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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Alogliptin
Generic Name
Alogliptin
Active Ingredient
AlogliptinCategory
Other
Salt Form
Benzoate
Variants
7
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 25 mg/1 | TABLET, FILM COATED | ORAL | 45802-150 |
| 25 mg/1 | TABLET, FILM COATED | ORAL | 63629-4946 |
| 25 mg/1 | TABLET, FILM COATED | ORAL | 71610-300 |
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Alogliptin, you must consult a qualified healthcare professional.
| 12.5 mg/1 | TABLET, FILM COATED | ORAL | 45802-103 |
| 12.5 mg/1 | TABLET, FILM COATED | ORAL | 71610-661 |
| 6.25 mg/1 | TABLET, FILM COATED | ORAL | 45802-087 |
| 25 mg/1 | TABLET, FILM COATED | ORAL | 50090-5574 |
Detailed information about Alogliptin
Alogliptin is a potent, highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor used to improve glycemic control in adults with type 2 diabetes mellitus. It works by increasing incretin levels to stimulate insulin secretion and reduce glucagon production in a glucose-dependent manner.
For the treatment of type 2 diabetes mellitus, the standard recommended adult dose of Alogliptin is 25 mg taken orally once daily. This dosage is intended to provide maximum inhibition of the DPP-4 enzyme (typically >80% over 24 hours). Healthcare providers often monitor Hemoglobin A1c (HbA1c) levels every 3 to 6 months to determine if the medication is achieving the desired glycemic targets. While 25 mg is the standard, the dose must be individualized based on the patient's kidney function and their use of other medications that might increase the risk of hypoglycemia.
As of 2026, the safety and effectiveness of Alogliptin in pediatric patients (under the age of 18) have not been established. Clinical trials in children are limited, and therefore, Alogliptin is not currently approved for pediatric use. Parents and caregivers should consult a pediatric endocrinologist for appropriate management of type 2 diabetes in children, which typically involves lifestyle modifications, metformin, or insulin.
Because Alogliptin is primarily cleared by the kidneys, dosage adjustments are mandatory for patients with decreased renal function to avoid drug accumulation and potential toxicity.
No dosage adjustment is necessary for patients with mild to moderate hepatic impairment (Child-Pugh Score 5 to 9). Alogliptin has not been extensively studied in patients with severe hepatic impairment, so healthcare providers use caution in this population.
No specific dose adjustment is required based on age alone. However, since elderly patients are more likely to have decreased renal function, healthcare providers must assess kidney function (Creatinine Clearance) before initiating therapy and periodically thereafter.
If you miss a dose of Alogliptin, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not take two doses at once to make up for a missed one, as this increases the risk of side effects.
In the event of an overdose, contact your local poison control center or seek emergency medical attention immediately. While Alogliptin has a high safety margin, massive doses could potentially cause severe hypoglycemia, especially if taken with other diabetes medications. Symptoms of overdose may include extreme weakness, confusion, tremors, sweating, or rapid heartbeat. Treatment is generally supportive, focusing on maintaining blood glucose levels and monitoring renal function.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking the medication without medical guidance, as this can lead to a spike in blood sugar levels (hyperglycemia).
While Alogliptin is generally well-tolerated, some patients may experience mild side effects. The most frequently reported common side effect is nasopharyngitis (inflammation of the nose and throat), which occurs in approximately 4-5% of patients. This typically feels like a common cold, characterized by a runny nose, sore throat, and sneezing. Most patients find that these symptoms are transient and do not require discontinuation of the drug.
Other common side effects include:
Some patients may experience gastrointestinal or musculoskeletal issues, including:
Alogliptin is a potent medication that requires careful clinical oversight. Patients should be aware that while it effectively lowers blood sugar, it does not replace the need for a healthy diet and regular physical activity. Furthermore, Alogliptin should not be used in patients with Type 1 diabetes or for the treatment of diabetic ketoacidosis, as it is ineffective for these conditions.
