Tolinase Side Effects

Generic Name: tolazamide

Please note - some side effects for Tolinase 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 Tolinase - for the Consumer

Tolinase

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 Tolinase:

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; skin redness; dizziness); 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.

Tolinase Side Effects - for the Professional

Tolinase

Tolinase Tablets have generally been well tolerated. In clinical studies in which more than 1,784 diabetic patients were specifically evaluated for incidence of side effects, only 2.1% were discontinued from therapy because of side effects.

Hypoglycemia

See PRECAUTIONS and OVERDOSAGE sections.

Gastrointestinal Reactions

Cholestatic jaundice may occur rarely; Tolinase Tablets should be discontinued if this occurs. Gastrointestinal disturbances, eg, nausea, epigastric fullness, and heartburn, are the most common reactions and occurred in 1% of patients treated during clinical trials. They tend to be dose-related and may disappear when dosage is reduced.

Dermatologic Reactions

Allergic skin reactions, eg, pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occurred in 0.4% of patients treated during clinical trials. These may be transient and may disappear despite continued use of Tolinase; 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; however, disulfiram-like reactions with Tolinase have been reported very rarely.

Cases of hyponatremia have been reported with tolazamide 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.

Miscellaneous

Weakness, fatigue, dizziness, vertigo, malaise and headache were reported infrequently in patients treated during clinical trials. The relationship to therapy with Tolinase is difficult to assess.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects have included nausea, epigastric fullness, and heart burn. These effects tend to be dose-related and may resolve upon a reduction in dose.

Dermatologic

Dermatologic side effects have included pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions. Porphyria cutanea tarda and photosensitivity reactions have been reported with the use of sulfonylureas.

Hematologic

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

Metabolic

Metabolic side effects have included hypoglycemia and hyponatremia. The syndrome of inappropriate antidiuretic hormone (SIADH) secretion has been reported with other sulfonylureas.

Nervous system

Nervous system side effects have included dizziness and headache.

General

General side effects have included weakness, fatigue, vertigo, and malaise.

Hepatic

A 54-year-old woman with self-limiting cholestatic jaundice after treatment with chlorpropamide experienced a recurrence of jaundice following subsequent treatment with tolazamide. Discontinuation of tolazamide resulted in resolution of the jaundice, indicating a possible hepatic cross-sensitivity with chlorpropamide.

Hepatic side effects have rarely included cholestatic jaundice.

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