Definition

The discontinuation or dose reduction of a suspected drug following an adverse event, with observation of whether the reaction improves or resolves.

Example

A patient's drug-induced hepatitis (elevated liver enzymes) resolved after stopping the suspect medication. This positive dechallenge supports the causal relationship between drug and event.

Regulatory source

ICH E2A, Naranjo Algorithm

Common mistakes

Recording dechallenge as 'positive' simply because the drug was stopped, without documenting whether the event actually improved.

Inspector question

How do you document and differentiate between positive, negative, and unknown dechallenge outcomes?

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