Brand name · Insulin lispro-aabc
Lyumjev Kwikpen: adverse event reports filed with FDA
902 reports list it as a suspect or interacting product, 2020–2026. Class: Insulin analog.
- 902
- reports as suspect product
- 0% of all reports · about 155 a year
- 132
- reports, 12 months to June 2026
- 226 in the 12 months before
- 13.4%
- marked serious by the reporter
- 42.7% across the class
- 0.8%
- record death among outcomes, as reported
- 7 reports · not verified by FDA
Between September 2020 and June 2026, 902 adverse event reports received by FDA list the brand name Lyumjev Kwikpen (insulin lispro-aabc) as a suspect or interacting product. Reports that mention it only as a concomitant medication (31) are left out of every figure here.
In the 12 months to June 2026, 132 reports listed it, down 42% from 226 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 155 reports a year and 0% of the 20,646,523 reports in the database, and 0.3% of the reports for the insulin analog class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are blood glucose increased (37.9%), incorrect dose administered (13.2%) and drug ineffective (12.3%). A report can list several reactions, so shares add to more than 100%; 103 different terms appear across these reports. Blood glucose increased is recorded in 37.9% of these reports, a larger share than in the median insulin analog drug (23%).
13.4% of the reports are marked serious by the reporter (42.7% across the class); 0.8% record death among the outcomes and 5.9% record hospitalisation, as reported. 89.4% of the reports came from consumers, and the largest patient age group is 45 to 64 (18.1%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Lyumjev Kwikpen reports recording the termmedian drug in insulin analog
- Blood glucose increasedraised blood sugar reading37.9%342
- Incorrect dose administeredthe wrong dose was given13.2%119
- Drug ineffectivethe medicine did not work as expected12.3%111
- Injection site painpain where the injection was given11.3%102
- Blood glucose decreasedlow blood sugar reading6.1%55
- Product dose omission issuea dose was missed5.9%53
- Haemorrhagebleeding4.9%44
- Visual impairmentreduced vision4.3%39
- Wrong technique in product usage processthe product was used in the wrong way3.5%32
- Product storage errorthe product was stored wrongly3.2%29
- Injection site bruisingbruising where the injection was given3.1%28
- Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure2.5%23
- Blood glucose abnormal2.3%21
- Injection site haemorrhagebleeding where the injection was given2.3%21
- Injection site erythemaredness where the injection was given1.7%15
- Painpain, site not specified1.7%15
- Expired product administeredthe product was used past its expiry date1.6%14
- Injection site pruritusitching where the injection was given1.6%14
- Rashskin rash1.4%13
- Discomfortdiscomfort1.3%12
- Headachehead pain1.3%12
- Hypoglycaemialow blood sugar1.3%12
- Injection site reactiona reaction where the injection was given1.3%12
- Infusion site pain1.2%11
- Pruritusitching1.2%11
- Dizzinesslight-headedness or unsteadiness1.1%10
- Contusiona bruise1%9
- Malaisegeneral feeling of being unwell1%9
Top 30 of 103 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 26 drugs in the insulin analog class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 289,293 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 95.9% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Diabetes mellitus | 126 | 14% |
| Type 1 diabetes mellitus | 119 | 13.2% |
| Type 2 diabetes mellitus | 85 | 9.4% |
| Blood glucose abnormal | 4 | 0.4% |
| Blood glucose increased | 4 | 0.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 902 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Lyumjev Kwikpen reports |
|---|---|---|
| Tresiba | 98 | 10.9% |
| Humalog | 82 | 9.1% |
| Lantus | 77 | 8.5% |
| Toujeo | 60 | 6.7% |
| Insulin glargine | 35 | 3.9% |
| Novolog | 20 | 2.2% |
| Metformin | 17 | 1.9% |
| Lyumjev | 16 | 1.8% |
| Trulicity | 16 | 1.8% |
| Insulin lispro | 13 | 1.4% |
Other products listed in reports where Lyumjev Kwikpen is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Lyumjev Kwikpen | Insulin analog | All reports |
|---|---|---|---|
| Reports as suspect product | 902 | 289,293 | 20,646,523 |
| Share of that pool | — | 0.3% | 0% |
| Reports, latest 12 months | 132 | — | 1,332,454 |
| Marked serious | 13.4% | 42.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 8 | 35 | 91 |
| Hospitalisation recorded, per 1,000 reports | 59 | 186 | 213 |
| Consumer-filed share | 89.4% | 78.7% | 45.8% |
| Top term, share of reports | Blood glucose increased 37.9% | median 23% | 0.9% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the insulin analog class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Humalog | brand | 71,174 | 2,312 | 34.4% |
| Lantus Solostar | brand | 45,715 | 4,230 | 24.6% |
| Lantus | brand | 39,128 | 3,718 | 63.8% |
| Insulin glargine | generic | 27,994 | 1,923 | 42.8% |
| Toujeo | brand | 15,491 | 1,332 | 24.7% |
| Novolog | brand | 14,477 | 1,576 | 61.8% |
| Levemir | brand | 13,652 | 671 | 54.8% |
| Tresiba | brand | 10,373 | 1,263 | 55.1% |
| Insulin lispro | generic | 8,209 | 1,116 | 45.6% |
| Humalog Mix75/25 | brand | 8,139 | 140 | 23.8% |
| Insulin | generic | 8,135 | 522 | 88.9% |
| Apidra | brand | 3,621 | 86 | 69.2% |
| Insulin aspart | generic | 3,232 | 553 | 88.6% |
| Sterile diluent | generic | 3,221 | 600 | 19.4% |
| Humalog Kwikpen | brand | 3,040 | 169 | 27.5% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Lyumjev Kwikpen reports
How many adverse event reports has FDA received for Lyumjev Kwikpen?
902 reports list Lyumjev Kwikpen as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 132 of them arrived in the latest 12 months. Another 31 list it only as a concomitant medication.
What reactions are recorded in Lyumjev Kwikpen reports?
blood glucose increased (37.9%), incorrect dose administered (13.2%), drug ineffective (12.3%), injection site pain (11.3%) and blood glucose decreased (6.1%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Lyumjev Kwikpen was responsible.
How serious are the reports?
13.4% are marked serious by the reporter. Among the outcomes recorded, 0.8% of reports include death and 5.9% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (89.4%), other health professional (6.2%) and physician (3.5%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Lyumjev Kwikpen rising?
132 reports in the 12 months to June 2026, down 42% from 226 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Lyumjev Kwikpen was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Lyumjev Kwikpen?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Lyumjev Kwikpen as a suspect or interacting product; reports listing it only as a concomitant medication (31) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.