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Information for Patients

Reporting of suspected adverse drug reaction by patients or consumers


If you think you are experiencing side effects to a medicine, seek the advice of a healthcare professional as soon as possible. These may be your doctor or pharmacist. You may ask them to report for you or you may report directly to the FDA. The FDA collects reports of side effects to monitor the safety of the medicines in the market, healthcare advice will be provided by your doctor or pharmacist.

 

All medicines and vaccines may have side effects, these include common side effects such as feeling of unease, an urge to vomit, headache, and other symptoms. However, the FDA ensures that benefits of the medicines are far higher than causing side effects or harm to patients. The FDA also regularly monitors the quality, safety, and efficacy of medicines through regular inspection of the manufacturers, distributors, pharmacies and drugstores.

 

Although the FDA is receiving reports from manufacturers and health professionals, patient and consumer reports are important as they give us additional information relative to the safety of medicines. This will give our health professionals and medicine users additional insights on how to best use our medicines.

 

The FDA is giving you several options in reporting side effects. Note that all information provided is treated with utmost confidentiality.


You may choose below the most convenient for you. 

Step 1: Visit the Online Adverse Drug Reaction Reporting.

Step 2: Fill in all available information and be as complete as possible.

Step 3: Review the information then click Send report.

Step 4: A prompt will appear that your report has been sent. You have the option to download your report.

Note: You may receive a follow-up if we need more information

Step 1: Download the FDA Suspected Side Effects Reporting Form.

Step 2: Fill in all available information and be as complete as possible.

Step 3: Save, print or scan the accomplished form.

Step 4: Send to [email protected]

Step 5: An acknowledgement email will be sent to you once the report is received.

Note: A follow-up email will be sent if additional information is needed.

 

Step 1: Download the FDA Suspected Side Effects Reporting Form.

Step 2: Fill in all information available. Information shall be as complete as possible.

Step 3: Save and print the accomplished form.

Step 4: Mail to the following address:

Pharmacovigilance Section
Product Research and Standards Development Division
Center for Drug Regulation and Research
FOOD AND DRUG ADMINISTRATION
Civic Drive, Filinvest City, Alabang, Muntinlupa City 1781

or

FDA Regional Field Office near you. Click here for the directory.

Step 5: An acknowledgement email will be sent to you once the report is received.

Note: It is also possible to report walk-ins to our FDA Action Center (FDAC).

Step 1: Call us at (02) 8809 5596.

Step 2: Somebody will receive your call and ask you for all the needed information with reference to the FDA Suspected Side Effects Reporting Form.

Note: You may receive a follow-up call if we need more information.

Last updated: 19 August 2022

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