Apo-Amlodipine Adverse Reactions





Full Prescribing Info
Adverse Reactions
Amlodipine is well tolerated. In placebo controlled clinical trials involving patients with hypertension or angina, the most commonly observed side effects were:
Autonomic Nervous System: flushing.
Body As A Whole: fatigue.
Cardiovascular, General: edema.
Central & Peripheral Nervous System: dizziness, headache.
Gastrointestinal: abdominal pain, nausea.
Heart Rate/Rhythm: palpitations.
Psychiatric: somnolence.
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: Autonomic Nervous System: dry mouth, increased sweating.
Body As A Whole: asthenia, back pain, malaise, pain, weight increase/decrease.
Cardiovascular, General: hypotension, syncope.
Central & Peripheral Nervous System: hypertonia, hypoesthesia/paresthesia, peripheral neuropathy, tremor.
Endocrine: gynecomastia.
Gastrointestinal: altered bowel habits, dyspepsia (including gastritis), gingival hyperplasia, pancreatitis, vomiting.
Metabolic/Nutritional: hyperglycemia.
Mucoskeletal: arthralgia, muscle cramps, myalgia.
Platelet/Bleeding/Clotting: purpura, thrombocytopenia.
Psychiatric: impotence, insomnia, mood changes.
Respiratory: coughing, dyspnea, rhinitis.
Skin/Appendages: alopecia, skin discolouration, urticaria.
Special Senses: taste perversion, tinnitus.
Urinary: increased urinary frequency, micturition disorder, nocturia.
Vascular (extracardiac): vasculitis.
Vision: visual disturbances.
White Blood Cell/R.E.S: leucopenia.
Rarely, allergic reactions 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 the 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, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation) and chest pain.
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