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Drug

Insulin Glargine And Lixisenatide

68 flagged reaction(s) · 3,184 total co-reports · max PRR 49.0
Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
Reaction Co-reports (a) PRR ROR Signal
1 Exposure Via Skin Contact 186 49.0 51.6 signal
2 Product Storage Error 400 27.4 30.8 signal
3 Blood Glucose Abnormal 72 23.0 23.5 signal
4 Blood Glucose Fluctuation 37 19.9 20.1 signal
5 Accidental Exposure To Product 323 19.1 21.0 signal
6 Product Dispensing Error 66 18.0 18.3 signal
7 Glycosylated Haemoglobin Increased 73 17.2 17.5 signal
8 Blood Glucose Increased 460 14.4 16.4 signal
9 Diabetes Mellitus Inadequate Control 38 12.7 12.8 signal
10 Device Mechanical Issue 26 11.9 12.0 signal
11 Blood Glucose Decreased 97 11.9 12.2 signal
12 Wrong Technique In Device Usage Process 77 10.0 10.2 signal
13 Injury Associated With Device 31 9.1 9.2 signal
14 Incorrect Dose Administered By Device 35 8.1 8.2 signal
15 Impaired Gastric Emptying 17 7.9 7.9 signal
16 Product Prescribing Issue 26 7.6 7.6 signal
17 Hypoglycaemia 58 7.1 7.2 signal
18 Visual Impairment 145 7.0 7.2 signal
19 Device Issue 95 6.4 6.6 signal
20 Hypoacusis 43 5.9 6.0 signal
21 Device Defective 16 5.8 5.9 signal
22 Inappropriate Schedule Of Product Administration 146 4.9 5.0 signal
23 Glomerular Filtration Rate Decreased 10 4.9 4.9 signal
24 Device Use Issue 14 4.8 4.8 signal
25 Device Leakage 31 4.3 4.4 signal
26 Poor Quality Product Administered 7 4.0 4.1 signal
27 Hyperglycaemia 21 3.4 3.4 signal
28 Product Odour Abnormal 6 3.4 3.4 signal
29 Intentional Product Misuse 48 3.3 3.3 signal
30 Product Dose Omission 36 3.2 3.2 signal
31 Contraindicated Product Administered 16 3.1 3.1 signal
32 Pancreatitis 28 3.1 3.1 signal
33 Foot Fracture 10 3.1 3.1 signal
34 Injection Site Discolouration 6 2.9 2.9 signal
35 Expired Product Administered 16 2.8 2.9 signal
36 Injection Site Rash 14 2.7 2.7 signal
37 Hunger 6 2.6 2.6 signal
38 Extra Dose Administered 17 2.5 2.5 signal
39 Needle Issue 12 2.5 2.5 signal
40 Diabetic Ketoacidosis 10 2.5 2.5 signal
41 Injection Site Extravasation 5 2.4 2.4 no signal
42 Dementia 11 2.3 2.3 signal
43 Product Use Complaint 6 2.3 2.3 no signal
44 Eye Disorder 12 2.2 2.2 signal
45 Drug Effect Less Than Expected 5 2.1 2.1 no signal
46 Product Prescribing Error 8 2.0 2.0 no signal
47 Device Breakage 12 1.8 1.8 no signal
48 Injection Site Reaction 20 1.7 1.7 no signal
49 Injection Site Discomfort 3 1.7 1.7 no signal
50 Accidental Underdose 4 1.6 1.6 no signal
51 Incorrect Dose Administered 60 1.6 1.6 no signal
52 Injection Site Haemorrhage 21 1.6 1.6 no signal
53 Injection Site Pain 78 1.5 1.5 no signal
54 Injection Site Pruritus 17 1.5 1.5 no signal
55 Injection Site Urticaria 6 1.5 1.5 no signal
56 Product Preparation Error 5 1.4 1.4 no signal
57 Circumstance Or Information Capable Of Leading To Medication Error 8 1.4 1.4 no signal
58 Injection Site Irritation 3 1.4 1.4 no signal
59 Intraocular Pressure Increased 3 1.4 1.4 no signal
60 Injection Site Bruising 18 1.3 1.3 no signal
61 Injection Site Swelling 17 1.3 1.3 no signal
62 Device Delivery System Issue 5 1.1 1.1 no signal
63 Injection Site Mass 7 1.1 1.1 no signal
64 Drug Dose Omission By Device 14 1.1 1.1 no signal
65 Pancreatic Carcinoma 5 1.0 1.0 no signal
66 Wrong Technique In Product Usage Process 34 1.0 1.0 no signal
67 Injection Site Erythema 17 0.8 0.8 no signal
68 Device Difficult To Use 5 0.4 0.4 no signal