Humalog Mix50/50 Kwikpeninsulin lispro
According to the FDA label: ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ADMELOG is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 )
121,315 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Humalog Mix50/50 Kwikpen in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
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Blood Glucose Increased 34,192 reports
A blood test result showing a higher than normal blood sugar level.
Full definition in the glossary →Blood Glucose Decreased 7,995 reports
A blood test result showing a lower than normal blood sugar level. The opposite of blood glucose increased.
Full definition in the glossary →Incorrect Dose Administered 7,752 reports
A report that the wrong dose was given or taken. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →Drug Ineffective 7,407 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Visual Impairment 4,681 reports
Reduced ability to see.
Full definition in the glossary →Nausea 4,568 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Malaise 3,597 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Hypoglycaemia 3,566 reports
A low level of sugar in the blood, which can cause shakiness, sweating, and confusion. Also spelled hypoglycemia in American English.
Full definition in the glossary →Fatigue 3,504 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Drug Dose Omission 3,240 reports
A report that a dose of medication was missed or skipped.
Full definition in the glossary →Fall 3,193 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Vomiting 3,015 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 2,984 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Underdose 2,936 reports
A report that less of a medication was taken than prescribed. This is a usage category.
Full definition in the glossary →Pain 2,910 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 64,956 |
| Male | 50,771 |
| Unknown | 106 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 2,585 |
| 18-34 | 4,235 |
| 35-49 | 7,775 |
| 50-64 | 20,415 |
| 65-74 | 17,365 |
| 75+ | 12,279 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Humalog Mix50/50 Kwikpen. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 63,295 |
| Other Serious | 35,146 |
| Hospitalization | 31,273 |
| Death | 5,531 |
| Life-Threatening | 3,020 |
| Disability | 2,655 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Humalog Mix50/50 Kwikpen. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 1,188 |
| 2005 | 1,265 |
| 2006 | 1,679 |
| 2007 | 1,554 |
| 2008 | 1,462 |
| 2009 | 1,792 |
| 2010 | 1,835 |
| 2011 | 2,030 |
| 2012 | 2,098 |
| 2013 | 1,703 |
| 2014 | 4,547 |
| 2015 | 24,696 |
| 2016 | 8,365 |
| 2017 | 8,084 |
| 2018 | 8,473 |
| 2019 | 8,511 |
| 2020 | 8,708 |
| 2021 | 7,306 |
| 2022 | 6,399 |
| 2023 | 5,579 |
| 2024 | 5,205 |
| 2025 | 7,576 |
| 2026 (partial) | 1,260 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Humalog Mix50/50 Kwikpen
In FDA adverse event reports that mention Humalog Mix50/50 Kwikpen, these medications appeared most often in the same report.
- Insulin Glargine (47,914 reports)
- Metformin (12,119 reports)
- Furosemide (9,461 reports)
- Aspirin (9,276 reports)
- Insulin Detemir (7,761 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026