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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B. Suspected Drug/s

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

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D. Adverse Drug Reaction Description

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E. Action Taken

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

F. Outcome of ADR

G. Seriousness of ADR

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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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