Tolerability of Amlodipine

Abstract

We examined the tolerability and safety of amlodipine in a large population of patients (n = 12831) by performing a meta-analysis of 16 consecutive studies in which this drug was used for treatment of hypertension (n = 9638; 75%) or ischaemic heart disease (n = 3193; 25%) and data were standardised and referred to a central core laboratory. Adverse events were reported by patients in response to an open questionnaire and completed at standardised times after starting amlodipine.Overall, the percentage of patients who experienced amlodipine-related adverse effects was about 15%, and only 3% of patients were withdrawn from amlodipine therapy because of drug intolerance.Four adverse events (peripheral oedema, headache, flushing and altered heart rate) occurred in I % or more of amlodipine recipients; these are typical of dihydropyridines and are predominantly related to arteriolar vasodilation.Rare adverse events attributable to idiosyncratic or allergic response (skin rash) were reported.Other adverse events (gastrointestinal disorders, tremor, polyuria, cough, etc.) were ill defined, and their nature was unclear.Finally, the percentage of patients with amlodipine-related adverse effects was not influenced by drug dosage or disease status, and a comparison of amlodipine's tolerability with that of alternative calcium antagonists, P-blockers or ACE inhibitors showed a significantly lower occurrence (17 .3 vs 39 .7% of patients, p < 0.00 I).

Uncommon Adverse Drug Reaction of Amlodipine

“…According to prolonged experience of use of amlodipine and various literature <1% to 1% patient show uncommon or rare type of adverse drug reaction along with very common one and amlodipine is required to withdraw in about 3% of the patients. 6 In this case study, patient recovered completely from rash and 90-95% in peripheral neuropathy/paraesthesia by cessation of amlodipine.…”

“…Idiosyncratic or allergic response (skin rash) and intolerance 5,6 are rare adverse effects seen with amlodipine recipients. Although, these are not very serious clinical problem and also reversible, oedema is reduced by the coprescription of diuretic or oedema and other adverse effects can also be relieved after withdrawal amlodipine.…”

Effect of dihydropyridine calcium channel blockers on blood pressure variability in the SPRINT trial: a treatment effects approach

“…One potential explanation for our finding is that the half-life of oral amlodipine is 40-60 h [46], which would allow for a very stable steady state of antihypertensive medication, despite occasional missed or mistimed doses. Amlodipine is inexpensive, effective at reducing mean blood pressure, has few drug-drug interactions, and is well tolerated [47,48]. SPRINT participants were on a variety of other classes of antihypertensive treatment, as seen in Fig.…”

Amlodipin versus Nifedipin retard Eine randomisierte Doppelblindstudie zum Vergleich der Langzeitwirksamkeit und Verträglichkeit von Amlodipin und Nifedipin retard in der Monotherapie der chronisch stabilen Angina pectoris

“…Bei der Dosierung ergaben sich Vorteile für Amlodipin: 79,5% der Amlodipinpatienten waren mit der Initialdosis von 5 [15].…”