Unexpected Serious Risk

**Semantic type:** Conceptual Entity

**Definition:** A serious adverse drug experience that is not listed in the labeling of a drug, or that may be symptomatically or pathophysiologically related to an adverse drug experience identified in the labeling, but differs because of greater severity, specificity, or prevalence. [505-1(b) of FD&C Act (21 USC. 355-1(b)

**Synonyms:** - unexpected serious risk