82/100 · Critical
Manufactured by Janssen Pharmaceuticals, Inc.
Canagliflozin Adverse Events: High Concern for Diabetic Ketoacidosis and Lower Limb Amputations
49,711 FDA adverse event reports analyzed
Last updated: 2026-05-12
CANAGLIFLOZIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Pharmaceuticals, Inc.. Based on analysis of 49,711 FDA adverse event reports, CANAGLIFLOZIN has a safety score of 82 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 CANAGLIFLOZIN include DIABETIC KETOACIDOSIS, TOE AMPUTATION, OSTEOMYELITIS, ACUTE KIDNEY INJURY, FUNGAL INFECTION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CANAGLIFLOZIN.
Canagliflozin has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 49,711 adverse event reports for this medication, which is primarily manufactured by Janssen Pharmaceuticals, Inc..
The most commonly reported adverse events include Diabetic Ketoacidosis, Toe Amputation, Osteomyelitis. Of classified reports, 64.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Canagliflozin reports a high incidence of diabetic ketoacidosis and lower limb amputations, indicating significant safety concerns.
Weight loss and increased blood glucose are common but less severe side effects. The drug is associated with serious adverse events, particularly in older adults. Fungal infections and urinary tract infections are also frequently reported.
Patients taking Canagliflozin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Canagliflozin is contraindicated in patients with severe renal impairment and should be used with caution in patients with a history of lower limb amputations or diabetic ketoacidosis. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Canagliflozin received a safety concern score of 82/100 (high concern). This is based on a 64.6% serious event ratio across 29,554 classified reports. The score accounts for 49,711 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: 13,356, Female: 12,723, Unknown: 47. The most frequently reported age groups are age 60 (648 reports), age 61 (606 reports), age 55 (600 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 29,554 classified reports for CANAGLIFLOZIN:
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.
Canagliflozin is contraindicated in patients with severe renal impairment and should be used with caution in patients with a history of lower limb amputations or diabetic ketoacidosis.
If you are taking Canagliflozin, here are important things to know. The most commonly reported side effects include diabetic ketoacidosis, toe amputation, osteomyelitis, acute kidney injury, fungal infection. 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 informed about the risk of diabetic ketoacidosis and lower limb amputations and should seek medical attention immediately if these symptoms occur. Regular monitoring of blood glucose levels and renal function is recommended. 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 canagliflozin and has issued warnings regarding the risk of diabetic ketoacidosis and lower limb amputations. Healthcare providers should closely monitor patients for these adverse events.
The FDA has received approximately 49,711 adverse event reports associated with Canagliflozin. 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 Canagliflozin include Diabetic Ketoacidosis, Toe Amputation, Osteomyelitis, Acute Kidney Injury, Fungal Infection. By volume, the top reported reactions are: Diabetic Ketoacidosis (3,421 reports), Toe Amputation (2,195 reports), Osteomyelitis (2,163 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Canagliflozin.
Out of 29,554 classified reports, 19,087 (64.6%) were classified as serious and 10,467 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 Canagliflozin break down by patient sex as follows: Male: 13,356, Female: 12,723, Unknown: 47. 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 Canagliflozin adverse events are: age 60: 648 reports, age 61: 606 reports, age 55: 600 reports, age 58: 562 reports, age 57: 551 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 Canagliflozin adverse event reports is Janssen 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 Canagliflozin include: Weight Decreased, Blood Glucose Increased, Gangrene, Cellulitis, Urinary Tract Infection. 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 Canagliflozin 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.
Canagliflozin has a safety concern score of 82 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. Canagliflozin reports a high incidence of diabetic ketoacidosis and lower limb amputations, indicating significant safety concerns.
Key safety signals identified in Canagliflozin's adverse event data include: Diabetic ketoacidosis. Lower limb amputations. Fungal infections. Urinary tract infections. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Canagliflozin is contraindicated in patients with severe renal impairment and should be used with caution in patients with a history of lower limb amputations or diabetic ketoacidosis. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Canagliflozin.
Patients should be informed about the risk of diabetic ketoacidosis and lower limb amputations and should seek medical attention immediately if these symptoms occur. Regular monitoring of blood glucose levels and renal function is recommended.
Canagliflozin has 49,711 adverse event reports on file with the FDA. Weight loss and increased blood glucose are common but less severe side effects. The volume of reports for Canagliflozin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of canagliflozin and has issued warnings regarding the risk of diabetic ketoacidosis and lower limb amputations. Healthcare providers should closely monitor patients for these adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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