Adverse drug reaction

An Adverse Drug Reaction (ADR) is an unintended and often harmful response to a pharmaceutical product, occurring at doses typically used in clinical practice. These reactions may include side effects, allergies, or other unexpected health issues and are a critical consideration in pharmaceutical safety and clinical research.

Definitions

ICH E6

In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out.

Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting) .

Causality

ADRs are typically assessed for causality, meaning they are considered to be a result of the drug.

Links to this page

• ADR (redirect page) ‎ (← links)
• Standard operating procedures ‎ (← links)
• Adverse Drug Reaction (redirect page) ‎ (← links)
  • Serious adverse event (serious adverse drug reaction) ‎ (← links)
  • Glossary:Adverse Drug Reaction (redirect page) ‎ (← links)
• Unexpected adverse drug reaction ‎ (← links)