Toujeo: adverse event reports filed with FDA

15,491

reports as suspect product

0.1% of all reports · about 1,094 a year

1,332

reports, 12 months to June 2026

1,134 in the 12 months before

24.7%

marked serious by the reporter

42.7% across the class

0.8%

record death among outcomes, as reported

120 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 Toujeo reports recording the termmedian drug in insulin analog

1. Blood glucose increasedraised blood sugar reading23.3%3,611
2. Product storage errorthe product was stored wrongly7.7%1,191
3. Off label useused for a purpose or in a way not on the label7.3%1,129
4. Inappropriate schedule of product administrationthe product was taken at the wrong times5.7%877
5. Product use issuea problem in how the product was used5.6%874
6. Drug ineffectivethe medicine did not work as expected5.5%850
7. Blood glucose decreasedlow blood sugar reading5.5%847
8. Hypoglycaemialow blood sugar4.6%713
9. Device issuea problem with the device4.4%681
10. Visual impairmentreduced vision3.6%563
11. Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure3.2%500
12. Blood glucose abnormal2.8%436
13. Injection site painpain where the injection was given2.3%353
14. Device operational issue2.3%351
15. Malaisegeneral feeling of being unwell2.3%351
16. Dizzinesslight-headedness or unsteadiness2.1%328
17. Hyperglycaemiahigh blood sugar2%306
18. Diabetes mellitus inadequate controldiabetes not well controlled2%304
19. Weight increasedweight gain1.9%295
20. Wrong technique in device usage process1.9%294
21. Intentional product misusedeliberate use not as intended1.8%281
22. Weight decreasedweight loss1.8%275
23. Nauseafeeling sick1.7%267
24. Dyspnoeashortness of breath1.6%244
25. Blood glucose fluctuation1.6%241
26. Drug dose omissiona dose was missed1.5%229
27. Product dose omissiona dose was missed1.5%227
28. Headachehead pain1.4%218
29. Rashskin rash1.4%214
30. Wrong technique in product usage processthe product was used in the wrong way1.3%199

Top 30 of 820 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. 86.7% 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 15,491 reports.

Drugs most often listed in the same reports

Other products listed in reports where Toujeo 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 Toujeo as a suspect or interacting product; reports listing it only as a concomitant medication (8,932) 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.