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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).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness:
| System organ class | Frequency | Adverse reactions |
| Blood and lymphatic system disorders | Very rare | Leukocytopenia, thrombocytopenia |
| Immune system disorders | Very rare | Allergic reactions |
| Metabolism and nutrition disorders | Very rare | Hyperglycaemia |
| 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 | |
| Eye disorders | Common | Visual disturbance (including diplopia) |
| Ear and labyrinth disorders | Uncommon | Tinnitus |
| 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 and mediastinal disorders | Common | Dyspnoea |
| Uncommon | Cough, rhinitis | |
| Gastrointestinal disorders | Common | Abdominal pain, nausea, dyspepsia, altered 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 tissue disorders | Uncommon | Alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, rash, exanthema, urticaria |
| Very rare | Angioedema, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke oedema, photosensitivity | |
| Unknown | Toxic Epidermal Necrolysis | |
| Musculoskeletal and connective tissue disorders | Common | Ankle swelling, muscle cramps |
| Uncommon | Arthralgia, myalgia, back pain | |
| Renal and urinary disorders | Uncommon | Micturition disorder, nocturia, increased urinary frequency |
| Reproductive system and breast disorders | Uncommon | Impotence, gynaecomastia |
| General disorders and administration site conditions | Very common | Oedema |
| Common | Fatigue, asthenia | |
| Uncommon | Chest pain, pain, malaise | |
| Investigations | Uncommon | Weight increased, weight decreased |
*mostly consistent with cholestasis
Exceptional cases of extrapyramidal syndrome have been reported.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Product Categories : Finished Drugs > Cardiovascular & Urine Drugs
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