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, 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 SIDE EFFECTS / ADVERSE REACTIONS RELATED TO AMARYL

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

Possible Amaryl side effects / adverse reactions in 47 year old male

Reported by a physician from Japan on 2007-01-24

Patient: 47 year old male

Reactions: Renal Failure Acute

Suspect drug(s):
Amaryl

Other drugs received by patient: Basen

Possible Amaryl side effects / adverse reactions in 51 year old female

Reported by a individual with unspecified qualification from France on 2007-01-24

Patient: 51 year old female

Reactions: Cerebrovascular Accident

Adverse event resulted in: hospitalization

Suspect drug(s):
Levothyroxine Sodium
    Dosage: 150 mcg (150 mcg, 1 d) oral
    Administration route: Oral
    Indication: Thyroidectomy
    Start date: 2002-01-01

Lodoz (Tablet) (Hydrochlorothiazide, Bisoprolol Fumarate)
    Dosage: 1 dosage forms (1 dosage forms, 1 d) oral
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication

Amaryl
    Dosage: 6 mg (6 mg, 1 d) oral
    Administration route: Oral
    Indication: Diabetes Mellitus

Atorvastatin Calcium
    Dosage: 10 mg (10 mg, 1 d) oral
    Administration route: Oral
    Indication: Hypercholesterolaemia

Cotareg (Tablet) (Hydrochlorothiazide, Valsartan)
    Dosage: 1 dosage forms (1 dosage forms, 1 d) oral
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication

Adepal (Tablet) (Ethinylestradiol, Levonorgestrel)
    Dosage: 1 dosage forms (1 dosage forms, 1 in 1 d) oral
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication
    End date: 2005-05-21

Lantus
    Dosage: 76 iu (76 iu, 1 in 1 d) intravenous
    Indication: Diabetes Mellitus

Possible Amaryl side effects / adverse reactions in 87 year old female

Reported by a physician from Japan on 2007-01-25

Patient: 87 year old female weighing 46.0 kg (101.2 pounds)

Reactions: Unresponsive TO Stimuli, Hyperglycaemia, Drug Interaction, Depressed Level of Consciousness, Hypoglycaemic Coma, Hyperhidrosis

Adverse event resulted in: life threatening event

Suspect drug(s):
Amaryl
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2005-04-23
    End date: 2006-12-28

Clarithromycin
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2006-12-25
    End date: 2006-12-28

Lenimec
    Administration route: Oral
    Indication: Hypertension
    Start date: 2005-04-27

Other drugs received by patient: Mucodyne; Tulobuten; Fiblast; Enpral; Gasmotin; Mucosta; Ticlopidine HCL; Platibit; Sennoside; Lasix; Allopurinol TAB; Atelec; Laxoselin

Possible Amaryl side effects / adverse reactions in 68 year old male

Reported by a pharmacist from Japan on 2007-01-29

Patient: 68 year old male

Reactions: RED Blood Cell Count Decreased, Shock Haemorrhagic, Melaena, Epistaxis

Adverse event resulted in: hospitalization

Suspect drug(s):
Amaryl

Other drugs received by patient: Amlodipine Besylate; Tenormin; Digoxin

Possible Amaryl side effects / adverse reactions in 46 year old male

Reported by a pharmacist from Japan on 2007-01-31

Patient: 46 year old male

Reactions: Intentional Overdose

Adverse event resulted in: hospitalization

Suspect drug(s):
Amaryl

Other drugs received by patient: Lorelco; Basen; Amoxan; Rohypnol; Solanax; Meilax

Possible Amaryl side effects / adverse reactions in 78 year old female

Reported by a individual with unspecified qualification on 2007-01-31

Patient: 78 year old female

Reactions: Dyspnoea, Vomiting, Hypoglycaemia

Adverse event resulted in: hospitalization

Suspect drug(s):
Amaryl
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 1999-01-01
    End date: 2006-04-21

Dianben
    Administration route: Oral
    Start date: 1999-01-01
    End date: 2006-04-21

Other drugs received by patient: Omeprazole; Furosemida; Lercadip /01366401/; Digoxin; Cozaar; Tromalyt

Possible Amaryl side effects / adverse reactions in 57 year old female

Reported by a physician from Japan on 2007-01-31

Patient: 57 year old female

Reactions: Blood Potassium Increased

Suspect drug(s):
Amaryl

Other drugs received by patient: Methycobal /00056201/

Possible Amaryl side effects / adverse reactions in 87 year old female

Reported by a physician from Japan on 2007-02-01

Patient: 87 year old female weighing 46.0 kg (101.2 pounds)

Reactions: Hypoglycaemic Coma, Drug Interaction

Adverse event resulted in: life threatening event

Suspect drug(s):
Amaryl
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2005-04-23
    End date: 2006-12-28

Clarithromycin
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2006-12-25
    End date: 2006-12-28

Lenimec
    Administration route: Oral
    Indication: Hypertension
    Start date: 2005-04-27

Other drugs received by patient: Mucodyne; Tulobuten; Fiblast; Enpral; Gasmotin; Mucosta; Ticlopidine HCL; Platibit; Sennoside; Lasix; Zyloric; Atelec; Laxoselin

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

Reported by a individual with unspecified qualification from Japan on 2007-02-02

Patient: 80 year old female

Reactions: White Blood Cell Count Decreased, Platelet Count Decreased

Adverse event resulted in: hospitalization

Suspect drug(s):
Actos
    Dosage: 15 mg (15 mg, 1 d) per oral; see image
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2007-01-01
    End date: 2007-01-01

Actos
    Dosage: 15 mg (15 mg, 1 d) per oral; see image
    Administration route: Oral
    Indication: Diabetes Mellitus
    End date: 2007-01-01

