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Tolbutamide Side Effects

For the Consumer

Applies to tolbutamide: oral tablet

Along with its needed effects, tolbutamide 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:

Rare
  • 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
Incidence not known
  • 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:

Symptoms of overdose
  • 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:

More common
  • Belching
  • indigestion
  • pain in the chest below the breastbone
  • passing of gas
  • stomach pain, fullness, or discomfort
Less common
  • Flushing or redness of skin
  • unusually warm skin
Incidence not known
  • Change in taste or bad, unusual, or unpleasant (after)taste
  • increased sensitivity of skin to sunlight
  • redness or other discoloration of skin
  • severe sunburn

For Healthcare Professionals

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 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]

References

1. "Product Information. Tolbutamide (TOLBUTamide)." Mylan Pharmaceuticals Inc, Morgantown, WV.

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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