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Adverse Drug Reaction (ADR) Reporting
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