Orinase Side Effects

Generic Name: tolbutamide

Note: This page contains side effects data for the generic drug tolbutamide. It is possible that some of the dosage forms included below may not apply to the brand name Orinase.

It is possible that some side effects of Orinase may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to tolbutamide: oral tablet

As well as its needed effects, tolbutamide (the active ingredient contained in Orinase) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking tolbutamide, check with your doctor immediately:

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

If any of the following symptoms of overdose occur while taking tolbutamide, get emergency help immediately:

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

Some tolbutamide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

Gastrointestinal

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

Hepatic

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

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.[Ref]

Hematologic

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

Metabolic

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

Endocrine

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

Nervous system

Nervous system side effects have included headache.[Ref]

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.[Ref]

References

1. "Product Information. Orinase (tolbutamide)" Pharmacia and Upjohn, Kalamazoo, MI.

2. "Product Information. Orinase Diagnostic (tolbutamide)." Pharmacia and Upjohn, Kalamazoo, MI.

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