Findings Suggestive of Possible Adverse Drug Reaction

Did the signs and symptoms of the reaction disappear after discontinuation of the drug?

Did re-exposure to the drug result in reappearance or worsening of the signs and symptoms?

Is the adverse reaction understandable based on the drug's mechanism of drug action or pharmacology?

Have similar adverse reaction been described for the drug or for other drugs in the same class?

Has the same adverse reaction been caused by the drug during in vitro or animal studies?

Has the adverse reaction followed the typical onset pattern for the type of injury suspected?

Is there any other condition or finding that could explain the findings better?

Were there any signs or symptoms of the condition prior to starting the drug?