Table 5.

Causality assessment criteria.

Criterion	Level
The context of administration and use of medicines is reasonable.	Certain, Probable, Possible
It is not described as another medication, chemical, or accompanying illness.	Certain, Probable
In case of administration interruption, there is a clinically reasonable response.	Certain, Probable
In case of readministration, there is a pharmacologically conclusive response.	Certain
It could be described as another medication, chemical, or accompanying illness.	Possible, Unlikely
It is a temporary condition, not related to the administration and use of medicines.	Unlikely
It requires more information to assess or it is under examination.	Unclassified
It is not assessable and cannot be supplemented.	Unassessable