Adverse reactions : תופעות לוואי

4.8 Undesirable effects

In controlled clinical studies in adult patients with hypertension, the overall incidence of adverse drug reactions (ADRs) was comparable with placebo and is consistent with the pharmacology of valsartan. The incidence of ADRs did not appear to be related to dose or treatment duration and also showed no association with gender, age or race.

The ADRs reported from clinical studies, post-marketing experience and laboratory findings are listed below according to system organ class.

Adverse Drug reactions

Adverse reactions are ranked by frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (frequency cannot be estimated from the available data).
Within each frequency grouping, adverse drug reactions are ranked in order of decreasing seriousness.
For all the ADRs reported from post-marketing experience and laboratory findings, it is not possible to apply any ADR frequency and therefore they are mentioned with a “not known” frequency.
Hypertension
Blood and lymphatic system disorders

Not known                                    Decrease in haemoglobin, Decrease in haematocrit, Neutropenia,
Thrombocytopenia

Immune system disorders

Not known                                    Hypersensitivity including serum sickness 
Metabolism and nutrition disorders

Not known                                    Increase of serum potassium, hyponatraemia

Ear and labyrinth disorders

Uncommon                                     Vertigo


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Vascular disorders

Not known                                    Vasculitis

Respiratory, thoracic and mediastinal disorders
Uncommon                                     Cough

Gastrointestinal disorders

Uncommon                                     Abdominal pain
Hepato-biliary disorders

Not known                                    Elevation of liver function values including increase of serum bilirubin

Skin and subcutaneous tissue disorders

Not known                                    Angioedema, Dermatitis bullous, Rash, Pruritus

Musculoskeletal and connective tissue disorders

Not known                                    Myalgia
Renal and urinary disorders

Not known                                    Renal failure and impairment, Elevation of serum creatinine

General disorders and administration site conditions

Uncommon                                     Fatigue
The safety profile seen in controlled-clinical studies in adult patients with post- myocardial infarction and/or heart failure varies from the overall safety profile seen in hypertensive patients. This may relate to the patients underlying disease. ADRs that occurred in adult patients with post-myocardial infarction and/or heart failure patients are listed below.

Post-myocardial infarction and/or heart failure (studied in adult patients only) 
Blood and lymphatic system disorders

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Not known                               Thrombocytopenia

Immune system disorders
Not known                               Hypersensitivity including serum sickness 
Metabolism and nutrition disorders

Uncommon                                Hyperkalaemia
Not known                               Increase of serum potassium, hyponatraemia

Nervous system disorders

Common                                  Dizziness, Postural dizziness 
Uncommon                                Syncope, Headache

Ear and labyrinth disorders
Uncommon                                Vertigo

Cardiac disorders

Uncommon                                Cardiac failure
Vascular disorders

Common                                  Hypotension, Orthostatic hypotension 
Not known                               Vasculitis

Respiratory, thoracic and mediastinal disorders
Uncommon                                Cough

Gastrointestinal disorders

Uncommon                                Nausea, Diarrhea
Hepato-biliary disorders


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Not known                                   Elevation of liver function values 
Skin and subcutaneous tissue disorders

Uncommon                                    Angioedema
Not known                                   Dermatitis bullous, Rash, Pruritus 
Musculoskeletal and connective tissue disorders

Not known                                   Myalgia
Renal and urinary disorders

Common                                      Renal failure and impairment 
Uncommon                                    Acute renal failure, Elevation of serum creatinine

Not known                                   Increase in Blood Urea Nitrogen 
General disorders and administration site conditions

Uncommon                                    Asthenia, fatigue 

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il