Identified risk

An untoward occurrence for which there is adequate evidence of an association with the medicinal product of interest (see ICH-E2F Guideline, Volume 10 of the Rules Governing Medicinal Products in the EU).

Examples include:

• an adverse reaction adequately demonstrated in non-clinical studies and confirmed by clinical data;
• an adverse reaction observed in well-designed clinical trials or epidemiological studies for which the magnitude of the difference, compared with the comparator group on a parameter of interest suggests a causal relationship;
• an adverse reaction suggested by a number of well-documented spontaneous reports where causality is strongly supported by temporal relationship and biological plausibility, such as anaphylactic reactions or application site reactions (see ICH-E2F Guideline, Volume 10 of the Rules Governing Medicinal Products in the EU).

In a clinical trial, the comparator may be placebo, an active substance or non-exposure.

Adverse reactions included in section 4.8 of the summary of product characteristics (SmPC) are also considered identified risks, unless they are class-related reactions which are mentioned in the SmPC but which are not specifically described as occurring with this product (these would normally be considered as a potential risk)).

See also Risks related to use of a medicinal product, Important identified risk and Important potential risk, Missing information, Unexpected adverse reaction