Reported adverse events associated with finasteride use in androgenetic alopecia: Monitoring priorities from a 20-year FDA Adverse Event Reporting System database analysis
Description
This dataset contains supplementary materials for the manuscript entitled "Reported adverse events associated with finasteride use in androgenetic alopecia: Monitoring priorities from a 20-year FDA Adverse Event Reporting System database analysis." The files include: Supplementary Figures illustrating the distribution of adverse event signals across organ systems and time-to-onset plots. Supplementary Tables listing detailed results of PT-level and SOC-level signal detection, clinical priority scoring metrics, and onset time statistics. A Supplementary Methods section describing advanced analytical procedures, including the multi-factor clinical priority scoring system. A Supplementary Results section summarizing additional findings not included in the main text. These materials provide extended support for the main analyses and are shared to promote transparency, reproducibility, and further pharmacovigilance research.
Files
Steps to reproduce
The supplementary materials were derived from adverse event reports in the FDA Adverse Event Reporting System (FAERS) from Q1 2004 to Q4 2024. To reproduce the analysis: 1. Download FAERS data from [FDA FAERS Public Dashboard](https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html). 2. Preprocess the data: Use R (v4.3.2) and tidyverse packages to merge DEMO, DRUG, REAC, THER, OUTC, and INDI tables. 3. Define cohorts: Extract "androgenetic alopecia" or "AGA" cases from INDICATION table and identify finasteride exposure using drug names ("finasteride", "propecia", "proscar"). 4. Signal detection: Calculate ROR, PRR, IC, IC_MGPS, and perform Fisher’s test using custom R scripts. 5. Priority scoring: Apply multi-dimensional clinical scoring system (details in Supplementary Methods). 6. Visualization: Generate plots and summary tables using ggplot2 and openxlsx. All supplementary figures, tables, and methods required to replicate key results are included in this dataset.
Institutions
- Southwest Medical University