INSULIN GLARGINE\LIXISENATIDE: 3,035 Adverse Event Reports & Safety Profile

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3,035

Total FAERS Reports

18 (0.6%)

Deaths Reported

194

Hospitalizations

3,035

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 20130704 · Latest Report: 20250915

What Are the Most Common INSULIN GLARGINE\LIXISENATIDE Side Effects?

#1 Most Reported

Blood glucose increased

419 reports (13.8%)

#2 Most Reported

Product storage error

379 reports (12.5%)

#3 Most Reported

Accidental exposure to product

258 reports (8.5%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Blood glucose increased	419	13.8%	1	20
Product storage error	379	12.5%	0	7
Accidental exposure to product	258	8.5%	0	0
Off label use	205	6.8%	0	4
Visual impairment	136	4.5%	1	2
Inappropriate schedule of product administration	132	4.4%	0	5
Nausea	132	4.4%	1	20
Exposure via skin contact	125	4.1%	0	0
Drug ineffective	98	3.2%	0	6
Blood glucose decreased	94	3.1%	0	6
Device issue	85	2.8%	0	2
Injection site pain	75	2.5%	0	2
Hypoglycaemia	74	2.4%	1	18
Wrong technique in device usage process	74	2.4%	0	0
Device operational issue	72	2.4%	0	0
Blood glucose abnormal	68	2.2%	0	4
Glycosylated haemoglobin increased	67	2.2%	0	5
Diarrhoea	66	2.2%	0	5
Vomiting	66	2.2%	1	22
Malaise	61	2.0%	0	9

Gender: 56.7% female, 43.3% male. Average age: 65.5 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2013	1	0	0
2014	1	0	1
2015	1	0	0
2016	1	0	0
2017	114	1	12
2018	76	0	15
2019	47	0	19
2020	71	0	10
2021	70	3	11
2022	62	2	6
2023	90	1	9
2024	85	1	11
2025	53	1	7

Indication	Reports
Type 2 diabetes mellitus	1,482
Diabetes mellitus	488
Product used for unknown indication	64
Type 1 diabetes mellitus	56
Blood glucose abnormal	34
Blood glucose increased	32
Blood glucose	9
Diabetes mellitus inadequate control	9
Hyperglycaemia	7

Official prescribing information from the FDA-approved drug label.