Unexpected adverse reaction is an adverse reaction of the body (including, but not limited to those caused by the use of a medicinal product in compliance with the Package Leaflet thereof), the essence and severity of which does not correspond to the information on the medicinal product provided in the Package Leaflet

Source: Russian Federation Law №61-FZ March 24, 2010 "On Circulation of Medicines"

Unexpected adverse reaction: An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics.

Source: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use