Drug information for EXFORGE HCT

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 10MG;12.5MG;160MG Prescription   AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN Exforge HCT NOVARTIS 22314
2012-02-21 Letter

2012-02-17 Label

2012-01-20 Letter

2011-12-14 Letter

2011-12-13 Label

2011-11-02 Letter

2011-10-31 Label

2011-06-27 Label

2011-06-13 Letter

2009-09-02 Review

2009-09-02 Summary Review

2009-05-14 Letter

2009-05-11 Label
TABLET; ORAL 10MG;25MG;160MG Prescription   AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN Exforge HCT NOVARTIS   "
TABLET; ORAL 10MG;25MG;320MG Prescription  (Reference Drug) AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN Exforge HCT NOVARTIS   "
TABLET; ORAL 5MG;12.5MG;160MG Prescription   AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN Exforge HCT NOVARTIS   "
TABLET; ORAL 5MG;25MG;160MG Prescription   AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN Exforge HCT NOVARTIS   "

Drug Adverse Effects information for EXFORGE HCT

Role code Indications Reaction # Reports
PS BLOOD CHOLESTEROL VIITH NERVE PARALYSIS 1
PS BLOOD CHOLESTEROL INCREASED CHOLELITHIASIS 1
PS BLOOD PRESSURE ABNORMAL BLOOD GLUCOSE INCREASED 1
PS BLOOD PRESSURE ABNORMAL EXPIRED DRUG ADMINISTERED 1
PS HYPERTENSION ABASIA 1
PS HYPERTENSION ACCIDENT 1
PS HYPERTENSION ANTINUCLEAR ANTIBODY POSITIVE 1
PS HYPERTENSION AORTIC DILATATION 2
PS HYPERTENSION AORTIC RUPTURE 1
PS HYPERTENSION AORTIC VALVE INCOMPETENCE 2
PS HYPERTENSION APHAGIA 1
PS HYPERTENSION APPENDICITIS 1
PS HYPERTENSION ARRHYTHMIA 1
PS HYPERTENSION ARTHRALGIA 1
PS HYPERTENSION ATRIOVENTRICULAR BLOCK FIRST DEGREE 2
PS HYPERTENSION BACK DISORDER 1
PS HYPERTENSION BALANCE DISORDER 2
PS HYPERTENSION BLOOD CHOLESTEROL INCREASED 1
PS HYPERTENSION BLOOD OSMOLARITY DECREASED 3
PS HYPERTENSION BLOOD PRESSURE FLUCTUATION 2
PS HYPERTENSION BLOOD PRESSURE INADEQUATELY CONTROLLED 2
PS HYPERTENSION BLOOD PRESSURE INCREASED 4
PS HYPERTENSION BLOOD PRESSURE SYSTOLIC INCREASED 1
PS HYPERTENSION BODY MASS INDEX INCREASED 1
PS HYPERTENSION BRAIN OEDEMA 1
PS HYPERTENSION CARDIAC DISORDER 1
PS HYPERTENSION CARDIAC FLUTTER 1
PS HYPERTENSION CARDIOVASCULAR DISORDER 1
PS HYPERTENSION CARDIOVASCULAR INSUFFICIENCY 1
PS HYPERTENSION CARTILAGE INJURY 1
PS HYPERTENSION CEREBROVASCULAR ACCIDENT 2
PS HYPERTENSION CHEST PAIN 3
PS HYPERTENSION CHOLELITHIASIS 2
PS HYPERTENSION CONTUSION 1
PS HYPERTENSION COUGH 1
