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 reactions are ranked in order of decreasing seriousness.
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.
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.
Paediatric population: With the exception of isolated gastrointestinal disorders (like abdominal pain, nausea, vomiting) and dizziness, no relevant differences in terms of type, frequency and severity of adverse reactions were identified between the safety profile for paediatric patients aged 6 to 18 years and that previously reported for adult patients.
Hyperkalaemia was more frequently observed in children and adolescents aged 6 to 18 years with underlying chronic kidney disease.
Post-myocardial infarction and/or heart failure (studied in adult patients only): Blood and lymphatic system disorders: 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, diarrhoea.
Hepato-biliary disorders: 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.