Which term is used for an ADR that is not described in the product labeling or Investigator's Brochure?

Which term is used for an ADR that is not described in the product labeling or Investigator's Brochure?

• A. Unexpected Adverse Drug Reaction
• B. Not described in labeling or IB
• C. Adverse Event
• D. Serious Adverse Event

Answer: (B)

In pharmacovigilance, an adverse drug reaction is classified as not described in the product labeling or the Investigator’s Brochure when it is not listed in those official references. That criterion is what makes the reaction “not described” or “unlisted,” which is the practical way regulators define an unexpected ADR. This designation is important because it often prompts expedited safety reporting to authorities and the sponsor. So the term that best fits an ADR not described in labeling or IB is the description of that criterion itself—not described in labeling or the Investigator’s Brochure. The other terms describe either broad adverse events in general or focus on seriousness, rather than whether the reaction is previously described in key regulatory documents.

In pharmacovigilance, an adverse drug reaction is classified as not described in the product labeling or the Investigator’s Brochure when it is not listed in those official references. That criterion is what makes the reaction “not described” or “unlisted,” which is the practical way regulators define an unexpected ADR. This designation is important because it often prompts expedited safety reporting to authorities and the sponsor.

So the term that best fits an ADR not described in labeling or IB is the description of that criterion itself—not described in labeling or the Investigator’s Brochure. The other terms describe either broad adverse events in general or focus on seriousness, rather than whether the reaction is previously described in key regulatory documents.