Byetta: adverse event reports filed with FDA

47,928

reports as suspect product

0.2% of all reports · about 2,274 a year

12

reports, 12 months to June 2026

89 in the 12 months before

24.7%

marked serious by the reporter

28% across the class

3.2%

record death among outcomes, as reported

1,536 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 Byetta reports recording the termmedian drug in glp-1 receptor agonist

1. Blood glucose increasedraised blood sugar reading31.3%14,994
2. Weight decreasedweight loss24.9%11,931
3. Nauseafeeling sick24.5%11,735
4. Decreased appetitereduced appetite11.6%5,550
5. Blood glucose decreasedlow blood sugar reading11.3%5,396
6. Vomitingbeing sick8.7%4,151
7. Diarrhoealoose or frequent stools5.3%2,561
8. Dizzinesslight-headedness or unsteadiness5.3%2,537
9. Drug ineffectivethe medicine did not work as expected4.2%2,035
10. Headachehead pain4.1%1,962
11. Pancreatitisinflammation of the pancreas4%1,936
12. Injection site painpain where the injection was given4%1,911
13. Injection site bruisingbruising where the injection was given3.8%1,806
14. Injection site haemorrhagebleeding where the injection was given3.6%1,735
15. Feeling abnormalfeeling odd or not right3.4%1,608
16. Fatiguetiredness3.3%1,604
17. Incorrect dose administeredthe wrong dose was given3.3%1,564
18. Drug effect decreasedthe medicine had less effect3.1%1,502
19. Astheniaweakness or lack of energy3.1%1,463
20. Malaisegeneral feeling of being unwell3.1%1,462
21. Tremorshaking3%1,460
22. Dyspepsiaindigestion2.8%1,328
23. Abdominal distensiona bloated abdomen2.6%1,268
24. Weight increasedweight gain2.6%1,224
25. Abdominal pain upperupper stomach pain2.5%1,181
26. Pancreatic carcinoma2.4%1,158
27. Constipationconstipation2.3%1,114
28. Hyperhidrosisexcessive sweating2.2%1,050
29. Off label useused for a purpose or in a way not on the label2.1%1,024
30. Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure1.9%908

Top 30 of 1,842 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. 94.3% 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 47,928 reports.

Drugs most often listed in the same reports

Other products listed in reports where Byetta 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 Byetta as a suspect or interacting product; reports listing it only as a concomitant medication (3,349) 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.