78/100 · Elevated
Manufactured by AstraZeneca Pharmaceuticals LP
Dapagliflozin Adverse Events: High Serious Reaction Rate and Renal Concerns
89,435 FDA adverse event reports analyzed
Last updated: 2026-05-12
DAPAGLIFLOZIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AstraZeneca Pharmaceuticals LP. Based on analysis of 89,435 FDA adverse event reports, DAPAGLIFLOZIN 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 DAPAGLIFLOZIN include DEATH, FATIGUE, NAUSEA, DIZZINESS, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DAPAGLIFLOZIN.
Dapagliflozin 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 89,435 adverse event reports for this medication, which is primarily manufactured by Astrazeneca Pharmaceuticals Lp.
The most commonly reported adverse events include Death, Fatigue, Nausea. Of classified reports, 75.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events such as death, acute kidney injury, and diabetic ketoacidosis are common.
Renal issues, including renal impairment and renal failure, are frequent and concerning. Cardiovascular events like myocardial infarction and cardiac failure are also reported.
Patients taking Dapagliflozin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Dapagliflozin is contraindicated in patients with severe renal impairment or end-stage renal disease. It may also interact with other drugs, such as potassium-sparing diuretics, which can lead to hyperkalemia. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Dapagliflozin received a safety concern score of 78/100 (high concern). This is based on a 75.7% serious event ratio across 50,468 classified reports. The score accounts for 89,435 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: Male: 24,261, Female: 20,350, Unknown: 54. The most frequently reported age groups are age 64 (766 reports), age 70 (735 reports), age 65 (729 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 50,468 classified reports for DAPAGLIFLOZIN:
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.
Dapagliflozin is contraindicated in patients with severe renal impairment or end-stage renal disease. It may also interact with other drugs, such as potassium-sparing diuretics, which can lead to hyperkalemia.
If you are taking Dapagliflozin, here are important things to know. The most commonly reported side effects include death, fatigue, nausea, dizziness, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of renal impairment and adjust dosing accordingly. Closely monitor for cardiovascular events, especially in patients with pre-existing conditions. Educate patients about the importance of proper hydration and signs of dehydration. 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 the safety of dapagliflozin, particularly for renal and cardiovascular outcomes. Healthcare providers should be vigilant and consider alternative therapies for patients with renal impairment.
The FDA has received approximately 89,435 adverse event reports associated with Dapagliflozin. 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 Dapagliflozin include Death, Fatigue, Nausea, Dizziness, Diarrhoea. By volume, the top reported reactions are: Death (7,017 reports), Fatigue (2,250 reports), Nausea (2,218 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Dapagliflozin.
Out of 50,468 classified reports, 38,221 (75.7%) were classified as serious and 12,247 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 Dapagliflozin break down by patient sex as follows: Male: 24,261, Female: 20,350, Unknown: 54. 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 Dapagliflozin adverse events are: age 64: 766 reports, age 70: 735 reports, age 65: 729 reports, age 72: 707 reports, age 75: 698 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 Dapagliflozin adverse event reports is Astrazeneca Pharmaceuticals Lp. 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 Dapagliflozin include: Dyspnoea, Blood Glucose Increased, Weight Decreased, Off Label Use, 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 Dapagliflozin 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.
Dapagliflozin 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. Serious adverse events such as death, acute kidney injury, and diabetic ketoacidosis are common.
Key safety signals identified in Dapagliflozin's adverse event data include: Acute kidney injury and renal failure are key safety signals.. Cardiovascular events, including myocardial infarction and cardiac failure, are significant.. Diabetic ketoacidosis and euglycemic diabetic ketoacidosis are notable.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Dapagliflozin is contraindicated in patients with severe renal impairment or end-stage renal disease. It may also interact with other drugs, such as potassium-sparing diuretics, which can lead to hyperkalemia. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Dapagliflozin.
Monitor patients for signs of renal impairment and adjust dosing accordingly. Closely monitor for cardiovascular events, especially in patients with pre-existing conditions. Educate patients about the importance of proper hydration and signs of dehydration.
Dapagliflozin has 89,435 adverse event reports on file with the FDA. Renal issues, including renal impairment and renal failure, are frequent and concerning. The volume of reports for Dapagliflozin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of dapagliflozin, particularly for renal and cardiovascular outcomes. Healthcare providers should be vigilant and consider alternative therapies for patients with renal impairment. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by AstraZeneca Pharmaceuticals LP and compare their safety profiles:
The following drugs share commonly reported adverse reactions with DAPAGLIFLOZIN:
Drugs related to DAPAGLIFLOZIN based on therapeutic use, drug class, or shared indications: