HUMALOG: 217 Adverse Event Reports & Safety Profile
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217
Total FAERS Reports
17 (7.8%)
Deaths Reported
64
Hospitalizations
217
As Primary/Secondary Suspect
5
Life-Threatening
2
Disabilities
First Report: 20030221 · Latest Report: 20140508
What Are the Most Common HUMALOG Side Effects?
#1 Most Reported
Blood glucose increased
66 reports (30.4%)
#2 Most Reported
Hypoglycaemia
28 reports (12.9%)
#3 Most Reported
Blood glucose decreased
21 reports (9.7%)
All HUMALOG Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Blood glucose increased | 66 | 30.4% | 2 | 16 |
| Hypoglycaemia | 28 | 12.9% | 2 | 11 |
| Blood glucose decreased | 21 | 9.7% | 0 | 7 |
| Drug ineffective | 18 | 8.3% | 0 | 3 |
| Malaise | 17 | 7.8% | 0 | 4 |
| Wrong drug administered | 15 | 6.9% | 0 | 1 |
| Drug dose omission | 14 | 6.5% | 0 | 6 |
| Weight decreased | 14 | 6.5% | 0 | 2 |
| Dizziness | 11 | 5.1% | 0 | 2 |
| Hyperglycaemia | 9 | 4.2% | 0 | 7 |
| Injection site pain | 9 | 4.2% | 0 | 4 |
| Glycosylated haemoglobin increased | 8 | 3.7% | 0 | 2 |
| Hyperhidrosis | 8 | 3.7% | 0 | 0 |
| Hypoglycaemic coma | 8 | 3.7% | 0 | 7 |
| Lobar pneumonia | 8 | 3.7% | 8 | 0 |
| Nausea | 8 | 3.7% | 0 | 2 |
| Asthenia | 7 | 3.2% | 1 | 3 |
| Loss of consciousness | 7 | 3.2% | 0 | 2 |
| Vomiting | 7 | 3.2% | 0 | 4 |
| Adverse event | 6 | 2.8% | 0 | 2 |
Who Reports HUMALOG Side Effects? Age & Gender Data
Average age: 61.6 years. Most reports from: US. View detailed demographics →
Is HUMALOG Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 1 | 0 |
| 2008 | 1 | 0 | 1 |
| 2009 | 4 | 0 | 1 |
| 2010 | 4 | 0 | 1 |
| 2011 | 4 | 1 | 1 |
| 2012 | 6 | 0 | 4 |
| 2013 | 46 | 2 | 19 |
| 2014 | 34 | 2 | 19 |
What Is HUMALOG Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 39 |
| Diabetes mellitus | 33 |
| Type 2 diabetes mellitus | 30 |
| Type 1 diabetes mellitus | 8 |
HUMALOG vs Alternatives: Which Is Safer?
HUMALOG vs HUMALOG LISPRO
HUMALOG vs HUMALOG LISPRO, NPL
HUMALOG vs HUMAN C1-ESTERASE INHIBITOR
HUMALOG vs HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX
HUMALOG vs HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN
HUMALOG vs HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
HUMALOG vs HUMAN IMMUNOGLOBULIN G
HUMALOG vs HUMAN IMMUNOGLOBULIN G\HYALURONIDASE
HUMALOG vs HUMAN IMMUNOGLOBULIN G\HYALURONIDASE RECOMBINANT HUMAN
HUMALOG vs HUMAN PAPILLOMAVIRUS QUADRIVALENT VACCINE, RECOMBINANT
Official FDA Label for HUMALOG
Official prescribing information from the FDA-approved drug label.