Onglyza (Saxagliptin): US Brand Discontinued, Generic Dosing, Heart Failure Warning and Cost

Onglyza is the brand name for saxagliptin, a once-daily tablet for type 2 diabetes from the DPP-4 inhibitor class, the same class as Januvia and Tradjenta. If you have been taking it in the US, you may have noticed the brand is hard to find: the FDA's Drugs@FDA database now lists both Onglyza strengths as discontinued, while generic saxagliptin tablets from several manufacturers are on sale.

This guide covers what that change means, how saxagliptin is dosed (including the kidney and drug interaction rules), what its large heart safety trial found, why the FDA added a heart failure warning, how it compares with a sulfonylurea for low blood sugar, and what a month of generic saxagliptin costs next to the other DPP-4 inhibitors. Figures come from the current US prescribing information for generic saxagliptin, the SAVOR-TIMI 53 trial and federal price data.

The short answer

Saxagliptin is taken as 2.5 mg or 5 mg once a day, with or without food, and the dose is 2.5 mg if your eGFR is below 45 or you take a strong CYP3A4/5 inhibitor. It lowers A1C by roughly half a point to just under a point compared with placebo, and on its own it rarely causes low blood sugar. In the SAVOR-TIMI 53 trial it did not change the rate of heart attacks, strokes or cardiovascular death, but more people taking it were admitted to hospital for heart failure (3.5% vs 2.8%), and its label now carries that warning. The Onglyza brand is listed as discontinued in the US, the FDA has determined it was not withdrawn for safety or effectiveness reasons, and generic saxagliptin is the cheapest DPP-4 inhibitor on US pharmacy cost data.

Onglyza at a glance

	Saxagliptin (Onglyza)
Drug class	DPP-4 inhibitor
Used for	Blood sugar control in adults with type 2 diabetes, with diet and exercise
Not for	Type 1 diabetes or diabetic ketoacidosis
Dose	2.5 mg or 5 mg once daily, with or without meals
Lower dose needed	eGFR below 45, or with strong CYP3A4/5 inhibitors: 2.5 mg
Main label warnings	Pancreatitis, heart failure, hypoglycemia with insulin or sulfonylureas, allergic reactions, severe joint pain, bullous pemphigoid
US brand status	Onglyza 2.5 mg and 5 mg listed as discontinued in Drugs@FDA
US pharmacy cost, generic 5 mg	About $1.04 a tablet (NADAC, 7 October 2026)

What happened to the Onglyza brand

In the FDA's Drugs@FDA data, accessed in October 2026, Onglyza (NDA 022350, AstraZeneca) 2.5 mg and 5 mg tablets both carry the marketing status "Discontinued", each with a note that the Federal Register determined the product was not discontinued or withdrawn for safety or effectiveness reasons. In other words, the brand left the market, but not because of a safety or effectiveness problem. AstraZeneca's other saxagliptin brands, Kombiglyze XR (with metformin), Qtern (with dapagliflozin) and Qternmet XR, are also listed as discontinued.

Generic saxagliptin tablets are listed on DailyMed, the US label database, from manufacturers including Glenmark, Mylan and Aurobindo. The federal NADAC price survey for 2026 has weekly prices for generic saxagliptin 2.5 mg and 5 mg tablets and no listing for the Onglyza brand. If your prescription says Onglyza, ask your pharmacist about filling it with generic saxagliptin; substitution rules depend on your state and on what your prescriber wrote.

How saxagliptin works

After a meal the gut releases incretin hormones that tell the pancreas to release insulin and reduce glucagon, so the liver makes less sugar. According to the label, the enzyme DPP-4 inactivates those hormones within minutes. Saxagliptin blocks DPP-4, so the hormones last longer and the body's own glucose-dependent response is stronger. Because the effect depends on glucose being high, DPP-4 inhibitors on their own cause little hypoglycemia, which is the main practical difference from sulfonylureas such as glipizide and glimepiride.

Dosing: 2.5 mg or 5 mg once a day

The label's recommended dose is 2.5 mg or 5 mg by mouth once daily, taken regardless of meals. The tablets should not be cut, crushed or chewed. If a dose is missed, the label says not to take an extra dose; take the next one at the usual time.

In three of the trials a 10 mg daily dose was also tested. It did not lower blood sugar more than 5 mg, and 10 mg is not an approved dose. A higher dose is therefore not a way to get a stronger effect.

