Orinase Side Effects

Generic name: tolbutamide

Medically reviewed by Drugs.com. Last updated on Oct 29, 2023.

Note: This document provides detailed information about Orinase Side Effects associated with tolbutamide. Some dosage forms listed on this page may not apply specifically to the brand name Orinase.

Applies to tolbutamide: oral tablet.

Common side effects of Orinase

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

Serious side effects of Orinase

Along with its needed effects, tolbutamide (the active ingredient contained in Orinase) 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

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

• Frequency not reported: Increased cardiovascular mortality^[Ref]

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]

Gastrointestinal

• Common (1% to 10%): Nausea, epigastric fullness, heartburn
• Frequency not reported: Anorexia, diarrhea, vomiting, constipation^[Ref]

Gastrointestinal disturbances such as nausea, epigastric fullness, and heartburn tend to be dose related and may disappear when dosage is reduced.^[Ref]

Metabolic

• Frequency not reported: Hypoglycemia, increased appetite, weight gain
• Sulfonylureas:
• Frequency not reported: Hepatic porphyria, disulfiram-like reactions^[Ref]

Hypersensitivity

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

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]

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]

Further information

Orinase side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer