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Dapagliflozin / metformin Side Effects

In Summary

Commonly reported side effects of dapagliflozin/metformin include: lactic acidosis. Other side effects include: cystitis, pyelonephritis, urinary tract infection, vulvovaginal candidiasis, bacterial vaginosis, genital candidiasis, genitourinary infection, nasopharyngitis, prostatitis, urethritis, vaginal infection, vulvitis, vulvovaginitis, nausea, and vomiting. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to dapagliflozin / metformin: oral tablet, oral tablet extended release

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

  • Bladder pain
  • bloody or cloudy urine
  • change in the color, amount, or odor of vaginal discharge
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • lower back or side pain


  • Abdominal or stomach discomfort
  • decreased appetite
  • diarrhea
  • fast, shallow breathing
  • general feeling of discomfort
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • muscle pain or cramping
  • nausea
  • shortness of breath
  • sleepiness
  • unusual tiredness or weakness

Incidence Not Known

  • Anxiety
  • blurred vision
  • chills
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • depression
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast heartbeat
  • fever
  • headache
  • hives, itching, or rash
  • hoarseness
  • increased hunger
  • irritation
  • joint pain, stiffness, or swelling
  • nightmares
  • redness of the skin
  • seizures
  • shakiness
  • slurred speech
  • sweating
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • troubled swallowing

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

  • Back pain
  • body aches or pain
  • congestion
  • difficulty having a bowel movement (stool)
  • tender, swollen glands in the neck
  • voice changes

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]


Hypoglycemia was reported more frequently when this drug was added to sulfonylurea or insulin (up to 43%). Hypoglycemia was not reported in dapagliflozin monotherapy trials, and was reported infrequently in add-on trials with metformin, or dipeptidyl peptidase-4 inhibitors.

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]


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


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]



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


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


Very common (10% or more): Gastrointestinal symptoms such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite occurring most frequently during initiation[Ref]


Uncommon (0.1% to 1%): Adverse reactions related to reduced intravascular volume (dehydration, hypovolemia, orthostatic hypotension, or hypotension)[Ref]


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



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. Bone mineral density in patients with normal or mildly impaired renal function did not indicate bone loss over a period of 2 years.[Ref]


Frequency not reported: Small increases in serum parathyroid hormone levels[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 compared with 1 of 3512 (0.3%) patients receiving placebo or comparator. Upon excluding patients in whom exposure to study drug was less than 1 year at time of diagnosis, there were no cases associated with placebo and 4 cases with this drug. Due to the low number of cases, further studies are needed.[Ref]


Common (1% to 10%): Female genital mycotic infections (including vulvovaginal mycotic infection, vaginal infection, genital infection, vulvovaginitis, fungal genital infection, vulvovaginal candidiasis, vulval abscess, 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, balanitis candida, genital candidiasis, balanoposthitis, balanoposthitis infective, genital infection, posthitis), increased urination, discomfort with urination

Uncommon (0.1% to 1%): Vulvovaginal pruritus[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.[Ref]



Common (1% to 10): Hematocrit increased


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[Ref]



Rare (less than 0.1%): Serious anaphylactic reactions, severe cutaneous reactions, and angioedema[Ref]


Common (1% to 10%): Back pain[Ref]

Nervous system


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


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



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

Frequency not reported: Decreases in eGFR[Ref]


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


1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Xigduo XR (dapagliflozin-metFORMIN)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

4. FDA. U.S. Food and Drug Administration "FDA: SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood Available from: URL:" (2015 May 15):

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.