Causality assessment and examples of adverse drug reactions (drug-induced liver injury, renal, skin, and major adverse cardiac events)

An adverse drug reaction is a side effect for which the cause can be directly attributed to a drug and its physiologic properties. The ability to discern if a side effect is truly caused by a specific drug or is confounded by the patient’s concurrent medical condition(s) and/or concomitant medications is an art based on the totality of the available evidence combined with a systematic approach. In addition to an introduction to the methodology for evaluating causality, this chapter focuses on the evaluation of side effects seen in commonly affected organs/organ systems (the liver, kidney, skin, and cardiovascular system) and highlights the factors that may need to be considered within these areas to determine a causal relationship. Examples of common drug-induced reactions in these organ systems are also provided to demonstrate the process of assessing such reactions.