ADVERSE REACTIONS
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. (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 (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.
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.
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO AMARYL
Below is a sample of reports where side effects / adverse reactions may be related to Amaryl. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Amaryl side effects / adverse reactions in 66 year old male
Reported by a pharmacist from Japan on 2007-01-17
Patient: 66 year old male weighing 58.0 kg (127.6 pounds)
Reactions: Medication Error, Depressed Level of Consciousness, Hypoglycaemic Coma
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Amaryl
Other drugs received by patient: Ferrum; Allopurinol TAB; Onealfa; Amoban; Caltan; Alinamin /00257802/; Myonal /00287502/; Mobic; Choutousan
Possible Amaryl side effects / adverse reactions in 68 year old male
Reported by a pharmacist from Japan on 2007-01-19
Patient: 68 year old male
Reactions: Shock Haemorrhagic, Pancytopenia, Melaena, Epistaxis
Suspect drug(s):
Amaryl
Other drugs received by patient: Amlodipine Besylate; Tenormin; Digoxin
Possible Amaryl side effects / adverse reactions in 65 year old male
Reported by a physician from Japan on 2007-01-19
Patient: 65 year old male weighing 64.0 kg (140.8 pounds)
Reactions: Hypoglycaemia, Hypoglycaemic Coma
Adverse event resulted in: life threatening event
Suspect drug(s):
Amaryl
Other drugs received by patient: Glucobay; Asphanate; Olmetec; Digoxin; Bieluzon S Maruko; Sornilart Taiyo; Amoban; Nifedipine
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