Glynase Side Effects

Please note - some side effects for Glynase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Glynase - for the Consumer

Glynase Tablets (Micronized)

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Glynase Tablets (Micronized):

Feeling of stomach fullness; heartburn; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); confusion; dark urine; fainting; fever, chills, or persistent sore throat; irregular heartbeat; low blood sugar symptoms (eg, anxiety, dizziness, drowsiness, fast heartbeat, headache, lightheadedness, tremors, unusual sweating, weakness); severe or persistent blurred vision or other vision problems; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the eyes or skin.

Glynase Side Effects - for the Professional

Glynase

Hypoglycemia: See PRECAUTIONS and OVERDOSAGE Sections.

Gastrointestinal Reactions: Cholestatic jaundice and hepatitis may occur rarely; Glynase PresTab Tablets should be discontinued if this occurs.

Liver function abnormalities, including isolated transaminase elevations, have been reported.

Gastrointestinal disturbances, eg, nausea, epigastric fullness, and heartburn are the most common reactions, having occurred in 1.8% of treated patients during clinical trials. They tend to be dose related and may disappear when dosage is reduced.

Dermatologic Reactions: Allergic skin reactions, eg, pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions occurred in 1.5% of treated patients during clinical trials. These may be transient and may disappear despite continued use of glyburide. If skin reactions persist, the drug should be discontinued.

Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas.

Hematologic Reactions: Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas.

Metabolic Reactions: Hepatic porphyria and disulfiram-like reactions have been reported with sulfonylureas; however, hepatic porphyria has not been reported with glyburide and disulfiram-like reactions have been reported very rarely.

Cases of hyponatremia have been reported with glyburide and all other sulfonylureas, most often in patients who are on other medications or have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone. The syndrome of inappropriate antidiuretic hormone (SIADH) secretion has been reported with certain other sulfonylureas, and it has been suggested that these sulfonylureas may augment the peripheral (antidiuretic) action of ADH and/or increase release of ADH.

Other Reactions: Changes in accommodation and/or blurred vision have been reported with glyburide and other sulfonylureas. These are thought to be related to fluctuation in glucose levels.

In addition to dermatologic reactions, allergic reactions such as angioedema, arthralgia, myalgia and vasculitis have been reported.

Side Effects by Body System

Metabolic

Hypoglycemia, an extension of glyburide's pharmacologic effects, may be severe, protracted, refractory to glucose infusion, and, in some cases, may require diazoxide. It most commonly presents as coma or disturbed consciousness. Other signs of hypoglycemia include tachycardia, tremor, chest pain, weakness, and increased sweating. In one review of 57 spontaneously reported cases, the mean dose of glyburide associated with hypoglycemia was 10 mg per day although there were cases with doses as low as 2.5 mg per day. The median age in these cases was 75 years. Ten patients died. In another review of 13 cases, in which renal failure, advanced age, and congestive heart failure were deemed to be predisposing factors, hypoglycemia persisted for more than 60 hours in two patients.

Patients with renal dysfunction, liver disease, adrenal or pituitary insufficiency, or congestive heart failure may be at increased risk for hypoglycemia as are those who are elderly, debilitated, or malnourished. In addition, acute illness, lack of adherence to diet, ethanol ingestion, or strenuous exercise may precipitate hypoglycemia.

Metabolic side effects have included hypoglycemia, an extension of glyburide's pharmacologic effects, in 1.6% to 3.1% of patients. Hypoglycemia has been severe and protracted in some cases. Fatalities have been reported. In addition, hyponatremia and disulfiram-like reactions have been reported. Glyburide metabolism and elimination, as well as hepatic gluconeogenesis and glycogenolysis, may be impaired in patients with renal dysfunction and/or liver disease.

Hematologic

Hematologic side effects have included rare reports of leukopenia, thrombocytopenia, eosinophilia, and hemolytic anemia.

Hepatic

Hepatic side effects have included elevations in serum transaminase, alkaline phosphatase, and bilirubin, although jaundice has been only rarely reported. Elevations in liver function tests were usually mild and often returned to normal despite continued therapy. Rare cases of acute hepatic hypersensitivity characterized by pruritus, icterus, and cholestatic jaundice have also been reported. In addition, at least two cases of granulomatous hepatitis have been associated with glyburide use.

Renal

Renal side effects have included polyuria and nocturia.

Dermatologic

Dermatologic side effects have occurred in 1.5% of patients in clinical trials and include pruritus, erythema, urticaria, morbilliform and maculopapular eruptions, and vesiculobullous rash. In addition, pemphigus vulgaris, porphyria cutanea tarda, Stevens-Johnson syndrome, and photosensitivity were reported.

Gastrointestinal

Gastrointestinal side effects have occurred in up to 1.8% of patients in clinical trials and included nausea, vomiting, dyspepsia, abdominal fullness, diarrhea, and anorexia. Gastrointestinal side effects tended to be mild and transient.

Hypersensitivity

Hypersensitivity side effects have predominantly included dermatological effects but have also included acute hepatic hypersensitivity, cholestatic jaundice, necrotizing angiitis, hemolytic anemia, angioedema, arthralgia, myalgia, and vasculitis.

Ocular

Ocular side effects have included changes in accommodation and blurred vision.

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 information does not endorse drugs, diagnose patients, or recommend therapy. This drug 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 drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information 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 drugs you are taking, check with your doctor, nurse, or pharmacist.