Note: This document contains side effect information about dapagliflozin / saxagliptin. Some of the dosage forms listed on this page may not apply to the brand name Qtern.
Applies to dapagliflozin/saxagliptin: oral tablet
Along with its needed effects, dapagliflozin / saxagliptin 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 / saxagliptin:
Incidence not known
Some side effects of dapagliflozin / saxagliptin 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 / saxagliptin: oral tablet
The more commonly reported adverse reactions have been upper respiratory tract infection, urinary tract infection, and dyslipidemia.
With this therapy, adverse reactions related to decreased renal function occurred in 2% of patients and included decreased glomerular filtration rate, renal impairment, increased blood creatinine, acute renal failure, and decreased urine output. None of the events were serious. Three subjects discontinued therapy due to decreased eGFR.
Postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, have been received in patients receiving dapagliflozin. Some cases have occurred in non-elderly patients.
Common (1% to 10%): Renal impairment
Frequency not reported: Serum creatinine increases, eGFR decreases
Postmarketing reports: Acute kidney injury
Common (1% to 10%): Urinary tract infection, genital infection, increased urination, dysuria
Postmarketing reports: Urosepsis, pyelonephritis, genital mycotic infections, Fournier's gangrene
The majority of genital infections were in females; reported genital infections included vulvovaginal mycotic infection, balanoposthitis, genital fungal infection, vaginal infection, and vulvovaginitis. The majority of urinary tract infections were also in females and included urinary tract infections, Escherichia urinary tract infection, prostatitis, and pyelonephritis.
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.
Postmarketing reports: Serious hypersensitivity reactions including anaphylaxis, angioedema, exfoliative skin conditions
Very common (10% or more): Upper respiratory tract infection (13.6%)
Frequency not reported: Hypotension
Frequency not reported: Heart failure requiring hospitalization
Events relating to volume depletion including hypotension, dehydration, and hypovolemia were reported in 2 patients (0.4%) in clinical trials with dapagliflozin-saxagliptin.
In a saxagliptin cardiovascular outcomes trial among patients with established atherosclerotic cardiovascular disease (ASCVD) or with multiple risk factors for ASCVD, hospitalization for heart failure occurred in 3.5% (289/8280) of patients receiving saxagliptin compared to 2.8% (228/8212) of patients receiving placebo. Hospitalization, irrespective of treatment, occurred more frequently among patients with renal impairment and a history of heart failure.
Newly diagnosed bladder cancer was reported in 0.17% (10/6045) of patients treated with dapagliflozin compared with 0.03% (1/3512) of patients receiving comparator/placebo therapy. After excluding cases in which exposure to drug was less than 1 year, 4 cases occurred in the dapagliflozin group and no cases in comparator/placebo group. Due to the low numbers, there is insufficient evidence to determine whether this is attributable to dapagliflozin nor is there data to determine whether there is an effect on preexisting bladder tumors.
Rare (0.01% to 0.1%): Bladder cancer
Postmarketing reports: Bullous pemphigoid
Postmarketing reports: Rash
Uncommon (0.1% to 1%): Erectile dysfunction, pruritus genital, vulvovaginal pruritus
Common (1% to 10%): Diarrhea, abdominal pain, dyspepsia, gastritis, nausea, vomiting
Uncommon (0.1% to 1%): Constipation, dry mouth
Postmarketing reports: Acute pancreatitis
In a saxagliptin cardiovascular outcomes trial among patients with established atherosclerotic cardiovascular disease (ASCVD) or with multiple risk factors for ASCVD, acute pancreatitis was confirmed in 0.2% (17/8240) of patients receiving saxagliptin compared to 0.1% (9/8173) of patients receiving placebo. Preexisting factors were reported in 15 and 9 patients receiving saxagliptin and placebo, respectively.
Very common (10% or more): Hypoglycemia (when combined with sulfonylurea)
Common (1% to 10%): Dyslipidemia, hypoglycemia
Uncommon (0.1% to 1%): Volume depletion, thirst, decreased weight
Frequency not reported: Increase in low-density lipoprotein cholesterol
Postmarketing reports: Ketoacidosis, including fatalities
Increases in LDL-cholesterol with dapagliflozin use have ranged from 2.1% to 6.9%.
Common (1% to 10%): Back pain, arthralgia
Postmarketing reports: Severe and disabling arthralgia
Common (1% to 10%): Headache, dizziness
Common (1% to 10%): Increase in mean hematocrit
Common (1% to 10%): Decrease in absolute lymphocyte count
Increase from baseline in mean hematocrit has been observed with dapagliflozin. Hematocrit values greater than 55% were reported in 1.3% of the subjects treated with dapagliflozin 10 mg versus 0.4% of placebo subjects.
A dose related mean decrease in absolute lymphocyte count has been observed with saxagliptin use; mean decreases to less than 750 cells/micro were observed in 0.5%, 1.5%, and 0.4% of patients receiving saxagliptin 2.5 mg or 5 mg, and placebo groups, respectively. The clinical significance of this is not known.
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Qtern