Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Summary of the safety profile

The most commonly reported adverse reactions during treatment are somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema and fatigue.

Tabulated list of adverse reactions

The following adverse reactions have been observed and reported during treatment with amlodipine with the following frequencies: 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 (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
System organ class              Frequency       Adverse reactions
Blood and lymphatic             Very rare       Leukocytopenia, thrombocytopenia system disorders
Immune system                   Very rare       Allergic reactions disorders
Metabolism and                  Very rare       Hyperglycaemia nutrition disorders
Psychiatric disorders           Uncommon        Depression, mood changes (including anxiety), insomnia

Rare            Confusion

Nervous system disorders        Common          Somnolence, dizziness, headache (especially at the beginning of the treatment)
Uncommon        Tremor, dysgeusia, syncope,
hypoaesthesia, paraesthesia
Very rare       Hypertonia, peripheral neuropathy
Not known       Extrapyramidal disorder
Eye disorders                   Common          Visual disturbance (including diplopia) Ear and labyrinth               Uncommon        Tinnitus disorders
Cardiac disorders               Common          Palpitations
Uncommon        Arrhythmia (including bradycardia,
ventricular tachycardia and atrial
                                              fibrillation)
Very rare        Myocardial infarction
Vascular disorders           Common           Flushing
Uncommon         Hypotension
Very rare        Vasculitis
Respiratory, thoracic        Common           Dyspnoea and mediastinal disorders                    Uncommon         Cough, rhinitis


Gastrointestinal             Common           Abdominal pain, nausea, dyspepsia, altered disorders                                     bowel habits (including diarrhoea and constipation)
Uncommon         Vomiting, dry mouth
Very rare        Pancreatitis, gastritis, gingival hyperplasia
Hepatobiliary disorders      Very rare        Hepatitis, jaundice, hepatic enzyme increased*
Skin and subcutaneous        Uncommon         Alopecia, purpura, skin discolouration, tissue disorders                              hyperhidrosis, pruritus, rash, exanthema, urticaria
Very rare        Angioedema, erythema multiforme,
exfoliative dermatitis, Stevens-Johnson syndrome, Quincke oedema,
photosensitivity
Not known        Toxic epidermal necrolysis
Musculoskeletal and          Common           Ankle swelling, muscle cramps connective tissue disorders                    Uncommon         Arthralgia, myalgia, back pain 
Renal and urinary            Uncommon         Micturition disorder, nocturia, increased disorders                                     urinary frequency
Reproductive system and      Uncommon         Impotence, gynaecomastia breast disorders
General disorders and        Very             Oedema administration site          common conditions                   Common           Fatigue, asthenia
Uncommon         Chest pain, pain, malaise
Investigations               Uncommon         Weight increased, weight decreased 

*mostly consistent with cholestasis
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/.