Saxagliptin
Pronunciation: pronunciation varies by local usage.
- Generic name
- saxagliptin
- Brand names
- ONGLYZA
- Drug class
- Dipeptidyl peptidase-4 (DPP-4) inhibitor
- Form
- Tablet
- Route
- Oral
- Legal status
- Prescription-only medicine
Availability and supply rules vary by country
Trade names by country: Canada
Australia: · Full directory
What saxagliptin is and how it works
Saxagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor that improves blood glucose control in adults with type 2 diabetes when used alongside diet and exercise. (1)
It is not a treatment for type 1 diabetes or diabetic ketoacidosis. A healthcare professional must confirm suitability and monitor treatment.
Mechanism of action: how saxagliptin works
Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. (1)
What saxagliptin is used for
Type 2 diabetes mellitus
Saxagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. (1)
Before taking saxagliptin
Do not take / not appropriate for
- Tell your prescriber or pharmacist if you have ever had a serious hypersensitivity reaction to saxagliptin, including anaphylaxis, angioedema, or exfoliative skin conditions — this is a contraindication they will need to assess. (all patients) (1)
- Saxagliptin is not indicated for type 1 diabetes or diabetic ketoacidosis. (all patients) (1)
Tell your clinician about
- Any history of heart failure, kidney disease, or pancreatitis.
- Whether you are taking strong CYP3A4/5 interacting medicines (examples given include ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin).
- Pregnancy, plans for pregnancy, or breastfeeding.
- Any new or worsening symptoms that could suggest heart failure after starting treatment — report these to your doctor promptly (
How to take saxagliptin
- The usual dose is 2.5 mg or 5 mg once daily, taken with or without food.
- For patients with moderate or severe renal impairment, or end-stage renal disease (creatinine clearance ≤50 mL/min), the recommended dose is 2.5 mg once daily.
- When saxagliptin is used together with a strong CYP3A4/5 inhibitor medicine, the dose should be limited to 2.5 mg once daily.
- Do not change your dose or stop treatment without your prescriber’s advice.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
Contact your prescriber or pharmacist for advice, rather than taking an extra dose to make up for one you missed.
Overdose
If too much saxagliptin has been taken, seek urgent medical advice or contact the prescriber straight away. In a controlled trial, healthy volunteers given up to 400 mg of saxagliptin daily for 2 weeks — 80 times the maximum recommended human dose — had no dose-related adverse reactions and no clinically meaningful effect on heart rate or the QTc interval. There is no specific antidote: the label states that appropriate supportive treatment should be started, guided by the person's clinical condition. Saxagliptin and its active metabolite are removed by haemodialysis (23% of the dose over 4 hours). (1)
Side effects
The most common side effects reported in clinical trials (occurring in ≥5% of patients and more often than placebo) were upper respiratory tract infection, urinary tract infection, and headache. Peripheral oedema was more common when saxagliptin was used with a thiazolidinedione (TZD).
Upper respiratory tract infection
What to notice: Symptoms such as nasal congestion, sore throat, or cough.
What to do: Reported as a common side effect in the reviewed FDA label information. (1)
Urinary tract infection
What to notice: Pain or burning when passing urine, frequent urination, or cloudy/bloody urine.
What to do: Reported as a common side effect in the reviewed FDA label information. (1)
Headache
What to notice: Persistent or severe headache.
What to do: Reported as a common side effect in the reviewed FDA label information. (1)
Peripheral oedema (fluid retention)
What to notice: Swelling of feet, ankles, or legs (oedema).
What to do: Reported as a side effect in the reviewed information, more common with concomitant thiazolidinedione use. (1) (2)
Pancreatitis
What to notice: Severe abdominal pain that may spread to the back, often with nausea and vomiting.
What to do: Seek medical attention immediately if pancreatitis is suspected, letting the clinician you see advise on whether to continue or stop saxagliptin. (1)
Serious hypersensitivity reaction
What to notice: Signs of anaphylaxis, angioedema (swelling of the face, lips, tongue, or throat), or exfoliative skin conditions.
