Drug-induced osteoporosis/osteopenia: a pharmacovigilance analysis using the FDA Adverse Event Reporting System database
Authors' conclusion
This FAERS-based study identified multiple drug classes associated with OP/OPN-related adverse event signals, with anti-viral drugs - particularly tenofovir disoproxil and its combination therapies - exhibiting the strongest signal.
Study context
- Population
- OP/OPN-related adverse event reports in the FDA Adverse Event Reporting System (FAERS), 2004 to 2023OP/OPN-related reports
- Participants
- 43,685 reports
- Outcome
- Signal strength of OP/OPN associated with different drug categories
Methodological detailsdisproportionality analysis of the FAERS database, reporting odds ratio and proportional reporting ratio, 2004–2023
- Disproportionality analysis of the FAERS database
- Reporting odds ratio and proportional reporting ratio
- 2004–2023
Main finding
As reported in the abstract
Proportion of OP/OPN-related reports by drug category
Anti-retroviral drugs
20.73%
Immunomodulatory/immunosuppressive agents
12.76%
Proton pump inhibitors
6.25%
Hormone-related
2.88%
Observational data: associations, not effects.
Further findings
Annual growth rate of anti-retroviral drug reports
- Average annual growth rate
- 2.20%
Median time-to-onset of OP/OPN by drug category
- Glucocorticoids (earliest), median days
- 164
- Anti-retroviral drugs (longest), median days
- 1,508
Most frequently reported drugs
- Tenofovir and its combinations, esomeprazole, adalimumab, MTX, medroxyprogesterone, interferon beta-1A, etanercept, and RTX
Original publication
Drug-induced osteoporosis/osteopenia: a pharmacovigilance analysis using the FDA Adverse Event Reporting System database. Clin Exp Rheumatol. Published 22 September 2025. doi:10.
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