Definition

An adverse event whose nature, severity, specificity, or outcome is not consistent with the applicable reference safety information for the product.

Example

If the label mentions 'transaminase elevation' but a patient develops fulminant hepatic failure, the severity exceeds what is described, making this unexpected.

Regulatory source

21 CFR 312.32, ICH E2A

Common mistakes

Only comparing event terms literally. Expectedness also considers severity, specificity, and outcome beyond simple term matching.

Inspector question

How do you assess expectedness for terms that are similar but not identical to label language?

Related terms