Tresiba: adverse event reports filed with FDA

10,373

reports as suspect product

0.1% of all reports · about 819 a year

1,263

reports, 12 months to June 2026

1,136 in the 12 months before

55.1%

marked serious by the reporter

42.7% across the class

4.1%

record death among outcomes, as reported

428 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 Tresiba reports recording the termmedian drug in insulin analog

1. Blood glucose increasedraised blood sugar reading20.2%2,097
2. Blood glucose decreasedlow blood sugar reading7.8%810
3. Hypoglycaemialow blood sugar6.5%670
4. Nauseafeeling sick4.1%421
5. Drug ineffectivethe medicine did not work as expected3.5%366
6. Dyspnoeashortness of breath3.2%336
7. Weight increasedweight gain3.1%322
8. Falla fall3%311
9. Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure2.9%298
10. Vomitingbeing sick2.6%273
11. Dizzinesslight-headedness or unsteadiness2.5%263
12. Visual impairmentreduced vision2.5%258
13. Diabetes mellitus inadequate controldiabetes not well controlled2.5%255
14. Stressstress2.4%251
15. Malaisegeneral feeling of being unwell2.4%248
16. Diabetic ketoacidosisa serious complication of diabetes with acid build-up2.3%240
17. Off label useused for a purpose or in a way not on the label2.3%234
18. Condition aggravatedthe condition being treated got worse2.2%232
19. Headachehead pain2.2%232
20. Constipationconstipation2.2%230
21. Weight decreasedweight loss2.1%219
22. Hyperglycaemiahigh blood sugar2.1%214
23. Fatiguetiredness2%211
24. Abdominal distensiona bloated abdomen2%208
25. Diarrhoealoose or frequent stools1.9%196
26. Product quality issuea problem with the product itself1.8%182
27. Abdominal painstomach or belly pain1.7%181
28. Hospitalisationadmission to hospital1.7%181
29. Blood glucose fluctuation1.7%174
30. Neuropathy peripheralnerve damage in hands or feet1.7%173

Top 30 of 964 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. 74.4% 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 10,373 reports.

Drugs most often listed in the same reports

Other products listed in reports where Tresiba 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 Tresiba as a suspect or interacting product; reports listing it only as a concomitant medication (11,464) 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.