Editing Adverse effect (section)

==Classification==
In terms of drugs, adverse events may be defined as: "Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment."<ref name=Defs/>

In [[clinical trial]]s, a distinction
is made between an [[adverse event]] and a [[serious adverse event]]. Generally, any event which causes death, permanent damage, [[Congenital disorder|birth defect]]s, or requires [[hospital]]ization is considered a serious adverse event.<ref>{{cite web|url=https://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm|title=Reporting Serious Problems to FDA - What is a Serious Adverse Event?| author =Office of the Commissioner |website=www.fda.gov|access-date=15 March 2018|url-status=dead|archive-url=https://web.archive.org/web/20180125012750/https://www.fda.gov/Safety/MedWatch/HowToReport/ucm053087.htm|archive-date=25 January 2018}}</ref> The results of trials are often included in the labelling of the medication to provide information both for patients and the prescribing physicians.

The term "life-threatening" in the context of a serious adverse event refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.<ref name=Defs>{{cite web | author=Expert Working Group (Efficacy) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use | title=Guideline for Industry – Clinical safety data management: definitions and standards for expedited reporting. | url=https://www.fda.gov/media/71188/download | date=March 1995 | publisher=FDA Center for Drug Evaluation and Research | url-status=dead | archive-url=https://web.archive.org/web/20090511201723/https://www.fda.gov/cder/guidance/iche2a.pdf | archive-date=May 11, 2009 }}</ref>