Drug Safety-related Labeling Changes (SrLC)

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DIABETA (NDA-017532)

(GLYBURIDE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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01/11/2017 (SUPPL-38)

Approved Drug Label (PDF)

6 Adverse Reactions

(additions underlined)

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 Diaßeta. 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.

Metabolic Reactions: Hepatic porphyria reactions have been reported with sulfonylureas; however, these have not been reported with Diaßeta. Disulfiram-like reactions have been reported very rarely with Diaßeta. Cases of hyponatremia have been reported with glyburide and all other sulfonylureas, most often in patients who are on other medications or have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone. The syndrome of inappropriate antidiuretic hormone (SIADH) secretion has been reported with certain other sulfonylureas, and it has been suggested that these sulfonylureas may augment the peripheral (antidiuretic) action of ADH and/or increase release of ADH. Diaßeta can cause weight gain.

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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