Kidney function changes the dose

Saxagliptin and its active metabolite are cleared partly by the kidneys, so the label asks prescribers to check kidney function before starting and then as needed:

Kidney function (eGFR, mL/min/1.73 m²)	Saxagliptin dose
45 or above	2.5 mg or 5 mg once daily, as for normal function
Below 45, including end-stage kidney disease on hemodialysis	2.5 mg once daily; on hemodialysis, take it after the session
Peritoneal dialysis	Not studied

In a 12-week trial of 85 people with moderate or severe kidney impairment or end-stage disease taking 2.5 mg, side effects and discontinuations were similar to placebo. Reported hypoglycemia was 20% with saxagliptin and 22% with placebo in that group, so low blood sugar is more common in people with kidney disease whatever they take.

Drugs that change the dose

Saxagliptin is broken down by the liver enzymes CYP3A4/5. Ketoconazole significantly increased saxagliptin exposure, and the label limits the dose to 2.5 mg once daily with any strong CYP3A4/5 inhibitor. It names ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir and telithromycin. Tell your prescriber or pharmacist before starting any of these.

The other interaction is with drugs that themselves cause hypoglycemia. With insulin or an insulin secretagogue such as a sulfonylurea, the label says a lower dose of the insulin or secretagogue may be needed.

How much it lowers blood sugar

In a 24-week monotherapy trial starting from an A1C of about 8%, saxagliptin 5 mg lowered A1C by 0.6 points more than placebo (adjusted mean difference). Added to metformin, the difference from placebo was 0.8 points with 5 mg and 0.7 points with 2.5 mg, and 44% of people on saxagliptin 5 mg plus metformin reached an A1C below 7%, against 17% on placebo plus metformin.

Trial (24 weeks)	A1C change vs placebo, 2.5 mg	A1C change vs placebo, 5 mg	A1C below 7%, 5 mg vs placebo
Monotherapy	−0.6	−0.6	38% vs 24%
Added to metformin	−0.7	−0.8	44% vs 17%

Saxagliptin was not linked to significant changes in body weight or fasting lipids against placebo.

Saxagliptin vs glipizide: the low blood sugar difference

The most useful comparison in the label is a 52-week trial in 858 people whose diabetes was not controlled on metformin, who added either saxagliptin 5 mg or glipizide, a sulfonylurea, with the glipizide dose adjusted upwards as needed. A1C fell by a similar amount in both groups (0.6 points with saxagliptin, 0.7 with glipizide). The differences were elsewhere:

• Reported hypoglycemia: 3% with saxagliptin (19 events in 13 patients) vs 36.3% with glipizide (750 events in 156 patients).
• Confirmed symptomatic hypoglycemia (fingerstick glucose 50 mg/dL or lower): no saxagliptin patients vs 35 glipizide patients (8.1%).
• Body weight: a mean loss of 1.1 kg with saxagliptin vs a mean gain of 1.1 kg with glipizide.

Sulfonylureas cost less still, and our metformin vs glimepiride guide covers that class. The trade-off this trial shows is fewer low blood sugar episodes with saxagliptin for similar A1C control.

The SAVOR-TIMI 53 heart safety trial

SAVOR-TIMI 53 randomly assigned 16,492 adults with type 2 diabetes who had cardiovascular disease (79%) or multiple risk factors (21%) to saxagliptin or placebo on top of their usual care, and followed them for a median of about 2 years. Their mean age was 65; about 16% had moderate or severe kidney impairment and 13% had a history of heart failure.

The main result was neutral. The combined rate of cardiovascular death, heart attack or ischemic stroke was 7.4% in both groups (613 vs 609 people; hazard ratio 1.00, 95.1% CI 0.89 to 1.12). The trial showed saxagliptin did not raise this risk, but it did not lower it either.

SAVOR-TIMI 53 outcome	Saxagliptin	Placebo	Hazard ratio (CI)
CV death, heart attack or ischemic stroke	613 (7.4%)	609 (7.4%)	1.00 (0.89 to 1.12)
Hospital admission for heart failure	289 (3.5%)	228 (2.8%)	1.27 (1.07 to 1.51)
Death from any cause	420 (5.1%)	378 (4.6%)	1.11 (0.96 to 1.27)

The heart failure warning

The one significant safety signal in SAVOR was heart failure. 289 of 8,280 people taking saxagliptin (3.5%) were admitted to hospital for heart failure, against 228 of 8,212 on placebo (2.8%), a 27% higher risk (hazard ratio 1.27, 95% CI 1.07 to 1.51). People with previous heart failure or kidney impairment had a higher risk of admission whichever treatment they were given.

In April 2016 the FDA added heart failure warnings to the labels of medicines containing saxagliptin and alogliptin, citing two large clinical trials, and advised that clinicians consider stopping these drugs if a patient develops heart failure. The current label asks prescribers to weigh the risks and benefits before starting saxagliptin in people at higher risk of heart failure and to tell patients the symptoms to report straight away. The patient information lists increasing shortness of breath or trouble breathing, especially when lying down, an unusually fast increase in weight, swelling or fluid retention in the feet, ankles or legs, and unusual tiredness.

This is a difference in the trial evidence within the class, though not in the labels: the Januvia and Tradjenta labels now carry a heart failure precaution too, based on the trials of two other DPP-4 inhibitors. In the sitagliptin outcome trial TECOS, heart failure admissions were not increased (hazard ratio 1.00, 95% CI 0.83 to 1.20); our Januvia vs Tradjenta comparison sets those trials side by side. For someone with heart failure or a high risk of it, an SGLT2 inhibitor such as those in our Jardiance vs Farxiga guide may be the class a doctor considers first.

Other label warnings

• Pancreatitis: acute pancreatitis has been reported. In SAVOR, definite acute pancreatitis was confirmed in 17 of 8,240 people on saxagliptin (0.2%) and 9 of 8,173 on placebo (0.1%). Stop the drug and seek care for severe, persistent stomach pain that may spread to the back.
• Hypoglycemia with insulin or sulfonylureas: confirmed hypoglycemia was more frequent when saxagliptin was added to these; a lower insulin or sulfonylurea dose may be needed.
• Allergic reactions: anaphylaxis, angioedema and exfoliative skin conditions have been reported, with onset within the first 3 months of treatment, some after the first dose. A serious allergic reaction to saxagliptin is the label's only contraindication.
• Severe joint pain: severe and disabling arthralgia has been reported with DPP-4 inhibitors, starting anywhere from a day to years after treatment began.
• Bullous pemphigoid: blisters or skin erosions should be reported; some cases needed hospital treatment.

Common side effects

In a pool of five placebo-controlled trials, the side effects reported in at least 5% of people on saxagliptin 5 mg and more often than on placebo were small differences:

Side effect	Saxagliptin 5 mg (n=882)	Placebo (n=799)
Upper respiratory tract infection	7.7%	7.6%
Urinary tract infection	6.8%	6.1%
Headache	6.5%	5.9%

Swelling of the legs (peripheral edema) was more frequent when saxagliptin 5 mg was added to a thiazolidinedione such as pioglitazone: 8.1% vs 4.3% on placebo. Saxagliptin also caused a small, dose-related fall in lymphocyte count; the label says the clinical significance is not known. Discontinuation for side effects was 3.3% on 5 mg, 2.2% on 2.5 mg and 1.8% on placebo.

Who should not take it, and when to ask first

• Do not take saxagliptin if you have had a serious allergic reaction to it.
• It is not for type 1 diabetes or diabetic ketoacidosis.
• Discuss it first if you have heart failure or are at higher risk of it, have had pancreatitis, or have kidney disease.
• Discuss it first if you have had angioedema (swelling of the face, lips, tongue or throat) with another DPP-4 inhibitor; the label advises caution because it is not known whether you would react to saxagliptin.
• Tell your prescriber about every other medicine, especially insulin, sulfonylureas and strong CYP3A4/5 inhibitors.
• Pregnancy: the label says limited data are not enough to determine a risk of birth defects or miscarriage, and that poorly controlled diabetes itself carries risks in pregnancy. Breastfeeding: there are no data on saxagliptin in human milk; the label asks for the benefits of breastfeeding to be weighed against the need for the drug.

What a month of saxagliptin costs

The federal NADAC survey records what US pharmacies pay for medicines. In the week of 7 October 2026, the median acquisition cost of generic saxagliptin 5 mg was $1.03871 a tablet, about $31.16 for 30 tablets, and the 2.5 mg tablet was $1.14446. That makes it the lowest-cost DPP-4 inhibitor in the survey by a wide margin.

