SUSPECTED ADVERSE REACTIONS FORM v 5 (4/2012)
Saving Lives Through Vigilant Reporting
*FIELDS MUST BE COMPLETED.
PATIENTS PARTICULARS
For FDA use only
All reports are confidential.
AER No. 2012-0001
Date received: _____________________
*Patient's Name or Initials___________________________ * Sex:
Male
Address or Contact Number: _____________________________________
Female
*Age________
Medical History/Admitting Diagnosis: _______________________________________
Any Known Allergy:
No
Yes, Specify:______________________________
Weight ______Kg
Height (cm) _____
Date of Birth (mm/dd/yr)__________________
Ethnic group: Filipino Chinese Caucasian
Pregnancy Status: ___ No
st
Hospital/facility , if admitted:_______________________________________________
nd
rd
___ Yes (1 , 2 , 3 trimester)
*DETAILS OF THE ADVERSE REACTION
Date
of onset:____________; ____am, ____pm
*
Do you consider the reaction to be serious?
Describe the reaction, including pertinent laboratory data:
Yes, if yes indicate why:
No
Patient died due to reaction
Involved or prolonged in-patient hospitalization
Life threatening
Involved persistent or significant disability
Congenital anomaly in the newborn
Other outcome, please give details:
Can this be due to Medication Error?
Yes, if yes, which type:
No
___Prescribing
___Transcription
___Dispensing
___Administration
Can the adverse reaction be due to :
1. Product quality defect ___No
___Yes, Specify, encircle: color change ; caking; powdering ; counterfeit; odor change; defective
container; contaminants; separation of components; undissolved suspension/powder
2. Therapeutic failure: ___No ___Yes, Specify, encircle: antimicrobial resistance, drug interaction, poor compliance, counterfeit, expired;
improper storage; under-dosing, inappropriate medication; inappropriate route of administration; excipients/preservatives
*Suspected drug product(s)
Indicate brand name
Daily Dose
Route
Date
started
Date
stopped
List all other drug/s taken at the same time and/ or 3 months before. If none, check box.
Brand name of the drug
Daily Dose
Route
Date
started
Date
stopped
Reason (s) for using
the product
(Indication)
Manufacturer and
Batch/Lot #
No Other drug/s taken
Reason/s for using the
drug
Manufacturer and
Batch & Lot No.
*MANAGEMENT OF ADVERSE REACTION
Was treatment given? No
Yes (If yes, please specify): ___________________________________________
Outcome:
Recovered (Date of recovery):___________________
Unrecovered
Other diseases: _____liver _____renal
Fatal (Date of death):______________________
Unknown
Sequela/e: (any permanent complications or injuries as a result of the ADR)
Yes (Please specify)_________________________
No
______HPN
_____ Diabetes _____CVS ____Endocrine
____Cancer
Re-challenge? Yes Result______________________
Unknown
No
* REPORTERS PARTICULARS
*Printed Name of Reporter: _______________________________________
Signature of reporter:
_______________________________________
Date reported (mm/dd/yr): _______________________________________
*Contact no:_________________________________________
Email address: ______________________________________
*Profession: __MD ___ RPh ___RN___Patient ___Dentist ___other
*Facility: ___Clinic ____Trial site _____Other
National Pharmacovigilance Center
Saving Lives Through Vigilant Reporting
Send completed form to: ADR Unit, FDA, Civic Drive, Filinvest Estate, Alabang, Muntinlupa ,1781.
Or fax to: (02) 8070751 or 807-85-11, c/o The ADR Unit. Send sample, if any, of suspect drug for analysis.
Website: www.fda.gov.ph
