definiens: or means any unfavora ble and unintended change in the structure, function, or chemistry of the body temporally assoc iated with any use of a product or of a derivative thereof containing API, whether or not the adverse experience is considered to be related to the use o f such product, including but not limited to any of t he following : an unexpected side effect, injury, toxicity or sensitivity reaction, which may include an experience of unexpected incidence and severity ; an adverse [ * ] CONFIDENTIAL TREATMENT REQUESTED experience occurring in the course of the use of a drug product in professional practice ; an adverse experience occurring in clinical studies ; an advers e experience occurring from drug overdose, whether accidental or intentional ; an adverse experience oc curring from drug abuse ; an adverse experience occurring from drug withdrawal ; and any significant failure of expected pharmacological action ; but in any event shall mean adverse drug experiences, as defin ed by 21 CFR Section 314.80