In terms of drugs,<unk>  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.” In clinical trials, a distinction is made between an<unk>  event and a serious<unk>  event. Generally, any event which causes death, permanent damage, birth defects, or requires hospitalization is considered a serious<unk>  event. 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<unk>  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.
Adverse effect
Side effect
Idiosyncrasy
Side Effect
Therapeutic inertia
Toxicity
Incident stress
Acute toxicity