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
Ads by Google