ERTUGLIFLOZIN: 84 Adverse Event Reports & Safety Profile
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84
Total FAERS Reports
3 (3.6%)
Deaths Reported
49
Hospitalizations
84
As Primary/Secondary Suspect
6
Life-Threatening
4
Disabilities
Dec 19, 2017
FDA Approved
Prescription
Status
Yes
Generic Available
FDA Application: 209803 ·
Patent Expires: Jul 13, 2030 · First Report: 20150319 · Latest Report: 20250811
What Are the Most Common ERTUGLIFLOZIN Side Effects?
#1 Most Reported
Diabetic ketoacidosis
12 reports (14.3%)
#2 Most Reported
Urine ketone body present
11 reports (13.1%)
#3 Most Reported
Pneumonia
5 reports (6.0%)
All ERTUGLIFLOZIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Diabetic ketoacidosis | 12 | 14.3% | 0 | 11 |
| Urine ketone body present | 11 | 13.1% | 0 | 0 |
| Ketoacidosis | 5 | 6.0% | 0 | 4 |
| Pneumonia | 5 | 6.0% | 0 | 5 |
Who Reports ERTUGLIFLOZIN Side Effects? Age & Gender Data
Gender: 31.0% female, 69.0% male. Average age: 57.8 years. Most reports from: CN. View detailed demographics →
Is ERTUGLIFLOZIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2015 | 1 | 0 | 1 |
| 2016 | 2 | 0 | 2 |
| 2017 | 11 | 0 | 11 |
| 2018 | 5 | 0 | 4 |
| 2019 | 4 | 0 | 3 |
| 2020 | 2 | 0 | 2 |
| 2021 | 1 | 0 | 1 |
| 2022 | 4 | 1 | 1 |
| 2023 | 18 | 0 | 7 |
| 2024 | 5 | 0 | 3 |
| 2025 | 9 | 0 | 6 |
What Is ERTUGLIFLOZIN Used For?
| Indication | Reports |
|---|---|
| Type 2 diabetes mellitus | 42 |
| Diabetes mellitus | 23 |
Official FDA Label for ERTUGLIFLOZIN
Official prescribing information from the FDA-approved drug label.