TOFOGLIFLOZIN: 54 Adverse Event Reports & Safety Profile
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54
Total FAERS Reports
7 (13.0%)
Deaths Reported
32
Hospitalizations
54
As Primary/Secondary Suspect
5
Life-Threatening
First Report: 20140604 · Latest Report: 20240901
What Are the Most Common TOFOGLIFLOZIN Side Effects?
#1 Most Reported
Hyperglycaemia
10 reports (18.5%)
#2 Most Reported
Diabetic ketoacidosis
6 reports (11.1%)
#3 Most Reported
Vomiting
5 reports (9.3%)
All TOFOGLIFLOZIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Hyperglycaemia | 10 | 18.5% | 4 | 7 |
| Diabetic ketoacidosis | 6 | 11.1% | 0 | 4 |
| Vomiting | 5 | 9.3% | 1 | 3 |
Who Reports TOFOGLIFLOZIN Side Effects? Age & Gender Data
Gender: 50.0% female, 50.0% male. Average age: 66.2 years. Most reports from: JP. View detailed demographics →
Is TOFOGLIFLOZIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 8 | 3 | 4 |
| 2015 | 6 | 1 | 2 |
| 2016 | 3 | 0 | 2 |
| 2017 | 3 | 0 | 3 |
| 2018 | 5 | 0 | 2 |
| 2019 | 4 | 1 | 4 |
| 2020 | 2 | 0 | 2 |
| 2021 | 2 | 2 | 0 |
| 2022 | 1 | 0 | 1 |
| 2023 | 2 | 0 | 2 |
| 2024 | 2 | 0 | 1 |
What Is TOFOGLIFLOZIN Used For?
| Indication | Reports |
|---|---|
| Type 2 diabetes mellitus | 26 |
| Diabetes mellitus | 14 |
| Product used for unknown indication | 7 |
Official FDA Label for TOFOGLIFLOZIN
Official prescribing information from the FDA-approved drug label.