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

G. Seriousness of ADR
H. Reporter Details

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