No FDA black box warnings for Alogliptin. Unlike some other diabetes medications, Alogliptin has not demonstrated a level of risk that requires the FDA's most stringent warning label. However, the absence of a black box warning does not imply the drug is without risk; patients must still adhere to all safety precautions listed below.
There are no absolute drug-drug contraindications where Alogliptin must never be used; however, it should not be used with other DPP-4 inhibitors (e.g., sitagliptin, saxagliptin, linagliptin). Combining two drugs from the same class does not provide additional benefit and significantly increases the risk of side effects like joint pain and pancreatitis.
There are specific circumstances where Alogliptin must NEVER be used due to the risk of life-threatening reactions:
Alogliptin is classified under the legacy FDA Pregnancy Category B. This means that animal reproduction studies have failed to demonstrate a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women.
It is not known whether Alogliptin is excreted in human milk. In animal studies (rats), Alogliptin was found to be secreted in milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Alogliptin is a selective inhibitor of the enzyme dipeptidyl peptidase-4 (DPP-4). Its primary role is to protect the incretin hormones, Glucagon-like Peptide-1 (GLP-1) and Glucose-dependent Insulinotropic Polypeptide (GIP), from rapid degradation. These hormones are released by the intestines throughout the day, and their levels increase in response to a meal.
By inhibiting DPP-4, Alogliptin increases the 'half-life' of these hormones. GLP-1 and GIP then act on the pancreas in a glucose-dependent manner: they increase insulin synthesis and release from pancreatic beta cells and decrease glucagon secretion from pancreatic alpha cells. Lower glucagon levels lead to reduced hepatic glucose production. Importantly, because this mechanism is glucose-dependent, Alogliptin does not typically cause hypoglycemia when blood sugar is already low.
Alogliptin produces a rapid and sustained inhibition of DPP-4. Following a single 25 mg oral dose, peak inhibition of >93% is achieved within 1-2 hours. Inhibition remains above 80% for 24 hours, which justifies the once-daily dosing. In clinical trials, Alogliptin has demonstrated significant reductions in fasting plasma glucose (FPG) and postprandial glucose (PPG) levels, leading to an average HbA1c reduction of 0.5% to 0.9% depending on baseline levels and combination therapy.
Common questions about Alogliptin
Alogliptin is a prescription medication used to improve blood sugar control in adults with type 2 diabetes mellitus. It belongs to a class of drugs called DPP-4 inhibitors, which work by increasing the levels of natural substances called incretins in the body. These incretins help the pancreas release more insulin when blood sugar is high and reduce the amount of sugar made by the liver. It is typically used along with a healthy diet and regular exercise program. It is not intended for use in people with type 1 diabetes or for treating diabetic ketoacidosis.
The most frequently reported side effects of Alogliptin include nasopharyngitis (cold-like symptoms such as a runny nose and sore throat), headache, and upper respiratory tract infections. Some patients may also experience mild stomach pain or diarrhea. While these are common, they are usually mild and tend to go away as your body adjusts to the medication. However, if these symptoms persist or become bothersome, you should consult your healthcare provider. More serious side effects, such as joint pain or skin blisters, are rare but require immediate medical attention.
You should exercise caution and limit alcohol consumption while taking Alogliptin. Alcohol can significantly affect blood sugar levels, increasing the risk of both hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar). Furthermore, heavy alcohol use is a major risk factor for pancreatitis, a serious inflammation of the pancreas that has been reported in some patients taking Alogliptin. It is essential to discuss your alcohol habits with your doctor to understand what is safe for your specific health situation. Always avoid drinking alcohol on an empty stomach if you are taking diabetes medications.