Amaryl
    Dosage: per oral
    Administration route: Oral

Possible Amaryl side effects / adverse reactions in 46 year old male

Reported by a pharmacist from Japan on 2007-02-02

Patient: 46 year old male

Reactions: Renal Disorder, Intentional Overdose, Depressed Level of Consciousness

Adverse event resulted in: hospitalization

Suspect drug(s):
Amaryl

Other drugs received by patient: Lorelco; Basen; Amoxan; Rohypnol; Solanax; Meilax

Possible Amaryl side effects / adverse reactions in 55 year old male

Reported by a physician from Japan on 2007-02-05

Patient: 55 year old male

Reactions: Iron Deficiency Anaemia, Hypocholesterolaemia, Hyperthyroidism

Suspect drug(s):
Amaryl

Possible Amaryl side effects / adverse reactions in 81 year old male

Reported by a individual with unspecified qualification from Japan on 2007-02-13

Patient: 81 year old male

Reactions: White Blood Cell Count Decreased, Nasopharyngitis, Glycosylated Haemoglobin Increased, Platelet Count Decreased, Diabetes Mellitus Inadequate Control

Suspect drug(s):
Actos
    Dosage: see image
    Administration route: Oral
    Indication: Insulin-Requiring Type II Diabetes Mellitus
    Start date: 2006-12-27
    End date: 2007-01-10

Actos
    Dosage: see image
    Administration route: Oral
    Indication: Insulin-Requiring Type II Diabetes Mellitus
    Start date: 2007-01-11

Amaryl
    Dosage: see image
    Indication: Insulin-Requiring Type II Diabetes Mellitus
    Start date: 2007-01-05
    End date: 2007-01-06

Amaryl
    Dosage: see image
    Indication: Insulin-Requiring Type II Diabetes Mellitus
    Start date: 2007-01-07
    End date: 2007-01-08

Amaryl
    Dosage: see image
    Indication: Insulin-Requiring Type II Diabetes Mellitus
    Start date: 2007-01-09
    End date: 2007-01-10

Amaryl
    Dosage: see image
    Indication: Insulin-Requiring Type II Diabetes Mellitus
    Start date: 2007-01-11
    End date: 2007-01-14

Amaryl
    Dosage: see image
    Indication: Insulin-Requiring Type II Diabetes Mellitus
    Start date: 2007-01-15
    End date: 2007-01-16

Amaryl
    Dosage: see image
    Indication: Insulin-Requiring Type II Diabetes Mellitus
    Start date: 2007-01-05

Amaryl
    Dosage: see image
    Indication: Insulin-Requiring Type II Diabetes Mellitus
    Start date: 2007-01-17

Other drugs received by patient: Glucobay; Losartan Potassium

Possible Amaryl side effects / adverse reactions in 47 year old male

Reported by a physician from Japan on 2007-02-23

Patient: 47 year old male

Reactions: Renal Failure Acute

Suspect drug(s):
Amaryl

Other drugs received by patient: Basen

Possible Amaryl side effects / adverse reactions in 75 year old male

Reported by a pharmacist from Japan on 2007-02-27

Patient: 75 year old male

Reactions: Platelet Count Decreased

Adverse event resulted in: death

Suspect drug(s):
Amaryl

Other drugs received by patient: NU-Lotan

Possible Amaryl side effects / adverse reactions in 47 year old male

Reported by a physician from Japan on 2007-02-28

Patient: 47 year old male

Reactions: Renal Failure Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Amaryl

Other drugs received by patient: Basen

Possible Amaryl side effects / adverse reactions in 78 year old female

Reported by a individual with unspecified qualification from France on 2007-03-01

Patient: 78 year old female

Reactions: Renal Failure Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Glucophage
    Dosage: 1700,00 mg (850 mg, 2 in 1 d) oral
    Administration route: Oral
    Indication: Diabetes Mellitus
    End date: 2006-08-30

Fozitec 10 Mg(10 MG, Tablet) (Fosinopril)
    Dosage: 10,000 mg (10 mg, 1 in 1 d) oral
    Administration route: Oral
    Indication: Essential Hypertension
    End date: 2006-08-30

Diamicron (30 MG, Tablet), (Gliclazide)
    Dosage: 0,75 mg (0,75 mg, 1 d) oral
    Administration route: Oral
    Indication: Diabetes Mellitus
    End date: 2006-08-30

Augmentin
    Dosage: 2,00 gm ( 1gm,2 in 1 d) intravenous (not otherwise specified)
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-08-27
    End date: 2006-08-31

Amaryl
    Dosage: 2,00 mg (2 mg,1 in 1 d) oral
    Administration route: Oral
    Indication: Diabetes Mellitus
    End date: 2006-08-30

Ofloxacin
    Dosage: 1,00 dosage forms (1 dosage forms, 1 in 1 d) intravenous (not otherwise specified)
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-08-28
    End date: 2006-08-29

Amlodipine Besylate
    Dosage: 5,00 mg (5 mg, 1 in 1 d) oral
    Administration route: Oral
    Indication: Essential Hypertension
    End date: 2006-09-03

Possible Amaryl side effects / adverse reactions in 66 year old male

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2007-03-01

Patient: 66 year old male

Reactions: Hypoglycaemia

Adverse event resulted in: hospitalization

Suspect drug(s):
Metoprolol Succinate
    Administration route: Oral
    End date: 2007-01-01

Amaryl
    Administration route: Oral
    End date: 2007-01-19

Glucophage
    Administration route: Oral
    End date: 2007-01-19

Actos
    Administration route: Oral
    End date: 2007-01-19

Other drugs received by patient: Digoxin Streuli; Allopurinol; Haldol