MedWatch Voluntary Report

en Español

Frequently Asked Questions

The MedWatch Online application uses Secure Socket Layers (SSL) and Pretty Good Protection (PGP) to encrypt and ensure the security and confidentiality of your MedWatch submission across the Internet.

The application supports the following platforms and browsers:

		Platforms
Browser	Browser version	Windows	Mac OSX	iOS 1	Android 2
Firefox	92 or greater
Chrome	98 or greater
Safari	15 or greater
Edge	88 or greater

¹ iOS Devices Tested:
iPhone 13 or above, iPad Pro (5th generation), iPad (9th generation)

² Android Devices Tested:
Android version 11.0 and higher

• Supported
• Not supported

• Acrobat Reader version 2021 standard/pro version or higher is required in order to view your submission as a PDF file. Users of earlier versions may upgrade by visiting the Adobe website.
• Java Scripting must be enabled for this form to work correctly. To learn how to enable Java Scripting, please read in information on this page.

Please note that using a different browser may result in difficulties using and submitting the form.

To submit a report, the reporter should have following information at minimum:

• Description of the adverse event or problem that occurred
• Name of the suspect medical product if reporting about a prescription or over-the-counter medicines*, biologics, special nutritional products, cosmetics, food etc.
• Name of the suspect device if reporting about a medical device (including diabetes glucose-test kit, hearing aids, breast pumps, and many more products)
• Reporter's name (FDA will not disclose your identity to the manufacturer if requested in the form.)

*Other details such as National Drug Code or NDC number, lot number, and expiration date should be reported when available but are not required to submit a report.

When you have the details of your adverse event or product problem available including the minimum information described above, you can begin your report. It may take about 15-20 minutes to fill out a report.

The MedWatch Online application will timeout in 30 minutes if you are not actively using the application. The session time can be extended by clicking on “OK” on the alert message before session expiration time. Once the session expires, you must start a new report.

Yes. After starting a report, if you find out that you need some extra time to gather all the information for the case, you can save your progress to come back to finish it later. An incomplete report will only be held for up to 3 days.

However, note that if you decide to submit a report instead of saving it, that same report cannot be retrieved. Please see how you can update your previous report in another question in this FAQ.

Yes. Help buttons are located in each section of the MedWatch Online application.

Consumers or patients can also view or print additional instructions available on the Form FDA 3500B - Voluntary Reporting for Consumers.

Health professionals can view complete instructions available on the Instructions for Completing Form FDA 3500.

Yes. Once you complete, review, and submit the form online, you will be given the option of viewing, printing, and saving your report as a PDF document. If you have only the Acrobat Reader application, you will not be able to save the document but can view and print a copy for your records.

A copy of your report can be downloaded on the confirmation page of the MedWatch Online application. The PDF file will download to the default location on your computer. You can open the PDF document from this file location using Adobe Acrobat Reader. Your computer must have Adobe Acrobat reader installed before you can open the file.

Depending on the version of Adobe Acrobat Reader installed, if you try to open the downloaded PDF in Chrome browser, you may not see the data. The PDF will appear to be a blank form and the data seems to be missing. However, if you open the PDF from file location as mentioned above you will see the complete submitted form.

A copy of your report can be downloaded on the confirmation page of the MedWatch Online application. The PDF file will download to the default location on your Mac. You can open the PDF document from this file location using Adobe Acrobat Reader. Your Mac must have Adobe Acrobat reader installed before you can open the file.

Depending on the version of Adobe Acrobat Reader installed, if you try to open the downloaded PDF in Mac, the Mac uses “Preview” to open a PDF, you may not see the data. The PDF will appear to be a blank form and the data seems to be missing. The default “Preview” tool used by Mac to open any PDF, is not designed to open a “fillable PDF”. However, if you open the PDF from file location as mentioned above you will see the complete submitted form.

Yes. You can upload pictures using the MedWatch Online application. Relevant pictures that can be uploaded include:

• Image(s) of the prescription (Rx) label.
• Image(s) of the product packaging showing the label/ingredients.
• Image(s) of front and back of the actual product.
• Image formats accepted by FDA are JPG, JPEG, GIF, and PNG.

You may select/upload multiple files with a maximum combined size of 8MB.

From a mobile or tablet device, you may take a photo or choose a photo from the gallery. The maximum combined size of the files is 8MB or 2-3 photos.

If you want to report an adverse event with attachments that exceeds 8 MB or has other limitations of the online application, please download the voluntary reporting form. Submit the completed form with attachments by fax to 1-800-FDA-0178, or mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852.

Your report may be critical in notifying the FDA of new or potential safety information. When problems with FDA-regulated products occur, the agency wants to know about them and has several ways for the public to make reports. Timely reporting by consumers, health professionals, and FDA-regulated companies allows the agency to take prompt action. The agency evaluates each report to determine how serious the problem is, and, if necessary, may request additional information from the person who filed the report before taking action.

For answers to questions about specific products:

• Call 1-888-INFO-FDA (1-888-463-6332) to speak to an FDA representative
• Visit one of the following FDA web sites:
• Drugs
• Special Nutritional Products (dietary supplements, infant formulas, medical foods), Cosmetics and Foods/Beverages
• Medical Devices
• Vaccines, Blood Products, Other Biologics
• Tobacco Products
• Veterinary Products including animal feed, pet food and drug products

No, after submitting, you cannot bring the report back and directly edit it. However, you can start a new report to supply more information about the case. Please make sure you include the necessary information ‐ at the very least, the suspect product and a brief summary of what kind of adverse events, medical/product use errors, or product quality issues. Other information such as the reporter and the patient characteristics (if available) should also be provided again. This may appear repetitive, but it helps FDA connect the new report with the previously submitted one.

(No, después de enviarlo, no puede recuperar el informe y editarlo directamente. Sin embargo, puede iniciar un nuevo informe para proporcionar más información sobre el caso. Asegúrese de incluir la información necesaria: como mínimo, el producto sospechoso y un breve resumen de qué tipo de eventos adversos, errores médicos/uso del producto o problemas de calidad del producto. También debe proporcionar nuevamente otra información como el informante y las características del paciente (si están disponibles). Esto puede parecer repetitivo, pero ayuda a la FDA a conectar el nuevo informe (reporte) con el sometido anteriormente.)

Yes. On the MedWatch Online (MWO) Landing page, click on “En español para el consumidor / paciente (formulario 3500B de la FDA)” to use the Spanish module to submit an adverse event report to FDA. Follow the instructions within the module to fill and upload the el formulario en español FDA 3500B PDF format to the MWO portal.

(Sí. En la página de inicio de MedWatch Online (MWO), haga clic en “En español para el consumidor / paciente (formulario 3500B de la FDA)” para utilizar el módulo en español y enviar un informe de eventos adversos a la FDA. Siga las instrucciones del módulo para completar y cargar el formulario en español en formato PDF FDA 3500B al portal MWO.)