What is the Origin of Adverse Drug Reaction (ADR)?

The formal concept of an Adverse Drug Reaction developed alongside the expansion of modern pharmacology and clinical trials in the mid-20th century. The necessity for a standardized, clear definition arose from catastrophic drug-related incidents, such as the thalidomide tragedy, which underscored the critical need for systematic post-market surveillance. This precise clinical terminology provides a regulatory framework for categorizing and reporting unintended drug effects.

What is the Mechanism of Adverse Drug Reaction (ADR)?

ADRs arise from diverse pathophysiological pathways, often categorized as Type A (predictable, dose-dependent exaggerations of the drug's intended action) or Type B (unpredictable, dose-independent reactions like allergies). Within endocrinology, a common mechanism may involve a drug's off-target binding to hormone receptors, interference with enzymatic pathways of hormone synthesis or degradation, or immune-mediated responses that damage endocrine tissue. Understanding the specific underlying mechanism is vital for effective clinical management and preventative prescribing.

Adverse Drug Reaction (ADR) ∞ Area

Adverse Drug Reaction (ADR)

Meaning

An Adverse Drug Reaction (ADR) is a clinically undesirable or harmful response to a medication that occurs at doses normally used in humans for prophylaxis, diagnosis, or therapy. In the hormonal health domain, ADRs can manifest as unexpected endocrine disruptions, such as altered thyroid function, changes in sex hormone metabolism, or hypothalamic-pituitary axis suppression. Recognizing and meticulously documenting these reactions is a fundamental component of pharmacovigilance and patient safety.