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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

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The field is required male female

B. Suspected Drug/s

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C. Concomitant Drug/s (Exclude those used to treat reaction)

D. Adverse Drug Reaction Description

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E. Action Taken

Drug discontinued Dose reduced Dose increased Dose not changed Unknown Not applicable

F. Outcome of ADR

The patient:

Recovered Recovering No improvement Died Unknown

Event subsided after stopping the suspected drug (Dechallenge)

No Yes Unknown

Event reappeared after reintroducing to the suspected drug (Rechallenge)

No Yes Not applicable

Specific antagonist used

No Yes specify:

G. Seriousness of ADR
The field is required Patient died Life threatening Hospitalization Permanent disability Congenital anomaly Prolonged hospitalization more than 24 hr. Required intervention to prevent permanent impairment/damage None of the above (Not serious)
H. Reporter Details

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