Skip to main content

Dapagliflozin / metformin Side Effects

Medically reviewed by Last updated on Oct 2, 2023.

Applies to dapagliflozin / metformin: oral tablet extended release.


Oral route (Tablet, Extended Release)

Lactic AcidosisPostmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (greater than 5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally greater than 5 mcg/mL.Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (eg, carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, acute congestive heart failure), excessive alcohol intake, and hepatic impairment.Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information.If metformin-associated lactic acidosis is suspected, immediately discontinue dapagliflozin/metformin hydrochloride and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

Serious side effects

Along with its needed effects, dapagliflozin / metformin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dapagliflozin / metformin:

More common


Incidence not known

Other side effects

Some side effects of dapagliflozin / metformin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

For Healthcare Professionals

Applies to dapagliflozin / metformin: oral tablet extended release.


The most common adverse reactions reported with this combination drug included female genital mycotic infection, nasopharyngitis, urinary tract infection, diarrhea, and headache.[Ref]


Uncommon (0.1% to 1%): Volume depletion (Including dehydration, hypovolemia, orthostatic hypotension, or hypotension)[Ref]



Postmarketing reports: Rash


Uncommon (0.1% to 1%): Angioedema

Very rare (less than 0.01%): Urticaria, erythema, pruritus[Ref]


-Small increases in serum parathyroid hormone (PTH) levels were observed with increases larger in subjects with higher baseline PTH concentrations.[Ref]


Frequency not reported: Small Increase in serum parathyroid hormone levels[Ref]



Common (1% to 10%): Diarrhea, nausea, constipation


Uncommon (0.1% to 1%): Constipation, dry mouth


Very common (10% or more): Nausea, vomiting, diarrhea, abdominal pain, loss of appetite[Ref]


Common (1% to 10%): Escherichia urinary tract infection, female genital mycotic infections (including vulvovaginal mycotic infection, vaginal infection, genital infection, vulvovaginitis, fungal genital infection, vulvovaginal candidiasis, vulval abscess, vulvitis, genital candidiasis, and vaginitis bacterial), urinary tract infections (including urinary tract infection, cystitis, pyelonephritis, urethritis, and prostatitis), male genital mycotic infections (including balanitis, fungal genital infection, penile infection, trigonitis, balanitis candida, genital candidiasis, balanoposthitis, balanoposthitis infective, genital infection, posthitis), nocturia (including pollakiuria, polyuria, and increased urine output), discomfort with urination

Uncommon (0.1% to 1%): Vulvovaginal pruritus

Postmarketing reports: Fournier's gangrene, urosepsis, pyelonephritis[Ref]

Genital mycotic infections have been commonly reported with dapagliflozin treatment. Discontinuation due to genital infection occurred in 0.2% of patients in dapagliflozin clinical trials. Infections were more frequently reported in females than males, and patients with a history of genital mycotic infections were more likely to have an infection than those without a history.

In the 5 years (2013 to 2018) since SGLT2 inhibitor approval, 12 cases of Fournier's gangrene have been reported. Reports were almost equal in adults (men=7; women=5), ages ranged from 38 to 78 years, and the average time to onset after starting an SGLT2 inhibitor was 9.2 months (range 7 days to 25 months).[Ref]



Common (1% to 10): Increased hematocrit


Very rare (less than 0.01%): Decreased vitamin B12 serum levels[Ref]



Very rare (less than 0.01%): Liver function disorders, liver function tests abnormalities, hepatitis

Postmarketing reports: Cholestatic, hepatocellular, mixed hepatocellular liver injury[Ref]



Uncommon (0.1% to 1%): Serious anaphylactic reactions, severe cutaneous reactions

Frequency not reported: Hypersensitivity reactions (included urticaria, hypersensitivity)[Ref]


Common (1% to 10): Influenza[Ref]



Very common (10% or more): Hypoglycemia (when used with sulfonylurea or insulin)

Common (1% to 10%): Dyslipidemia


Common (1% to 10%): Hyperphosphatemia, increases in low-density lipoprotein cholesterol (LDL-C)

Uncommon (0.1% to 1%): Decreased weight, thirst

Postmarketing reports: Acidosis including diabetic ketoacidosis, ketoacidosis, or ketosis


Very rare (less than 0.01%): Lactic acidosis, vitamin B12 deficiency[Ref]

Hypoglycemia was reported more frequently when this drug was added to sulfonylurea or insulin (up to 43%).

Twenty reports of acidosis have been identified in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database during the period March 2013 through 06 June 2014. All patients required emergency room treatment or hospitalization. These cases were not typical of ketoacidosis or diabetic ketoacidosis (DKA) in that they occurred in patients with type 2 diabetes and their blood sugar levels were only slightly increased. Some factors identified as potentially triggering the acidosis included major illness, reduced food and fluid intake, and reduced insulin dose.[Ref]



Common (1% to 10%): Back pain


Common (1% to 10%): Pain in extremity[Ref]

Nervous system


Common (1% to 10%): Headache, dizziness


Common (1% to 10%): Taste disturbance[Ref]



Uncommon (0.1% to 1%): Bladder cancer[Ref]

Newly diagnosed bladder cancer was reported in 10 of 6045 (0.17%) patients receiving dapagliflozin in clinical trials.[Ref]


Uncommon (0.1% to 1%): Fungal infection



Uncommon (0.1% to 1%): Increased serum creatinine, increased blood urea

Frequency not reported: Decreases in eGFR, kidney infection

Postmarketing reports: Acute kidney injury and impaired renal function[Ref]

Cases of acute kidney injury have been reported during the postmarketing period with dapagliflozin. Some cases required hospitalization and dialysis; some reports were in patients less than 65 years old.[Ref]


Common (1% to 10%): Nasopharyngitis, cough, pharyngitis[Ref]

Frequently asked questions


1. Cerner Multum, Inc. "UK Summary of Product Characteristics."

2. Cerner Multum, Inc. "Australian Product Information."

3. (2014) "Product Information. Xigduo XR (dapagliflozin-metformin)." Astra-Zeneca Pharmaceuticals

4. FDA (2018) FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes.

5. FDA. U.S. Food and Drug Administration (2015) FDA: SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.