Glyburide: adverse event reports filed with FDA

2,696

reports as suspect product

0% of all reports · about 120 a year

66

reports, 12 months to June 2026

72 in the 12 months before

76.9%

marked serious by the reporter

70.9% across the class

13.2%

record death among outcomes, as reported

356 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 Glyburide reports recording the termmedian drug in sulfonylurea

1. Hypoglycaemialow blood sugar26.1%703
2. Blood glucose increasedraised blood sugar reading10.2%276
3. Drug ineffectivethe medicine did not work as expected7%189
4. Blood glucose decreasedlow blood sugar reading6.5%176
5. Toxicity to various agentspoisoning or toxic effect of one or more substances5.8%157
6. Drug interactionan interaction between medicines5.5%147
7. Completed suicidedeath by suicide5.1%138
8. Dizzinesslight-headedness or unsteadiness4.5%120
9. Nauseafeeling sick4.3%115
10. Astheniaweakness or lack of energy4%108
11. Diarrhoealoose or frequent stools3.4%93
12. Weight decreasedweight loss3.3%90
13. Falla fall3.2%85
14. Confusional stateconfusion3.1%84
15. Drug intolerancethe medicine was not tolerated3.1%83
16. Anaphylactic reactiona severe, sudden allergic reaction2.9%78
17. Hyperhidrosisexcessive sweating2.6%70
18. Hypotensionlow blood pressure2.5%67
19. Renal failure acute2.4%66
20. Loss of consciousnesspassing out2.3%61
21. Coma2.1%57
22. Lactic acidosisa build-up of lactic acid in the blood2%55
23. Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure2%54
24. Mental status changes2%53
25. Diabetes mellitus inadequate controldiabetes not well controlled1.9%52
26. Decreased appetitereduced appetite1.9%51
27. Drug hypersensitivityan allergic-type reaction to a medicine1.9%51
28. Abdominal pain upperupper stomach pain1.9%50
29. Acute kidney injurysudden loss of kidney function1.8%48
30. Malaisegeneral feeling of being unwell1.7%47

Top 30 of 612 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 4 drugs in the sulfonylurea 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 15,194 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. 62.5% 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 2,696 reports.

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 sulfonylurea 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 Glyburide as a suspect or interacting product; reports listing it only as a concomitant medication (21,475) 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.