SafetyGlossary Term
ICH E2A Section II.A
A response to a medicinal product that is noxious and unintended, where a causal relationship between the product and the adverse event is at least a reasonable possibility.
An adverse drug reaction differs from an adverse event in that it implies a suspected causal relationship between the medicinal product and the observed harm. While adverse events encompass all untoward medical occurrences temporally associated with drug use regardless of causality, adverse drug reactions represent the subset of events where evidence supports a reasonable possibility that the product contributed to or caused the effect. This distinction has significant regulatory implications, as adverse drug reactions trigger different reporting requirements and inform the product's characterized safety profile.
For premarketing clinical trials of investigational products, regulatory guidance defines an adverse drug reaction as any adverse event for which there is a reasonable possibility of a causal relationship with the medicinal product. This determination considers factors such as temporal relationship, known pharmacological properties of the product, biological plausibility, and the results of dechallenge or rechallenge when applicable. For marketed products, the definition expands to include adverse events occurring at any dose used in medical practice, including overdose, off-label use, and medication errors.
The aggregate of adverse drug reactions identified during clinical development and post-marketing surveillance constitutes the product's known safety profile, which forms the basis for labeling and prescribing information. Expected adverse drug reactions are those already identified in the reference safety information, while unexpected reactions represent new information that may require expedited regulatory reporting. Understanding the distinction between adverse events and adverse drug reactions is essential for clinical research professionals involved in safety data collection, assessment, and reporting.
Safety profile characterization
"Based on the Phase III program, the most common adverse drug reactions were headache, nausea, and dizziness, occurring in more than 10% of treated participants and at rates significantly higher than placebo."
Causality determination
"The investigator considered the participant's Stevens-Johnson syndrome to be an adverse drug reaction given the temporal relationship with drug initiation, improvement after discontinuation, and the absence of alternative explanations."
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product.
The strictest warning required by the FDA to appear on prescription drug labeling, alerting prescribers and patients to serious risks that may lead to death or severe injury.
The systematic evaluation of the likelihood that an adverse event was caused by the investigational product or another factor, using established criteria to determine the relationship between exposure and outcome.
A standardized one-page format developed by the Council for International Organizations of Medical Sciences for reporting suspected adverse drug reactions from clinical trials to regulatory authorities.
A specific situation or condition in which a drug, procedure, or treatment should not be used because it may be harmful to the patient.
ICH E2A Section II.A
A response to a medicinal product that is noxious and unintended, where a causal relationship between the product and the adverse event is at least a reasonable possibility.
An adverse drug reaction differs from an adverse event in that it implies a suspected causal relationship between the medicinal product and the observed harm. While adverse events encompass all untoward medical occurrences temporally associated with drug use regardless of causality, adverse drug reactions represent the subset of events where evidence supports a reasonable possibility that the product contributed to or caused the effect. This distinction has significant regulatory implications, as adverse drug reactions trigger different reporting requirements and inform the product's characterized safety profile.
For premarketing clinical trials of investigational products, regulatory guidance defines an adverse drug reaction as any adverse event for which there is a reasonable possibility of a causal relationship with the medicinal product. This determination considers factors such as temporal relationship, known pharmacological properties of the product, biological plausibility, and the results of dechallenge or rechallenge when applicable. For marketed products, the definition expands to include adverse events occurring at any dose used in medical practice, including overdose, off-label use, and medication errors.
The aggregate of adverse drug reactions identified during clinical development and post-marketing surveillance constitutes the product's known safety profile, which forms the basis for labeling and prescribing information. Expected adverse drug reactions are those already identified in the reference safety information, while unexpected reactions represent new information that may require expedited regulatory reporting. Understanding the distinction between adverse events and adverse drug reactions is essential for clinical research professionals involved in safety data collection, assessment, and reporting.
Safety profile characterization
"Based on the Phase III program, the most common adverse drug reactions were headache, nausea, and dizziness, occurring in more than 10% of treated participants and at rates significantly higher than placebo."
Causality determination
"The investigator considered the participant's Stevens-Johnson syndrome to be an adverse drug reaction given the temporal relationship with drug initiation, improvement after discontinuation, and the absence of alternative explanations."
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product.
The strictest warning required by the FDA to appear on prescription drug labeling, alerting prescribers and patients to serious risks that may lead to death or severe injury.
The systematic evaluation of the likelihood that an adverse event was caused by the investigational product or another factor, using established criteria to determine the relationship between exposure and outcome.
A standardized one-page format developed by the Council for International Organizations of Medical Sciences for reporting suspected adverse drug reactions from clinical trials to regulatory authorities.
A specific situation or condition in which a drug, procedure, or treatment should not be used because it may be harmful to the patient.