Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Frequency is defined using the following convention: common (> 1/100, < 1/10), uncommon (> 1/1,000, < 1/100), rare (> 1/10,000, < 1/1,000) and very rare (< 1/10,000). Undesirable effects reported for captopril and/or ACE inhibitor therapy include:
Blood and lymphatic disorders:
Very rare: neutropenia/agranulocytosis (see section 4.4), pancytopenia particularly in patients with renal dysfunction (see section 4.4), anaemia (including aplastic and haemolytic), thrombocytopenia, lymphadenopathy, eosinophilia, auto-immune diseases and/or positive ANA- titres.
Metabolic and nutritional disorder:
Rare: Anorexia
Very rare: hyperkalaemia, hyponatremia and hypoglycaemia (see section 4.4) Psychiatric disorders:
Common: sleep disorders
Very rare: confusion, depression.
Nervous system disorders:
Common: reversible and self-limiting taste impairment and dizziness.
Uncommon: paraesthesia, headache.
Rare: Somnolence
Very rare: cerebrovascular incidents, including stroke and syncope.
Eye disorders:
Very rare: blurred vision.
Cardiac disorders:
Uncommon: tachycardia or tachyarrhythmia, angina pectoris, palpitations.
Very rare: cardiac arrest, cardiogenic shock
Vascular disorders:
Uncommon: hypotension (see section 4.4), Raynaud syndrome, flush, pallor Respiratory, thoracic and mediastinal disorders:
Common: dry, irritating (non-productive) cough (see section 4.4) and dyspnoea Vary rare: bronchospasms, rhinitis, allergic alveolitis/ eosinophilic pneumonia.
Gastrointestinal disorders:
Common: nausea, vomiting, epigastric discomfort, abdominal pain, diarrhoea, constipation, dry mouth, peptic ulcer, dyspepsia.
Rare: stomatitis/aphthous stomatitis, small bowel angioedema (see section 4.4) Very rare: glossitis, pancreatitis.
Hepato-biliary disorders:
Very rare: hepatic function abnormal, cholestasis, jaundice, hepatitis, hepatic necrosis, hepatic enzyme increased, blood bilirubin increased, transaminase increased, blood alkaline phosphatase increased.
Skin and subcutaneous tissue disorders:
Common: pruritus with or without a rash, rash, and alopecia.
Uncommon: angioedema (see Section 4.4)
Very rare: urticaria, Stevens Johnson syndrome, erythema multiforme, photosensitivity, erythroderma, pemphigoid reactions and exfoliative dermatitis.
Musculoskeletal, connective tissue and bone disorders:
Very rare: myalgia, arthralgia.
Renal and Urinary Disorders:
Rare: renal impairment, renal failure, polyuria, oliguria, pollakiuria.
Very rare: nephrotic syndrome.
Reproductive system and breast disorders:
Very rare: erectile dysfunction, gynaecomastia.
General disorders and administration site conditions:
Uncommon: chest pain, fatigue, malaise, asthenia
Very rare: pyrexia
Investigations: very rare: proteinuria, eosinophilia, blood potassium increased, blood sodium decreased, blood urea increased, blood creatinine increased, blood bilirubin increased, haemoglobin decreased, haematocrit decreased, white blood cell count decreased, platelet count decreased, antinuclear antibody positive, red blood cell sedimentation rate increased.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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