study population, and the overall safety profile of dapagliflozin in patients with Chronic Kidney Disease was consistent with the known profile of FORXIGA1 in type 2 diabetes.
Please refer to the Summary of Product Characteristics for a full list of adverse events before prescribing.
Serious Adverse Event
Select adverse events (AEs) | DAPA-CKD | |
|---|---|---|
| Dapagliflozin 10 mg (n=2,149) | Placebo (n=2,149) | |
| Major hypoglycaemic event | 0.7% | 1.3% |
| Diabetic ketoacidosis* | 0.0% | <0.1% |
| Amputation | 1.6% | 1.8% |
| Fracture | 4.0% | 3.2% |
| Symptoms of volume depletion | 5.9% | 4.2% |
| Acute kidney injury | 1.8% | 2.4% |
| Genital infection | <0.1%† | 0.0%† |
| Urinary Tract Infection | 0.9% | 0.7% |
| Hypersensitivity | <0.1% | 0.0% |
| Hepatic events | 0.0%‡ | <0.1%‡ |
| Fournier’s gangrene | 0.0% | 0.05% |
Not all AEs are included in the table, see Heerspink et al. 2020 for the full list.
*Adjudicated. †Urogenital infection bacterial. ‡Hepatic failure.
DAPA-CKD - Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease.
Serious Adverse Event
Select adverse events (AEs) | DAPA-CKD | |||
|---|---|---|---|---|
Patients with T2D | Patients without T2D
| |||
| Dapagliflozin 10 mg (n=1,455) | Placebo (n=1,451) | Dapagliflozin 10 mg (n=697) | Placebo (n=701) | |
| Diabetic ketoacidosis* | 0 | 2 (<1%) | - | - |
| Major hypoglycaemia | 14 (1%) | 28 (2%) | - | - |
| Volume depletion | 92 (6%) | 71 (5%) | 35 (5%) | 19 (3%) |
| Amputation | 35 (2%) | 38 (3%) | 0 | 1 (<1%) |
| Fracture | 65 (4%) | 51 (4%) | 20 (3%) | 18 (3%) |
| Renal-related AE | 121 (8%) | 148 (10%) | 34 (5%) | 40 (6%) |
| Urinary Tract Infection | 17 (1.2%) | 10 (0.7%) | 3 (0.4%) | 3 (0.4%) |
In patients with or without T2D, incidence of hyperkalaemia was 0.3% in patients on FORXIGA vs. 0.6% in patients receiving placebo.6
Rates of overall serious AEs were lower with FORXIGA vs. placebo (30% vs. 34% p=0.002).3,6
Please refer to the SmPC for full list of AEs.
DAPA-CKD - Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease
Dapagliflozin has a well established safety profile, and the overall safety profile of dapagliflozin in patients with Heart Failure was consistent with the known safety profile of dapagliflozin in T2D.4,5,8,9
Please refer to the Summary of Product Characteristics for a full list of adverse events before prescribing.
Serious Adverse Event
Select adverse events (AEs)
| DAPA-HF (HFrEF, LVEF ≤40%) | DELIVER (HFpEF and HFmEF,
| ||
|---|---|---|---|---|
| Dapagliflozin 10 mg (n=2368) | Placebo (n=2368) | Dapagliflozin 10 mg (n=3126) | Placebo (n=3127) | |
| Major hypoglycaemic event | 0.2% | 0.2% | 0.2% | 0.2% |
| Diabetic ketoacidosis* | 0.1% | 0.0% | 0.1% | 0.0% |
| Amputation | 0.5% | 0.5% | 0.6% | 0.8% |
| Fracture | 2.1% | 2.1% | NR | NR |
| Symptoms of volume depletion | 7.5% | 6.8% | 1.3% | 1.0% |
| Acute kidney injury | 1.0% | 1.9% | 1.5% | 1.6% |
| Genital infection | NR | NR | NR | NR |
| Urinary Tract Infection | 0.5% | 0.7% | 1.0% | 1.0% |
| Hypersensitivity | NR | NR | NR | NR |
| Hepatic events | <0.1%† | 0.0%† | NR | NR |
| Fournier’s gangrene | 0.0% | <0.1% | 0.0% | 0.0% |
Not all AEs are included in the table, see supplementary appendix to McMurray et al.4 and Solomon et al.5 for the full list. NR = Not recorded.
*Adjudicated. †Hepatic failure.
For illustrative purposes only. Direct comparisons cannot be made due to differences in study design, study population and endpoints.
DAPA-HF - Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure; DELIVER - Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure.
Select adverse events (AEs) | DAPA-HF | |||
|---|---|---|---|---|
Patients with T2D | Patients without T2D
| |||
| Dapagliflozin 10 mg (n=1,455) | Placebo (n=1,451) | Dapagliflozin 10 mg (n=697) | Placebo (n=701) | |
| Diabetic ketoacidosis* | 0.3% | 0.0% | 0.0% | 0.0% |
| Major hypoglycaemia | 0.4% | 0.4% | 0.0% | 0.0% |
| Volume depletion | 7.8% | 7.8% | 7.3% | 6.1% |
| Amputation | 1.1% | 0.8% | 0.1% | 0.2% |
| Fracture | 2.1% | 2.4% | 2.1% | 1.9% |
| Kidney adverse event | 8.5% | 8.7% | 4.8% | 6.0% |
| Discontinuation rates due to AEs | 4.0% | 5.4% | 5.3% | 4.5% |
*Adjudicated.
DAPA-HF - Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure.
GB-70101 | DOP: September 2025
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AstraZeneca by visiting https://contactazmedical.astrazeneca.com/ or by calling 0800 783 0033.
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