Adverse drug experience is the unexpected side effect, injury, toxicity, sensitivity reaction, or unexpected incidence or severity of side effects or any unfavorable and unintended sign, symptom, or disease temporally associated with the use of medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. It also includes failure of a drug product to exhibit expected pharmacological action and abnormal laboratory finding.
According to 21 USCS § 355-1(b)(1), the term "adverse drug experience" means any adverse event associated with the use of a drug in humans, whether or not considered drug related, including:
(A) an adverse event occurring in the course of the use of the drug in professional practice;
(B) an adverse event occurring from an overdose of the drug, whether accidental or intentional;
(C) an adverse event occurring from abuse of the drug;
(D) an adverse event occurring from withdrawal of the drug; and
(E) any failure of expected pharmacological action of the drug.