Saxagliptin
Saxagliptin is a prescription oral tablet used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 3 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Saxagliptin: Patient Information Guide
A plain-language walkthrough of Saxagliptin — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Saxagliptin tablets are approved for use in adults with type 2 diabetes to help improve blood sugar control, always as an addition to diet and exercise.
- Treats type 2 diabetes mellitus in adults — as a standalone therapy or combined with other diabetes medicines such as metformin, thiazolidinediones, sulfonylureas, or insulin
- Can be used in adults with moderate or severe kidney disease or end-stage renal disease requiring hemodialysis, at a lower dose
- Not indicated for type 1 diabetes mellitus
- Not indicated for diabetic ketoacidosis
- Effectiveness was not demonstrated in a clinical trial in pediatric patients aged 10–17; saxagliptin is not recommended for use in children
⚙️How it works▾
When you eat, your small intestine releases hormones called incretins — specifically GLP-1 and GIP. These hormones tell the pancreas to release insulin and tell the liver to produce less sugar. The problem is that an enzyme called DPP-4 destroys these hormones within minutes. Saxagliptin is a DPP-4 inhibitor — it blocks that enzyme, so GLP-1 and GIP stick around longer and do their job more effectively. This leads to more insulin release and lower blood sugar after meals, but only when blood sugar is actually elevated, which helps reduce the risk of blood sugar dropping too low.
💊How it's taken▾
Saxagliptin tablets are taken once daily by mouth, and can be taken with or without food. Swallow the tablet whole — do not cut, crush, or chew it. If you miss a dose, simply skip it and take your next dose at the usual time; never take a double dose to make up for a missed one.
- People with moderate to severe kidney disease or end-stage renal disease (on hemodialysis) take a lower dose — administered after the dialysis session
- If you take certain strong antifungal or antiviral medicines (strong CYP3A4/5 inhibitors), your prescriber may lower your saxagliptin dose
🤒Side effects — in detail▾
Most people tolerate saxagliptin well. The most commonly reported side effects include:
- Upper respiratory tract infection (cold symptoms)
- Urinary tract infection
- Headache
- Low blood sugar (hypoglycemia), most likely when combined with insulin or sulfonylureas like glyburide
- Leg or foot swelling (peripheral edema), especially if also taking a thiazolidinedione diabetes medicine
Seek medical attention right away if you experience severe stomach pain, signs of an allergic reaction (swelling of the face or throat, skin peeling), blistering skin, severe joint pain, or symptoms of heart failure like sudden shortness of breath or rapid weight gain.
⚠️Warnings & precautions▾
- Heart failure risk: In a large clinical trial, more patients taking saxagliptin were hospitalized for heart failure than those on placebo. The risk was highest in people with a prior history of heart failure or kidney problems. Report symptoms like shortness of breath, leg swelling, or sudden weight gain to your doctor immediately.
- Pancreatitis: Acute pancreatitis (sudden severe inflammation of the pancreas) has been reported. Stop taking saxagliptin and get medical help right away if you have severe belly pain, nausea, or vomiting.
- Serious allergic reactions: Reactions including anaphylaxis (life-threatening allergic response), angioedema (severe swelling), and skin peeling have occurred, sometimes after just the first dose. Do not take saxagliptin if you have had a serious allergic reaction to it before.
- Severe joint pain: Disabling arthralgia (joint pain) has been reported with DPP-4 inhibitors. It can start days to years after beginning therapy. Symptoms usually improve after stopping the medicine.
- Bullous pemphigoid: A blistering skin condition requiring hospitalization has been reported. Tell your doctor if you develop blisters or open sores on your skin.
- Tartrazine sensitivity: The 2.5 mg tablet contains FD&C Yellow No. 5 (tartrazine), which can trigger allergic reactions — especially in people who are sensitive to aspirin.
🔀What it interacts with▾
Saxagliptin is processed mainly by liver enzymes (CYP3A4/5), so medicines that affect these enzymes can change how much saxagliptin is in your system:
- Strong CYP3A4/5 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, atazanavir, and others) — these drugs significantly increase saxagliptin blood levels; your prescriber will likely lower your saxagliptin dose
- Insulin — using saxagliptin with insulin raises the risk of hypoglycemia (low blood sugar); your insulin dose may need to be reduced
- Insulin secretagogues (such as sulfonylureas like glyburide or glipizide) — combining these with saxagliptin increases low blood sugar risk; dose adjustments may be needed
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not take saxagliptin if you have had a serious allergic reaction (anaphylaxis, angioedema, skin peeling) to saxagliptin or any ingredient in the tablet
- Tell your doctor if you have ever had angioedema with another DPP-4 inhibitor — extra caution is needed
- Tell your doctor about any kidney problems — dose adjustment is required for moderate to severe kidney disease or if you are on hemodialysis
- Tell your doctor if you have a history of heart failure or are at higher risk for it
- Tell your doctor if you have had pancreatitis before
- Older adults (65+): kidney function tends to decline with age, so it should be checked before starting and monitored during treatment
- Children and teenagers: saxagliptin was not shown to be effective in patients aged 10–17 and is not recommended for pediatric use
- Pregnancy: human data is limited; discuss risks and benefits with your doctor, as poorly controlled diabetes in pregnancy also carries serious risks
- Breastfeeding: it is not known whether saxagliptin passes into human breast milk; discuss with your doctor before breastfeeding
🚑If you take too much▾
In clinical studies, healthy volunteers who took very high doses of saxagliptin daily for two weeks did not experience serious adverse effects or heart rhythm problems. If an overdose is suspected, contact the Poison Help Line at 1-800-222-1222 or seek emergency medical care. Saxagliptin and its active metabolite can be partially removed by hemodialysis.
