From the Guidelines
Saxagliptin can cause several side effects, including upper respiratory tract infections, urinary tract infections, headache, and mild gastrointestinal symptoms, as well as more concerning side effects like joint pain, skin reactions, hypoglycemia, and an increased risk of heart failure hospitalization, particularly in patients with existing cardiovascular disease or risk factors, as reported in the 2018 consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) 1.
Common Side Effects
- Upper respiratory tract infections
- Urinary tract infections
- Headache
- Mild gastrointestinal symptoms like nausea or diarrhea
Less Common but More Concerning Side Effects
- Joint pain
- Skin reactions
- Hypoglycemia, particularly when combined with other diabetes medications like sulfonylureas or insulin
- Increased risk of heart failure hospitalization in patients with existing cardiovascular disease or risk factors
- Pancreatitis, which presents as severe abdominal pain that may radiate to the back
- Rarely, severe allergic reactions can occur, manifesting as rash, hives, swelling of face/throat, or difficulty breathing These side effects occur because saxagliptin works by inhibiting the DPP-4 enzyme, which increases incretin hormones that stimulate insulin release and reduce glucagon levels, as explained in the 2019 standards of medical care for type 2 diabetes in China 1.
Important Considerations
- Patients should report persistent or severe side effects to their healthcare provider immediately, especially shortness of breath, unusual swelling, severe joint pain, or signs of pancreatitis.
- The FDA has warned that saxagliptin may increase the risk for heart failure, especially in patients with preexisting heart failure or renal impairment, as noted in the 2017 American Diabetes Association standards of medical care in diabetes 1.
From the FDA Drug Label
Saxagliptin tablets can cause serious side effects, including: Low blood sugar (hypoglycemia) Allergic (hypersensitivity) reactions, such as: swelling of your face, lips, throat, and other areas on your skin difficulty with swallowing or breathing raised, red areas on your skin (hives) skin rash, itching, flaking, or peeling Joint pain. Some people who take medicines called DPP-4 inhibitors like saxagliptin tablets, may develop joint pain that can be severe. Skin reaction Some people who take medicines called DPP-4 inhibitors, like saxagliptin tablets, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. The most common side effects of saxagliptin tablets include: upper respiratory tract infection urinary tract infection headache swelling or fluid retention in your hands, feet, or ankles (peripheral edema)
The side effects of Saxagliptin (DPP-4 inhibitor) include:
- Serious side effects:
- Low blood sugar (hypoglycemia)
- Allergic (hypersensitivity) reactions
- Joint pain
- Skin reaction (bullous pemphigoid)
- Common side effects:
- Upper respiratory tract infection
- Urinary tract infection
- Headache
- Swelling or fluid retention in hands, feet, or ankles (peripheral edema) 2
From the Research
Side Effects of Saxagliptin
The side effects of Saxagliptin, a DPP-4 inhibitor, are as follows:
- Headache 3, 4
- Upper-respiratory-tract infection 3, 4
- Urinary tract infection 3, 4 It is reported that Saxagliptin is well tolerated with a side-effect profile similar to placebo 5.
Special Considerations
Saxagliptin has a low risk for hypoglycemia in patients with type 2 diabetes, especially when used as monotherapy or in combination with metformin 3, 6, 5, 7. Saxagliptin is also weight neutral, which is an advantage over other antidiabetic medications that may cause weight gain 6, 7.
Dosage and Administration
The usual adult dose of Saxagliptin is 2.5 to 5 mg once daily, regardless of meals 4. A daily dose of 2.5 mg is recommended for patients with moderate to severe renal impairment or those who are taking potent CYP 3A4 inhibitors 3, 4.