Tolbutamide Side Effects

Please note - some side effects for Tolbutamide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Tolbutamide - for the consumer

Tolbutamide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tolbutamide:

Feeling of stomach fullness; heartburn; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; dark urine; fainting; fever, chills, or persistent sore throat; irregular heartbeat; low blood sugar symptoms (eg, anxiety, dizziness, drowsiness, fast heartbeat, headache, lightheadedness, tremors, unusual sweating, weakness); severe or persistent blurred vision or other vision problems; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the eyes or skin.

For the professional

Tolbutamide

Hypoglycemia

See PRECAUTIONS and OVERDOSAGE sections.

Gastrointestinal Reactions

Cholestatic jaundice may occur rarely; Tolbutamide should be discontinued if this occurs. Gastrointestinal disturbances, e.g., nausea, epigastric fullness, and heartburn, are the most common reactions and occur in 1.4% of patients treated during clinical trial. 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 1.1% of patients treated during clinical trials. These may be transient and may disappear despite continued use of Tolbutamide; 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, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas.

Metabolic Reactions

Hepatic porphyria and disulfiram-like reactions have been reported with sulfonylureas.

Endocrine Reactions

Cases of hyponatremia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with this and other sulfonylureas.

Miscellaneous Reactions

Headache and taste alterations have occasionally been reported with Tolbutamide administration.

By body system

Gastrointestinal side effects

Gastrointestinal side effects have included nausea, epigastric fullness, heartburn, and taste alterations.

Hepatic side effects

Hepatic side effects have rarely included cholestatic jaundice. Tolbutamide should be discontinued if this occurs.

Dermatologic side effects

Dermatologic side effects have included pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions. Photosensitivity and porphyria cutanea tarda have been reported with the use on sulfonylureas.

Hematologic side effects

Hematological side effects have included leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia.

Metabolic side effects

Metabolic side effects have included hepatic porphyria and disulfiram-like reactions.

Endocrine side effects

Endocrine side effects have included hyponatremia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion.

Nervous system side effects

Nervous system side effects have included headache.

Local side effects

Local side effects have included pain and/or a burning sensation at the injection site. Thrombophlebitis with thrombosis of the injected vein has also been reported.

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