Tolazamide Recall

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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


Tolazamide tablets are indicated as an adjunct to diet to lower the blood glucose in patients with noninsulin-dependent diabetes mellitus (Type II) whose hyperglycemia cannot be satisfactorily controlled by diet alone.

In initiating treatment for noninsulin-dependent diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed and cardiovascular risk factors should be identified and corrective measures taken where possible.

If this treatment program fails to reduce symptoms and/or blood glucose, the use of an oral sulfonylurea or insulin should be considered. Use of tolazamide must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone may be transient thus requiring only short-term administration of tolazamide.

During maintenance programs, tolazamide should be discontinued if satisfactory lowering of blood glucose is no longer achieved. Judgments should be based on regular clinical and laboratory evaluations.

In considering the use of tolazamide in asymptomatic patients, it should be recognized that controlling the blood glucose in noninsulin-dependent diabetes has not been definitely established to be effective in preventing the long-term cardiovascular or neural complications of diabetes.


There is currently no drug history available for this drug.

Other Information

Tolazamide tablets contain tolazamide, an oral blood glucose lowering drug of the sulfonylurea class. Tolazamide is a white or creamy-white powder with a melting point of 165° to 173° C. The solubility of tolazamide at pH 6.0 (mean urinary pH) is 27.8 mg per 100 mL.

The chemical names for tolazamide are (1) Benzenesulfonamide, N-[[(hexahydro-1H-azepin-1-yl) amino] carbonyl]-4-methyl-; (2) 1-(Hexahydro-1H-azepin-1-yl)-3-(p-tolylsulfonyl) urea and its molecular weight is 311.40. The structural formula is represented below:

Image from Drug Label Content

Tolazamide tablets for oral administration are available as scored, white tablets containing 100 mg, 250 mg or 500 mg tolazamide.

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, docusate sodium, magnesium stearate, microcrystalline cellulose, plasdone, sodium benzoate, stearic acid.

Tolazamide Manufacturers

  • Mutual Pharmaceutical Company, Inc
    Tolazamide (Tolazamide) Tablet [Mutual Pharmaceutical Company, Inc]
  • Pd-rx Pharmaceuticals, Inc.
    Tolazamide Tablet [Pd-rx Pharmaceuticals, Inc.]
  • American Health Packaging
    Tolazamide Tablet [American Health Packaging]
  • Mylan Pharmaceuticals Inc.
    Tolazamide Tablet [Mylan Pharmaceuticals Inc.]

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