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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