Pharmacologic class (EPC) · 4 drug pages

Sulfonylurea: adverse event reports filed with FDA

15,194 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

15,194
reports across the class: 0.1% of all reports; 504
reports, 12 months to June 2026: 577 in the 12 months before; 70.9%
marked serious by the reporter: 57.4% across all reports; 4
drugs with a page: brand and generic names counted separately

Sulfonylurea is a pharmacologic class (an FDA Established Pharmacologic Class) with 4 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 15,194 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

504 reports arrived in the 12 months to June 2026, down 13% from 577 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 70.9% of the class's reports are marked serious, 12.3% record death among the outcomes and 36.3% record hospitalisation, as reported.

Across the class the reactions recorded most often are hypoglycaemia (18.5%), blood glucose increased (12.2%) and drug ineffective (8.2%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Glipizide	generic	6,616	214	58.7%	Blood glucose increased
Glimepiride	generic	5,289	224	83.4%	Hypoglycaemia
Glyburide	generic	2,696	66	76.9%	Hypoglycaemia
GlucotrolGlipizide	brand	593	0	69.3%	Blood glucose increased

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Hypoglycaemialow blood sugar18.5%2,810
Blood glucose increasedraised blood sugar reading12.2%1,849
Drug ineffectivethe medicine did not work as expected8.2%1,242
Blood glucose decreasedlow blood sugar reading6.2%940
Completed suicidedeath by suicide5.9%904
Drug interactionan interaction between medicines4.3%650
Toxicity to various agentspoisoning or toxic effect of one or more substances4%604
Diarrhoealoose or frequent stools3.7%557
Nauseafeeling sick3.4%521
Dizzinesslight-headedness or unsteadiness3.4%518
Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure3%457
Diabetes mellitus inadequate controldiabetes not well controlled2.8%430
Acute kidney injurysudden loss of kidney function2.6%402
Drug hypersensitivityan allergic-type reaction to a medicine2.5%383
Astheniaweakness or lack of energy2.5%379
Weight decreasedweight loss2.5%376
Malaisegeneral feeling of being unwell2.4%358
Falla fall2.3%357
Vomitingbeing sick2.3%356
Lactic acidosisa build-up of lactic acid in the blood2.2%337
Fatiguetiredness2.2%332
Weight increasedweight gain2.1%322
Hypotensionlow blood pressure1.8%276
Confusional stateconfusion1.8%272
Loss of consciousnesspassing out1.8%269

Solid bar: share of all class reports. Hollow bar: the median share across the 4 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death12.3%1,874

Life-threatening6.1%920

Hospitalisation (initial or prolonged)36.3%5,508

Disability1.6%236

Congenital anomaly0.1%22

Other serious38.5%5,844

Not serious29.1%4,416

Patient age

Under 20.5%81

2 to 110.4%57

12 to 170.2%29

18 to 445.3%811

45 to 6422.6%3,430

65 to 7418.8%2,849

75 and over18.8%2,854

Age not given33.5%5,083

Who reported

Physician23.9%3,630

Pharmacist11.6%1,766

Other health professional20.7%3,144

Lawyer0.2%25

Consumer or non-health professional36.5%5,543

Not given7.1%1,086

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Sulfonylurea reports

Which drugs are in the Sulfonylurea class on this site?

Glipizide, Glimepiride, Glyburide and Glucotrol. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

15,194 reports through June 2026, 504 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

hypoglycaemia (18.5%), blood glucose increased (12.2%), drug ineffective (8.2%), blood glucose decreased (6.2%) and completed suicide (5.9%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.