Pharmacovigilance Open Access

Although somewhat intuitive, there are a set of criteria within pharmacovigilance that are used to distinguish a serious adverse event from a non-serious one. An adverse event is considered serious if it meets one or more of the following criteria:   ·         results in death, or is life-threatening; ·         requires inpatient hospitalization or prolongation of existing hospitalization; ·         results in persistent or significant disability or incapacity; ·         results in a congenital anomaly (birth defect); or ·         is otherwise "medically significant" (i.e., that it does not meet preceding criteria, but is considered serious because treatment/intervention would be required to prevent one of the preceding criteria.