Sulfonylurea side effects compared: 3 drugs, 123,323 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Glipizide | 60,530 | 56% | 5,339 | – | Blood glucose increased; Blood glucose decreased; Hypoglycaemia | Chronic kidney disease; Coronary artery disease |
| Glimepiride | 38,726 | 64% | 3,272 | – | Blood glucose increased; Hypoglycaemia; Blood glucose decreased | Chronic kidney disease; Lactic acidosis |
| Glyburide | 24,067 | 63% | 2,135 | – | Blood glucose increased; Hypoglycaemia; Blood glucose decreased | Coronary artery disease; Nephrogenic anaemia |
Class-wide signals (flagged in at least 2 of 3 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Chronic kidney disease-mineral and bone disorder | 3/3 | 25.8 | 164 | 0/3 members' labels |
| Hyperparathyroidism secondary | 3/3 | 23.9 | 328 | 0/3 members' labels |
| Nephrogenic anaemia | 3/3 | 23.9 | 646 | 0/3 members' labels |
| Hypoglycaemia | 3/3 | 19.4 | 4,212 | 3/3 members' labels |
| Early satiety | 3/3 | 18.5 | 180 | 0/3 members' labels |
| Diabetic neuropathy | 3/3 | 17.1 | 437 | 2/3 members' labels |
| Hypoglycaemic coma | 3/3 | 16.9 | 335 | 1/3 members' labels |
| Diabetes mellitus inadequate control | 3/3 | 14.2 | 1,377 | 3/3 members' labels |
| Rebound acid hypersecretion | 3/3 | 13.7 | 238 | 0/3 members' labels |
| Bladder transitional cell carcinoma | 3/3 | 12.3 | 117 | 0/3 members' labels |
| Pancreatic carcinoma metastatic | 3/3 | 9.8 | 161 | 0/3 members' labels |
| Diabetic retinopathy | 3/3 | 8.8 | 200 | 0/3 members' labels |
| Diabetic nephropathy | 3/3 | 8.4 | 123 | 0/3 members' labels |
| Ischaemic cardiomyopathy | 2/3 | 17.5 | 199 | 0/2 members' labels |
| Gastrointestinal hypomotility | 2/3 | 15.1 | 152 | 0/2 members' labels |
| Dilatation atrial | 2/3 | 12.5 | 53 | 0/2 members' labels |
| Colonic polyp | 2/3 | 11.5 | 65 | 0/2 members' labels |
| Diabetes mellitus non-insulin-dependent | 2/3 | 11.4 | 59 | 2/2 members' labels |
| Left atrial dilatation | 2/3 | 10.9 | 52 | 0/2 members' labels |
| Heart injury | 2/3 | 10.7 | 103 | 0/2 members' labels |
| Impaired gastric emptying | 2/3 | 10.3 | 611 | 0/2 members' labels |
| Adenocarcinoma pancreas | 2/3 | 10.2 | 60 | 0/2 members' labels |
| End stage renal disease | 2/3 | 10.1 | 882 | 0/2 members' labels |
| Coronary artery disease | 2/3 | 10.0 | 1,122 | 0/2 members' labels |
| Chronic kidney disease | 2/3 | 7.0 | 2,554 | 0/2 members' labels |
Member-specific signals (flagged in exactly one drug)
No strong single-member signals (n ≥ 50) in this class.
Common questions
Which sulfonylurea has the most FDA adverse event reports?
Glipizide has the most FAERS co-reports in this class (60,530), followed by Glimepiride (38,726). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.
Which side effects are shared across sulfonylurea drugs?
Reaction terms flagged in at least half of the 3 members include chronic kidney disease-mineral and bone disorder, hyperparathyroidism secondary, nephrogenic anaemia, hypoglycaemia, early satiety. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.
Does a FAERS signal mean the drug causes the reaction?
No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.