Note: This document contains side effect information about dapagliflozin / metformin. Some of the dosage forms listed on this page may not apply to the brand name Xigduo XR.
Common side effects of Xigduo XR 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.
Applies to dapagliflozin / metformin: oral tablet extended release
Oral route (Tablet, Extended Release)
Fatal metformin-associated lactic acidosis has been reported during postmarketing surveillance. The onset is often subtle and subtle and accompanied only by nonspecific symptoms (eg, malaise, myalgias, respiratory distress, somnolence, abdominal pain). Risk factors include concomitant carbonic anhydrase inhibitor use (eg, topiramate), age 65 or older, surgery and other procedures, radiological study with contrast, hypoxic states, excessive alcohol consumption, or hepatic impairment. If suspected, discontinue use and initiate hemodialysis and general supportive measures.
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:
Incidence not known
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:
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.
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.
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
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
Uncommon (0.1% to 1%): Adverse reactions related to reduced intravascular volume (dehydration, hypovolemia, orthostatic hypotension, or hypotension)
Common (1% to 10%): Nasopharyngitis, cough, pharyngitis
Postmarketing reports: Rash
Very rare (less than 0.01%): Urticaria, erythema, pruritus
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.
Frequency not reported: Small increases in serum parathyroid hormone levels
Uncommon (0.1% to 1%): Bladder cancer
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.
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
Postmarketing reports: Fournier's gangrene
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 men and women (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). All SGLT2 inhibitor drugs except ertugliflozin were included in the reports. Ertugliflozin being the most recently approved agent, is expected to have the same risk, but insufficient patient use to assess risk. All patients were hospitalized, all required surgery, all required surgical debridement, 5 required more than 1 surgery and 1 required skin grafting. Four cases were complicated by diabetic ketoacidosis, acute kidney injury, and septic shock, leading to prolonged hospitalization, and death in 1 case. In the general population, Fournier's gangrene occurs in about 1.6 out of 100,000 males annually, with the highest incidence in men 50 to 79 years. Since diabetes is a risk factor for Fournier's gangrene, a review of the FAERS database for the last 34 years was done and only 6 cases (all males, median age 57 years) were found with several other classes of antidiabetic drugs. Findings with SGLT2 inhibitors appear to show an association over a shorter time frame and involve both males and females.
Common (1% to 10): Hematocrit increased
Very rare (less than 0.01%): Decreased vitamin B12 serum levels
Very rare (less than 0.01%): Liver function disorders, liver function tests abnormalities, hepatitis
Postmarketing reports: Cholestatic, hepatocellular, and mixed hepatocellular liver injury
Rare (less than 0.1%): Serious anaphylactic reactions, severe cutaneous reactions, and angioedema
Common (1% to 10%): Back pain
Common (1% to 10%): Headache, dizziness,
Common (1% to 10%): Taste disturbance
Uncommon (0.1% to 1%): Increased serum creatinine, blood urea increased
Frequency not reported: Decreases in eGFR
Postmarketing reports: Acute kidney injury and impaired renal function
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.
Common (1% to 10): Influenza
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Xigduo Xr