Dyrenium Recall

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Questions & Answers

Side Effects & Adverse Reactions

The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups (Diabetes, 19 (Suppl. 2):747-830, 1970).

UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2 1/2 times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and advantages of glyburide (micronized) and of alternative modes of therapy.

Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Glyburide Tablets USP (micronized) are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.


There is currently no drug history available for this drug.

Other Information

Glyburide Tablets USP (micronized) contain smaller particle size glyburide, USP which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide, USP is a white, crystalline compound. Each tablet, for oral administration, contains 1.5 mg, 3 mg, or 6 mg of glyburide, USP. Inactive ingredients: microcrystalline cellulose, pregelatinized corn starch, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate. In addition, the 3 mg and 6 mg strengths contain FD&C Blue No. 1 Aluminum Lake and FD&C Blue No. 2 Aluminum Lake. The chemical name for glyburide, USP is 1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohex-ylurea. The structural formula is represented below:

structural formula - glyburide, USP

C23H28ClN3O5S M.W. 494.00

Glyburide Tablets USP (micronized) meet USP Dissolution Test 2

Dyrenium Manufacturers

  • Wellspring Pharmaceutical Corporation
    Dyrenium (Triamterene) Capsule [Wellspring Pharmaceutical Corporation]
  • Carilion Materials Management
    Dyrenium (Triamterene) Capsule [Carilion Materials Management]
  • Concordia Pharmaceuticals Inc.
    Dyrenium (Triamterene) Capsule [Concordia Pharmaceuticals Inc.]

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