What the label lists and what reports show
Saxagliptin side effects
Saxagliptin's FDA label: “Most common adverse reactions (incidence ≥ 5% and more often than placebo) are upper respiratory tract infection, urinary tract infection, and headache.” FAERS holds 1,458 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is acute kidney injury (75 reports).
- Generic listed
Check it at the source: the saxagliptin FDA label on DailyMed (effective January 27, 2026, Glenmark Pharmaceuticals Inc., USA); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of saxagliptin tablets?Saxagliptin tablets can cause serious side effects, including: • See " What is the most important information I should know about saxagliptin tablets? " Low blood sugar (hypoglycemia) If you take saxagliptin tablets with another medicine that can cause low blood sugar, such as a sulfonylureas or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine • or insulin may need to be lowered while you take ONGLYZA. […]
Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective January 27, 2026 (SPL set e286ffd4-c598-47fb-af06-2e15f7e6f99f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 5% and more often than placebo) are upper respiratory tract infection, urinary tract infection, and headache.
From the label: adverse reactions, continuedThe following serious adverse reactions are described below or elsewhere in the prescribing information: • Pancreatitis [ see Warnings and Precautions (5.1) ] • Heart Failure [ see Warnings and Precautions (5.2) ] • Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues [ see Warnings and Precautions ( 5.3 ) ] • Hypersensitivity Reactions [ see Warnings and Precautions ( 5.4 ) ] • Severe and disabling arthralgia [ see Warnings and Precautions (5.5) ] • Bullous pemphigoid [ see Warnings and Precautions (5.6) ] • Most common adverse reactions (incidence ≥ 5% and more often than placebo) are upper respiratory tract infection, urinary tract infection, and headache. ( 6.1 ) • Peripheral edema was reported more commonly in patients treated with the combination of saxagliptin and a thiazolidinedione (TZD) than in patients treated with the combination of placebo and TZD. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective January 27, 2026 (SPL set e286ffd4-c598-47fb-af06-2e15f7e6f99f), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,458 reports list saxagliptin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 96 are coded as a death and 854 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Saxagliptin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions