FAERS Drug-Induced Osteoporosis Reports with WHO Vigibase Validation, 2014-2025

Table 1 from a pharmacovigilance study by Wenbin Gao, last updated April 2026. The dataset contains 55,895 deduplicated osteoporosis-related adverse event reports from the FDA Adverse Event Reporting System (FAERS) between Q1 2014 and Q1 2025. It includes results from disproportionality analyses, LASSO regression, and multivariate analysis identifying high-risk drugs and demographic factors, with external validation using WHO Vigibase.

Use Cases

• Identify high-risk medications for drug-induced osteoporosis based on disproportionality analysis signals.
• Analyze demographic risk factors like age and sex based on multivariate regression results.
• Examine onset time patterns for major implicated drugs mentioned in the description.
• Validate pharmacovigilance signals by comparing FAERS data with WHO Vigibase results.

Strengths

• Contains 55,895 deduplicated case reports from a major pharmacovigilance database.
• Covers a defined time range from Q1 2014 to Q1 2025.
• Results are validated externally using the WHO Vigibase database.
• Employs multiple analytical methods (ROR, PRR, LASSO, multivariate regression).

Limitations

• Column-level documentation is absent; field semantics must be inferred after download.
• Row count for the specific table is unknown, which may limit suitability assessment.
• Data may reflect reporting bias inherent to spontaneous adverse event reporting systems.

Provenance

Source

FDA Adverse Event Reporting System (FAERS) and WHO Vigibase.

Collection Method

Deduplicated reports collected from FAERS, analyzed with disproportionality methods and regression.

Time Range

Q1 2014 to Q1 2025.

Freshness

Last updated 2026-04-13 04:35:34; freshness should be verified.

Geography

Likely international, based on FAERS and WHO Vigibase sources, but not explicitly stated.