Ambesyl Adverse Reactions

Summary of the safely profile: The most commonly reported adverse reactions during treatment are somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema and fatigue.
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.
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.
Not known: Extrapyramidal disorder.
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.
Not known: 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.