Drug information for VALTURNA

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL EQ 150MG BASE;160MG Prescription   ALISKIREN HEMIFUMARATE; VALSARTAN aliskiren NOVARTIS 22217
2012-04-27 Letter

2012-04-26 Label

2012-02-07 Label

2012-02-06 Letter

2012-02-06 Label

2012-01-30 Letter

2011-10-20 Label

2011-10-17 Letter

2011-05-05 Letter

2011-05-05 Label

2011-02-14 Letter

2011-02-11 Label

2010-08-10 Label

2010-08-09 Letter

2010-05-06 Review

2010-05-06 Summary Review

2009-10-26 Letter

2009-09-21 Label
TABLET; ORAL EQ 300MG BASE;320MG Prescription  (Reference Drug) ALISKIREN HEMIFUMARATE; VALSARTAN aliskiren NOVARTIS   "

Drug Adverse Effects information for VALTURNA

Role code Indications Reaction # Reports
PS HYPERTENSION HYPERSENSITIVITY 3
PS HYPERTENSION MALAISE 3
PS HYPERTENSION RASH 3
PS HYPERTENSION STEVENS-JOHNSON SYNDROME 3
SS ANXIETY BLOOD PRESSURE FLUCTUATION 8
SS ANXIETY DRUG INEFFECTIVE 8
SS ANXIETY HAEMORRHAGE 8
SS ANXIETY HEAD INJURY 8
SS ANXIETY LOSS OF CONSCIOUSNESS 8
SS ANXIETY ROAD TRAFFIC ACCIDENT 8
SS ANXIETY VERTIGO 8
SS BACK PAIN BLOOD PRESSURE FLUCTUATION 12
SS BACK PAIN DRUG INEFFECTIVE 12
SS BACK PAIN HAEMORRHAGE 12
SS BACK PAIN HEAD INJURY 12
SS BACK PAIN LOSS OF CONSCIOUSNESS 12
SS BACK PAIN ROAD TRAFFIC ACCIDENT 12
SS BACK PAIN VERTIGO 12
SS BLOOD CHOLESTEROL BLOOD PRESSURE FLUCTUATION 4
SS BLOOD CHOLESTEROL DRUG INEFFECTIVE 4
SS BLOOD CHOLESTEROL HAEMORRHAGE 4
SS BLOOD CHOLESTEROL HEAD INJURY 4
SS BLOOD CHOLESTEROL LOSS OF CONSCIOUSNESS 4
SS BLOOD CHOLESTEROL ROAD TRAFFIC ACCIDENT 4
SS BLOOD CHOLESTEROL VERTIGO 4
SS BLOOD PRESSURE BLOOD PRESSURE FLUCTUATION 4
SS BLOOD PRESSURE DRUG INEFFECTIVE 4
SS BLOOD PRESSURE HAEMORRHAGE 4
SS BLOOD PRESSURE HEAD INJURY 4
SS BLOOD PRESSURE LOSS OF CONSCIOUSNESS 4
SS BLOOD PRESSURE ROAD TRAFFIC ACCIDENT 4
SS BLOOD PRESSURE VERTIGO 4
SS IMMUNODEFICIENCY COMMON VARIABLE BLOOD SODIUM DECREASED 1
SS IMMUNODEFICIENCY COMMON VARIABLE BLOOD SODIUM INCREASED 1
SS IMMUNODEFICIENCY COMMON VARIABLE BRONCHITIS 1
SS IMMUNODEFICIENCY COMMON VARIABLE HYPOTENSION 1
SS IMMUNODEFICIENCY COMMON VARIABLE NAUSEA 1
SS SELECTIVE IGA IMMUNODEFICIENCY BLOOD SODIUM DECREASED 1
SS SELECTIVE IGA IMMUNODEFICIENCY BLOOD SODIUM INCREASED 1
SS SELECTIVE IGA IMMUNODEFICIENCY BRONCHITIS 1
SS SELECTIVE IGA IMMUNODEFICIENCY HYPOTENSION 1
SS SELECTIVE IGA IMMUNODEFICIENCY NAUSEA 1
SS THYROID DISORDER BLOOD PRESSURE FLUCTUATION 4
SS THYROID DISORDER DRUG INEFFECTIVE 4
SS THYROID DISORDER HAEMORRHAGE 4
SS THYROID DISORDER HEAD INJURY 4
SS THYROID DISORDER LOSS OF CONSCIOUSNESS 4
SS THYROID DISORDER ROAD TRAFFIC ACCIDENT 4
SS THYROID DISORDER VERTIGO 4
C BLOOD CHOLESTEROL GYNAECOMASTIA 1
C BLOOD CHOLESTEROL HOT FLUSH 1
C BLOOD CHOLESTEROL WEIGHT INCREASED 1
C BLOOD PRESSURE GYNAECOMASTIA 1
C BLOOD PRESSURE HOT FLUSH 1
C BLOOD PRESSURE WEIGHT INCREASED 1
C DIABETES MELLITUS GYNAECOMASTIA 1
C DIABETES MELLITUS HOT FLUSH 1
C DIABETES MELLITUS WEIGHT INCREASED 1
C HYPERTENSION ASTHENIA 2
C HYPERTENSION DIABETES MELLITUS INADEQUATE CONTROL 2
C HYPERTENSION GOITRE 2
C HYPERTENSION HYPONATRAEMIA 2
C HYPERTENSION HYPOTHYROIDISM 2
C HYPERTENSION MUSCLE SPASMS 1
C HYPERTENSION PANCREATITIS ACUTE 2
C HYPERTENSION RENAL FAILURE ACUTE 2
C HYPERTENSION WEIGHT INCREASED 1
C PRODUCT USED FOR UNKNOWN INDICATION ASTHENIA 1
C PRODUCT USED FOR UNKNOWN INDICATION DIABETES MELLITUS INADEQUATE CONTROL 1
C PRODUCT USED FOR UNKNOWN INDICATION GOITRE 1
C PRODUCT USED FOR UNKNOWN INDICATION GYNAECOMASTIA 1
C PRODUCT USED FOR UNKNOWN INDICATION HOT FLUSH 1
C PRODUCT USED FOR UNKNOWN INDICATION HYPONATRAEMIA 1
C PRODUCT USED FOR UNKNOWN INDICATION HYPOTHYROIDISM 1
C PRODUCT USED FOR UNKNOWN INDICATION PANCREATITIS ACUTE 1
C PRODUCT USED FOR UNKNOWN INDICATION RENAL FAILURE ACUTE 1
C PRODUCT USED FOR UNKNOWN INDICATION WEIGHT INCREASED 1
C PROSTATE CANCER GYNAECOMASTIA 1
C PROSTATE CANCER HOT FLUSH 1
C PROSTATE CANCER WEIGHT INCREASED 1
C RHEUMATOID ARTHRITIS DIZZINESS 1
C RHEUMATOID ARTHRITIS FALL 1
C RHEUMATOID ARTHRITIS HYPOTENSION 1
C RHEUMATOID ARTHRITIS OEDEMA PERIPHERAL 1
C TYPE 2 DIABETES MELLITUS ASTHENIA 3
C TYPE 2 DIABETES MELLITUS DIABETES MELLITUS INADEQUATE CONTROL 3
C TYPE 2 DIABETES MELLITUS GOITRE 3
C TYPE 2 DIABETES MELLITUS HYPONATRAEMIA 3
C TYPE 2 DIABETES MELLITUS HYPOTHYROIDISM 3
C TYPE 2 DIABETES MELLITUS PANCREATITIS ACUTE 3
C TYPE 2 DIABETES MELLITUS RENAL FAILURE ACUTE 3
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