Rare (less than 0.The FDA urges consumers taking the supplements to immediately talk to a healthcare provider about safely discontinuing their use because suddenly stopping the undeclared drugs may be dangerous. Rare (less than 0.1%): Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, pancytopenia Hepatic Rare (less than 0.1%): Cholestatic jaundiceįrequency not reported: Hepatic function disturbances Dermatologicįrequency not reported: Porphyria cutanea tarda Otherįrequency not reported: Tinnitus, alcohol intolerance Nervous systemįrequency not reported: Headache, taste disturbances, paraesthesia Hematologic Allergic skin reactions may occur and progress rarely to erythema multiforme exfoliative dermatitis, and fever. Hypersensitivity reactions usually develop within 6 to 8 weeks of starting therapy. Ĭommon (1% to 10%): Nausea, epigastric fullness, heartburnįrequency not reported: Anorexia, diarrhea, vomiting, constipation Metabolicįrequency not reported: Hypoglycemia, increased appetite, weight gainįrequency not reported: Hepatic porphyria, disulfiram-like reactions Hypersensitivity Gastrointestinal disturbances such as nausea, epigastric fullness, and heartburn tend to be dose related and may disappear when dosage is reduced. 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. 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). 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. Cardiovascularįrequency not reported: Increased cardiovascular mortality The most commonly reported adverse reactions have included gastrointestinal disturbances such as nausea, epigastric fullness, and heartburn. increased sensitivity of skin to sunlightĪpplies to tolbutamide: intravenous powder for injection, oral tablet.Change in taste or bad, unusual, or unpleasant (after)taste.Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.Ĭheck 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 These side effects may go away during treatment as your body adjusts to the medicine. Some side effects of tolbutamide may occur that usually do not need medical attention. Get emergency help immediately if any of the following symptoms of overdose occur while taking tolbutamide: Symptoms of overdose sores, ulcers, or white spots on the lips or in the mouth.general feeling of tiredness or weakness.Although not all of these side effects may occur, if they do occur they may need medical attention.Ĭheck with your doctor immediately if any of the following side effects occur while taking tolbutamide: Rare Serious side effects of OrinaseĪlong with its needed effects, tolbutamide (the active ingredient contained in Orinase) may cause some unwanted effects. Some dosage forms listed on this page may not apply to the brand name Orinase.Īpplies to tolbutamide: oral tablet. Note: This document contains side effect information about tolbutamide.
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