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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\LINAGLIPTIN: 1,618 Adverse Event Reports & Safety Profile

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1,618
Total FAERS Reports
60 (3.7%)
Deaths Reported
435
Hospitalizations
1,618
As Primary/Secondary Suspect
57
Life-Threatening
30
Disabilities

First Report: 20040101 · Latest Report: 20250822

What Are the Most Common EMPAGLIFLOZIN\LINAGLIPTIN Side Effects?

#1 Most Reported
Diabetic ketoacidosis
149 reports (9.2%)
#2 Most Reported
Blood glucose increased
121 reports (7.5%)
#3 Most Reported
Fungal infection
92 reports (5.7%)

All EMPAGLIFLOZIN\LINAGLIPTIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Diabetic ketoacidosis 149 9.2% 3 121
Blood glucose increased 121 7.5% 1 15
Fungal infection 92 5.7% 0 3
Weight decreased 77 4.8% 4 10
Nausea 68 4.2% 3 26
Dizziness 58 3.6% 0 10
Vomiting 55 3.4% 3 34
Urinary tract infection 52 3.2% 4 18
Euglycaemic diabetic ketoacidosis 49 3.0% 2 34
Dehydration 44 2.7% 2 26
Ketoacidosis 43 2.7% 5 28
Pollakiuria 34 2.1% 0 3
Glycosylated haemoglobin increased 32 2.0% 0 3
Headache 32 2.0% 0 5
Pancreatitis 32 2.0% 0 16
Abdominal pain upper 30 1.9% 3 7
Drug ineffective 30 1.9% 1 3
Diarrhoea 29 1.8% 1 9
Off label use 28 1.7% 0 11
Asthenia 27 1.7% 2 11

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

Gender: 53.8% female, 46.2% male. Average age: 61.2 years. Most reports from: US. View detailed demographics →

Is EMPAGLIFLOZIN\LINAGLIPTIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 1 0 0
2008 1 0 0
2009 1 0 0
2010 1 0 0
2013 1 0 0
2015 172 0 38
2016 145 3 43
2017 84 2 32
2018 91 3 39
2019 88 6 38
2020 76 4 35
2021 71 3 26
2022 49 1 13
2023 48 6 14
2024 46 6 25
2025 16 1 9

View full timeline →

What Is EMPAGLIFLOZIN\LINAGLIPTIN Used For?

IndicationReports
Type 2 diabetes mellitus 676
Product used for unknown indication 661
Diabetes mellitus 213
Blood glucose increased 8
Type 1 diabetes mellitus 7
Diabetes mellitus management 6

EMPAGLIFLOZIN\LINAGLIPTIN vs Alternatives: Which Is Safer?

EMPAGLIFLOZIN\LINAGLIPTIN vs EMPAGLIFLOZIN\LINAGLIPTIN\METFORMIN EMPAGLIFLOZIN\LINAGLIPTIN vs EMPAGLIFLOZIN\METFORMIN EMPAGLIFLOZIN\LINAGLIPTIN vs EMTRICITABINE EMPAGLIFLOZIN\LINAGLIPTIN vs EMTRICITABINE\RILPIVIRINE\TENOFOVIR ALAFENAMIDE EMPAGLIFLOZIN\LINAGLIPTIN vs EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL EMPAGLIFLOZIN\LINAGLIPTIN vs EMTRICITABINE\TENOFOVIR EMPAGLIFLOZIN\LINAGLIPTIN vs EMTRICITABINE\TENOFOVIR ALAFENAMIDE EMPAGLIFLOZIN\LINAGLIPTIN vs EMTRICITABINE/TENOFOVIR DISOPROXIL EMPAGLIFLOZIN\LINAGLIPTIN vs EMTRICITABINE\TENOFOVIR DISOPROXIL EMPAGLIFLOZIN\LINAGLIPTIN vs ENALAPRIL

Official FDA Label for EMPAGLIFLOZIN\LINAGLIPTIN

Official prescribing information from the FDA-approved drug label.