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Tolazamide Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 21, 2022.

Applies to tolazamide: oral tablets.

Side effects include:

Nausea, epigastric fullness, heartburn, vomiting, anorexia, intestinal gas, diarrhea, constipation, cramps.

For Healthcare Professionals

Applies to tolazamide: oral tablet.

General

The most commonly reported adverse reactions have included gastrointestinal disturbances such as nausea, epigastric fullness, and heartburn.[Ref]

Metabolic

Very rare (less than 0.01%): Disulfiram-like reactions

Frequency not reported: Hypoglycemia

Sulfonylureas:

Frequency not reported: Hepatic porphyria[Ref]

Gastrointestinal

Gastrointestinal disturbances such as nausea, epigastric fullness, and heartburn tend to be dose related and may disappear when dosage is reduced.[Ref]

Common (1% to 10%): Nausea, epigastric fullness, heartburn[Ref]

Cardiovascular

In the University Group Diabetes Program (UGDP) study, cardiovascular mortality rate was approximately 2.5 times higher in patients treated for 5 to 8 years with diet plus tolbutamide 1.5 g per day compared with that of patients treated with diet alone. The UGDP study was a long-term prospective clinical trial designed to evaluate the effectiveness of glucose lowering drugs in preventing or delaying vascular complications in patients with type 2 diabetes mellitus (n=823). Tolbutamide was stopped based on the increase in cardiovascular mortality; a significant increase in total mortality was not observed, but stopping the drug may have limited the ability to measure that. In view of the close similarities in mode of action and chemical structure among sulfonylureas, these results may apply to other drug in this class.[Ref]

Sulfonylureas:

Frequency not reported: Increased cardiovascular mortality[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions[Ref]

Hypersensitivity reactions described as skin reactions, e.g. pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions occurred in 0.4% of patients during clinical trials. These may be transient and may disappear despite continued therapy; however, if skin reactions persist, this drug should be discontinued.[Ref]

Nervous system

Uncommon (0.1% to 1%): Dizziness, headache, weakness[Ref]

Hepatic

Rare (less than 0.1%): Cholestatic jaundice[Ref]

Endocrine

Frequency not reported: Hyponatremia

Sulfonylureas:

Frequency not reported: Syndrome of inappropriate antidiuretic hormone (SIADH) secretion[Ref]

Other

Uncommon (0.1% to 1%): Fatigue, malaise, vertigo[Ref]

Hematologic

Sulfonylureas:

Rare (less than 0.1%): Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, pancytopenia

Dermatologic

Uncommon (0.1% to 1%): Allergic skin reactions (pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions)

Sulfonylureas:

Frequency not reported: Photosensitivity, porphyria cutanea tarda[Ref]

References

1. "Product Information. Tolazamide (tolazamide)." Mylan Pharmaceuticals Inc (2016):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.