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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.

DEVICE: 12,750 Adverse Event Reports & Safety Profile

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12,750
Total FAERS Reports
398 (3.1%)
Deaths Reported
1,716
Hospitalizations
12,750
As Primary/Secondary Suspect
193
Life-Threatening
188
Disabilities

First Report: 1969 · Latest Report: 20250916

What Are the Most Common DEVICE Side Effects?

#1 Most Reported
Blood glucose increased
2,114 reports (16.6%)
#2 Most Reported
Device issue
1,417 reports (11.1%)
#3 Most Reported
Product use issue
1,076 reports (8.4%)

All DEVICE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Blood glucose increased 2,114 16.6% 5 161
Device issue 1,417 11.1% 7 85
Product use issue 1,076 8.4% 5 94
Intercepted product preparation error 1,033 8.1% 1 1
Wrong technique in product usage process 935 7.3% 1 25
Device leakage 795 6.2% 0 9
Injection site pain 751 5.9% 1 40
Syringe issue 634 5.0% 0 1
Product quality issue 567 4.5% 2 9
Drug ineffective 488 3.8% 22 94
Dyspnoea 482 3.8% 28 135
Cough 458 3.6% 15 58
Off label use 443 3.5% 22 63
Visual impairment 437 3.4% 5 31
Device use issue 396 3.1% 0 24
Malaise 386 3.0% 14 81
Blood glucose decreased 374 2.9% 1 43
Fatigue 370 2.9% 13 84
Dysphonia 305 2.4% 7 28
Injection site bruising 284 2.2% 1 13

Who Reports DEVICE Side Effects? Age & Gender Data

Gender: 57.4% female, 42.6% male. Average age: 63.7 years. Most reports from: US. View detailed demographics →

Is DEVICE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 3 0 2
2001 5 0 0
2002 1 0 0
2003 3 0 1
2004 4 0 0
2005 7 0 2
2006 6 0 1
2007 21 0 6
2008 13 0 0
2009 12 0 2
2010 23 0 6
2011 32 2 8
2012 81 4 23
2013 80 4 24
2014 191 3 43
2015 374 7 121
2016 541 12 123
2017 1,057 9 158
2018 515 13 78
2019 878 89 225
2020 474 47 104
2021 317 15 67
2022 231 13 50
2023 616 8 33
2024 281 6 26
2025 268 4 20

View full timeline →

What Is DEVICE Used For?

IndicationReports
Type 2 diabetes mellitus 3,625
Product used for unknown indication 942
Prostate cancer 852
Diabetes mellitus 660
Type 1 diabetes mellitus 495
Dyslipidaemia 172
Keratoconus 139
Multiple sclerosis 104
Precocious puberty 103
Dermatitis atopic 89

DEVICE vs Alternatives: Which Is Safer?

DEVICE vs DEXAMETHASONE DEVICE vs DEXAMETHASONE\DEXAMETHASONE DEVICE vs DEXAMETHASONE\NEOMYCIN DEVICE vs DEXAMETHASONE\NEOMYCIN\POLYMYXIN B DEVICE vs DEXAMETHASONE\TOBRAMYCIN DEVICE vs DEXCHLORPHENIRAMINE DEVICE vs DEXKETOPROFEN DEVICE vs DEXKETOPROFEN TROMETAMOL DEVICE vs DEXLANSOPRAZOLE DEVICE vs DEXMEDETOMIDINE

Official FDA Label for DEVICE

Official prescribing information from the FDA-approved drug label.