Amlodipine is well tolerated. In placebo controlled clinical trials involving patients with hypertension or angina, the most commonly observed side effects were: Vascular Disorders: Flushing.
Nervous System Disorders: Dizziness, headaches, somnolence.
Gastrointestinal Disorders: Abdominal pain, nausea.
Cardiac Disorders: Palpitations.
General Disorders and Administration Site Conditions: Fatigue, oedema.
In these clinical trials no pattern of clinically significant laboratory test abnormalities related to amlodipine has been observed.
Less commonly observed side effects in marketing experience include: General Disorders and Administrative Site Conditions: Asthenia, malaise, pain.
Investigations: Weight increased/decreased.
Nervous System Disorders: Hypertonia, hypoaesthesia/paraesthesia, peripheral neuropathy, syncope, dysgeusia, tremor, extrapyramidal disorder.
Reproductive System and Breast Disorders: Gynaecomastia, erectile dysfunction.
Gastrointestinal Disorders: Change in bowel habits, dry mouth, dyspepsia (including gastritis), gingival hyperplasia, pancreatitis, vomiting.
Metabolism and Nutrition Disorders: Hyperglycemia.
Musculoskeletal and Connective Tissue Disorders: Arthralgia, back pain, muscle spasms, myalgia.
Blood and Lymphatic System Disorders: Leukopenia, thrombocytopenia.
Psychiatric Disorders: Insomnia, mood altered.
Respiratory, Thoracic and Mediastinal Disorders: Coughing, dyspnoea, rhinitis.
Skin and Subcutaneous Tissue Disorders: Alopecia, hyperhidrosis, purpura, skin discoloration, urticaria.
Ear and Labyrinth Disorders: Tinnitus.
Renal and Urinary Disorders: Pollakiuria, micturition disorder, nocturia.
Vascular Disorders: Hypotension, vasculitis.
Eye Disorders: Visual impairment.
Rarely reported events were allergic reaction including pruritus, rash, angioedema, and erythema multiforme.
Hepatitis, jaundice and hepatic enzyme elevations have also been reported very infrequently (mostly consistent with cholestasis). Some cases severe enough to require hospitalization have been reported in association with use of amlodipine. In many instances, causal association is uncertain.
As with other calcium channel blockers the following adverse events have been rarely reported and cannot be distinguished from the natural history of the underlying disease: myocardial infarction (MI), arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation) and chest pain.