May 16, 2022

Open Data: OpenFDA Formally Launches, First Dataset Now Online

From the Blog:

openFDA launched today and with it the first publicly available dataset—Drug Adverse Reaction and Medication Error Reports—that covers more than 4 million records from 2004 to 2013.

Direct to Data Files (Updated Quarterly)

From the OpenFDA Blog:

In the past, these vast datasets could be difficult for industry to access and to use. Pharmaceutical companies, for example, send hundreds of Freedom of Information Act (FOIA) requests to FDA every year because that has been one of the ways they could get this data. Other methods called for downloading large amounts of files encoded in a variety of formats or not fully documented, or using a website to point-and-click and browse through a database – all slow and labor-intensive processes.

From a Second OpenFDA Blog Post:  “Ten Things to Know About Drug Adverse Events”

Here are a few things shared in this post:

1. We’ve created a number of fantastic interactive examples to help you get some perspective on the data at large.

2. The data within the openFDA drug adverse event endpoint does have limitations. The reports within the dataset do not undergo extensive screening or validation. There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event.

3. Perhaps the most innovative part of openFDA is the extensive work we’ve done to harmonize data and provide additional identifiers and information about products.

4. The drug adverse events API is openFDA’s first product, and so will be evolving over time. We’ll be announcing changes on the website and via the listserv.

Read the Complete “Ten Things to Know About Drug Adverse Events” Post

See Also:  Open Data: U.S. Food and Drug Administration Launches openFDA (March 17, 2014)

About Gary Price

Gary Price ( is a librarian, writer, consultant, and frequent conference speaker based in the Washington D.C. metro area. Before launching INFOdocket, Price and Shirl Kennedy were the founders and senior editors at ResourceShelf and DocuTicker for 10 years. From 2006-2009 he was Director of Online Information Services at, and is currently a contributing editor at Search Engine Land.