What is an Adverse Event?
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have to have a casual relationship with this treatment.
An adverse event (AE) can therefore be described as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
EMA 2006 Guideline on good pharmacovigilance practices (GVP) – Annex I (Rev 3) EMA/876333/2011 Rev 3
What is an Adverse Reaction?
This is a response to a medicinal product that is noxious and unintended. This includes adverse reactions which arise from:
- the use of a medicinal product within the terms of the marketing authorisation
- the use outside the terms of the marketing authorisation, including overdose, off-label use, misuse, abuse and medication errors.
(Regulation (EU) 1235/2010, Directive 2010/84/EU)
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