dapagliflozin Side Effects
Also known as: Farxiga
Analysis of 50,521 adverse event reports submitted to the FDA from 2008 to 2025.
Total Reports
50,521
Death-Related
8,602
17.0% of reports
Hospitalizations
14,338
28.4% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 8,602 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 7,012 |
| CARDIAC FAILURE | 189 |
| ACUTE KIDNEY INJURY | 150 |
| PNEUMONIA | 145 |
| DYSPNOEA | 98 |
| HYPOTENSION | 86 |
| MYOCARDIAL INFARCTION | 84 |
| RENAL FAILURE | 84 |
| CARDIAC ARREST | 83 |
| DIARRHOEA | 80 |
| SEPSIS | 77 |
| DEHYDRATION | 76 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 69 |
| SEPTIC SHOCK | 69 |
| OFF LABEL USE | 68 |
| LACTIC ACIDOSIS | 67 |
| ASTHENIA | 66 |
| DRUG INTERACTION | 63 |
| VOMITING | 63 |
| URINARY TRACT INFECTION | 60 |
Reactions in Hospitalization Reports
Top reactions in 14,338 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| ACUTE KIDNEY INJURY | 1,305 |
| DIABETIC KETOACIDOSIS | 1,061 |
| DYSPNOEA | 866 |
| NAUSEA | 759 |
| VOMITING | 724 |
| DIARRHOEA | 715 |
| DEHYDRATION | 682 |
| HYPOTENSION | 604 |
| URINARY TRACT INFECTION | 600 |
| CARDIAC FAILURE | 598 |
| DIZZINESS | 572 |
| OFF LABEL USE | 556 |
| FATIGUE | 545 |
| PNEUMONIA | 514 |
| ASTHENIA | 492 |
| MALAISE | 490 |
| FALL | 480 |
| EUGLYCAEMIC DIABETIC KETOACIDOSIS | 426 |
| WEIGHT DECREASED | 400 |
| BLOOD GLUCOSE INCREASED | 392 |
Nearby — Related Medications
What the FAERS Data Reveals About dapagliflozin Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 50,521 voluntary reports linked to dapagliflozin and its brand equivalents (Farxiga), spanning 2008 through 2025. Of those, 8,602 (17.0%) listed death as an outcome and 14,338 (28.4%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 46% were female and 54% male; age distribution skews toward 45-64, with 9,055 reports in that bracket. The single most reported reaction is death with 7,017 submissions, followed by fatigue and nausea.
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.
Read our methodology — how this data is sourced, computed, and verified.