DPP-4 inhibitor (once-daily tablet)	NADAC per tablet	30 tablets
Saxagliptin 5 mg, generic	$1.03871	$31.16
Sitagliptin 100 mg, generic	$3.77084	$113.13
Alogliptin 25 mg, generic	$4.90690	$147.21
Januvia 100 mg, brand	$10.55179	$316.55
Tradjenta 5 mg, brand	$16.79819	$503.95

These are pharmacy acquisition costs, not what you pay at the counter, which depends on your insurance and the pharmacy's markup. They are still a fair guide to which drugs are cheap: a patient paying cash for generic saxagliptin should expect a far lower price than for brand Januvia or Tradjenta.

How it compares with other DPP-4 inhibitors

The DPP-4 inhibitors sold in the US work the same way and are taken once a day. Three differences matter in practice. Kidney dosing: saxagliptin and sitagliptin need lower doses as kidney function falls (alogliptin is also sold in lower strengths; check its label), while the Tradjenta label recommends no dose adjustment for kidney impairment. Heart failure: saxagliptin and alogliptin received heart failure warnings in 2016 after their own outcome trials; the Januvia and Tradjenta labels now carry a class-wide heart failure precaution as well, although TECOS found no increase in heart failure admissions with sitagliptin. Cost: generic saxagliptin is the cheapest on the NADAC data above. Our Januvia vs Tradjenta guide covers sitagliptin and linagliptin in detail.

What generic saxagliptin looks like

Each manufacturer's tablet looks different, so check yours against its own label. As one example, Glenmark's saxagliptin 2.5 mg is a pale yellow to yellow round film-coated tablet printed "G74" in blue ink, and the 5 mg is a pink round tablet printed "G75". The label says to store the tablets at 20°C to 25°C (68°F to 77°F).

Combination products

Saxagliptin was also sold with metformin as Kombiglyze XR and with dapagliflozin as Qtern; Drugs@FDA lists both brands as discontinued. Generic saxagliptin and metformin extended-release tablets are listed on DailyMed, and the NADAC 2026 data include them. These suit people already taking both drugs at the matching doses; the heart failure and pancreatitis warnings apply to them too.

Buying saxagliptin from SafeRxPills

SafeRxPills sells Onglyza 5 mg and Onglyza 2.5 mg listed as made by AstraZeneca Pharma India Ltd. These are packs for the Indian market, not the US-approved product, and SafeRxPills is not a US-licensed pharmacy. Saxagliptin is a prescription medicine in the US, and dose decisions depend on your kidney function and other medicines, so it should only be taken under the care of a doctor who checks both. If you are in the US with insurance, generic saxagliptin from a local pharmacy may cost less than you expect.

Practical points

• Take it once a day at any time, with or without food; do not split or crush the tablet.
• Know your eGFR; below 45 the dose is 2.5 mg.
• Learn the symptoms of heart failure and report them promptly.
• If you also take insulin or a sulfonylurea, learn the signs of low blood sugar and ask whether those doses should be reduced.
• Stop and seek care for severe stomach pain, a serious allergic reaction, blistering skin or severe joint pain.
• Keep taking metformin and lifestyle measures as prescribed; saxagliptin is an add-on in most regimens.

Related guides

For first-line treatment, see the metformin dosage guide and metformin side effects. For other classes, read Amaryl (glimepiride), Rybelsus dosage and generic semaglutide. Our type 2 diabetes page brings the treatment options together.

Sources

• Saxagliptin tablets, US prescribing information, Glenmark Pharmaceuticals, DailyMed listing January 2026, sections 1, 2, 3, 4, 5, 6.1, 7, 8, 10, 14 and 16. DailyMed
• JANUVIA (sitagliptin) tablets, US prescribing information, section 5.2.
• Green JB et al. Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes (TECOS). New England Journal of Medicine 2015. PMID 26052984.
• TRADJENTA (linagliptin) tablets, US prescribing information, sections 5.6 and 8.6.
• Scirica BM et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. New England Journal of Medicine 2013. PMID 23992601.
• US Food and Drug Administration. Drugs@FDA data for saxagliptin products including NDA 022350 (Onglyza), accessed October 2026. openFDA
• American College of Cardiology. FDA warns of HF risk with diabetes medication, April 2016. ACC
• Centers for Medicare and Medicaid Services. National Average Drug Acquisition Cost (NADAC), 2026 file, week of 7 October 2026. data.medicaid.gov

This guide is for information only and is not medical advice. Saxagliptin is a prescription medicine; do not start, stop or change a diabetes medicine without speaking to your doctor.