August 01, 2014
1 min read

FDA allows open access to adverse drug reaction database

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The FDA announced it is making access to its adverse drug reaction reports easier to obtain, with open access to the public.

In a press release, Taha Kass-Hout, MD, MS, chief health informatics officer at FDA, said that the information previously difficult to obtain will now be available online in a computer format that will allow for relatively easy searches. Software developers will also have the ability to develop their own search tools to complete more advanced queries of the data. Data will be available for reports submitted between 2004 and 2013, but no patient information will be disclosed.

Taha Kass-Hout

“As we focus on making existing public data more easily accessible, and providing appropriate documentation and examples to developers, it’s important to note that we will not release any data that could be used to identify individuals or reveal other private information,” Kass-Hout said in the release on the FDA’s website.

In the past, adverse drug reaction reports were only made available by filing Freedom of Information Act requests, which can be a lengthy process, or by downloading large amounts of data that may not have been encoded in a user-friendly format.

Industry, researchers and consumers will have access to the database, but upon visiting the database, a warning to potential users is displayed, explaining that the program is in beta development mode and that users should assume the data are incomplete and not validated. New users are required to submit an email address to obtain an application program interface (API) code.

The website states, “We require API keys above a certain number of requests to manage load on the system, promote equitable access and prevent abuse.”

A brief tutorial on using the API and methods for conducting search queries is also available here: