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Medications and Drugs

Brand Names: Orinase

Generic Name: tolbutamide (Pronunciation: tole BUE ta mide)

What is tolbutamide (Orinase)?

Tolbutamide is an oral diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin.

Tolbutamide is used together with diet and exercise to treat type 2 diabetes. Other diabetes medicines are sometimes used in combination with tolbutamide if needed.

Tolbutamide should not be used by itself to treat type 1 diabetes.

Tolbutamide may also be used for purposes not listed in this medication guide.

Tolbutamide 500 mg-MYL

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What are the possible side effects of tolbutamide (Orinase)?

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about tolbutamide (Orinase)?

Do not use this medication if you are allergic to tolbutamide, or if you are in a state of diabetic ketoacidosis. Call your doctor for treatment with insulin.

Before taking tolbutamide, tell your doctor if you have kidney or liver disease, a disorder of your pituitary or adrenal glands, an enzyme deficiency called G6PD, a history of heart disease, or if you are malnourished.

Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss. Your blood sugar will need to be checked often, and you may need to adjust your tolbutamide dose.

Tolbutamide is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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