Nosebleeds associated with amlodipine use

Netherlands Pharmacovigilance Centre Lareb received 8 reports of nosebleeds associated with the use of amlodipine. In most cases, the nosebleeds started within a few days after start of amlodipine. After discontinuation of amlodipine, the patients recovered. 

Amlodipine is a calcium channel antagonist, indicated for hypertension, chronic stable angina pectoris and vasospastic angina. Nosebleeds are not mentioned in the Dutch Summary of Product Characteristics (SPC) of amlodipine. It is however mention in the US SPC, and also in the Dutch SPC of nifedipine, which is also a calcium channel antagonist, structurally related to amlodipine. 

The Dutch Medicines Evaluation Board will ask the Marketing Authorization Holders of amlodipine to monitor for nosebleeds in the next periodic safety update reports (PSUR). 

Read the analysis of the reports.