Data source

This website gives access to web reports on suspected side effects (also known as adverse drug reactions) by medicine or by active substance name. All the data displayed in the web reports is taken from EudraVigilance, a system designed for collecting reports of suspected side effects, 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).

Here is a list of important facts about the source of the data you can view on this website for each web report:

  • Each individual case in EudraVigilance refers generally to a single patient; an individual case is composed of at least one report, called the initial report, which might be complemented by follow-up reports.
  • A web report shows serious spontaneous cases held in EudraVigilance since the medicine or active substance was authorised for use in the EEA. A case is classified as 'serious' by the reporter when a side effect is one that (i) results in death, (ii) is life-threatening, (iii) requires hospitalisation or prolongation of existing hospitalisation, (iv) results in persistent or significant disability/incapacity (as per reporter's opinion), (v) is a congenital anomaly/birth defect, or (vi) results in some other medically important conditions.
  • A web report shows serious spontaneous cases where an authorised medicine or active substance is suspected by the reporter to have caused or contributed (e.g. by interacting with one or more other medicines) to a serious side effect. Reports where an authorised medicine or active substance is reported as a concomitant medicine are excluded.
  • The figure displayed is always the running total of serious spontaneous cases reported up to the end of the previous month. The figures are updated online on the 15th of the current month.
  • Pharmaceutical companies that hold the marketing authorisation of a medicine, as well as national medicines regulatory authorities, are legally required to submit reports of suspected side effects that occurred in the EEA to EudraVigilance. This includes reports received from healthcare professionals and patients.
  • Pharmaceutical companies that hold the marketing authorisation for a medicine in the EEA are also legally required to submit to EudraVigilance all reports of suspected unexpected adverse reactions that are serious and that occurred in a third country (non-EEA) where they hold a marketing authorisation.
  • The web report does not include reports from studies (e.g. clinical trial, non-interventional study) or other types of reports (i.e. only spontaneous reports).

Each time you search for a web report you will be shown a disclaimer. To view individual reports you must confirm that you have read and understood the disclaimer. You are also provided with important information on how to understand a web report.

 EMA
EudraVigilance