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Serious adverse events

A serious adverse event or reaction is an untoward medical occurrence that is considered to represent a significant hazard to the patient. This definition is derived from regulatory authorities, including the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), and includes events that result in:

  1. Death
  2. Life-threatening (immediately)
  3. Overnight hospitalisation (initial or prolonged)
  4. Requires an intravenous antibiotic/anti-viral/fungal drug
  5. Significant loss of function or disability
  6. Congenital malformation/birth defect
  7. Other medically important event*

Certain adverse events may not necessarily belong to any of these classifications but are still considered medically significant/important and should be considered serious (ie all malignancies).

Help with adverse events and ESIs

If you have any queries related to adverse events of ESIs, our pharmacovigilance team will be happy help you. 

Tel: +44 (0)161 275 1613