OnSIDES, side effects extracted from FDA Structured Product Labels

OnSIDES (ON label SIDE effectS resource) is the newest member of the NSIDES family. The initial release (v01) of the OnSIDES database of adverse reactions and boxed warnings extracted from the FDA structured product labels. All labels available to download from DailyMed (https://dailymed.nlm.nih.gov/dailymed/spl-resources-all-drug-labels.cfm) as of April 2022 were processed in this analysis. In total 2.7 million adverse reactions were extracted from 42,000 labels for just under 2,000 drug ingredients or combination of ingredients.

We created OnSIDES using the ClinicalBERT language model and 200 manually curated labels available from Denmer-Fushman et al.. The model achieves an F1 score of 0.86, AUROC of 0.88, and AUPR of 0.91 at extracting effects from the ADVERSE REACTIONS section of the label and an F1 score of 0.66, AUROC of 0.71, and AUPR of 0.60 at extracting effects from the BOXED WARNINGS section.

Read more at nsides.io.