PS HYPERTENSION DEATH 3
PS HYPERTENSION DEHYDRATION 2
PS HYPERTENSION DEPRESSION 6
PS HYPERTENSION DISCOMFORT 1
PS HYPERTENSION DIZZINESS 1
PS HYPERTENSION DRUG DEPENDENCE 1
PS HYPERTENSION DRUG INTOLERANCE 1
PS HYPERTENSION DRY EYE 1
PS HYPERTENSION DYSPHAGIA 1
PS HYPERTENSION EAR INJURY 1
PS HYPERTENSION EMBOLISM 1
PS HYPERTENSION EPISCLERITIS 1
PS HYPERTENSION ERYTHEMA 1
PS HYPERTENSION EYE HAEMORRHAGE 1
PS HYPERTENSION EYE PAIN 1
PS HYPERTENSION FACE INJURY 1
PS HYPERTENSION FACIAL BONES FRACTURE 1
PS HYPERTENSION FALL 1
PS HYPERTENSION FATIGUE 2
PS HYPERTENSION FEELING ABNORMAL 1
PS HYPERTENSION FLUID RETENTION 1
PS HYPERTENSION GAIT DISTURBANCE 1
PS HYPERTENSION GENERAL PHYSICAL HEALTH DETERIORATION 3
PS HYPERTENSION GLOMERULOSCLEROSIS 11
PS HYPERTENSION HAEMORRHAGE 1
PS HYPERTENSION HEAD INJURY 1
PS HYPERTENSION HEADACHE 1
PS HYPERTENSION HEART RATE INCREASED 1
PS HYPERTENSION HEMIPARESIS 1
PS HYPERTENSION HYPERGAMMAGLOBULINAEMIA 1
PS HYPERTENSION HYPERTENSION 11
PS HYPERTENSION HYPERTENSIVE CRISIS 2
PS HYPERTENSION HYPONATRAEMIA 3
PS HYPERTENSION HYPOTENSION 4
PS HYPERTENSION INFARCTION 2
PS HYPERTENSION INFECTIOUS PERITONITIS 1
PS HYPERTENSION JOINT DISLOCATION 1
PS HYPERTENSION JOINT SWELLING 1
PS HYPERTENSION LIMB INJURY 2
PS HYPERTENSION LIP BLISTER 1
PS HYPERTENSION LIP SWELLING 1
PS HYPERTENSION LOW DENSITY LIPOPROTEIN INCREASED 1
PS HYPERTENSION MACULAR DEGENERATION 1
PS HYPERTENSION MALAISE 1
PS HYPERTENSION MUSCLE SPASMS 1
PS HYPERTENSION MUSCULOSKELETAL DISCOMFORT 1
PS HYPERTENSION OEDEMA 7
PS HYPERTENSION OEDEMA DUE TO RENAL DISEASE 1
PS HYPERTENSION OEDEMA PERIPHERAL 4
PS HYPERTENSION PAIN IN EXTREMITY 1
PS HYPERTENSION PULMONARY OEDEMA 1
PS HYPERTENSION RASH 1
PS HYPERTENSION RENAL ARTERIOSCLEROSIS 11
PS HYPERTENSION RENAL DISORDER 1
PS HYPERTENSION RENAL FAILURE 4
PS HYPERTENSION RENAL INJURY 2
PS HYPERTENSION ROAD TRAFFIC ACCIDENT 1
PS HYPERTENSION SCLERITIS 1
PS HYPERTENSION SJOGREN'S SYNDROME 1
PS HYPERTENSION SYSTEMIC LUPUS ERYTHEMATOSUS 1
PS HYPERTENSION THROMBOSIS 1
PS HYPERTENSION TREATMENT NONCOMPLIANCE 1
PS HYPERTENSION TREMOR 1
PS HYPERTENSION VENTRICULAR EXTRASYSTOLES 2
PS HYPERTENSION VIITH NERVE PARALYSIS 1
PS HYPERTENSION VISION BLURRED 1
PS HYPERTENSION WAIST CIRCUMFERENCE INCREASED 1
PS HYPERTENSION WEIGHT INCREASED 1
PS HYPERTENSION WEIGHT LOSS POOR 1
PS HYPOTHYROIDISM ARTHRALGIA 1
PS HYPOTHYROIDISM JOINT DISLOCATION 1
PS HYPOTHYROIDISM JOINT SWELLING 1
