An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). Meaning of Adverse Reaction. Adverse reaction definition at Dictionary.com, a free online dictionary with pronunciation, synonyms and translation. adverse drug reaction (ADR), "a response to a drug which is noxious and unintended and which occurs at doses normally used in man [sic] for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function." Shocking number of allergic reactions . The onset of the adverse reaction may be sudden or develop over time. While sometimes used interchangeably with side effects, the term side effect often refers to effects that are minor or confer less harm. An adverse reaction is an unexpected negative reaction to a medication or treatment that is used in an approved manner. Clinical findings Change in food or liquid consumption, body or organ weight, enzyme activity, visible illness or death. Definition of Adverse Reaction in the Definitions.net dictionary. Adverse reaction WHO, (1972) • '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 modifications of physiological function'. [International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use.]

An adverse drug reaction (ADR) is an injury caused by taking medication. 1.1 Adverse Drug Reaction (ADR) 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. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs.

“Observed” refers to a newly noted adverse outcome, typically within the past 3 months. Information and translations of Adverse Reaction in the most comprehensive dictionary definitions resource on the web.

Als Suspected Unexpected Serious Adverse Reaction (SUSAR) oder auch als Verdachtsfall einer Unerwarteten Schwerwiegenden Nebenwirkung bezeichnet man ein unerwünschtes Ereignis in einer klinischen Prüfung, das unerwartet und schwerwiegend ist sowie zugleich vermutlich in einem ursächlichen Zusammenhang mit einem Prüfpräparat steht und demnach eine Nebenwirkung …

Adverse events cause functional or anatomic damage, irreversible changes in homeostasis, or increased susceptibility to other chemical or biologic stress.