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In addition, signs of adrenergic counter-regulation may be present such as sweating, clammy skin, anxiety, tachycardia, hypertension, palpitations, angina pectoris, and cardiac arrhythmias.
The clinical picture of a severe hypoglycemic attack may resemble that of a stroke. The symptoms nearly always subside when hypoglycemia is corrected.
Eye disorders: Especially at the start of treatment, there may be temporary visual impairment due to the change in blood glucose levels. The cause is a temporary alteration in the turgidity and hence the refractive index of the lens, this being dependent on blood glucose level.
Gastrointestinal disorders: Occasionally, gastrointestinal symptoms such as nausea, vomiting, sensations of pressure or fullness in the epigastrium, abdominal pain and diarrhoea may occur.
Hepatobiliary: In cases, elevation of liver enzymes levels and impairment of liver function (e.g., cholestasis and jaundice) may occur, as well as hepatitis which may progress to liver failure.
Dysgeusia (frequency not known).
Blood and lymphatic system disorders: Changes in the blood picture may occur: Rarely, thrombocytopenia and, in isolated cases, leucopenia, haemolytic anaemia, erythrocytopenia, granulocytopenia, agranulocytosis or pancytopenia may develop. Because it is reported that aplastic anemia and pancytopenia may occur in sulfonylureas, careful monitoring should be performed. If these occur, the medication should be discontinued and adequate treatment taken. Cases of severe thrombocytopenia with platelet count less than 10,000/μl and thrombocytopenic purpura have been reported in post-marketing experience (frequency not known).
Skin and subcutaneous tissue disorders: Alopecia (frequency not known).
General disorders: Occasionally, allergic or pseudoallergic reactions. Occasionally, allergic or pseudo-allergic reactions (e.g., itching, urticaria, or rashes) may occur. These reactions are almost mild but may develop into serious reactions with dyspnoea and a fall in blood pressure, sometimes progressing to shock. In the event of urticaria a physician must therefore be notified immediately.
In isolated cases, a decrease in serum sodium concentration and allergic vasculitis or hypersensitivity of the skin to light may occur.
Investigations: Glimepiride, like all sulfonylureas, can cause weight gain (frequency not known).
Metformin: Hypoglycemia.
Gastrointestinal symptoms (diarrhea, nausea, vomiting, abdominal bloating, flatulence, and anorexia) are the most common reactions to this drug and are approximately 30% more frequent in patients on monotherapy than in placebo-treated patients, particularly during initiation of this drug therapy. These symptoms are generally transient and resolve spontaneously during continued treatment. Occasionally, temporary dose reduction may be useful. In clinical trials, this drug was discontinued due to GI reactions in approximately 4% of patients. Because GI symptoms during therapy initiation appear to be dose-related, they may be decreased by gradual dose escalation and by having patients take this drug with meals.
Because significant diarrhea and/or vomiting may cause dehydration and prerenal azotemia, under such circumstances, this drug should be temporarily discontinued. For patients who have been stabilized on this drug, nonspecific GI symptoms should not be attributed to therapy unless intercurrent illness or lactic acidosis has been excluded.
Special senses: During initiation of this drug therapy, approximately 3% of patients may complain of an unpleasant or metallic taste, which usually resolve spontaneously.
Skin reactions such as erythema, pruritus, urticarial are very rare.
Rarely, anemia, leukocytopenia, or thrombocytopenia may occur. Approximately 9% of patients on this drug monotherapy and 6% of patients on this drug/sulfonylurea monotherapy developed asymptomatic subnormal serum vitamin B12 levels; serum folic acid levels did not decrease significantly. Only megaloblastic anemia have been reported with this drug administration. Therefore, serum B12 levels should be appropriately monitored or periodic parenteral B12 supplementation considered. However, cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known) (see Precautions).
Lactic acidosis is very rare.
Hemolytic anemia (frequency unknown).
Reduction of thyrotropin level in patients with hypothyroidism (see Precautions) (frequency unknown).
Hypomagnesemia in the context of diarrhea (frequency unknown).
Encephalopathy (frequency unknown).
Photosensitivity (frequency unknown).
Hepatobiliary disorders: Reports of liver function tests abnormalities and hepatitis resolving upon metformin discontinuation.
If the adverse reactions mentioned previously, other undesirable reactions, or unexpected changes may occur, patients should promptly notify their health practitioner. Certain adverse reactions including severe hypoglycemia, special hematological change, severe allergic or pseudo-allergic reactions, and hepatic insufficiency may be life-threatening in certain conditions, and if these reactions occur, patients should promptly inform their physician and stop taking the drug until physician's instructions.
In local phase 1 and open phase 3 clinical trials, unexpected adverse reactions of this drug except for those of glimepiride and metformin already known have not been observed.
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