Expected Adverse Drug Reaction

An Expected Adverse Drug Reaction pertains to an adverse event resulting from drug usage, wherein its nature and severity align with the details outlined in the pertinent reference safety information. This information could encompass various sources, such as the Investigator’s brochure for an investigational product that hasn’t gained approval, or the package insert/summary of product characteristics for an already approved pharmaceutical product.

In essence, an expected adverse drug reaction is one that is anticipated based on the documented safety profile of the drug as outlined in authorized references.