An unintended reaction to a drug taken at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. In clinical trials, an ADR would include any injuries by overdosing, abuse/dependence, and unintended interactions with other medicinal products.
an undesirable effect, reasonably associated with
an unintended or undesired effect of a drug therapy
An unintended reaction to a drug taken at a normal dose to prevent, diagnose, or treat disease or injury
An undesirable response associated with use of a drug that either compromises therapeutic efficacy, enhances toxicity, or both.
Any unwanted physical or mental state caused as a result of using a drug. Also called a "side effect."
A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. 8
For unapproved medicines: 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 also: Unexpected Adverse Drug Reaction and Serious Adverse Event Therapeutic Goods Administration TGA Guidance on Good Clinical Practice (CPMP/ICH/135/95) Definitions for Adverse Event, Unexpected Adverse Drug Reaction and Serious Adverse Event.
A reaction which is noxious and unintended and which occurs at doses normally used in humans for prevention, the diagnosis or therapy of disease, or for the modification of physiological function. In the case of clinical trials, injuries by overdosing, abuse/dependence and interactions with other medicinal products should be considered as an Adverse Drug Reaction.
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). (ICH)
Any noxious and unintended response associated with the use of a drug In humans. 1. Post-approval: an adverse event that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function. 2. Pre-approval: an adverse event that occurs at any dose and where a causal relationship is at least a reasonable possibility. NOTE: FDA 21CFR 310.305 defines an adverse drug experience to include any adverse event, "whether on not considered to be drug-related." CDISC recognizes that current usage incorporates the concept of causality. [WHO technical Report 498(1972); ICH E2A
An adverse drug reaction (abbreviated ADR) is a term to describe the unwanted, negative consequences sometimes associated with the use of different medications. ADR is a particular type of adverse effect. The term is preferred over the colloquial and imprecise "side effect", as the term "side effect" implies the potential for beneficial consequences, and that the effects are not explained by the pharmacological actions of the drug.