Dapagliflozin / Saxagliptin Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 12, 2024.

Applies to dapagliflozin / saxagliptin: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.

Pancreatitis (swelling and inflammation of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain. These may be signs of heart failure.

Dizziness, lightheadedness, or fainting may occur with this medicine. This is more common if you have kidney disease, low blood pressure, or if you are taking a diuretic (water pill). Taking plenty of fluids each day may help. Drink plenty of water during exercise or in hot weather. Check with your doctor if you have severe nausea, vomiting, or diarrhea that does not stop. This may cause you to lose too much water.

Diabetic ketoacidosis (high ketones and acid in the blood) may occur while you are using this medicine. This can be life-threatening and requires immediate medical attention. Your doctor may give you insulin, fluid, and carbohydrate replacement to treat this condition. Tell your doctor right away if you have nausea, vomiting, trouble breathing, increased thirst or urination, or stomach pain.

This medicine may increase risk of having urinary tract infections, including pyelonephritis or urosepsis. Check with your doctor right away if you have bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, or lower back or side pain.

This medicine may cause vaginal yeast infections in women and yeast infections of the penis in men. This is more common in patients who have a history of genital yeast infections or in men who are not circumcised. Women may have a vaginal discharge, itching, or odor. Men may have redness, itching, swelling, or pain around the penis, or a discharge with a strong odor from the penis. Check with your doctor right away if you have any of these symptoms.

This medicine may cause a rare but serious bacterial infection, called necrotizing fasciitis of the perineum or Fournier's gangrene, which can cause damage to the tissue under the skin in the area between and around the anus and genitals (perineum). Fournier's gangrene may lead to hospitalization, multiple surgeries, or death. Check with your doctor right away if you have fever, unusual tiredness or weakness, or pain, tenderness, redness, or swelling of the area between and around your anus and genitals.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Some symptoms of low blood sugar include: behavior changes that are similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headaches that continue, nausea, shakiness, slurred speech, or unusual tiredness or weakness. Talk to your doctor about how to treat low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions. These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

This medicine may cause severe joint pain. Call your doctor right away if you have severe joint pain with this medicine.

This medicine may cause bullous pemphigoid. Tell your doctor if you have large, hard skin blisters while using this medicine.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine for at least 3 days before you have surgery or other procedures that require fasting. This medicine may also affect the results of certain medical tests (eg, urine glucose tests may not be accurate).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects

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:

Other side effects

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:

For healthcare professionals

Applies to dapagliflozin / saxagliptin: oral tablet.

General adverse events

The more commonly reported adverse reactions have been upper respiratory tract infection, urinary tract infection, and dyslipidemia.^[Ref]

Renal

• Common (1% to 10%): Renal impairment

Dapagliflozin:

• Frequency not reported: Serum creatinine increases, eGFR decreases
• Postmarketing reports: Acute kidney injury^[Ref]

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.^[Ref]

Dapagliflozin-Saxagliptin

Genitourinary

Dapagliflozin-Saxagliptin:

• Common (1% to 10%): Urinary tract infection, genital infection, increased urination, dysuria

Dapagliflozin:

• Postmarketing reports: Urosepsis, pyelonephritis, genital mycotic infections, Fournier's gangrene^[Ref]

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.^[Ref]

Hypersensitivity

Saxagliptin:

• Postmarketing reports: Serious hypersensitivity reactions including anaphylaxis, angioedema, exfoliative skin conditions^[Ref]

Respiratory

• Very common (10% or more): Upper respiratory tract infection (13.6%)^[Ref]

Dapagliflozin-saxagliptin

Cardiovascular

Dapagliflozin-Saxagliptin:

• Frequency not reported: Hypotension

Saxagliptin:

• Frequency not reported: Heart failure requiring hospitalization^[Ref]

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.^[Ref]

Oncologic

• Rare (0.01% to 0.1%): Bladder cancer^[Ref]

Dapagliflozin

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.^[Ref]

Dermatologic

DPP-4 Inhibitors:

• Postmarketing reports: Bullous pemphigoid

Dapagliflozin:

• Postmarketing reports: Rash^[Ref]

Endocrine

Dapagliflozin-Saxagliptin:

• Uncommon (0.1% to 1%): Erectile dysfunction, pruritus genital, vulvovaginal pruritus^[Ref]

Gastrointestinal

Dapagliflozin-Saxagliptin:

• Common (1% to 10%): Diarrhea, abdominal pain, dyspepsia, gastritis, nausea, vomiting
• Uncommon (0.1% to 1%): Constipation, dry mouth

Saxagliptin:

• Postmarketing reports: Acute pancreatitis^[Ref]

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.^[Ref]

Metabolic

Dapagliflozin-Saxagliptin:

• 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

Dapagliflozin

• Frequency not reported: Increase in low-density lipoprotein cholesterol
• Postmarketing reports: Ketoacidosis, including fatalities^[Ref]

Increases in LDL-cholesterol with dapagliflozin use have ranged from 2.1% to 6.9%.^[Ref]

Musculoskeletal

Dapagliflozin-Saxagliptin:

• Common (1% to 10%): Back pain, arthralgia

DPP-4 inhibitors:

• Postmarketing reports: Severe and disabling arthralgia^[Ref]

Nervous system

Dapagliflozin-Saxagliptin:

• Common (1% to 10%): Headache, dizziness^[Ref]

Hematologic

Dapagliflozin:

• Common (1% to 10%): Increase in mean hematocrit

Saxagliptin:

• Common (1% to 10%): Decrease in absolute lymphocyte count^[Ref]

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.^[Ref]

See also:

Frequently asked questions

• What are the ingredient drugs contained in Qternmet XR?

Further information

Dapagliflozin/saxagliptin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer