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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

EMPAGLIFLOZIN\METFORMIN: 2,476 Adverse Event Reports & Safety Profile

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2,476
Total FAERS Reports
89 (3.6%)
Deaths Reported
950
Hospitalizations
2,476
As Primary/Secondary Suspect
218
Life-Threatening
38
Disabilities

Active Ingredient: EMPAGLIFLOZIN\METFORMIN HYDROCHLORIDE ·

First Report: 2011 · Latest Report: 20250805

What Are the Most Common EMPAGLIFLOZIN\METFORMIN Side Effects?

#1 Most Reported
Diabetic ketoacidosis
312 reports (12.6%)
#2 Most Reported
Blood glucose increased
157 reports (6.3%)
#3 Most Reported
Euglycaemic diabetic ketoacidosis
156 reports (6.3%)

All EMPAGLIFLOZIN\METFORMIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Diabetic ketoacidosis 312 12.6% 12 251
Blood glucose increased 157 6.3% 3 22
Euglycaemic diabetic ketoacidosis 156 6.3% 4 131
Vomiting 149 6.0% 6 91
Weight decreased 143 5.8% 1 40
Ketoacidosis 139 5.6% 2 105
Nausea 128 5.2% 3 60
Diarrhoea 101 4.1% 2 36
Dizziness 84 3.4% 1 20
Fournier's gangrene 71 2.9% 4 53
Urinary tract infection 66 2.7% 1 38
Fungal infection 64 2.6% 0 4
Acute kidney injury 59 2.4% 3 50
Drug ineffective 52 2.1% 1 4
Abdominal pain 51 2.1% 3 32
Abdominal pain upper 49 2.0% 0 15
Asthenia 49 2.0% 2 21
Decreased appetite 49 2.0% 1 25
Glycosylated haemoglobin increased 47 1.9% 2 4
Lactic acidosis 47 1.9% 7 34

Who Reports EMPAGLIFLOZIN\METFORMIN Side Effects? Age & Gender Data

Gender: 46.1% female, 53.9% male. Average age: 61.0 years. Most reports from: US. View detailed demographics →

Is EMPAGLIFLOZIN\METFORMIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 1 0 0
2015 7 0 4
2016 44 1 21
2017 117 3 62
2018 156 9 87
2019 205 6 111
2020 185 12 94
2021 184 8 78
2022 150 4 56
2023 144 4 55
2024 112 4 48
2025 56 5 25

View full timeline →

What Is EMPAGLIFLOZIN\METFORMIN Used For?

IndicationReports
Product used for unknown indication 1,032
Type 2 diabetes mellitus 986
Diabetes mellitus 353
Type 1 diabetes mellitus 14
Cardiac failure 6
Diabetes mellitus inadequate control 6
Latent autoimmune diabetes in adults 6
Blood glucose increased 5

EMPAGLIFLOZIN\METFORMIN vs Alternatives: Which Is Safer?

EMPAGLIFLOZIN\METFORMIN vs EMSAM EMPAGLIFLOZIN\METFORMIN vs EMTRICITABINE EMPAGLIFLOZIN\METFORMIN vs EMTRICITABINE\RILPIVIRINE\TENOFOVIR ALAFENAMIDE EMPAGLIFLOZIN\METFORMIN vs EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL EMPAGLIFLOZIN\METFORMIN vs EMTRICITABINE\TENOFOVIR EMPAGLIFLOZIN\METFORMIN vs EMTRICITABINE\TENOFOVIR ALAFENAMIDE EMPAGLIFLOZIN\METFORMIN vs EMTRICITABINE/TENOFOVIR DISOPROXIL EMPAGLIFLOZIN\METFORMIN vs EMTRICITABINE\TENOFOVIR DISOPROXIL EMPAGLIFLOZIN\METFORMIN vs ENALAPRIL EMPAGLIFLOZIN\METFORMIN vs ENALAPRIL\HYDROCHLOROTHIAZIDE

Official FDA Label for EMPAGLIFLOZIN\METFORMIN

Official prescribing information from the FDA-approved drug label.