SUSPECTED ADVERSE REACTIONS FORM
Saving Lives Through Vigilant Reporting
For BFAD use only
All reports are confidential.
AER No. _________________________
Date received: _____________________
Patient Particulars
Patient's Surname_ __________________________________________________________________________________________
First Name __________________________________________________________________________________________________
Age _________
Date of Birth (mm/dd/yyyy) ___________________ Sex:  Male  Female
Weight _________Kg
Ethnic group:  Filipino  Chinese  Amerasian
Contact Number________________________________
 Other (please specify) : ________________________
Details of the Adverse Reaction
Date of onset: ______________________
mm/dd/yyyy
Outcome:
 Recovered (Date of recovery):___________________
 Unrecovered
 Fatal (Date of death):______________________
 Unknown
Sequela/e (any permanent complications or injuries as a result of the ADR):
Time:_________AM
___________PM
 Yes (Please specify)_________________________
 No
 Unknown
Describe the reaction/s:________________________________________________________________________________________________
____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________
Suspected drug product(s)
Indicate brand name
Dose
Frequency
Route
Date
started
Date
stopped
List all other drug/s taken at the same time and/ or 3 months before
Brand name of the drug
Dose
Frequency
Route
Reason (s) for
using the product
Manufacturer:
Include: Batch/Lot
#
No Other drug/s taken
Date
started
Date
stopped
Reason/s for using
the drug
Manufacturer/Bat
ch & Lot No.
MANAGEMENT OF ADVERSE REACTION
Hospitalization (following the ADR):
 Yes

No
 Already hospitalized before ADR occurred
Do you consider the reaction to be serious?
 Yes

No
If yes, please indicate why the reaction is considered to be serious (please tick ✓ all that apply):
 Patient died due to reaction
 Involved or prolonged in-patient hospitalization
 Life threatening
 Involved persistent or significant disability or incapacity
 Congenital anomaly
 Other outcome, please give details: _____________________________________
Treatment given:  Yes
 No (If yes, please specify): ________________________________________________________________
REPORTER’S PARTICULARS
Printed Name of Reporter:
Signature of reporter:
Date reported (dd/mm/yr):
Contact no:_________________________________________
Email address: ______________________________________
Profession: __MD ___ RPh ___RN___ Patient ____Others
Send completed form to: The ADR Unit, BFAD, Civic Drive, Filinvest Estate, Alabang, Muntinlupa 1781. Or fax to: (02) 807-85-11, c/o The
ADR Unit. Remaining sample of the drug can be sent to BFAD for analysis.
National Pharmacovigilance Center
“Saving lives through Vigilant Reporting”
Bureau of Food and Drugs
Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City
www. bfad.gov.ph