What to do: Obtain emergency medical care immediately, letting the clinician you see advise on whether to continue or stop saxagliptin. (1)
Heart failure
What to notice: Any new or worsening symptoms that could suggest heart failure (
What to do: Contact your doctor right away if you notice any new or worsening symptoms after starting treatment. (2) (1)
Serious warnings
Heart failure hospitalisation risk — high
Symptoms: In a large cardiovascular outcomes trial (SAVOR-TIMI 53), more patients on saxagliptin were hospitalised for heart failure than on placebo (3.5% vs 2.8%; hazard ratio 1.27). The risk may be greater in patients with pre-existing heart or kidney disease.
Action: Discuss your individual heart failure risk with your prescriber before starting treatment. Seek urgent medical help for symptoms of heart failure. (2) (1)
Pancreatitis — high
Symptoms: Severe abdominal pain that may radiate to the back, accompanied by nausea and vomiting.
Action: Seek medical care immediately, letting the clinician you see advise on whether to continue or stop saxagliptin. (1)
Serious hypersensitivity — emergency
Symptoms: Anaphylaxis, angioedema (swelling of deep skin layers, often around eyes and lips, or throat), or exfoliative skin conditions.
Action: Call emergency services immediately, letting the clinician you see advise on whether to continue or stop saxagliptin. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Strong CYP3A4/5 inhibitors | Medicines such as ketoconazole, itraconazole, atazanavir, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin can markedly increase saxagliptin exposure, requiring a dose adjustment. | Ensure your prescriber knows about all your medicines, including over‑the‑counter and herbal products. If a strong CYP3A4/5 inhibitor is prescribed, your saxagliptin dose will be limited to 2.5 mg once daily. (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Renal impairment
For patients with moderate or severe renal impairment (creatinine clearance ≤50 mL/min) or end-stage renal disease, the recommended dose is 2.5 mg once daily. (1)
Pregnancy
There are no adequate, well-controlled studies in pregnant women. Saxagliptin was formerly classified as FDA pregnancy category B. (1)
Breastfeeding
Saxagliptin is secreted in rat milk at a ratio approximately equal to plasma; whether it is secreted in human milk is unknown. Caution should be exercised when administered to a nursing woman. (1)
Monitoring
Before starting
- Renal function (creatinine clearance) is used to determine the appropriate starting dose, as identified in the reviewed source.
During treatment
- The reviewed source establishes that suspected pancreatitis requires prompt medical assessment.
Storage
Follow the exact product label and keep medicines away from children.
Professional information
Clinician-facing context only. Always consult the current local prescribing information and relevant guidelines before making treatment decisions.
All regions
Indication: Type 2 diabetes mellitus
Dose summary: Standard dose 2.5 mg or 5 mg once daily; 2.5 mg daily for creatinine clearance ≤50 mL/min or concurrent strong CYP3A4/5 inhibitor use. No universal dose can be stated; refer to the approved local label.
Renal context: Dose adjustment to 2.5 mg daily is recommended for patients with moderate/severe renal impairment (CrCl ≤50 mL/min) or end-stage renal disease. (1)
Frequently asked questions
Can saxagliptin cause heart failure?
In a large clinical trial, saxagliptin was associated with an increased rate of hospitalisation for heart failure. Discuss your personal risk with your doctor, particularly if you have existing heart or kidney disease. Do not stop the medicine abruptly without medical advice. (2) (1)
What should I do if I miss a dose of saxagliptin?
No specific missed-dose instructions were established in the sources reviewed for this page. Contact your prescriber or pharmacist for advice, rather than taking an extra dose to make up for one you missed.
Does saxagliptin cause pancreatitis?
Acute pancreatitis has been reported in patients taking saxagliptin. Seek urgent medical help if you develop severe abdominal pain, nausea, or vomiting, letting the clinician you see advise on whether to continue or stop saxagliptin. (1)
What is the mechanism of action of saxagliptin?
Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. (1)
References
- ONGLYZA (saxagliptin) tablet, film coated — prescribing informationU.S. Food and Drug Administration · United States · dated 2026 · accessed 2026-08-05 · source 1
- Heart failure outcomes in the SAVOR-TIMI 53 trialSAVOR-TIMI 53 trial investigators (as cited by FDA) · United States · dated 2013 · accessed 2026-08-05 · source 2
- SAXAGLIPTIN AND METFORMIN TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
- DAPAGLIFLOZIN AND SAXAGLIPTIN — FDA approval record (Drugs@FDA ANDA211533)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- saxagliptin — RxNorm normalized drug concept (RXCUI 1043560)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient saxagliptin names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
Canada
- ONGLYZA