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Glossary

Adverse Drug Reaction (ADR)

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Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients.

Adverse Drug Reaction:

The detection, assessment, understanding and prevention of ADR are the objectives of the Pharmacovigilance.

ADR in the European Union:

  • An ADR is characterized as unintended and noxious responses to a drug and implies a possible causal relationship between the drug and the adverse event. ADR can happen during clinical trials or once the product is on the market.
  • ADR should be distinguished from untoward medical occurrence occurring after drug administration and where a causal relationship between the drug and the medical occurrence is excluded (called. Adverse Event).
  • Non-serious ADRs should be distinguished from the serious ones which can result in death, life-threatening, hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity or congenial anomaly / birth defect.

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