saxagliptin
Brand names: Onglyza
QTERN is a drug that combines two medicines to help lower blood sugar in adults with type 2 diabetes. It should be used with diet and exercise.
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
QTERN helps adults with type 2 diabetes control their blood sugar levels.
Common side effects
Upper respiratory tract infection, Urinary tract infection, High cholesterol
Key warnings
QTERN can cause a serious condition called diabetic ketoacidosis, especially if you have type 1 diabetes.
How It Works
QTERN contains two medicines that work in different ways to lower blood sugar. One medicine helps your kidneys remove sugar from your blood through your urine. The other medicine helps your body release more insulin after you eat.
How to Take It
Take QTERN once a day in the morning. You can take it with or without food. If you are not already taking dapagliflozin, the usual starting dose is one 5mg/5mg tablet daily. Your doctor may increase your dose to one 10mg/5mg tablet daily if needed.
Pregnancy & Breastfeeding
QTERN may harm your unborn baby, especially during the second and third trimesters. It is not recommended to use QTERN while breastfeeding.
Missed Dose
If you miss a dose of QTERN, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
Storage
Store QTERN at room temperature, between 68°F and 77°F.
Side Effects (from patient reports)
Based on 3,280 FDA adverse event reports.
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
Death-Related Reports
648
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 |
| 5 | DRUG INEFFECTIVE | 333 |
| 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 |
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
Serious Warnings
QTERN can cause a serious condition called diabetic ketoacidosis, especially if you have type 1 diabetes. Symptoms include trouble breathing, nausea, vomiting, belly pain, confusion, and unusual fatigue. If you have these symptoms, get medical help right away. QTERN may also increase your risk of heart failure. Tell your doctor if you have any heart problems.
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.
Common Questions
What should I do if I experience severe joint pain while taking QTERN?
Can QTERN be used to treat type 1 diabetes?
What should I do before having surgery?
What if I have kidney problems?
Can QTERN cause low blood sugar?
What are the symptoms of a genital yeast infection?
What should I do if I think I have a serious allergic reaction to QTERN?
Will QTERN affect urine glucose tests?
Can I cut or crush the QTERN tablet?
What should I do if I develop blisters while taking QTERN?
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?
Is saxagliptin safe during pregnancy?
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
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.
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colesevelam
Welchol
Colesevelam is a medicine that helps lower bad cholesterol (LDL-C) and control blood sugar in adults.
Compare with saxagliptin →
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
Related Health & Safety Data
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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. QTERN helps adults with type 2 diabetes control their blood sugar levels. 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 3,280 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.
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