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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