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openfda

Explore and analyze FDA Drug Adverse Event (FAERS) data

FDA Drug Adverse Event Overview

FDA Adverse Event Reporting System (FAERS) Quarterly Data Extract Files

openFDA github repository

FAERS ascii ERD

Component Details
Question Are different adverse events reported in different countries?
Sources (FAERS) REAC19Q3.txt, DEMO19Q3.txt -> join on PRIMARYID
Data for each case, record DEMO.OCCR_COUNTRY, REAC.PT pairs
Analyses frequency of each event-type in each country (profile)
. frequency profile comparisons across countries
. distance matrices
. classification/clustering
  • 2019Q3 data is only an incremental subset (<10%) of the entire FAERS dataset

2-Way Heatmap of normalized event frequencies (countries in columns):

event-country-heatmap

Zoomed-in on left side with distinct sets of events for top reporting countries:

event-country-heatmap

Histogram of counts of frequency values of each event in individual countries (excludes zero counts) - a frequency cutoff of 0.9 seems reasonable.

event-frequency-histogram

"Distinct" drug event terms above frequency cutoff here: event-distinct-top

Possible other analyses:

Analysis Methods
Clustering K-means, biclustering, non-negative matrix factorization

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