Drug side effects
canagliflozin Side Effects
The reactions most often reported to the FDA for canagliflozin (also sold as Invokana), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 29,554
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2011 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of canagliflozin come from 29,554 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 29,554 reports to the FDA Adverse Event Reporting System (FAERS) for canagliflozin (Invokana): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
29,554
Reports Mentioning Death
678
2.3% of reports — not proof the medicine caused the death
Hospitalizations
10,619
35.9% of reports
Top Indication
Type 2 Diabetes Mellitus
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 678 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 235 |
| ACUTE KIDNEY INJURY | 80 |
| DIABETIC KETOACIDOSIS | 65 |
| MYOCARDIAL INFARCTION | 38 |
| SEPSIS | 30 |
| CARDIAC ARREST | 27 |
| RENAL FAILURE | 27 |
| HYPOTENSION | 23 |
| LEG AMPUTATION | 22 |
| PNEUMONIA | 22 |
| URINARY TRACT INFECTION | 22 |
| WEIGHT DECREASED | 22 |
| DECREASED APPETITE | 20 |
| DIARRHOEA | 20 |
| OSTEOMYELITIS | 20 |
| DEHYDRATION | 19 |
| FATIGUE | 19 |
| SEPTIC SHOCK | 19 |
| TOE AMPUTATION | 19 |
Reactions in Hospitalization Reports
Top reactions in 10,619 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DIABETIC KETOACIDOSIS | 2,850 |
| OSTEOMYELITIS | 1,816 |
| ACUTE KIDNEY INJURY | 1,680 |
| TOE AMPUTATION | 1,649 |
| GANGRENE | 956 |
| CELLULITIS | 906 |
| DIABETIC FOOT INFECTION | 756 |
| LEG AMPUTATION | 668 |
| DIABETIC FOOT | 664 |
| SEPSIS | 543 |
| FOOT AMPUTATION | 491 |
| DEHYDRATION | 398 |
| SKIN ULCER | 387 |
| URINARY TRACT INFECTION | 358 |
| METABOLIC ACIDOSIS | 331 |
| VOMITING | 285 |
| NAUSEA | 281 |
| KETOACIDOSIS | 274 |
| FOURNIER^S GANGRENE | 254 |
Nearby, Related Medications
What the FAERS Data Reveals About canagliflozin Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 29,554 voluntary reports linked to canagliflozin and its brand equivalents (Invokana), spanning 2011 through 2025. Of those, 678 (2.3%) listed death as an outcome and 10,619 (35.9%) involved hospitalization. The most common indication reported alongside adverse events was Type 2 Diabetes Mellitus.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 49% were female and 51% male; age distribution skews toward 45-64, with 9,573 reports in that bracket. The single most reported reaction is diabetic ketoacidosis with 3,421 submissions, followed by toe amputation and osteomyelitis.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to canagliflozin's 29,554.
Read our methodology - how this data is sourced, computed, and verified.