Tol-Tab

Common side effects include:

• nausea
• upper abdominal fullness
• heartburn
• rash
• headache
• changes in taste

This is not a complete list of Tol-Tab side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Serious side effects have been reported with Tol-Tab including the following:

• Tol-Tab may increase your chance of death from heart problems.
• Tol-Tab can cause low blood sugar levels (hypoglycemia) in patients. Tell your doctor if you have a history of kidney or liver disease or drink alcohol. Symptoms of low blood sugar include:
  • shakiness
  • tremors
  • cold sweat
  • fast heart rate
  • headache
  • moodiness
  • dizziness
  • blurred vision
  • confusion

• Tol-Tab can decrease the number of red blood cells in people with glucose-6-phosphate dehydrogenase (G6PD) deficiency.  Alert your doctor if you have a history of G6PD deficiency or anemia.

Ask your doctor about the safe use of alcoholic beverages while you are taking Tol-Tab. Alcohol can make the side effects from Tol-Tab worse. Consuming alcohol while taking Tol-Tab also may cause symptoms such as flushing (reddening of the face), headache, nausea, vomiting, chest pain, weakness, blurred vision, mental confusion, sweating, choking, breathing difficulty, and anxiety.

Avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Tol-Tab may make your skin sensitive to sunlight.

After exposure to stress, such as fever, trauma, infection, or surgery, Tol-Tab may cause you to lose control over your blood glucose levels. These conditions can affect your blood sugar and the amount of Tol-Tab  you may need. Ask your doctor what to do in any of these cases.

Do not take Tol-Tab if you:

• are allergic to Tol-Tab or to any of its ingredients
• have Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
• are being treated for Type I diabetes (as sole therapy)

Tell your doctor if you are breastfeeding or plan to breastfeed.

Although it is not known whether Tol-Tab is excreted in human milk, some sulfonylurea drugs are known to be excreted in human milk. Because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Tol-Tab.

If the drug is discontinued, and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.

If you take too much Tol-Tab, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

In the U.S.

• Tol-Tab

Available Dosage Forms:

• Tablet

Therapeutic Class: Hypoglycemic

Chemical Class: 1st Generation Sulfonylurea

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For type 2 diabetes:
  • For oral dosage form (tablets):
    • Adults—At first, 1000 to 2000 milligrams (mg) per day, taken in the morning or in divided doses. Your doctor may adjust your dose if needed. The dose is usually not more than 3000 mg per day.
    • Children—Use and dose must be determined by your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach pain
• chills
• clay-colored stools
• dark urine
• diarrhea
• dizziness
• fever
• headache
• itching
• loss of appetite
• nausea
• rash
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood

• Agitation
• back or leg pains
• bleeding gums
• blood in urine or stools
• bloody, black, or tarry stools
• chest pain
• coma
• confusion
• convulsions
• cough or hoarseness
• decreased urine output
• depression
• difficulty breathing
• fast or irregular heartbeat
• fatigue
• fever with or without chills
• fluid-filled skin blisters
• general body swelling
• general feeling of tiredness or weakness
• high fever
• hostility
• increased thirst
• irritability
• lethargy
• light-colored stools
• lower back or side pain
• muscle pain or cramps
• muscle twitching
• nosebleeds
• painful or difficult urination
• pale skin
• pinpoint red spots on skin
• rapid weight gain
• seizures
• sensitivity to the sun
• shortness of breath
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stupor
• swelling of face, ankles, or hands
• swollen or painful glands
• tightness in the chest
• unexplained bleeding or bruising
• wheezing
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• Anxiety
• blurred vision
• cold sweats
• cool, pale skin
• increased hunger
• nervousness
• nightmares
• shakiness
• slurred speech

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Belching
• indigestion
• pain in the chest below the breastbone
• passing of gas
• stomach pain, fullness, or discomfort

• Flushing or redness of skin
• unusually warm skin

• Change in taste or bad, unusual, or unpleasant (after)taste
• increased sensitivity of skin to sunlight
• redness or other discoloration of skin
• severe sunburn

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Applies to tolbutamide: oral tablet

Along with its needed effects, tolbutamide (the active ingredient contained in Tol-Tab) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tolbutamide:

• Abdominal or stomach pain
• chills
• clay-colored stools
• dark urine
• diarrhea
• dizziness
• fever
• headache
• itching
• loss of appetite
• nausea
• rash
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood

• Agitation
• back or leg pains
• bleeding gums
• blood in urine or stools
• bloody, black, or tarry stools
• chest pain
• coma
• confusion
• convulsions
• cough or hoarseness
• decreased urine output
• depression
• difficulty breathing
• fast or irregular heartbeat
• fatigue
• fever with or without chills
• fluid-filled skin blisters
• general body swelling
• general feeling of tiredness or weakness
• high fever
• hostility
• increased thirst
• irritability
• lethargy
• light-colored stools
• lower back or side pain
• muscle pain or cramps
• muscle twitching
• nosebleeds
• painful or difficult urination
• pale skin
• pinpoint red spots on skin
• rapid weight gain
• seizures
• sensitivity to the sun
• shortness of breath
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stupor
• swelling of face, ankles, or hands
• swollen or painful glands
• tightness in the chest
• unexplained bleeding or bruising
• wheezing
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking tolbutamide:

• Anxiety
• blurred vision
• cold sweats
• cool, pale skin
• increased hunger
• nervousness
• nightmares
• shakiness
• slurred speech

Some side effects of tolbutamide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Belching
• indigestion
• pain in the chest below the breastbone
• passing of gas
• stomach pain, fullness, or discomfort

• Flushing or redness of skin
• unusually warm skin

• Change in taste or bad, unusual, or unpleasant (after)taste
• increased sensitivity of skin to sunlight
• redness or other discoloration of skin
• severe sunburn

Applies to tolbutamide: intravenous powder for injection, oral tablet

General

The most commonly reported adverse reactions have included gastrointestinal disturbances such as nausea, epigastric fullness, and 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 (the active ingredient contained in Tol-Tab) 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.[Ref]

Frequency not reported: Increased cardiovascular mortality[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
Frequency not reported: Anorexia, diarrhea, vomiting, constipation[Ref]

Metabolic

Frequency not reported: Hypoglycemia, increased appetite, weight gain

Sulfonylureas:
Frequency not reported: Hepatic porphyria, disulfiram-like reactions[Ref]

Hypersensitivity

Hypersensitivity reactions usually develop within 6 to 8 weeks of starting therapy. Allergic skin reactions may occur and progress rarely to erythema multiforme exfoliative dermatitis, and fever.[Ref]

Rare (less than 0.1%): Cholestatic jaundice
Frequency not reported: Hepatic function disturbances[Ref]

Dermatologic

Frequency not reported: Photosensitivity

Sulfonylureas:
Frequency not reported: Porphyria cutanea tarda[Ref]

Other

Frequency not reported: Tinnitus, alcohol intolerance[Ref]

Nervous system

Frequency not reported: Headache, taste disturbances, paraesthesia[Ref]

Hematologic

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

Hepatic

Rare (less than 0.1%): Cholestatic jaundice
Frequency not reported: Hepatic function disturbances[Ref]

Endocrine

Frequency not reported: Hyponatremia, syndrome of inappropriate antidiuretic hormone (SIADH) secretion[Ref]

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