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Table 1 ADR Definitions

From: Consumers of natural health products: natural-born pharmacovigilantes?

Term Definition
Adverse Drug Reaction (ADR) A noxious and unintended response to a drug, and which occurs at doses normally used in persons for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.
Suspected ADR An adverse event that for which there is a suspicion of a causal relationship with a drug
Adverse event/experience Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment.
Serious ADR Fatal, life threatening (such as liver failure, abnormal heart rhythms, certain types of allergic reactions), result in persistent or significant disability or incapacity, require or prolong hospitalization, are congenital anomalies or birth defects, or are otherwise medically important.
Severe ADR Severity describes the intensity of the adverse event or ADR. A severe ADR (e.g., a severe headache) is not necessarily a serious ADR
  1. • World Health Organization Upsalla Monitoring Centre: The Global Intelligence Network for Benefits and Risk in Medicinal Products http://www.who-umc.org/ Accessed on: Feb 8, 2010
  2. • World Health Organization: Note for guidance on clinical safety data management: definitions and standards for expedited reporting. 1995.