PS MAJOR DEPRESSION DEHYDRATION 2
PS PARKINSON'S DISEASE BLOOD PRESSURE INADEQUATELY CONTROLLED 1
PS PARKINSON'S DISEASE HAEMORRHAGE 1
PS SLEEP DISORDER ABASIA 1
PS SLEEP DISORDER BALANCE DISORDER 1
PS SLEEP DISORDER CEREBROVASCULAR ACCIDENT 1
PS SLEEP DISORDER EAR INJURY 1
PS SLEEP DISORDER FACE INJURY 1
PS SLEEP DISORDER FACIAL BONES FRACTURE 1
PS SLEEP DISORDER FALL 1
PS THROMBOSIS ARTHRALGIA 1
PS THROMBOSIS JOINT DISLOCATION 1
PS THROMBOSIS JOINT SWELLING 1
PS THROMBOSIS PROPHYLAXIS VIITH NERVE PARALYSIS 1
SS ANTICOAGULANT THERAPY BLOOD PRESSURE SYSTOLIC INCREASED 1
SS ANTICOAGULANT THERAPY HYPOAESTHESIA 1
SS ANTICOAGULANT THERAPY PARAESTHESIA 1
SS ANTICOAGULANT THERAPY PERIPHERAL COLDNESS 1
SS ANTICOAGULANT THERAPY UPPER LIMB FRACTURE 1
SS DIABETES MELLITUS ALBUMIN URINE PRESENT 6
SS DIABETES MELLITUS AORTIC VALVE STENOSIS 6
SS DIABETES MELLITUS CARDIAC VALVE DISEASE 6
SS DIABETES MELLITUS CREATINE URINE INCREASED 6
SS DIABETES MELLITUS DIABETIC NEPHROPATHY 6
SS DIABETES MELLITUS GLAUCOMA 6
SS DIABETES MELLITUS HYPERTENSION 6
SS DIABETES MELLITUS LEFT VENTRICULAR DYSFUNCTION 6
SS DIABETES MELLITUS MYOCARDIAL ISCHAEMIA 6
SS HYPERTENSION ALBUMIN URINE PRESENT 4
SS HYPERTENSION AORTIC DILATATION 2
SS HYPERTENSION AORTIC VALVE INCOMPETENCE 2
SS HYPERTENSION AORTIC VALVE STENOSIS 4
SS HYPERTENSION ATRIOVENTRICULAR BLOCK FIRST DEGREE 2
SS HYPERTENSION BLOOD OSMOLARITY DECREASED 3
SS HYPERTENSION BLOOD PRESSURE SYSTOLIC INCREASED 2
SS HYPERTENSION CARDIAC VALVE DISEASE 4
SS HYPERTENSION CHEST DISCOMFORT 2
SS HYPERTENSION CHEST PAIN 3
SS HYPERTENSION CIRCULATORY COLLAPSE 4
SS HYPERTENSION CONTUSION 1
SS HYPERTENSION CREATINE URINE INCREASED 4
SS HYPERTENSION DEPRESSION 3
SS HYPERTENSION DIABETIC NEPHROPATHY 4
SS HYPERTENSION DIZZINESS 4
SS HYPERTENSION DYSGEUSIA 2
SS HYPERTENSION DYSPNOEA 2
SS HYPERTENSION ERYTHEMA 1
SS HYPERTENSION FATIGUE 1
SS HYPERTENSION FEELING ABNORMAL 1
SS HYPERTENSION GAIT DISTURBANCE 1
SS HYPERTENSION GENERAL PHYSICAL HEALTH DETERIORATION 3
SS HYPERTENSION GENERALISED OEDEMA 4
SS HYPERTENSION GLAUCOMA 4
SS HYPERTENSION GLOMERULOSCLEROSIS 11
SS HYPERTENSION HEADACHE 2
SS HYPERTENSION HERPES ZOSTER 3
SS HYPERTENSION HYPERTENSION 14
SS HYPERTENSION HYPERTENSIVE CRISIS 2
SS HYPERTENSION HYPOAESTHESIA 2
SS HYPERTENSION HYPONATRAEMIA 4
SS HYPERTENSION HYPOTENSION 4
SS HYPERTENSION HYPOTONIA 1
SS HYPERTENSION INFARCTION 1
SS HYPERTENSION JOINT SWELLING 4
