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Dapagliflozin oral

Updated 2 Feb 2023 | SGLT 2 inhibitors


Tablets containing dapagliflozin.

Drugs List

  • dapagliflozin 10mg tablets
  • dapagliflozin 5mg tablets
  • FORXIGA 10mg film coated tablets
  • FORXIGA 5mg film coated tablets
  • Therapeutic Indications


    Chronic kidney disease
    Symptomatic chronic cardiac failure
    Type 2 diabetes (NIDDM) not controlled by diet,weight loss & exercise alone

    Type 2 diabetes mellitus:
    a) As monotherapy when diet and exercise do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate.
    b) In combination with other glucose lowering medication including insulin where the existing regimen with diet and exercise does not provide adequate glycaemic control.

    Heart failure
    Treatment of adults with symptomatic chronic heart failure.

    Chronic kidney disease
    Treatment of adults with chronic kidney disease.



    Type 2 diabetes mellitus monotherapy or as adjunctive treatment
    10mg once daily.

    Heart failure
    10mg once daily.

    Chronic kidney disease
    10mg once daily.


    Type 2 diabetes mellitus monotherapy or as adjunctive treatment
    Children aged 10 years and above
    10mg once daily.

    Patients with Hepatic Impairment

    Severe hepatic impairment
    A starting dose of 5mg is recommended. If well tolerated, the dose may be increased to 10mg.

    Additional Dosage Information

    Type 2 diabetes mellitus monotherapy or as adjunctive treatment
    If used in combination with insulin or a sulfonylurea, a lower dose of insulin or a sulfonylurea may be considered to reduce the risk of hypoglycaemia.


    Children under 10 years
    Diabetic ketoacidosis
    Renal impairment - eGFR below 15ml/minute/1.73m sq

    Precautions and Warnings

    Children under 18 years
    Major surgery
    Patients over 65 years
    Predisposition to hypotension
    Glucose-galactose malabsorption syndrome
    Lactose intolerance
    Renal impairment - eGFR below 60 ml/minute/1.73 m squared
    Severe hepatic impairment
    Urinary tract infection

    Correct hypovolaemia prior to administration
    Exclude volume depletion before commencing treatment
    Not all available strengths are licensed for all indications
    Contains lactose
    Monitor renal function prior to initiating treatment
    Electrolyte & volume depletion may occur - interrupt treatment as necessary
    Hospitalised patients: Monitor blood ketones before restart treatment
    Monitor blood pressure
    Monitor fluid and electrolyte status
    Monitor renal function 2-4 times a year in renal impairment
    Monitor renal function annually in patients with normal renal function
    Monitor renal function if concomitant drugs that impair renal function
    Test for raised ketones in patients with symptoms of diabetic ketoacidosis
    Advise patient to report genital/perineal symptoms with fever or malaise
    Advise patient to report symptoms of diabetic ketoacidosis immediately
    Discontinue SGLT2 inhibitor if Fournier's gangrene is suspected
    Interrupt treatment temporarily in complicated urinary tract infections
    May affect results of some laboratory tests
    Test results for urinary glucose will be positive
    Interrupt therapy if acute serious illness requiring hospitalisation occurs
    Interrupt treatment in patients undergoing major surgery
    Pregnancy confirmed: Discontinue this medication
    Discontinue if diabetic ketoacidosis is suspected
    Advise patient on the need for adequate foot hygiene
    Advise patient on the need for adequate hydration
    Advise patient to report symptoms of volume depletion
    Patient to inform DVLA if fitness to drive impaired or hypoglycaemic risk

    Clinical trials suggest there is an increased risk of lower limb amputation in patients treated with another sodium-glucose co-transporter 2 (SGLT2) inhibitor. An increased risk of amputation has not yet been seen in studies of dapagliflozin. However, the increased risk of amputation cannot be excluded and caution should be advised in patients receiving dapagliflozin.

    Cases of necrotising fasciitis of the perineum (Fournier's gangrene) have been reported in patients taking SGLT2 inhibitors. This a rare but serious event that requires urgent intervention and may be preceded by genital infection or perineal abscess. Patients should be advised to report a combination of symptoms of pain, tenderness, erythema, or swelling in the genital or perineal area, accompanied by fever or malaise.

    Cases of diabetic ketoacidosis (DKA) have been reported in patient taking SGLT2 inhibitors. The signs and symptoms of DKA are rapid weight loss; feeling or being sick; stomach pain; fast and deep breathing; sleepiness; a sweet smell to the breath; a sweet or metallic taste in the mouth; or a different odour to urine or sweat. The risk factors for DKA include low beta cell function reserve; conditions leading to restricted food intake or severe dehydration; sudden reduction in insulin; increased insulin requirements due to acute illness; surgery and alcohol abuse.
    Restarting treatment in patients with previous DKA while on SGLT2 inhibitor is not recommended, unless another precipitating factor has been identified and resolved.

    Treatment for patient's with type 2 diabetes mellitus should consider additional glucose-lowering treatment if glomerular filtration rate falls persistently below 45 ml/minute.

    Patients with glomerular filtration rate below 60 ml/minute has been observed to have adverse reactions of increased parathyroid hormone (PTH) and hypotension.

    Pregnancy and Lactation


    Dapagliflozin is contraindicated during pregnancy.

    Manufacturer states that dapagliflozin should be discontinued if pregnancy is detected. There are no data from the use of dapagliflozin in pregnant women. Studies in rats have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters for human pregnancy.

    Detailed guidance on the treatment of diabetes during pregnancy is available from the National Institute for Health and Clinical Excellence (NICE) at


    Dapagliflozin is contraindicated during breastfeeding.

    Manufacturer recommends that dapagliflozin should not be used during breastfeeding. It is unknown whether dapagliflozin and/or its metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of dapagliflozin and/or its metabolites in milk, as well as pharmacologically-mediated effects in nursing offspring. A risk to the newborns/infants cannot be excluded.


    Advise the patient of the signs and symptoms of diabetic ketoacidosis (DKA) and to seek medical advice if they occur. The risk factors of DKA should be discussed with the patient.

    Advise patient on how to monitor for ketone levels and what action to take if levels are elevated.

    When dapagliflozin is used in combination with other antidiabetics, patients should be advised of the potential risk of hypoglycaemia.

    Advise patient on the need for adequate foot hygiene.

    Advise patient on the need for adequate hydration.

    Advise patient to report symptoms of volume depletion.

    Advise patient to report symptoms of pain, tenderness, erythema, or swelling in the genital or perineal area, accompanied by fever or malaise.

    Advise female patients to consult GP if pregnancy suspected or planned.

    Advise patients that their ability to drive or operate machinery may be impaired.

    Advise patient to report to DVLA if there is a risk of hypoglycaemia, or if fitness to drive may be impaired due to diabetes complications. Guidance can be found by accessing website.

    Side Effects

    Back pain
    Dry mouth
    Fournier's gangrene
    Genital infections
    Genital pruritus
    Increase in blood urea or creatinine
    Increase in haematocrit
    Plasma volume depletion
    Urinary tract infections
    Vulvovaginal infections
    Vulvovaginal itching
    Weight loss

    Effects on Laboratory Tests

    In diabetic patients taking dapagliflozin, it is advisable not to use the 1,5-anhydroglucitol (1,5 AG) assay to monitor glycaemic control. This is because measurements of 1,5 AG are unreliable in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycaemic control.


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: January 2019

    Reference Sources

    Summary of Product Characteristics: Forxiga 5mg & 10mg film coated tablets. AstraZeneca UK Ltd. Revised December 2022.

    NICE Evidence Services Available at: Last accessed: 18 August 2022

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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