Amaryl (Glimepiride) - Side Effects and Adverse Reactions

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.

REPORTS OF SUSPECTED AMARYL SIDE EFFECTS / ADVERSE REACTIONS

Possible Amaryl side effects / adverse reactions in 62 year old male

Reported by a consumer/non-health professional from Mexico on 2011-10-06

Patient: 62 year old male weighing 65.0 kg (143.0 pounds)

Reactions: Renal Failure, Hyperglycaemia, Hypertension

Suspect drug(s):
Insulin Glargine
    Indication: Type 2 Diabetes Mellitus
    Start date: 2009-01-01

Amaryl
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2009-01-01
    End date: 2011-03-01

Possible Amaryl side effects / adverse reactions in 73 year old male

Reported by a consumer/non-health professional from United States on 2011-10-08

Patient: 73 year old male

Reactions: Cardio-Respiratory Arrest, Hypoaesthesia

Adverse event resulted in: death

Suspect drug(s):
Lyrica
    Administration route: Oral
    Indication: Hypoaesthesia
    Start date: 2011-06-13
    End date: 2011-06-16

Zestoretic
    Administration route: Oral
    Indication: Hypertension

Amaryl
    Indication: Diabetes Mellitus

Possible Amaryl side effects / adverse reactions in 80 year old male

Reported by a physician from Japan on 2011-10-12

Patient: 80 year old male weighing 42.0 kg (92.4 pounds)

Reactions: Hypoglycaemia, Altered State of Consciousness, Acute Prerenal Failure

Adverse event resulted in: hospitalization

Suspect drug(s):
Solostar
    Indication: Device Therapy
    Start date: 2009-11-04
    End date: 2011-06-30

Amaryl
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2011-04-20
    End date: 2011-06-30

Lantus
    Indication: Diabetes Mellitus
    Start date: 2009-11-07
    End date: 2011-06-30

Januvia
    Administration route: Oral
    Start date: 2011-07-02
    End date: 2011-07-04

Other drugs received by patient: Furosemide; Aldactone; Levofloxacin; Spironolactone