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Suspected Adverse Reaction Form

FDA reaction form for suspected adverse

Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: SUSPECTED ADVERSE REACTIONS FORM v 5 (4/2012)
“Saving Lives Through Vigilant Reporting”
*FIELDS MUST BE COMPLETED.
PATIENT’S 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
___ Yes (1st, 2nd, 3rd trimester)

Hospital/facility , if admitted:_______________________________________________
*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)_________________________
* REPORTER’S PARTICULARS

 No

Signature of reporter:

_______________________________________

Date reported (mm/dd/yr): _______________________________________

____Cancer

Re-challenge?  Yes Result______________________

 Unknown

*Printed Name of Reporter: _______________________________________

______HPN

_____ Diabetes _____CVS ____Endocrine
 No

*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) 807-85-11, c/o The ADR Unit. Send sample, if any, of suspect drug for analysis.
Website: www.fda.gov.ph

CONFIDENTIALITY
Any information including attachment/s related to the identities of the reporter and patient will be kept
confidential.
GUIDELINES FOR REPORTING
Please report any of the following:
 All suspected adverse drug reactions for medicines and vaccines, including established medicines, traditional
medicines, household and herbal remedies & suspected counterfeit
 All serious expected and/or unexpected adverse drug reactions
 All suspected adverse drug reaction for new medicines
 All suspected adverse drug reaction occurred in special populations including children, pregnant women and
elderly
 All medication errors that result in an adverse reaction
 Report even if you are not sure that the drug caused the event

For follow-up reports:
Any follow-up information that has already been reported may be sent to us in another form or through other
reporting channels. Please indicate follow up report.

Send this report thru:

Mail or Direct submission to:
Pharmacovigilance Unit
Center for Drug Regulation and Research
FOOD AND DRUG ADMINISTRATION
Civic Drive, Filinvest Corporate City,
Alabang, Muntinlupa City





Fax: (02) 809 5596
Telephone: (02) 809 5596
Email: adr@fda.gov.ph
Online reporting:
http://www.fda.gov.ph/adr-report-new

This form can be downloaded from FDA website http://www.fda.gov.ph/industry-corner/downloadables/265suspected-adverse-reaction-form
For more information :
Contact the National Pharmacovigilance Center at (02) 809 5596

Thank you for reporting

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