The safety of Alogliptin during pregnancy has not been fully established in human studies. Animal studies did not show direct harm to the fetus, but because human data is lacking, it is generally not the first choice for pregnant women. Most healthcare providers prefer using insulin to manage diabetes during pregnancy because it provides more predictable control and does not cross the placenta. If you are pregnant, planning to become pregnant, or breastfeeding, you must inform your doctor. They will help you weigh the benefits of Alogliptin against potential risks to your baby.
Alogliptin begins to inhibit the DPP-4 enzyme within 1 to 2 hours of taking the first dose, which starts the process of regulating your blood sugar. However, it may take several weeks of consistent daily use to see a significant and stable decrease in your fasting blood sugar and Hemoglobin A1c (HbA1c) levels. Most doctors will wait at least 3 months before checking your HbA1c to determine the full effectiveness of the medication. It is important to continue taking the medication every day even if you do not feel an immediate difference in your symptoms.
You should never stop taking Alogliptin suddenly without first consulting your healthcare provider. Diabetes is a chronic condition, and Alogliptin helps keep your blood sugar levels stable over the long term. If you stop taking it abruptly, your blood sugar levels could spike rapidly, increasing the risk of serious complications like blurred vision, extreme thirst, or even long-term damage to your kidneys and nerves. If you need to stop the medication due to side effects, your doctor will guide you on how to safely transition to a different treatment plan.
If you miss a dose of Alogliptin, you should take it as soon as you remember. However, if it is nearly time for your next scheduled dose, you should skip the missed dose and simply take the next one at your regular time. Do not take two tablets at once to make up for a missed dose, as this can increase your risk of experiencing side effects. To help prevent missed doses, try taking your medication at the same time every day, such as with breakfast or right before bed. Consistency is key to managing type 2 diabetes effectively.
One of the benefits of Alogliptin and other DPP-4 inhibitors is that they are generally 'weight neutral.' This means that, unlike some other diabetes medications like sulfonylureas or insulin, Alogliptin is not typically associated with significant weight gain. In clinical trials, most patients taking Alogliptin maintained a stable weight. This makes it a favorable option for patients with type 2 diabetes who are already struggling with weight management. However, it is still important to maintain a healthy diet and exercise routine as part of your overall diabetes care plan.
Alogliptin is often prescribed in combination with other diabetes medications like metformin, pioglitazone, or insulin to provide better blood sugar control. However, it can interact with certain drugs. For example, taking Alogliptin with insulin or a sulfonylurea can increase your risk of low blood sugar (hypoglycemia). It is also important to tell your doctor about any other medications you take, including over-the-counter drugs, vitamins, and herbal supplements, as some can affect your kidney function or blood sugar levels. Your doctor will monitor you closely when starting or changing any medications.
Yes, Alogliptin is available as a generic medication. The FDA approved the first generic versions of Alogliptin (Nesina) several years ago, which has made the medication more affordable and accessible for many patients. Generic Alogliptin contains the same active ingredient and meets the same strict quality and effectiveness standards as the brand-name version. When your doctor prescribes Alogliptin, your pharmacist may provide the generic version unless your doctor specifically requests the brand name. Using the generic version can significantly lower your out-of-pocket prescription costs.
Other drugs with the same active ingredient (Alogliptin)
Rare but documented side effects include:
> Warning: Stop taking Alogliptin and call your doctor immediately if you experience any of these serious conditions.
Long-term use of Alogliptin is generally considered safe; however, patients must remain vigilant for the development of chronic joint pain or skin changes. Because Alogliptin is a relatively newer class of medication, long-term observational studies are ongoing to monitor for any rare metabolic or immunological shifts over decades of use. Regular renal function monitoring is essential, as age-related decline in kidney function may necessitate a dose reduction over time.
As of 2026, Alogliptin does not carry an FDA Black Box Warning. However, the FDA has issued 'Drug Safety Communications' regarding the risk of heart failure and severe joint pain for the entire DPP-4 inhibitor class. It is vital to distinguish between a standard warning and a Black Box warning; while Alogliptin is considered safe for most, the precautions regarding heart failure (stemming from the EXAMINE trial data) are treated with high clinical priority.
