78/100 · Elevated
Manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.
Linagliptin Adverse Events: High Serious Reaction Rate
46,358 FDA adverse event reports analyzed
Last updated: 2026-05-12
LINAGLIPTIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.. Based on analysis of 46,358 FDA adverse event reports, LINAGLIPTIN has a safety score of 78 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for LINAGLIPTIN include BLOOD GLUCOSE INCREASED, DIARRHOEA, NAUSEA, FATIGUE, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LINAGLIPTIN.
Linagliptin has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 46,358 adverse event reports for this medication, which is primarily manufactured by Boehringer Ingelheim Pharmaceuticals, Inc..
The most commonly reported adverse events include Blood Glucose Increased, Diarrhoea, Nausea. Of classified reports, 69.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions are gastrointestinal issues like nausea and diarrhea, indicating a potential for digestive side effects.
Serious reactions, such as acute kidney injury and myocardial infarction, are concerning and account for a significant portion of reports. A diverse range of reactions, including neurological and cardiovascular issues, suggests a broad safety profile.
Patients taking Linagliptin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Linagliptin may interact with other drugs, including those affecting blood glucose levels, and warnings should be followed to avoid adverse effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Linagliptin received a safety concern score of 78/100 (high concern). This is based on a 69.5% serious event ratio across 17,375 classified reports. The score accounts for 46,358 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 8,051, Male: 7,782, Unknown: 93. The most frequently reported age groups are age 70 (422 reports), age 71 (411 reports), age 75 (407 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 17,375 classified reports for LINAGLIPTIN:
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.
Linagliptin may interact with other drugs, including those affecting blood glucose levels, and warnings should be followed to avoid adverse effects.
If you are taking Linagliptin, here are important things to know. The most commonly reported side effects include blood glucose increased, diarrhoea, nausea, fatigue, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be closely monitored for signs of serious reactions such as kidney injury or heart issues. Follow prescribed dosages and monitor blood glucose levels regularly to manage potential side effects. 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.
The FDA continues to monitor Linagliptin for safety, and updates will be provided as necessary. Healthcare providers should report any adverse events.
The FDA has received approximately 46,358 adverse event reports associated with Linagliptin. 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 Linagliptin include Blood Glucose Increased, Diarrhoea, Nausea, Fatigue, Dyspnoea. By volume, the top reported reactions are: Blood Glucose Increased (1,326 reports), Diarrhoea (1,196 reports), Nausea (1,138 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Linagliptin.
Out of 17,375 classified reports, 12,079 (69.5%) were classified as serious and 5,296 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 Linagliptin break down by patient sex as follows: Female: 8,051, Male: 7,782, Unknown: 93. 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 Linagliptin adverse events are: age 70: 422 reports, age 71: 411 reports, age 75: 407 reports, age 73: 385 reports, age 80: 362 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 Linagliptin adverse event reports is Boehringer Ingelheim Pharmaceuticals, Inc.. 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 Linagliptin include: Off Label Use, Dizziness, Vomiting, Malaise, Acute Kidney Injury. 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 Linagliptin 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.
Linagliptin has a safety concern score of 78 out of 100 (high 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. The most common reactions are gastrointestinal issues like nausea and diarrhea, indicating a potential for digestive side effects.
Key safety signals identified in Linagliptin's adverse event data include: Acute kidney injury and myocardial infarction are key safety signals, indicating potential renal and cardiovascular risks.. Reports of falls and death highlight the need for careful patient monitoring, especially in elderly patients.. Drug ineffectiveness and hypoglycemia suggest potential issues with efficacy and blood glucose control.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Linagliptin may interact with other drugs, including those affecting blood glucose levels, and warnings should be followed to avoid adverse effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Linagliptin.
Patients should be closely monitored for signs of serious reactions such as kidney injury or heart issues. Follow prescribed dosages and monitor blood glucose levels regularly to manage potential side effects.
Linagliptin has 46,358 adverse event reports on file with the FDA. Serious reactions, such as acute kidney injury and myocardial infarction, are concerning and account for a significant portion of reports. The volume of reports for Linagliptin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Linagliptin for safety, and updates will be provided as necessary. Healthcare providers should report any adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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