What the label lists and what reports show
Glyburide side effects
Glyburide's FDA label: “Gastrointestinal disturbances, e.g., nausea, epigastric fullness, and heartburn, are the most common reactions and occur in 1.8% of treated patients.” FAERS holds 24,067 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is blood glucose increased (3,042 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the glyburide FDA label on DailyMed (effective July 1, 2021, TEVA Pharmaceuticals USA Inc); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsGastrointestinal disturbances, e.g., nausea, epigastric fullness, and heartburn, are the most common reactions and occur in 1.8% of treated patients.
From the label: adverse reactions, continuedHypoglycemia See PRECAUTIONS and OVERDOSAGE Sections. Gastrointestinal Reactions Cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure; Glyburide should be discontinued if this occurs. Liver function abnormalities, including isolated transaminase elevations, have been reported. Gastrointestinal disturbances, e.g., nausea, epigastric fullness, and heartburn, are the most common reactions and occur in 1.8% of treated patients. They tend to be dose-related and may disappear when dosage is reduced. Dermatologic Reactions Allergic skin reactions, e.g., pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occur in 1.5% of treated patients. These may be transient and may disappear despite continued use of Glyburide. Bullous reactions, erythema multiforme, and exfoliative dermatitis, have been reported. If skin reactions persist, the drug should be discontinued. Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas. Hematologic Reactions Leukopenia, agranulocytosis, thrombocytopenia, which occasionally may present as purpura, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas. Metabolic Reactions Hepatic porphyria reactions have been reported with sulfonylureas; however, these have not been reported with Glyburide. …
Source: FDA drug label, NDA017532 (Sanofi Aventis Us), as published by TEVA Pharmaceuticals USA Inc, effective July 1, 2021 (SPL set 50d16f1d-c814-4411-8749-62561321ecce), via openFDA; the full label on DailyMed
What do FAERS reports show?
24,067 reports list glyburide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,135 are coded as a death and 8,464 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 24 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Glyburide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions