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
- Congestive heart failure
Congestive heart failure
428 reports
- Increased blood sugar
Increased blood sugar
401 reports
- Heart failure
Heart failure
400 reports
- Feeling sick to your stomach
Feeling sick to your stomach
372 reports
- Loose stools
Loose stools
328 reports
- Feeling tired
Feeling tired
261 reports
- Feeling lightheaded
Feeling lightheaded
260 reports
- Head pain
Head pain
253 reports
- Weight loss
Weight loss
244 reports
- Death
Death
232 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) 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.
What to do: Do not take these two medications at the same time.
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.
What to do: Your doctor should check your lithium blood levels more frequently when you start or change your dose of this medicine.
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.
What to do: Your doctor may need to adjust your dose or watch you more closely for side effects while taking both drugs.
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.
What to do: Watch for signs of low blood sugar and talk to your doctor about whether your dose needs to be adjusted.
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.
What to do: Your doctor may need to lower your dose of saxagliptin while you are taking this medication.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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.
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alogliptin
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bromocriptine
Cycloset
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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.
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colesevelam
Welchol
Colesevelam is a medicine that helps lower bad cholesterol (LDL-C) and control blood sugar in adults.
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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
Why some drugs demand precise dosing and monitoring
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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: November 13, 2024
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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