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. Additional data outputs are line listings individual case report forms.
All the data displayed in the web reports, line listings and individual case report forms 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, including a line listing or an ICSR form, shows side effects related to spontaneous cases held in EudraVigilance since the medicine or active substance was authorised for use in the EEA.
  • A spontaneous case can refer to serious and/or non-serious side effects. A side effect is classified as 'serious' or ‘non-serious’ 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 the event.
  • A side effect is classified as 'serious' if it (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.
  • Reports where medicines or active substances are reported as a concomitant medicine are excluded.
  • The figure displayed is always the running total of serious/non-serious side effects reported up to the end of the previous week. The figures are updated online every Monday.
  • Pharmaceutical companies that hold the marketing authorisation of a medicine, as well as medicines regulatory authorities in the EEA, are legally required to submit reports of suspected side effects to EudraVigilance. This includes reports received from healthcare professionals and patients. This excludes non-serious side effects occurring outside the EEA.
  • 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).
  • A line listing provides an overview of individual cases related to a particular medicine/active substance and associated suspected side effects in tabular format and in compliance with EU personal data protection legislation.
  • An ICSR form presents reported information on a specific case in a user friendly format in compliance with EU personal data protection legislation.

Each time you search for a web report, including a line listing or an ICSR form, 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