Amaryl Side Effects - Amaryl (glimepiride) Side Effects

Amaryl Side Effects

Amaryl Side Effects
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dult 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. (See WARNINGS and PRECAUTIONS.)

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.

Adverse Events Occurring in > 1% AMARYL Patients
AMARYL Placebo
No. % No. %
Total Treated 746 100 294 100
Dizziness 13 1.7 1 0.3
Asthenia 12 1.6 3 1.0
Headache 11 1.5 4 1.4
Nausea 8 1.1 0 0.0
Gastrointestinal Reactions

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.
Dermatologic Reactions

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, the drug should be discontinued. Porphyria cutanea tarda, photosensitivity reactions, and allergic vasculitis have been reported with sulfonylureas, including AMARYL.
Hematologic Reactions

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

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.
Other Reactions

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.