FAERS analysis-ready datasets for non-statin lipid-lowering drugs and muscle toxicity (2015Q3–2025Q3)

This Zenodo deposit provides analysis-ready, derived, datasets used to calculate muscle-related adverse event signals associated with non-statin lipid-lowering therapies in FAERS (from third quarter 2015 to third quarter 2025). The deposit is designed to enable full reproducibility of the reported disproportionality analyses (ROR) and reporting frequencies (per 10,000 exposed reports). All identifiers refer to FAERS reports (ICSRs), not unique patients. These files are derived analytical datasets and do not contain patient-level narratives or personal identifiers. Data source and period FAERS quarterly ASCII datasets from 2015Q3 through 2025Q3 (inclusive).Case-level deduplication was performed using CASEID, retaining the most recent version by CASEVERSION (then FDA_DT, then PRIMARYID as tie-breaker). File list and purpose all_ids.csv contains a single column primaryid, representing the complete set of deduplicated FAERS reports used as the analysis universe (N). nonstatin_ps.csv contains two columns: primaryid and ing. This is the report-level exposure table for non-statin lipid-lowering therapies where the active ingredient (ing) was coded as Primary Suspect in the FAERS DRUG file. Drug mapping was performed using a curated dictionary of generic and brand names (defined in dictionary.txt) statin_any_ids.csv contains a single column, primaryid, representing reports with any statin exposure in any role (Primary Suspect, Secondary Suspect, or concomitant medication), including fixed-dose combination product names. Drug mapping was performed using a curated dictionary of generic and brand names (defined in dictionary.txt) nonstatins_ids.csv contains the column primaryid and it is constructed as all_ids minus statin_any_ids. myositis_ids.csv contains primaryid values for reports containing Preferred Terms included in the prespecified narrow inflammatory myositis endpoint (defined in dictionary.txt) ck_ids.csv Contains primaryid values for reports containing the MedDRA Preferred "BLOOD CREATINE PHOSPHOKINASE INCREASED." muscle_c1_ids.csv: contains primaryid values for reports meeting Cluster 1, a specific/severe muscle injury composite endpoint defined in dictionary.txt. muscle_c2_ids.csv contains primaryid values for reports meeting Cluster 2, defined as Cluster 1 plus additional muscle symptom Preferred Terms defined in dictionary.txt dictionary.txt contains the curated dictionaries and code lists used to generate the derived datasets.