Victoza: adverse event reports filed with FDA

28,899

reports as suspect product

0.1% of all reports · about 1,309 a year

998

reports, 12 months to June 2026

631 in the 12 months before

41.8%

marked serious by the reporter

28% across the class

3.6%

record death among outcomes, as reported

1,044 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 Victoza reports recording the termmedian drug in glp-1 receptor agonist

1. Nauseafeeling sick17.9%5,162
2. Blood glucose increasedraised blood sugar reading9.8%2,835
3. Vomitingbeing sick8.1%2,332
4. Diarrhoealoose or frequent stools7.9%2,287
5. Pancreatitisinflammation of the pancreas6.8%1,968
6. Decreased appetitereduced appetite5.6%1,620
7. Weight decreasedweight loss5.5%1,593
8. Headachehead pain4.2%1,227
9. Abdominal pain upperupper stomach pain3.7%1,055
10. Constipationconstipation3.5%1,024
11. Off label useused for a purpose or in a way not on the label3.4%995
12. Abdominal painstomach or belly pain3.1%890
13. Pancreatic carcinoma3.1%882
14. Dizzinesslight-headedness or unsteadiness3%874
15. Blood glucose decreasedlow blood sugar reading2.9%846
16. Malaisegeneral feeling of being unwell2.9%832
17. Abdominal discomfortstomach discomfort2.6%758
18. Fatiguetiredness2.5%726
19. Pancreatitis acute2.2%622
20. Eructation2%592
21. Dyspepsiaindigestion2%570
22. Weight increasedweight gain2%566
23. Astheniaweakness or lack of energy1.9%558
24. Drug ineffectivethe medicine did not work as expected1.8%530
25. Abdominal distensiona bloated abdomen1.8%506
26. Impaired gastric emptying1.7%480
27. Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure1.6%465
28. Injection site painpain where the injection was given1.6%459
29. Dehydrationdehydration1.6%457
30. Flatulencewind1.5%438

Top 30 of 1,277 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. 85% 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 28,899 reports.

Drugs most often listed in the same reports

Other products listed in reports where Victoza 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 Victoza as a suspect or interacting product; reports listing it only as a concomitant medication (10,542) 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.