📡Pharmacodynamics — effects in the body▾
In people with type 2 diabetes, saxagliptin blocks the DPP-4 enzyme for a full 24-hour period after each dose. After a meal or glucose load, this results in a 2- to 3-fold increase in active GLP-1 and GIP hormone levels, lower glucagon (a hormone that raises blood sugar), and greater insulin release from the pancreas. The net effect is lower fasting blood sugar and smaller blood sugar spikes after eating. Studies show saxagliptin does not meaningfully affect heart rate or heart rhythm.
🔬Pharmacokinetics — how your body processes it▾
After an oral dose, saxagliptin is absorbed relatively quickly (reaching peak levels in about 2 hours) and can be taken with or without food. It is broken down mainly by liver enzymes (CYP3A4/5) into an active metabolite that also lowers blood sugar. Both saxagliptin and its active metabolite are eliminated through the kidneys and liver, with a short half-life of about 2.5 to 3 hours. Because the kidneys play a key role in clearing this medicine, people with kidney disease have higher drug exposure and may need a lower dose.
📦How to store it▾
Store at 20° to 25°C (68° to 77°F). Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
📄 Written from Saxagliptin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Saxagliptin
256 supplements and herbal products have documented interactions with Saxagliptin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 2
- Moderate · 215
- Minor · 39
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Saxagliptin has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Saxagliptin — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does saxagliptin do — and how is it different from other diabetes pills? ▾
Can I take this pill with food, or do I need to take it on an empty stomach? ▾
What side effects should I actually worry about versus what's just annoying but okay? ▾
I also take insulin. Do I need to worry about low blood sugar? ▾
I have kidney disease. Is it safe for me to take saxagliptin? ▾
Is saxagliptin safe to take during pregnancy or while breastfeeding? ▾
Is Saxagliptin available over the counter? ▾
When was Saxagliptin first available? ▾
Who makes Saxagliptin? ▾
💬 Answers drafted from Saxagliptin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Saxagliptin comes
Saxagliptin is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Used as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus
- Not recommended for type 1 diabetes or diabetic ketoacidosis
- Take once daily by mouth, with or without food
- Swallow whole — do not cut, crush, or chew the tablet
- If on hemodialysis, take the tablet after your dialysis session
- If you miss a dose, skip it and resume at your next scheduled time — do not take two doses at once
📊 Saxagliptin across the U.S. market
How Saxagliptin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (12) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Saxagliptin is used
A general measure of how commonly Saxagliptin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Saxagliptin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Saxagliptin prescribed? Of the 1,596 medications we measure, Saxagliptin ranks #1,069 by Medicaid prescriptions — more than 33% of them.
Utilization by Saxagliptin product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
saxagliptin 5 MG Oral Tablet Most dispensed
Summed across the 6 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 858036
saxagliptin 2.5 MG Oral Tablet
Summed across the 6 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 858042
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Saxagliptin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 12 of 32 listed Saxagliptin NDCs with Medicaid activity.
🔍 Compare Saxagliptin products
A representative set of FDA-listed product records for Saxagliptin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 2.5 mg | Oral | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 5 mg | Oral | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 2.5 mg | Oral | AstraZeneca Pharmaceuticals LP × 2 listings | NDA | View NDC → |
| 5 mg | Oral | AstraZeneca Pharmaceuticals LP × 2 listings | NDA | View NDC → |
| 2.5 mg | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| 5 mg | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| 5 mg | Oral | Cardinal Health | NDA | View NDC → |
| 5 mg | Oral | Cardinal Health 107, LLC | NDA | View NDC → |
| 2.5 mg | Oral | Glenmark Pharmaceuticals Inc., USA × 2 listings | ANDA | View NDC → |
| 5 mg | Oral | Glenmark Pharmaceuticals Inc., USA × 2 listings | ANDA | View NDC → |
| 2.5 mg | Oral | Mylan Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 5 mg | Oral | Mylan Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Alivus Life Sciences Limited | BULK INGREDIENT | View NDC → |
| 50 kg/50 kg | — | Aurobindo Pharma Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Dr.Reddy's Laboratories Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Honour Lab Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Metrochem API Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Pharmachem Private Limited × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Mylan Laboratories Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Sk Biotek Ireland Limited | BULK INGREDIENT | View NDC → |
| 25 kg/25 kg | — | Sun Pharmaceutical Industries, Inc. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | TAPI Croatia Industries Ltd. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Viyash Life Sciences Private Limited | BULK INGREDIENT | View NDC → |
Showing 32 of 32 products — FDA National Drug Code Directory. See every product, package size and price: browse all 32 Saxagliptin NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Saxagliptin — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Saxagliptin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Saxagliptin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 857974 1 dose form · 2 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 858035In current FDA listings
Look up RxCUI 857974 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Saxagliptin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Saxagliptin belongs to the Dipeptidyl Peptidase 4 Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 3 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Mylan Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.