Adverse Drug Reaction reporting EMA, the European Medicines
Agency, has recently launched a new website giving public access
to the European database of suspected adverse drug reaction
(ADR) reports. The website provides an A-Z list of reports that
have been submitted to EudraVigilance by national medicines
regulatory authorities. The list is classified by product and
substance. For medical translators the new website offers a good
opportunity to brush up on terms and definitions used in ADR
reporting, so the rest of this post is a brief review of ADR
terminology in the form of a Q&A section. What’s an adverse drug
reaction? - An ADR is defined as “a response to a medicinal
product which is noxious and unintended” (Article 1 of Directive
2001/83/EC). - In layman’s terms: a side effect. Are seriousness
and severity the same thing? → No. - Seriousness refers to the
patient outcome. If the ADR results in death or is life-
threatening, it is serious. The antonym is non-serious. -
Severity is the intensity of the r