Drug side effects
ertugliflozin Side Effects
The reactions most often reported to the FDA for ertugliflozin (also sold as Steglatro), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 1,037
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2013 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 ertugliflozin come from 1,037 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 1,037 reports to the FDA Adverse Event Reporting System (FAERS) for ertugliflozin (Steglatro): 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
1,037
Reports Mentioning Death
12
1.2% of reports — not proof the medicine caused the death
Hospitalizations
290
28.0% 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 12 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 4 |
| OEDEMA PERIPHERAL | 3 |
| SEPSIS | 3 |
| BLOOD ALBUMIN DECREASED | 2 |
| BLOOD ALKALINE PHOSPHATASE INCREASED | 2 |
| BLOOD CALCIUM DECREASED | 2 |
| BLOOD CREATININE DECREASED | 2 |
| C-REACTIVE PROTEIN ABNORMAL | 2 |
| CARDIAC ARREST | 2 |
| CHOLELITHIASIS | 2 |
| ENTEROCOCCAL INFECTION | 2 |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | 2 |
| HEPARIN-INDUCED THROMBOCYTOPENIA | 2 |
| HYPERGLYCAEMIA | 2 |
| ORGAN FAILURE | 2 |
| PANCREATIC DUCT OBSTRUCTION | 2 |
| PANCREATITIS NECROTISING | 2 |
| PROTEIN TOTAL DECREASED | 2 |
| PULMONARY EMBOLISM | 2 |
| WOUND NECROSIS | 2 |
Reactions in Hospitalization Reports
Top reactions in 290 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DIABETIC KETOACIDOSIS | 45 |
| VOMITING | 25 |
| NAUSEA | 24 |
| URINARY TRACT INFECTION | 20 |
| DECREASED APPETITE | 18 |
| DIARRHOEA | 14 |
| DIZZINESS | 14 |
| FOURNIER^S GANGRENE | 14 |
| BRASH SYNDROME | 13 |
| EUGLYCAEMIC DIABETIC KETOACIDOSIS | 13 |
| PNEUMONIA | 12 |
| ABDOMINAL PAIN | 10 |
| ACUTE KIDNEY INJURY | 10 |
| DIABETES MELLITUS | 10 |
| ASTHENIA | 9 |
| IMPAIRED GASTRIC EMPTYING | 9 |
| KETOACIDOSIS | 9 |
| CONSTIPATION | 8 |
| DIABETES MELLITUS INADEQUATE CONTROL | 8 |
Nearby, Related Medications
What the FAERS Data Reveals About ertugliflozin Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 1,037 voluntary reports linked to ertugliflozin and its brand equivalents (Steglatro), spanning 2013 through 2025. Of those, 12 (1.2%) listed death as an outcome and 290 (28.0%) 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, 55% were female and 45% male; age distribution skews toward 45-64, with 271 reports in that bracket. The single most reported reaction is nausea with 86 submissions, followed by urinary tract infection and vomiting.
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 ertugliflozin's 1,037.
Read our methodology - how this data is sourced, computed, and verified.