65/100 · Elevated
Manufactured by Merck Sharp & Dohme LLC
Sitagliptin Safety Profile: Moderate Concern with Common Gastrointestinal and Metabolic Reactions
119,503 FDA adverse event reports analyzed
Last updated: 2026-05-12
SITAGLIPTIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Merck Sharp & Dohme LLC. Based on analysis of 119,503 FDA adverse event reports, SITAGLIPTIN has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for SITAGLIPTIN include BLOOD GLUCOSE INCREASED, NAUSEA, DIARRHOEA, DRUG INEFFECTIVE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SITAGLIPTIN.
Sitagliptin has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 119,503 adverse event reports for this medication, which is primarily manufactured by Merck Sharp & Dohme Llc.
The most commonly reported adverse events include Blood Glucose Increased, Nausea, Diarrhoea. Of classified reports, 64.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Gastrointestinal issues like nausea, diarrhea, and vomiting are common and frequent.
Metabolic changes, including increased blood glucose, are also reported. Serious adverse events, such as pancreatitis and acute kidney injury, are notable but less frequent.
Patients taking Sitagliptin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Sitagliptin may interact with other drugs, and patients should be cautious about dose omissions, as these are common reports. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sitagliptin received a safety concern score of 65/100 (elevated concern). This is based on a 64.2% serious event ratio across 70,286 classified reports. The score accounts for 119,503 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 33,271, Male: 30,472, Unknown: 734. The most frequently reported age groups are age 70 (1,688 reports), age 65 (1,539 reports), age 69 (1,363 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 70,286 classified reports for SITAGLIPTIN:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Sitagliptin may interact with other drugs, and patients should be cautious about dose omissions, as these are common reports.
If you are taking Sitagliptin, here are important things to know. The most commonly reported side effects include blood glucose increased, nausea, diarrhoea, drug ineffective, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor blood glucose levels regularly, especially if you experience symptoms of hypoglycemia or hyperglycemia. Report any unusual symptoms to your healthcare provider promptly. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is ongoing, with no major safety concerns but a need for continued monitoring of serious events.
The FDA has received approximately 119,503 adverse event reports associated with Sitagliptin. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Sitagliptin include Blood Glucose Increased, Nausea, Diarrhoea, Drug Ineffective, Fatigue. By volume, the top reported reactions are: Blood Glucose Increased (4,455 reports), Nausea (3,790 reports), Diarrhoea (3,469 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Sitagliptin.
Out of 70,286 classified reports, 45,124 (64.2%) were classified as serious and 25,162 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Sitagliptin break down by patient sex as follows: Female: 33,271, Male: 30,472, Unknown: 734. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Sitagliptin adverse events are: age 70: 1,688 reports, age 65: 1,539 reports, age 69: 1,363 reports, age 68: 1,340 reports, age 72: 1,321 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Sitagliptin adverse event reports is Merck Sharp & Dohme Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Sitagliptin include: Headache, Dizziness, Dyspnoea, Vomiting, Pancreatitis. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Sitagliptin to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Sitagliptin has a safety concern score of 65 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Gastrointestinal issues like nausea, diarrhea, and vomiting are common and frequent.
Key safety signals identified in Sitagliptin's adverse event data include: Pancreatitis and acute kidney injury are key safety signals, indicating potential severe side effects.. Reports of diabetes mellitus inadequate control and hyperglycemia suggest concerns with blood sugar management.. Drug interactions and dose omissions are frequently reported, highlighting the need for careful monitoring.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Sitagliptin may interact with other drugs, and patients should be cautious about dose omissions, as these are common reports. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Sitagliptin.
Monitor blood glucose levels regularly, especially if you experience symptoms of hypoglycemia or hyperglycemia. Report any unusual symptoms to your healthcare provider promptly.
Sitagliptin has 119,503 adverse event reports on file with the FDA. Metabolic changes, including increased blood glucose, are also reported. The volume of reports for Sitagliptin reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with no major safety concerns but a need for continued monitoring of serious events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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