1 | Known adverse drug reaction, toxic reaction, response to omission of therapy or inadequate therapy |
2 | Reasonable temporal relationship between commencement or cessation/omission of therapy and onset of problem |
3 | Risk of further problems likely to be reduced by dose reduction or increase, discontinuation, closer monitoring or commencement of therapy |
4 | Not explained by any other known condition of predisposition to the patient, or This condition/predisposition is likely to be exacerbated by the presence/absence of the drug |
5 | For drug toxicity: |
Symptoms reappeared upon re-exposure | |
Laboratory tests showed toxic drug levels or drug-induced metabolic disturbances that explained the symptom | |
Symptoms resolved on dose reduction or discontinuation of the drug | |
For drug omission: | |
Symptoms resolved upon re-introduction of the drug or dose increase |
If five criteria fulfilled, then definite. If four criteria fulfilled, then probable. If three criteria fulfilled, then possible. If two or fewer criteria fulfilled, then either not drug-related or unevaluable.