Insulin Glargine

Common brands: Lantus, Lantus Solostar, Humalog Kwikpen, Humalog Mix75/25, Humalog Junior Kwikpen

Top reporter: Sanofi-Aventis U.S. Llc

Insulin Analog [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Loop Diuretic [EPC]GLP-1 Receptor Agonist [EPC]Platelet Aggregation Inhibitor [EPC]
240,130
Total Reports
78,659
Serious Reports
13,381
Death Reports
30
Reported Reactions
Death Report Ratio: High (5.57%)

Patient Demographics

Male
100,310
Female
121,940

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Insulin Glargine.

# Reaction Reports % of Total
1 BLOOD GLUCOSE INCREASED 38,573
16.6%
2 OFF LABEL USE 12,530
5.4%
3 DRUG INEFFECTIVE 10,409
4.5%
4 BLOOD GLUCOSE DECREASED 10,394
4.5%
5 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION 9,976
4.3%
6 NAUSEA 9,743
4.2%
7 PRODUCT STORAGE ERROR 8,871
3.8%
8 VISUAL IMPAIRMENT 8,661
3.7%
9 HYPOGLYCAEMIA 7,859
3.4%
10 DIARRHOEA 7,049
3.0%
11 FATIGUE 6,876
3.0%
12 INCORRECT DOSE ADMINISTERED 6,664
2.9%
13 MALAISE 6,601
2.8%
14 WEIGHT DECREASED 6,364
2.7%
15 INJECTION SITE PAIN 6,308
2.7%
16 DYSPNOEA 6,282
2.7%
17 VOMITING 6,178
2.7%
18 FALL 6,063
2.6%
19 DIZZINESS 5,964
2.6%
20 HEADACHE 5,398
2.3%
21 ASTHENIA 5,312
2.3%
22 PAIN 5,052
2.2%
23 GLYCOSYLATED HAEMOGLOBIN INCREASED 4,843
2.1%
24 HYPERGLYCAEMIA 4,680
2.0%
25 DEATH 4,593
2.0%
26 CEREBROVASCULAR ACCIDENT 4,479
1.9%
27 ACUTE KIDNEY INJURY 4,212
1.8%
28 PNEUMONIA 4,071
1.8%
29 BLOOD GLUCOSE ABNORMAL 3,941
1.7%
30 DRUG DOSE OMISSION 3,920
1.7%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.