Report any unusual symptoms, especially persistent abdominal pain or new-onset swelling, to your healthcare provider immediately. Early detection of side effects is key to preventing long-term complications.
To ensure the safe use of Alogliptin, the following monitoring is typically recommended:
Alogliptin itself does not typically cause drowsiness or impaired coordination. However, if taken in combination with other diabetes drugs (like insulin), it can cause hypoglycemia (low blood sugar), which may lead to dizziness, blurred vision, or confusion. Do not drive or operate heavy machinery until you know how your blood sugar responds to this medication.
Alcohol can interfere with blood sugar control and increase the risk of both hypoglycemia and pancreatitis. Patients are advised to limit alcohol consumption while taking Alogliptin. Discuss your alcohol intake with your doctor to determine a safe limit.
Do not stop taking Alogliptin abruptly without consulting your doctor. Stopping the medication can lead to a rapid increase in blood sugar levels, increasing the risk of long-term diabetes complications. If discontinuation is necessary due to side effects, your doctor will provide a transition plan to another medication.
> Important: Discuss all your medical conditions, especially any history of heart, kidney, or pancreas problems, with your healthcare provider before starting Alogliptin.
For each major interaction, it is important to understand that the clinical consequence is usually a shift in blood sugar levels rather than direct toxicity. The management strategy almost always involves more frequent blood glucose monitoring and potential dose adjustments of the concomitant medication rather than Alogliptin itself.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter drugs like ibuprofen or aspirin, as they can sometimes affect kidney function which in turn affects Alogliptin levels.
These are conditions where the medication may be used, but only with extreme caution and a careful risk-benefit analysis by a healthcare provider:
Patients should be aware of cross-sensitivity between different gliptins. If you have had a mild rash with Sitagliptin, you might also experience a reaction with Alogliptin. Always inform your doctor of any previous drug allergies, even if they seemed minor at the time.
> Important: Your healthcare provider will evaluate your complete medical history, including any history of alcoholism, gallstones (which increase pancreatitis risk), or heart disease, before prescribing Alogliptin.
Alogliptin is not approved for use in patients under 18 years of age. Type 2 diabetes in children is typically managed with lifestyle changes and medications that have a longer history of pediatric use, such as Metformin or Liraglutide. The long-term effects of DPP-4 inhibition on growth and development are currently unknown.
Clinical studies of Alogliptin included a significant number of patients aged 65 and over. No overall differences in safety or effectiveness were observed between these patients and younger patients. However, the elderly are more prone to age-related decline in renal function.
Renal impairment is the most significant factor in Alogliptin dosing.
Because Alogliptin is dialyzable, it can be taken regardless of the timing of hemodialysis sessions.
In patients with mild to moderate hepatic impairment, the pharmacokinetics of Alogliptin are not significantly altered, and no dose adjustment is required. However, for patients with severe hepatic impairment, the drug should be used with caution as there is no clinical data for this specific population.
> Important: Special populations require individualized medical assessment. Always inform your doctor if you are planning to become pregnant or if you have noticed changes in your kidney function.
| Parameter | Value |
|---|---|
| Bioavailability | ~100% |
| Protein Binding | ~20% |
| Half-life | ~21 hours |
| Tmax | 1 - 2 hours |
| Metabolism | Minimal (CYP2D6, CYP3A4) |
| Excretion | Renal 76%, Fecal 13% |
Alogliptin is classified as an Antidiabetic Agent, specifically a Dipeptidyl Peptidase-4 (DPP-4) Inhibitor. It is therapeutically related to other 'gliptins' such as Sitagliptin (Januvia), Saxagliptin (Onglyza), and Linagliptin (Tradjenta). Within the hierarchy of diabetes treatment, it is considered a second-line agent after Metformin, or a first-line agent in patients who cannot tolerate Metformin.