OnSIDES Data Release 2.1.0-20240925

September 25th, 2024 Data Release for OnSIDES v2.1.0. These data were generating using available structured product labels (SPLs) from DailyMed as of September 25th, 2024. This is the first release that includes the Warnings and Precautions section in addition to the Adverse Reactions and the Boxed Warnings sections.

Data releases are tagged with the release version of the code used to generate them followed by the date in YYYYMMDD format

OnSIDES Data Release v2.0.0-20240312

March 12th, 2024 Data Release for OnSIDES v2.0.0. These data were generating using available structured product labels (SPLs) from DailyMed as of March 12th, 2024.

Data releases are tagged with the release version of the code used to generate them followed by the date in YYYYMMDD format.

OnSIDES Data Release v2.0.0-20231113

November 13th, 2023 Data Release for OnSIDES v2.0.0. These data were generating using available structured product labels (SPLs) from DailyMed as of November 13th, 2023.

Data releases are tagged with the release version of the code used to generate them followed by the date in YYYYMMDD format.

OnSIDES Data Release v2.0.0-20230629

June 29, 2023 Data Release for OnSIDES v2.0.0. These data were generating using available structured product labels (SPLs) from DailyMed as of June 29, 2023.

Data releases are tagged with the release version of the code used to generate them followed by the date in YYYYMMDD format.

OnSIDES Data Release v2.0.0-20230309

March 9, 2023 Data Release for OnSIDES v2.0.0. These data were generating using available structured product labels (SPLs) from DailyMed as of March 9, 2023.

Data releases are tagged with the release version of the code used to generate them followed by the date in YYYYMMDD format.

OnSIDES Data Release v2.0.0-20230203

February 4, 2023 Data Release for OnSIDES v2.0.0. These data were generating using available structured product labels (SPLs) from DailyMed as of Feb 4, 2023.

Data releases are tagged with the release version of the code used to generate them followed by the date in YYYYMMDD format.

OnSIDES Data Release v2.0.0-20230113

January 13, 2023 Data Release for OnSIDES v2.0.0. These data were generating using available structured product labels (SPLs) from DailyMed as of January 13, 2023.

Data releases are tagged with the release version of the code used to generate them followed by the date in YYYYMMDD format.

OnSIDES Data Release v2.0.0-20221112

November 12, 2022 Data Release for OnSIDES v2.0.0. These data were generating using available structured product labels (SPLs) from DailyMed as of November 12th, 2022.

Data releases are tagged with the release version of the code used to generate them followed by the date in YYYYMMDD format.

OnSIDES v2.0.0

Second major release of OnSIDES code to extract adverse reactions and boxed warnings from the FDA structured product labels (SPLs). This version contains significant model improvements as well as updated labels. All labels available to download from DailyMed as of November 10, 2022 were processed in this analysis. In total 2.8 million adverse reactions were extracted from over 45,000 labels for just under 2,000 drug products (single agents or combinations).

OnSIDES was created using the PubMedBERT language model and 200 manually curated labels available from Denmer-Fushman et al.. The model achieves an F1 score of 0.90, AUROC of 0.92, and AUPR of 0.95 at extracting effects from the ADVERSE REACTIONS section of the label. This constitutes an absolute increase of 4% in each of the performance metrics over v1.0.0. For the BOXED WARNINGS section, the model achieves a F1 score of 0.71, AUROC of 0.85, and AUPR of 0.72. This constitutes an absolute increase of 10-17% in the performance metrics over v1.0.0. Compared against the TAC reference standard using the official evaluation script the model achieves a Micro-F1 score of 0.87 and a Macro-F1 of 0.85.

The model checkpoints for the Adverse Reactions (AR) and Boxed Warnings (BW) sections are also provided as part of this release as pth files.

For the data check for the latest "Data Release" under releases.

OnSIDES v1.0.0

Initial release 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.

Onsides was created 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.