Trulicity: adverse event reports filed with FDA

75,864

reports as suspect product

0.4% of all reports · about 5,265 a year

4,282

reports, 12 months to June 2026

4,832 in the 12 months before

20.7%

marked serious by the reporter

28% across the class

1.5%

record death among outcomes, as reported

1,101 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 Trulicity reports recording the termmedian drug in glp-1 receptor agonist

1. Injection site painpain where the injection was given12.7%9,664
2. Nauseafeeling sick12.6%9,526
3. Blood glucose increasedraised blood sugar reading12.2%9,239
4. Incorrect dose administeredthe wrong dose was given7.1%5,413
5. Diarrhoealoose or frequent stools7.1%5,361
6. Vomitingbeing sick6.9%5,241
7. Inappropriate schedule of product administrationthe product was taken at the wrong times4.8%3,633
8. Extra dose administered4.2%3,152
9. Drug ineffectivethe medicine did not work as expected4.1%3,136
10. Injection site haemorrhagebleeding where the injection was given4%3,065
11. Weight decreasedweight loss4%3,037
12. Decreased appetitereduced appetite3.9%2,960
13. Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure3.6%2,732
14. Accidental underdose3.1%2,332
15. Abdominal pain upperupper stomach pain3%2,282
16. Abdominal painstomach or belly pain2.8%2,155
17. Constipationconstipation2.8%2,099
18. Injection site bruisingbruising where the injection was given2.5%1,879
19. Accidental overdosean accidental overdose2.5%1,860
20. Product dose omission issuea dose was missed2.4%1,857
21. Malaisegeneral feeling of being unwell2.3%1,778
22. Impaired gastric emptying2.3%1,763
23. Fatiguetiredness2.3%1,755
24. Blood glucose decreasedlow blood sugar reading2.2%1,673
25. Abdominal discomfortstomach discomfort2.1%1,575
26. Injection site erythemaredness where the injection was given2.1%1,563
27. Dizzinesslight-headedness or unsteadiness2%1,485
28. Pancreatitisinflammation of the pancreas1.9%1,438
29. Off label useused for a purpose or in a way not on the label1.9%1,409
30. Dyspepsiaindigestion1.8%1,379

Top 30 of 1,559 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 18 drugs in the glp-1 receptor agonist 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 404,853 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. 93.9% 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 75,864 reports.

Drugs most often listed in the same reports

Other products listed in reports where Trulicity 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 glp-1 receptor agonist 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 Trulicity as a suspect or interacting product; reports listing it only as a concomitant medication (10,101) 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.