Saxagliptin side effects: what 1,458 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,458 reports · 92% serious · 96 with death outcome · 43% female
Used for
Saxagliptin tablets are a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1.1 ) Limitations of use: • Not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
What it is
Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin hydrochloride dihydrate is described chemically as (1S,3S,5S)-2-[(2S)-Amino-(3-hydroxytricyclo [3.3.1.1 3,7 ]dec-1-yl.
Boxed warning
None in the current label
Causality screen of the 26 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 16 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Urosepsis | 17 | 26.6 16.6–42.6ROR 26.9 · χ² 392 / p 1e-87 | 25.8 EB05 17.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 16.6 | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 18 | 25.5 16.1–40.3ROR 25.8 · χ² 399 / p 6e-89 | 24.8 EB05 16.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 16.0 | no trial data cached |
| Sleep apnoea syndrome | 30 | 22.6 15.8–32.2ROR 23.0 · χ² 597 / p 3e-132 | 22.3 EB05 16.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.7 · ♀ 100% (drug 43%) · 73% consumer | no trial data cached |
| Hypoglycaemia (low blood sugar) | 65 | 19.3 15.2–24.5ROR 20.1 · χ² 1,110 / p 1e-243 | 19.2 EB05 15.5 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 | no trial data cached |
| Small intestinal obstruction | 16 | 18.8 11.5–30.6ROR 19.0 · χ² 252 / p 6e-57 | 18.2 EB05 11.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | no trial data cached |
| Diabetes mellitus inadequate control | 22 | 17.9 11.8–27.1ROR 18.1 · χ² 334 / p 7e-75 | 17.5 EB05 12.0 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.5 | no trial data cached |
| Renal failure acute | 53 | 17.7 13.6–23.1ROR 18.4 · χ² 821 / p 9e-181 | 17.6 EB05 13.9 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.0 | no trial data cached |
| Pancreatitis acute | 26 | 16.8 11.5–24.6ROR 17.1 · χ² 370 / p 9e-83 | 16.4 EB05 11.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.5 · ♀ 13% (drug 43%) | no trial data cached |
| Diabetic ketoacidosis | 23 | 13.8 9.2–20.7ROR 14.0 · χ² 261 / p 6e-59 | 13.3 EB05 8.9 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 8.6 · ♀ 75% (drug 43%) | no trial data cached |
| Electrolyte imbalance | 10 | 12.5 6.7–23.2ROR 12.6 · χ² 95 / p 1e-22 | 10.5 EB05 5.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Gastroenteritis | 12 | 11.9 6.7–20.8ROR 11.9 · χ² 109 / p 1e-25 | 10.2 EB05 5.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Cardiomegaly | 10 | 11.6 6.3–21.5ROR 11.7 · χ² 87 / p 7e-21 | 9.5 EB05 4.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 29 | 9.5 6.6–13.6ROR 9.6 · χ² 211 / p 4e-48 | 8.7 EB05 6.2 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 | no trial data cached |
| Pancreatitis (pancreas inflammation) | 33 | 9.0 6.4–12.6ROR 9.2 · χ² 226 / p 2e-51 | 8.3 EB05 6.1 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Diabetes mellitus | 47 | 8.8 6.7–11.7ROR 9.1 · χ² 320 / p 9e-72 | 8.4 EB05 6.5 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.9 · ♀ 85% (drug 43%) | no trial data cached |
| Hyperglycaemia (high blood sugar) | 22 | 8.7 5.8–13.2ROR 8.8 · χ² 143 / p 3e-33 | 7.8 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Gastric ulcer | 11 | 8.3 4.6–15.0ROR 8.4 · χ² 64 / p 7e-16 | 6.6 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 10 | 8.2 4.4–15.3ROR 8.3 · χ² 57 / p 3e-14 | 6.4 EB05 3.6 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Drug eruption | 10 | 8.2 4.4–15.1ROR 8.2 · χ² 56 / p 4e-14 | 6.4 EB05 3.6 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Hyperkalaemia (high potassium) | 19 | 7.8 5.0–12.2ROR 7.9 · χ² 107 / p 3e-25 | 6.8 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Renal injury | 13 | 6.2 3.6–10.7ROR 6.3 · χ² 52 / p 3e-13 | 5.2 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Angina pectoris | 12 | 6.0 3.4–10.5ROR 6.0 · χ² 45 / p 1e-11 | 5.0 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Blood creatine phosphokinase increased | 12 | 5.9 3.4–10.4ROR 5.9 · χ² 44 / p 2e-11 | 4.9 EB05 3.0 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Cardiac failure congestive | 32 | 5.7 4.0–8.0ROR 5.8 · χ² 119 / p 5e-28 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Lactic acidosis | 11 | 4.9 2.7–8.9ROR 5.0 · χ² 31 / p 2e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Intentional overdose | 14 | 3.2 1.9–5.3ROR 3.2 · χ² 19 / p 8e-6 | 2.9 EB05 1.9 · IC025 +0.7 | Reporting / coding artifact | serious PRR 2.0 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hypoglycaemia (low blood sugar) | 65 | 19.3 15.2–24.5ROR 20.1 · χ² 1,110 / p 1e-243 | 19.2 EB05 15.5 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 | no trial data cached |
| Renal failure acute | 53 | 17.7 13.6–23.1ROR 18.4 · χ² 821 / p 9e-181 | 17.6 EB05 13.9 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.0 | no trial data cached |
| Diabetes mellitus | 47 | 8.8 6.7–11.7ROR 9.1 · χ² 320 / p 9e-72 | 8.4 EB05 6.5 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.9 · ♀ 85% (drug 43%) | no trial data cached |
| Pancreatitis (pancreas inflammation) | 33 | 9.0 6.4–12.6ROR 9.2 · χ² 226 / p 2e-51 | 8.3 EB05 6.1 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Cardiac failure congestive | 32 | 5.7 4.0–8.0ROR 5.8 · χ² 119 / p 5e-28 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Sleep apnoea syndrome | 30 | 22.6 15.8–32.2ROR 23.0 · χ² 597 / p 3e-132 | 22.3 EB05 16.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.7 · ♀ 100% (drug 43%) · 73% consumer | no trial data cached |
| Angioedema (deep swelling of face/throat) | 29 | 9.5 6.6–13.6ROR 9.6 · χ² 211 / p 4e-48 | 8.7 EB05 6.2 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 | no trial data cached |
| Pancreatitis acute | 26 | 16.8 11.5–24.6ROR 17.1 · χ² 370 / p 9e-83 | 16.4 EB05 11.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.5 · ♀ 13% (drug 43%) | no trial data cached |
| Diabetic ketoacidosis | 23 | 13.8 9.2–20.7ROR 14.0 · χ² 261 / p 6e-59 | 13.3 EB05 8.9 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 8.6 · ♀ 75% (drug 43%) | no trial data cached |
| Hyperglycaemia (high blood sugar) | 22 | 8.7 5.8–13.2ROR 8.8 · χ² 143 / p 3e-33 | 7.8 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Diabetes mellitus inadequate control | 22 | 17.9 11.8–27.1ROR 18.1 · χ² 334 / p 7e-75 | 17.5 EB05 12.0 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.5 | no trial data cached |
| Hyperkalaemia (high potassium) | 19 | 7.8 5.0–12.2ROR 7.9 · χ² 107 / p 3e-25 | 6.8 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 18 | 25.5 16.1–40.3ROR 25.8 · χ² 399 / p 6e-89 | 24.8 EB05 16.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 16.0 | no trial data cached |
| Urosepsis | 17 | 26.6 16.6–42.6ROR 26.9 · χ² 392 / p 1e-87 | 25.8 EB05 17.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 16.6 | no trial data cached |
| Small intestinal obstruction | 16 | 18.8 11.5–30.6ROR 19.0 · χ² 252 / p 6e-57 | 18.2 EB05 11.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Sleep apnoea syndrome — n=30, PRR 22.6
- Hyperglycaemia — n=22, PRR 8.7
- Cardiac failure congestive — n=32, PRR 5.7
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Saxagliptin?
In FDA FAERS, the most frequently co-reported reaction terms for Saxagliptin are hypoglycaemia, renal failure acute, diabetes mellitus, pancreatitis, cardiac failure congestive, sleep apnoea syndrome. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Saxagliptin have an FDA boxed warning?
No. The FDA label retrieved for Saxagliptin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Saxagliptin causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 6e8d8c4f-96eb-4b64-9c8c-4a5448a23a78, effective 20250228; matched on
openfda.generic_name.exact:"SAXAGLIPTIN") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 42 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.