Glimepiride: adverse event reports filed with FDA

5,289

reports as suspect product

0% of all reports · about 235 a year

224

reports, 12 months to June 2026

293 in the 12 months before

83.4%

marked serious by the reporter

70.9% across the class

10.3%

record death among outcomes, as reported

547 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 Glimepiride reports recording the termmedian drug in sulfonylurea

1. Hypoglycaemialow blood sugar23.7%1,256
2. Blood glucose increasedraised blood sugar reading8.3%438
3. Drug ineffectivethe medicine did not work as expected5.5%293
4. Drug interactionan interaction between medicines5.4%288
5. Acute kidney injurysudden loss of kidney function4.8%254
6. Blood glucose decreasedlow blood sugar reading4.5%240
7. Lactic acidosisa build-up of lactic acid in the blood4.3%228
8. Toxicity to various agentspoisoning or toxic effect of one or more substances4.1%216
9. Diarrhoealoose or frequent stools3.8%201
10. Completed suicidedeath by suicide3.7%197
11. Diabetes mellitus inadequate controldiabetes not well controlled3.7%197
12. Hypoglycaemic coma3.7%194
13. Vomitingbeing sick3.4%180
14. Hypotensionlow blood pressure3.2%170
15. Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure3.1%163
16. Nauseafeeling sick2.8%148
17. Dizzinesslight-headedness or unsteadiness2.7%141
18. Loss of consciousnesspassing out2.5%134
19. Falla fall2.4%125
20. Fatiguetiredness2.3%123
21. Weight increasedweight gain2.3%121
22. Renal failurekidney failure2.2%119
23. Malaisegeneral feeling of being unwell2.2%118
24. Astheniaweakness or lack of energy2.2%115
25. Weight decreasedweight loss2.1%113
26. Intentional overdosea deliberate overdose2.1%111
27. Hyperhidrosisexcessive sweating2%104
28. Decreased appetitereduced appetite1.9%102
29. Dyspnoeashortness of breath1.9%102
30. Renal impairmentreduced kidney function1.9%102

Top 30 of 834 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. 39.2% 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 5,289 reports.

Drugs most often listed in the same reports

Other products listed in reports where Glimepiride 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 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 Glimepiride as a suspect or interacting product; reports listing it only as a concomitant medication (33,794) 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.