SS HYPERTENSION LEFT VENTRICULAR DYSFUNCTION 4
SS HYPERTENSION LIGAMENT SPRAIN 2
SS HYPERTENSION LIP DISCOLOURATION 2
SS HYPERTENSION LOSS OF CONSCIOUSNESS 1
SS HYPERTENSION MALAISE 2
SS HYPERTENSION MUSCLE SPASMS 4
SS HYPERTENSION MUSCLE TIGHTNESS 2
SS HYPERTENSION MYOCARDIAL ISCHAEMIA 4
SS HYPERTENSION OEDEMA 3
SS HYPERTENSION OEDEMA PERIPHERAL 10
SS HYPERTENSION PAIN IN EXTREMITY 1
SS HYPERTENSION PARAESTHESIA 2
SS HYPERTENSION PERIPHERAL COLDNESS 2
SS HYPERTENSION PLATELET COUNT DECREASED 2
SS HYPERTENSION RASH 1
SS HYPERTENSION RASH MACULO-PAPULAR 4
SS HYPERTENSION RENAL ARTERIOSCLEROSIS 11
SS HYPERTENSION RENAL FAILURE 3
SS HYPERTENSION SWELLING FACE 4
SS HYPERTENSION SYNCOPE 3
SS HYPERTENSION THROMBOSIS 1
SS HYPERTENSION TREMOR 1
SS HYPERTENSION UPPER LIMB FRACTURE 2
SS HYPERTENSION VENTRICULAR EXTRASYSTOLES 2
SS HYPERTENSION WEIGHT INCREASED 3
SS HYPERTENSION WEIGHT LOSS POOR 1
SS OSTEOPOROSIS HYPONATRAEMIA 1
SS OSTEOPOROSIS HYPOTONIA 1
SS OSTEOPOROSIS LOSS OF CONSCIOUSNESS 1
SS OSTEOPOROSIS SYNCOPE 1
C ANTIBIOTIC THERAPY TOOTH DISORDER 1
C ANTIBIOTIC THERAPY TOOTHACHE 1
C GASTRITIS DILATATION ATRIAL 1
C GASTRITIS HYPERTENSIVE CRISIS 1
C GASTRITIS SINUS TACHYCARDIA 1
C HEADACHE BLOOD PRESSURE INCREASED 1
C HEADACHE OVERDOSE 1
C HYPERPARATHYROIDISM SECONDARY BACTERIAL INFECTION 1
C HYPERPARATHYROIDISM SECONDARY DILATATION ATRIAL 1
C HYPERPARATHYROIDISM SECONDARY HEADACHE 2
C HYPERPARATHYROIDISM SECONDARY HYPERCALCAEMIA 1
C HYPERPARATHYROIDISM SECONDARY HYPERKALAEMIA 1
C HYPERPARATHYROIDISM SECONDARY HYPERTENSIVE CRISIS 1
C HYPERPARATHYROIDISM SECONDARY INFECTION 1
C HYPERPARATHYROIDISM SECONDARY LEUKOPENIA 1
C HYPERPARATHYROIDISM SECONDARY PERICARDIAL EFFUSION 1
C HYPERPARATHYROIDISM SECONDARY PERICARDITIS 1
C HYPERPARATHYROIDISM SECONDARY PNEUMONIA 2
C HYPERPARATHYROIDISM SECONDARY SINUS TACHYCARDIA 1
C HYPERPARATHYROIDISM SECONDARY TONSILLITIS 1
C HYPERTENSION BLOOD PRESSURE INCREASED 1
C HYPERTENSION DILATATION ATRIAL 2
C HYPERTENSION HYPERTENSIVE CRISIS 2
C HYPERTENSION OVERDOSE 1
C HYPERTENSION SINUS TACHYCARDIA 2
C LIVER TRANSPLANT INTERMITTENT CLAUDICATION 1
C LIVER TRANSPLANT TREMOR 1
C PRODUCT USED FOR UNKNOWN INDICATION BACTERIAL INFECTION 25
C PRODUCT USED FOR UNKNOWN INDICATION DILATATION ATRIAL 16
C PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 54
C PRODUCT USED FOR UNKNOWN INDICATION HYPERCALCAEMIA 27
C PRODUCT USED FOR UNKNOWN INDICATION HYPERKALAEMIA 27
