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pharmacovigilance report

Adverse Drug Reaction (ADR)

Is a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility

Serious adverse reaction; is an adverse reaction which :

  • Results in death,
  • Is life-threatening,
  • Requires in-patient hospitalization or prolongation of existing hospitalization
  • Is a congenital anomaly/birth defect

Adverse Drug Reaction (ADR) Reporting Form

    A. Patient Details

       
       

    B. Suspected Drug/s

       
       

    C. Concomitant Drug/s (Exclude Those Used To Treat Reaction)

       
       
       

    D. Adverse Drug Reaction Description

       

       

    E. Action Taken

    F. Outcome of ADR

    Patient*

    Event subsided after stopping the suspected drug (Dechallenge)

    Event reappeared after reintroducing to the suspected drug (Rechallenge)

    Specific antagonist used

    G. Seriousness of ADR

    H. Reporter Details