FAERS Drug-Induced Osteoporosis Risk Signals for Antiretroviral Therapy

Supplementary data from a pharmacovigilance study analyzing adverse event reports from the FDA Adverse Event Reporting System (FAERS) between 2004 and Q2 2025. The dataset contains calculated risk signals, such as Reporting Odds Ratios, for drug-induced bone density reduction and osteoporosis, with a focus on antiretroviral therapy in elderly patients. It was authored by Xiaoyu Liu and shared in April 2026.

Use Cases

• Compare Reporting Odds Ratios (RORs) and confidence intervals for specific drug-event pairs like 'Emtricitabine/Tenofovir Disoproxil' and 'decreased bone density'.
• Analyze gender-specific risk differences using reported signals for antiviral drugs versus bone metabolic regulators.
• Identify high-risk drugs for osteoporosis, such as Esomeprazole and Adalimumab, based on their reported ROR values.
• Support toxicological mechanism research by linking drug names to disrupted pathways like vitamin D metabolism or calcium homeostasis.

Strengths

• Risk metrics include specific Reporting Odds Ratios (e.g., 713.48) with 95% confidence intervals for precise interpretation.
• Data covers a long temporal range from 2004 to the second quarter of 2025.
• Analysis focuses on a specific, high-impact clinical issue: drug-induced osteoporosis in the elderly.

Limitations

• Dataset is small (18.5 KB), indicating it contains summary statistics, not the underlying patient-level FAERS reports.
• Findings are based on spontaneous reporting data, which carries inherent biases like under-reporting and cannot establish causality.
• The specific row count and column schema are unknown, limiting assessment of granularity.

Provenance

Source

FDA Adverse Event Reporting System (FAERS).

Collection Method

Disproportionality analysis (DPA) applied to spontaneous adverse event reports.

Time Range

2004 to Q2 2025.

Freshness

Data reflects FAERS reports up to Q2 2025 and was last updated in April 2026.

Geography

Primarily United States (FAERS), but reports are international in origin.