Adverse drug effects monitoring of amlodipine in a tertiary care hospital

M. Venkateswaran, M. Poornima, C. Vinoth Kumar


Background: Amlodipine have been widely used drug for the treatment of Hypertension. It has many beneficial effects and less side effects. But, only very few adverse effects of Amlodipine have been documented and many were not reported. So, this study will bring out the possible adverse effect of Amlodipine.

Methods: This study included 100 patients with hypertension who are taking amlodipine only. Patients who were willing to participate in the study were given a questionnaire containing demographic data and adverse drug profile of amlodipine. The symptoms of adverse drug reaction were documented. They were also asked about the other symptoms they are having, other than the questionnaire. The causality assessment was done by WHO assessment scale and severity by using modified Hartwig seigel severity assessment scale.

Results: This study showed that most of the patients belong to 51-60 years age group. Mostly they were females, and many were having disease for less than a year. Most of the patients developed adverse drug reaction. Many patients had more than one adverse drug reaction. The commonest adverse effect were fatigue, palpitation, dizziness, insomnia, headache, joint pain, light-headedness, somnolence, nausea, flushing abdominal pain, tremor, leg pain, neck pain, back pain and edema. The adverse drug reaction(ADRs) mostly belongs to possible category and were mild.

Conclusions: Most of the patients who were taking amlodipine had atleast one adverse drug reaction during their treatment period. It is mild, needs dose adjustment and healthy life style modification.


Adverse drug reaction, Amlodipine, Causality assessment, Hypertension

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