Semglee: adverse event reports filed with FDA

2,028

reports as suspect product

0% of all reports · about 338 a year

156

reports, 12 months to June 2026

259 in the 12 months before

6.8%

marked serious by the reporter

42.7% across the class

0.3%

record death among outcomes, as reported

6 reports · not verified by FDA

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 Semglee reports recording the termmedian drug in insulin analog

1. Device mechanical issue45%913
2. Product quality issuea problem with the product itself22.8%463
3. Device issuea problem with the device17.2%348
4. Device delivery system issuea problem with the delivery system12.5%254
5. Device defective11%223
6. Product storage errorthe product was stored wrongly10.9%221
7. Wrong technique in product usage processthe product was used in the wrong way9.4%191
8. Device breakagethe device broke8.8%179
9. Incorrect dose administeredthe wrong dose was given8.6%174
10. Product dose omission issuea dose was missed6.7%136
11. Blood glucose increasedraised blood sugar reading6.7%135
12. Wrong technique in device usage process5%102
13. Drug ineffectivethe medicine did not work as expected4.7%95
14. Device leakagethe device leaked3.4%68
15. Device malfunctionthe device did not work properly3.3%66
16. Weight increasedweight gain3.2%64
17. Needle issuea problem with the needle2.9%58
18. Weight decreasedweight loss2.4%49
19. Incorrect dose administered by devicethe device gave the wrong dose2.2%44
20. Product use issuea problem in how the product was used1.6%32
21. Inappropriate schedule of product administrationthe product was taken at the wrong times1.5%30
22. Injection site atrophy1.4%29
23. Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure1%21
24. Lack of injection site rotation1%20
25. Product packaging quantity issue1%20
26. Stressstress1%20
27. Device failurethe device failed0.9%19
28. Device difficult to usethe device was hard to use0.9%18
29. Dizzinesslight-headedness or unsteadiness0.9%18
30. Lipohypertrophy0.9%18

Top 30 of 143 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 97.4% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 2,028 reports.

Drugs most often listed in the same reports

Other products listed in reports where Semglee 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

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

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.

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 Semglee as a suspect or interacting product; reports listing it only as a concomitant medication (296) 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.