Orinase Side Effects

Generic name: tolbutamide

Note: This document contains side effect information about tolbutamide. Some of the dosage forms listed on this page may not apply to the brand name Orinase.

Some side effects of Orinase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to tolbutamide: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking tolbutamide (the active ingredient contained in Orinase) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Hypoglycemia, or low blood sugar, is the most common side effect of tolbutamide. Symptoms include headache, hunger, weakness, sweating, tremor, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets with you in case you have low blood sugar.

Stop taking tolbutamide and call your doctor at once if you have a serious side effect such as:

• easy bruising or bleeding, unusual weakness;

• pale or yellowed skin, dark colored urine, fever, confusion; or

• memory problems, loss of appetite, feeling unsteady, or hallucinations.

Less serious side effects of tolbutamide may include:

• mild nausea, heartburn, full feeling;

• headache;

• unusual or unpleasant taste in your mouth; or

• skin rash, redness, or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to tolbutamide: intravenous powder for injection, oral tablet

Gastrointestinal

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

Hepatic

Hepatic side effects have rarely included cholestatic jaundice. Tolbutamide (the active ingredient contained in Orinase) should be discontinued if this occurs.

Dermatologic

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

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

Metabolic

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

Endocrine

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

Nervous system

Nervous system side effects have included headache.

Local

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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