I cannot seem to find information on what the lag time is between FDA approval (drug on market) and results for adverse events being listed on openFDA. Does anyone have an idea of the timeline?

For example I can find adverse event reports for Promacta which was approved on August 24th 2015 (almost 2 months since approval). Looking at a drug that has just under 1 month of approval I cannot find any AE reports (or any basic information), an example is Lonsurf which was approved September 22nd 2015. What is the general time for posting of this information? Thanks!

1 Answer 1


In the past, the public data, which is the basis of the openFDA API, lagged about a year behind. Great improvements have been made this last year and we are starting to see that data within 3 months. The data is published quarterly and we are up-to-date as of the latest quarter (2015q2).

I am not expert enough to speak to the average time between approval and a drug showing up in AE system. You would have to contact the FDA.

Hope that helps.

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