C PRODUCT USED FOR UNKNOWN INDICATION HYPERTENSIVE CRISIS 16
C PRODUCT USED FOR UNKNOWN INDICATION INFECTION 25
C PRODUCT USED FOR UNKNOWN INDICATION LEUKOPENIA 25
C PRODUCT USED FOR UNKNOWN INDICATION PERICARDIAL EFFUSION 25
C PRODUCT USED FOR UNKNOWN INDICATION PERICARDITIS 25
C PRODUCT USED FOR UNKNOWN INDICATION PNEUMONIA 54
C PRODUCT USED FOR UNKNOWN INDICATION SINUS TACHYCARDIA 16
C PRODUCT USED FOR UNKNOWN INDICATION TONSILLITIS 25
C PRODUCT USED FOR UNKNOWN INDICATION TOOTH DISORDER 83
C PRODUCT USED FOR UNKNOWN INDICATION TOOTHACHE 29
C SECONDARY HYPERTHYROIDISM TOOTH DISORDER 3
C SECONDARY HYPERTHYROIDISM TOOTHACHE 1
C TYPE 2 DIABETES MELLITUS BLOOD GLUCOSE INCREASED 2
C TYPE 2 DIABETES MELLITUS DRUG INTERACTION 2
C TYPE 2 DIABETES MELLITUS HOSPITALISATION 2
I DEPRESSION ALTERED STATE OF CONSCIOUSNESS 2
I DEPRESSION BLOOD SODIUM INCREASED 2
I DEPRESSION DRUG INTERACTION 2
I DEPRESSION EXTREMITY NECROSIS 2
I DEPRESSION INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION 2
I DEPRESSION NAUSEA 2
I DEPRESSION VOMITING 2
I HYPERTENSION ALTERED STATE OF CONSCIOUSNESS 4
I HYPERTENSION BLOOD SODIUM INCREASED 4
I HYPERTENSION DRUG INTERACTION 4
I HYPERTENSION EXTREMITY NECROSIS 4
I HYPERTENSION INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION 4
I HYPERTENSION NAUSEA 4
I HYPERTENSION VOMITING 4
I PARKINSON'S DISEASE ALTERED STATE OF CONSCIOUSNESS 2
I PARKINSON'S DISEASE BLOOD SODIUM INCREASED 2
I PARKINSON'S DISEASE DRUG INTERACTION 2
I PARKINSON'S DISEASE EXTREMITY NECROSIS 2
I PARKINSON'S DISEASE INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION 2
I PARKINSON'S DISEASE NAUSEA 2
I PARKINSON'S DISEASE VOMITING 2
I SOFT TISSUE INFECTION ALTERED STATE OF CONSCIOUSNESS 2
I SOFT TISSUE INFECTION BLOOD SODIUM INCREASED 2
I SOFT TISSUE INFECTION DRUG INTERACTION 2
I SOFT TISSUE INFECTION EXTREMITY NECROSIS 2
I SOFT TISSUE INFECTION INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION 2
I SOFT TISSUE INFECTION NAUSEA 2
I SOFT TISSUE INFECTION VOMITING 2
I TYPE 2 DIABETES MELLITUS ALTERED STATE OF CONSCIOUSNESS 2
I TYPE 2 DIABETES MELLITUS BLOOD SODIUM INCREASED 2
I TYPE 2 DIABETES MELLITUS DRUG INTERACTION 2
I TYPE 2 DIABETES MELLITUS EXTREMITY NECROSIS 2
I TYPE 2 DIABETES MELLITUS INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION 2
I TYPE 2 DIABETES MELLITUS NAUSEA 2
I TYPE 2 DIABETES MELLITUS VOMITING 2
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