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Synonyms: Adverse drug reaction (ADR), Suspected adverse (drug) reaction or serious adverse reaction (SAR), Adverse effect, Undesirable effect (see EMA GVP Module Annex 1 Definitions).

For pre-approval (i.e., not yet marketed, experimental) products, the definition is as follows:

“All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions.” This means “that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out.” (ICH E2A)

For post-approval (i.e., marketed) products, the definition is as follows:

“A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function.” (ICH E2A)

EMA (GVP Module Annex I Definitions): A response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an AE is at least a reasonable possibility (see GVP Annex I). An adverse reaction, in contrast to an AE, is characterized by the fact that a causal relationship between a medicinal product and an occurrence is suspected. For regulatory reporting purposes, if an event is spontaneously reported, even if the relationship is unknown or unstated by the healthcare professional or consumer as the primary source, it meets the definition of an adverse reaction.

Therefore, all spontaneous reports notified by healthcare professionals or consumers are considered suspected adverse reactions, since they convey the suspicions of the primary source, unless the primary source specifically states that they believe the event to be unrelated or that a causal relationship can be excluded.