What should I do first if I suspect an adverse drug effect?

Always try to contact your doctor, or another healthcare professional, your pharmacist or your nurse.

If the reaction you experience is severe, or if you fear it can worsen, if you read something about a possible severe reaction in the notice, or if you are anxious for any other reason, always try to contact your doctor, or another healthcare professional. In other words, get help! In some cases you may need to contact the emergency services or go to the nearest emergency unit.

Soon you will see this logo in the package leaflet of some medicines: 

This is what it means: “This medicine is subject to additional monitoring. This is to allow any safety information on the medicine to be identified rapidly. You can help by reporting any side effects you may get“.


Additional monitoring is one of the key public health deliverables of the new pharmacovigilance legislation and a quick uptake of the symbol is considered important in order to achieve its goals. This includes the need to make healthcare professionals and patients aware of the products that are subject to additional monitoring in order to trigger a more targeted supervision of such products and to directly involve patients and health professionals in the reporting of specific observations they notice when using the product.

Without the symbol, healthcare professionals and patients may miss this information. Hence, the symbol is an important communication and awareness-raising tool.

EudraVigilance is a system designed for collecting reports of suspected side effects. These reports are used for evaluating the benefits and risks of medicines during their development and monitoring their safety following their authorisation in the European Economic Area (EEA). It has been in use since December 2001.

The European Database of Suspected Adverse Drug Reactions Reports


Page created: 16/01/2013
Page last updated: 07/11/2014
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