Adverse Drug Reaction (ADR) Reporting Form

A.Patient Details

Patient initials

Date Of Birth

Weight (kg)

Height (cm)

Gender

Select Male Female

Pregnancy

Select Pregnant Not Pregnant

B. Suspected Drug/s

Suspected Drugs Name

Suspected Manufacturer & Batch No.

Start Date

Dose Route

Purpose Of Use

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

Concomitant Drugs Name

Concomitant Manufacturer & Batch No.

Start Date

End Date

Dose Route

Purpose Of Use

D. Adverse Drug Reaction Description

Adverse event including relevant tests/lab data and dates Other relevant history, including preexisting medical conditions;(Diagnosis, allergies, pregnancy, hepatic, renal etc

Date when event started

Date when event end

E. Action Taken

Action Taken

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

F. Outcome of ADR

Patient

Select Recovered Recovering No improvement Died Unknown

Specific antagonist used

Select No Yes specify

Event reappeared after reintroducing to the suspected drug (Rechallenge)

Select No Yes Not applicable

Event subsided after stopping the suspected drug (Dechallenge)

Select Yes No Unknown

G. Seriousness of ADR

Seriousness Of ADR

Select 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

Reporter Name

Reporter Address

Reporting Date

Email

Phone No

Submit Report