Adverse drug reaction definition

Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

Adverse drug reaction means a noxious and unintended response to a drug, which occurs at doses normally used or tested for the diagnosis, treatment, or prevention of a disease or the modification of an organic function.

Adverse drug reaction or “adverse reaction” means a response to a medicine in humans which is noxious and unintended, including lack of efficacy, and which occurs at doses normally used in man and which can also result from overdose, misuse or abuse of a medicine

Examples of Adverse drug reaction in a sentence

• Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.

• Classifications - Excessive pharmacological effects, secondary pharmacological effects, idiosyncrasy, allergic drug reactions, genetically determined toxicity, toxicity following sudden withdrawal of drugs, Drug interaction- beneficial interactions, adverse interactions, and pharmacokinetic drug interactions, Methods for detecting drug interactions, spontaneous case reports and record linkage studies, and Adverse drug reaction reporting and management.

• Adverse drug reaction reporting systems and communication in pharmacovigilance8.

• Adverse drug reaction and drug interaction monitoring and reporting.

• Examples include, but are not limited to: Needs additional therapy; Unnecessary drug therapy; Dosage too high; Dosage too low; More effective drug available; Adverse drug reaction; or Medication Non-compliance/Non-adherence).

More Definitions of Adverse drug reaction

Adverse drug reaction or “ADR” means a response to any Licensed Product or Demonstration Sample which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or for modification of physiological function.

Adverse drug reaction means an unexpected and untoward reaction to medication.

Adverse drug reaction shall have the meaning as defined in the then-current guidelines and regulations promulgated by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) and shall include any “Adverse Drug Experience” as defined in the then-current 21 CFR Section 314.80.

Adverse drug reaction means a harmful and unintended response by a resident to a drug or combination of drugs which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function; (“réaction indésirable à un médicament”)

Adverse drug reaction means an adverse physical or psychological reaction that is experienced by a person resulting from diagnostic therapeutic agents administered by an optometrist and that occurs within 24 hours after the drug is administered. An adverse drug reaction may be indicated by symptoms that include any of the following:

Adverse drug reaction means any noxious and unintended response to a drug that is caused by the administration of any dose of the drug. (réaction indésirable à une drogue)

Adverse drug reaction means any unexpected, unintended, undesired or excessive response to a drug such that it: