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Qtern Side Effects

Generic Name: dapagliflozin / saxagliptin

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.

For the Consumer

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:

More common
  • Bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • lower back or side pain
Less common Incidence not known
  • Agitation
  • bloating
  • chest pain
  • constipation
  • cough
  • cracks in the skin
  • darkened urine
  • decreased urine output
  • difficulty with swallowing
  • dilated neck veins
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • extreme fatigue
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • hives, itching, or skin rash
  • hostility
  • increased urination
  • indigestion
  • irregular breathing
  • irregular heartbeat
  • irritability
  • large, hard skin blisters
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lethargy
  • loss of consciousness
  • loss of heat from the body
  • muscle twitching
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • red, swollen skin
  • redness, itching, swelling, or pain around the penis
  • scaly skin
  • severe joint pain
  • shakiness
  • stupor
  • sweating
  • tightness in the chest
  • unexplained weight loss
  • yellow eyes or skin

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:

More common Less common

For Healthcare Professionals

Applies to dapagliflozin / saxagliptin: oral tablet

General

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

Renal

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
Common (1% to 10%): Renal impairment

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

Genitourinary

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

Dapagliflozin:
Postmarketing reports: Urosepsis, pyelonephritis, genital mycotic infections[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.[Ref]

Hypersensitivity

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

Respiratory

Dapagliflozin-saxagliptin
Very common (10% or more): Upper respiratory tract infection (13.6%)[Ref]

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

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]

Dapagliflozin
Rare (0.01% to 0.1%): Bladder cancer[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]

References

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

2. "Product Information. Qtern (dapagliflozin-saxagliptin)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

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.

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