What is an Adverse Event (side effect)?
An adverse event is a response to a medicinal product which is noxious and unintended and which does not necessarily have a causal relationship (association) with a medicinal product. An adverse event can therefore be any unfavorable and unintended sign (for example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. For Example: A patient suffers from vomiting and had red patches all over his body while taking medicinal product X for leg injury. In this example, vomiting and red patches all over his body are considered as adverse events.
