Prescription medication · DPP-4 Inhibitor
saxagliptin
Also sold as Onglyza.
Data updated 2026-05-15
- 8,141
- FDA reportsLightly reported
- 5
- InteractionsFew interactions
- 72% less
- Generic vs brandBig savings
- 2
- Recall records
What the data shows
saxagliptin (Onglyza) is a prescription DPP-4 Inhibitor, reported less often than most tracked drugs (8,141 FDA reports), whose generic runs roughly half the brand price or less (72% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$15.51/unit
Generic Price
$4.39/unit
Generic Savings
72%
Generic Available
Yes (5 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Information not available.
Common side effects
Upper respiratory tract infection, Urinary tract infection, High cholesterol
Key warnings
No specific warnings noted. Always follow your prescriber's instructions.
Side Effects (from patient reports)
Based on 8,141 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for saxagliptin, by number of reports
- Cardiac Failure Congestive
Cardiac Failure Congestive
428 reports
- Blood Glucose Increased
Blood Glucose Increased
401 reports
- Cardiac Failure
Cardiac Failure
400 reports
- Nausea
Nausea
372 reports
- Diarrhoea
Diarrhoea
328 reports
- Fatigue
Fatigue
261 reports
- Dizziness
Dizziness
260 reports
- Headache
Headache
253 reports
- Weight Decreased
Weight Decreased
244 reports
- Death
Death
233 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for saxagliptin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where saxagliptin sits
saxagliptin has more FDA adverse-event reports than 35% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is saxagliptin; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 8,141 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2007–2025.
Total Reports
8,141
Reports Mentioning Death
648
8.0% of reports — not proof of cause
Hospitalization Reports
2,815
Top Indication
Type 2 Diabetes Mellitus
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | CARDIAC FAILURE CONGESTIVE | 428 |
| 2 | BLOOD GLUCOSE INCREASED | 401 |
| 3 | CARDIAC FAILURE | 400 |
| 4 | NAUSEA | 372 |
| 6 | DIARRHOEA | 328 |
| 7 | FATIGUE | 261 |
| 8 | DIZZINESS | 260 |
| 9 | HEADACHE | 253 |
| 10 | WEIGHT DECREASED | 244 |
| 11 | DEATH | 233 |
| 12 | VOMITING | 227 |
| 13 | RASH | 217 |
| 14 | ACUTE KIDNEY INJURY | 213 |
| 15 | DYSPNOEA | 204 |
| 16 | PANCREATITIS | 197 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Known Drug Interactions
7 DRUG INTERACTIONS Table 3: Clinically Relevant Interactions with QTERN Strong Inhibitors of CYP3A4/5 Enzymes Clinical Impact Ketoconazole significantly increased saxagliptin exposure. • Strong CYP3A4/5 Inhibitors (e.g., Ketoconazole): Do not coadminister QTERN with strong cytochrome P450 3A4/5 inhibitors.
Mechanism: Ketoconazole blocks the enzymes that clear saxagliptin from your body, which significantly increases the amount of drug in your blood.
Lithium Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequently during QTERN initiation and dosage changes.
Mechanism: This medication can cause your body to get rid of lithium more quickly, leading to lower levels in your blood.
Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin).
Mechanism: Clarithromycin stops the body from breaking down saxagliptin, which can lead to higher levels of the drug in your system.
Antidiabetic Drugs Repaglinide a Saxagliptin Monitor for adverse reactions.
Mechanism: Itraconazole blocks the enzymes that process saxagliptin, which can make the diabetes medicine stay in your system longer.
Dipeptidyl peptidase 4 (DPP4) inhibitors saxagliptin ↑ saxagliptin Dosage adjustment of saxagliptin is recommended. Refer to the saxagliptin product label for more information.
Mechanism: Ritonavir slows down the body's ability to clear saxagliptin, which causes the drug levels to rise.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What are the common side effects of saxagliptin?
Does saxagliptin interact with other medications?
What drug class is saxagliptin?
Is there a generic version of saxagliptin?
Has saxagliptin been recalled?
Active Recalls
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA
Related Medications in DPP-4 Inhibitor
Other drugs grouped near saxagliptin - same-class peers and common alternatives.
acarbose
Precose
Acarbose is a medicine that helps lower blood sugar levels in people with type 2 diabetes.
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alogliptin
Nesina
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bromocriptine
Cycloset
Bromocriptine (Cycloset) is a medicine that acts like dopamine in your body.
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canagliflozin
Invokana
Invokana is a medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes.
Compare with saxagliptin →
colesevelam
Welchol
Colesevelam is a medicine that helps lower bad cholesterol (LDL-C) and control blood sugar in adults.
Compare with saxagliptin →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for saxagliptin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 8,141.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 7.96%.
- methotrexate Δ 0.03 pts · 410,053 reports · Disease-Modifying Antirheumatic Drug (DMARD) 7.93%death share
- insulin glulisine Δ 0.04 pts · 9,944 reports · Rapid-Acting Insulin 7.99%death share
- pregabalin Δ 0.05 pts · 264,092 reports · Anticonvulsant / Nerve Pain Agent 8.01%death share
- mirabegron Δ 0.07 pts · 36,931 reports · Beta-3 Agonist (Overactive Bladder) 7.89%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for saxagliptin
The FDA label for saxagliptin (sold under brand names such as Onglyza) classifies it as a prescription-only medication in the DPP-4 Inhibitor class. Regulatory labeling describes its approved uses and the patient populations studied in pre-market trials. Official labeling lists 3 commonly reported side effects, including Upper respiratory tract infection, Urinary tract infection, High cholesterol.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 8,141 voluntary reports. The database also lists 5 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $4.39 versus $15.51 for the brand - a 72% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 2 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: November 13, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages