Drug information for KOMBIGLYZE XR
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
TABLET, EXTENDED RELEASE; ORAL
1GM;2.5MG
Prescription
METFORMIN HYDROCHLORIDE
;
SAXAGLIPTIN
saxagliptin
BRISTOL MYERS SQUIBB
200678
2012-04-05 Letter
2012-03-13 Letter
2012-03-13 Letter
2012-03-09 Medication Guide
2012-03-09 Medication Guide
2012-03-09 Label
2012-03-09 Label
2011-11-21 Letter
2011-11-16 Label
2011-11-16 Medication Guide
2011-09-16 Review
2011-09-16 Summary Review
2010-11-12 Letter
2010-11-12 Label
TABLET, EXTENDED RELEASE; ORAL
1GM;5MG
Prescription
(Reference Drug)
METFORMIN HYDROCHLORIDE
;
SAXAGLIPTIN
saxagliptin
BRISTOL MYERS SQUIBB
"
TABLET, EXTENDED RELEASE; ORAL
500MG;5MG
Prescription
METFORMIN HYDROCHLORIDE
;
SAXAGLIPTIN
saxagliptin
BRISTOL MYERS SQUIBB
"
Drug Adverse Effects information for KOMBIGLYZE XR
Role code
Indications
Reaction
# Reports
PS
BIPOLAR DISORDER
PANCREATITIS ACUTE
1
PS
BLOOD CHOLESTEROL ABNORMAL
DYSPNOEA
1
PS
BLOOD CHOLESTEROL ABNORMAL
MUSCLE SPASMS
1
PS
BLOOD CHOLESTEROL ABNORMAL
MYALGIA
1
PS
BLOOD CHOLESTEROL INCREASED
PANCREATITIS ACUTE
1
PS
DIABETES MELLITUS
ABDOMINAL PAIN
1
PS
DIABETES MELLITUS
BLOOD CREATINE PHOSPHOKINASE ABNORMAL
1
PS
DIABETES MELLITUS
BLOOD GLUCOSE FLUCTUATION
3
PS
DIABETES MELLITUS
DYSPEPSIA
1
PS
DIABETES MELLITUS
HAEMORRHAGE
1
PS
DIABETES MELLITUS
HAIR GROWTH ABNORMAL
2
PS
DIABETES MELLITUS
MYALGIA
1
PS
DIABETES MELLITUS
PANCREATITIS
1
PS
DIABETES MELLITUS
RENAL IMPAIRMENT
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
PANCREATITIS ACUTE
1
PS
HYPERLIPIDAEMIA
HAIR GROWTH ABNORMAL
1
PS
HYPERTENSION
PANCREATITIS ACUTE
1
PS
SCHIZOPHRENIA
PANCREATITIS ACUTE
2
PS
TYPE 2 DIABETES MELLITUS
ABDOMINAL PAIN
2
PS
TYPE 2 DIABETES MELLITUS
ASTHENIA
1
PS
TYPE 2 DIABETES MELLITUS
DIARRHOEA
1
PS
TYPE 2 DIABETES MELLITUS
DRUG PRESCRIBING ERROR
1
PS
TYPE 2 DIABETES MELLITUS
DYSPNOEA
1
PS
TYPE 2 DIABETES MELLITUS
ECONOMIC PROBLEM
1
PS
TYPE 2 DIABETES MELLITUS
HEPATIC CIRRHOSIS
1
PS
TYPE 2 DIABETES MELLITUS
MALAISE
1
PS
TYPE 2 DIABETES MELLITUS
MUSCLE SPASMS
1
PS
TYPE 2 DIABETES MELLITUS
MYALGIA
1
PS
TYPE 2 DIABETES MELLITUS
NAUSEA
1
PS
TYPE 2 DIABETES MELLITUS
PANCREATITIS
1
PS
TYPE 2 DIABETES MELLITUS
PANCREATITIS ACUTE
1
PS
TYPE 2 DIABETES MELLITUS
RASH PRURITIC
1
PS
TYPE 2 DIABETES MELLITUS
SWELLING FACE
1
PS
TYPE 2 DIABETES MELLITUS
THERAPY CESSATION
1
PS
TYPE 2 DIABETES MELLITUS
URTICARIA
1
SS
BLOOD CHOLESTEROL ABNORMAL
DYSPNOEA
1
SS
BLOOD CHOLESTEROL ABNORMAL
MUSCLE SPASMS
1
SS
BLOOD CHOLESTEROL ABNORMAL
MYALGIA
1
SS
TYPE 2 DIABETES MELLITUS
DYSPNOEA
1
SS
TYPE 2 DIABETES MELLITUS
MUSCLE SPASMS
1
SS
TYPE 2 DIABETES MELLITUS
MYALGIA
1
C
ATRIAL FIBRILLATION
WEIGHT DECREASED
2
C
BLOOD CHOLESTEROL
WEIGHT DECREASED
2
C
BLOOD PRESSURE
DRUG INTERACTION
2
C
BLOOD PRESSURE
RENAL FAILURE ACUTE
2
C
CARDIAC DISORDER
WEIGHT DECREASED
2
C
CORONARY ARTERY DISEASE
WEIGHT DECREASED
2
C
DIABETES MELLITUS
WEIGHT DECREASED
6
C
ERECTILE DYSFUNCTION
ADVERSE EVENT
1
C
ERECTILE DYSFUNCTION
DIARRHOEA
1
C
ERECTILE DYSFUNCTION
NAUSEA
1
C
ERECTILE DYSFUNCTION
PANCREATITIS
1
C
ERECTILE DYSFUNCTION
VOMITING
1
C
HYPERTENSION
ADVERSE EVENT
1
C
HYPERTENSION
DIARRHOEA
1
C
HYPERTENSION
NAUSEA
1
C
HYPERTENSION
PANCREATITIS
1
C
HYPERTENSION
VOMITING
1
C
HYPERTENSION
WEIGHT DECREASED
4
C
PRODUCT USED FOR UNKNOWN INDICATION
DRUG INTERACTION
14
C
PRODUCT USED FOR UNKNOWN INDICATION
RENAL FAILURE ACUTE
14
C
TYPE 2 DIABETES MELLITUS
ADVERSE EVENT
2
C
TYPE 2 DIABETES MELLITUS
DIARRHOEA
2
C
TYPE 2 DIABETES MELLITUS
NAUSEA
2
C
TYPE 2 DIABETES MELLITUS
PANCREATITIS
2
C
TYPE 2 DIABETES MELLITUS
VOMITING
2
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