Amaryl Side Effects

Generic Name: glimepiride

Please note - some side effects for Amaryl 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 Amaryl - for the Consumer

Amaryl

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 Amaryl:

Nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or irregular heartbeat; confusion; dark urine; fainting; fever, chills, or persistent sore throat; 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.

Amaryl Side Effects - for the Professional

Amaryl

Adult Patients

The incidence of hypoglycemia with Amaryl, as documented by blood glucose values <60 mg/dL, ranged from 0.9–1.7% in two large, well-controlled, 1-year studies.

Amaryl has been evaluated for safety in 2,013 patients in US controlled trials, and in 1,551 patients in foreign controlled trials. More than 1,650 of these patients were treated for at least 1 year.

Adverse events, other than hypoglycemia, considered to be possibly or probably related to study drug that occurred in US placebo-controlled trials in more than 1% of patients treated with Amaryl are shown below.

Vomiting, gastrointestinal pain, and diarrhea have been reported, but the incidence in placebo-controlled trials was less than 1%. In rare cases, there may be an elevation of liver enzyme levels. In isolated instances, impairment of liver function (e.g. with cholestasis and jaundice), as well as hepatitis, which may also lead to liver failure have been reported with sulfonylureas, including Amaryl.

Allergic skin reactions, e.g., pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occur in less than 1% of treated patients. These may be transient and may disappear despite continued use of Amaryl. If those hypersensitivity reactions persist or worsen (e.g., dyspnea, fall in blood pressure, shock), the drug should be discontinued.

Porphyria cutanea tarda, photosensitivity reactions, and allergic vasculitis have been reported with sulfonylureas, including Amaryl.

Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas, including Amaryl.

Hepatic porphyria reactions and disulfiram-like reactions have been reported with sulfonylureas, including Amaryl. Cases of hyponatremia have been reported with glimepiride 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 sulfonylureas, including Amaryl, and it has been suggested that certain sulfonylureas may augment the peripheral (antidiuretic) action of ADH and/or increase release of ADH.

Changes in accommodation and/or blurred vision may occur with the use of Amaryl. This is thought to be due to changes in blood glucose, and may be more pronounced when treatment is initiated. This condition is also seen in untreated diabetic patients, and may actually be reduced by treatment. In placebo-controlled trials of Amaryl, the incidence of blurred vision was placebo, 0.7%, and Amaryl, 0.4%.

Pediatric Patients

In a clinical trial, 135 pediatric patients with Type 2 diabetes were treated with Amaryl. The profile of adverse reactions in these patients was similar to that observed in adults.

Side Effects by Body System

Cardiovascular

The administration of oral hypoglycemic drugs has been associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on a study of 823 patients, which reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 G per day) had a rate of cardiovascular mortality approximately 2.5 times that of patients treated with diet alone. Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, this warning may also apply to other drugs in this class in view of their close similarities in mode of action and chemical structure.

Cardiovascular side effects have included reports of increased mortality with some sulfonylurea agents, however, no such data exists for glimepiride.

Metabolic

Metabolic side effects have included hypoglycemia (blood sugars less than 60 mg/dl) in 0.9% to 1.7%. Hyponatremia occurred rarely. The syndrome of inappropriate antidiuretic hormone (SIADH) secretion, hepatic porphyria reactions, and disulfiram reactions have also been reported.

Nervous system

Nervous system side effects have included dizziness (1.7%), asthenia (1.6%), and headache (1.5%).

Ocular

Ocular side effects have included blurred vision and loss of accommodation in less than 1% of treated patients.

Dermatologic

Dermatologic side effects have included pruritus, erythema, urticaria, and morbilliform or maculopapular rashes in less than 1% of cases. Sulfonylureas have caused porphyria cutanea tarda and photosensitivity reactions.

Gastrointestinal

Gastrointestinal side effects have included nausea (1.1%). Vomiting, diarrhea, and pain were noted in less than 1% of cases.

Hematologic

Hematologic side effects have included leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia.

Hepatic

Hepatic side effects have included cholestatic jaundice with other sulfonylureas. However, no data exists for glimepiride.

Hypersensitivity

Hypersensitivity side effects have included allergic skin reactions, e.g., pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, which occurred in less than 1% of treated patients. Some of these were transient and disappeared despite continued use of glimepiride. Allergic vasculitis has also been reported. Additional reports included hypersensitivity reactions worsening: such as dyspnea, fall in blood pressure, and shock.

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