Table 1 ADR Definitions

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