72/100 · Elevated
Manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.
Empagliflozin Adverse Events: High Serious Reaction Rate
100,203 FDA adverse event reports analyzed
Last updated: 2026-05-12
EMPAGLIFLOZIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.. Based on analysis of 100,203 FDA adverse event reports, EMPAGLIFLOZIN has a safety score of 72 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 EMPAGLIFLOZIN include DIABETIC KETOACIDOSIS, NAUSEA, BLOOD GLUCOSE INCREASED, DIARRHOEA, WEIGHT DECREASED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for EMPAGLIFLOZIN.
Empagliflozin has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 100,203 adverse event reports for this medication, which is primarily manufactured by Boehringer Ingelheim Pharmaceuticals, Inc..
The most commonly reported adverse events include Diabetic Ketoacidosis, Nausea, Blood Glucose Increased. Of classified reports, 60.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Empagliflozin reports include a high percentage of serious adverse events, particularly diabetic ketoacidosis and euglycaemic diabetic ketoacidosis.
Weight loss and nausea are common side effects, but do not significantly impact the overall safety score. The drug is associated with a range of cardiovascular and renal issues, including acute kidney injury and cardiac failure.
Patients taking Empagliflozin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Empagliflozin can cause diabetic ketoacidosis, particularly in patients with type 1 diabetes or those who are not well-controlled on insulin. It is contraindicated in patients with severe renal impairment (GFR <30 mL/min/1.73 m²). This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Empagliflozin received a safety concern score of 72/100 (elevated concern). This is based on a 60.7% serious event ratio across 61,481 classified reports. The score accounts for 100,203 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: Male: 29,221, Female: 25,426, Unknown: 82. The most frequently reported age groups are age 70 (1,328 reports), age 75 (1,241 reports), age 65 (1,213 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 61,481 classified reports for EMPAGLIFLOZIN:
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.
Empagliflozin can cause diabetic ketoacidosis, particularly in patients with type 1 diabetes or those who are not well-controlled on insulin. It is contraindicated in patients with severe renal impairment (GFR <30 mL/min/1.73 m²).
If you are taking Empagliflozin, here are important things to know. The most commonly reported side effects include diabetic ketoacidosis, nausea, blood glucose increased, diarrhoea, weight decreased. 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 in the first few months of treatment. Be aware of signs of diabetic ketoacidosis, such as nausea, vomiting, and abdominal pain, and seek medical attention immediately if they occur. 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 Empagliflozin for safety, particularly for serious adverse events like diabetic ketoacidosis and renal impairment. Regular monitoring of blood glucose and renal function is recommended.
The FDA has received approximately 100,203 adverse event reports associated with Empagliflozin. 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 Empagliflozin include Diabetic Ketoacidosis, Nausea, Blood Glucose Increased, Diarrhoea, Weight Decreased. By volume, the top reported reactions are: Diabetic Ketoacidosis (3,773 reports), Nausea (3,212 reports), Blood Glucose Increased (3,043 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Empagliflozin.
Out of 61,481 classified reports, 37,333 (60.7%) were classified as serious and 24,148 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 Empagliflozin break down by patient sex as follows: Male: 29,221, Female: 25,426, Unknown: 82. 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 Empagliflozin adverse events are: age 70: 1,328 reports, age 75: 1,241 reports, age 65: 1,213 reports, age 67: 1,190 reports, age 68: 1,187 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 Empagliflozin 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 Empagliflozin include: Fatigue, Dizziness, Off Label Use, Vomiting, Drug Ineffective. 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 Empagliflozin 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.
Empagliflozin has a safety concern score of 72 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. Empagliflozin reports include a high percentage of serious adverse events, particularly diabetic ketoacidosis and euglycaemic diabetic ketoacidosis.
Key safety signals identified in Empagliflozin's adverse event data include: Diabetic ketoacidosis and euglycaemic diabetic ketoacidosis are key safety signals, with a high count of serious reports.. Renal impairment and acute kidney injury are also significant safety signals, especially in older patients.. Cardiovascular events, including myocardial infarction and atrial fibrillation, are notable safety concerns.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Empagliflozin can cause diabetic ketoacidosis, particularly in patients with type 1 diabetes or those who are not well-controlled on insulin. It is contraindicated in patients with severe renal impairment (GFR <30 mL/min/1.73 m²). Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Empagliflozin.
Monitor blood glucose levels regularly, especially in the first few months of treatment. Be aware of signs of diabetic ketoacidosis, such as nausea, vomiting, and abdominal pain, and seek medical attention immediately if they occur.
Empagliflozin has 100,203 adverse event reports on file with the FDA. Weight loss and nausea are common side effects, but do not significantly impact the overall safety score. The volume of reports for Empagliflozin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Empagliflozin for safety, particularly for serious adverse events like diabetic ketoacidosis and renal impairment. Regular monitoring of blood glucose and renal function is recommended. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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