Cardiovascular Safety Signals of Osteoporosis Therapies: A FAERS Pharmacovigilance Study.

Sondhi M, Singh N, Carkin J, Hughes G

Mediterranean journal of rheumatology16 Jun 2026

PMID42756536PMCIDPMC13583191DOI10.31138/mjr.250126.psjPepBankPUB-42756536

Summary

ObjectiveTo evaluate the associations between commonly used osteoporosis medications and major adverse cardiovascular events (MACE) using data from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).MethodsWe conducted a retrospective pharmacovigilance analysis of FAERS reports between January 2019 and December 2024, identifying all reports involving alendronate, risedronate, zoledronic acid, denosumab, teriparatide, abaloparatide, or romosozumab. MACE outcomes included myocardial infarction (MI), stroke, atrial fibrillation (A-fib), and cardiac failure (CF), defined using Medical Dictionary for Regulatory Activities Preferred Terms. Disproportionality was assessed using reporting odds ratios (RORs), with signals defined by a lower 95% confidence interval >1. All analyses were descriptive and hypothesis-generating.ResultsFAERS contained more than 30 million adverse event reports during the study period. Romosozumab demonstrated the highest ROR for MI (2.38) and stroke (3.72), and also showed elevated signals for A-fib and CF (ROR 3.76). Zoledronic acid showed notable associations with stroke (ROR 2.42) and A-fib (ROR 3.22). Denosumab and abaloparatide were associated with the lowest RORs across all cardiovascular outcomes. Alendronate and risedronate demonstrated intermediate disproportionality signals, particularly for A-fib and CF.ConclusionRomosozumab and zoledronic acid demonstrated prominent cardiovascular disproportionality signals in FAERS, whereas denosumab, abaloparatide, and teriparatide showed more favorable reporting profiles. These findings should not discourage osteoporosis treatment but underscore the importance of individualised cardiovascular risk assessment and the need for further prospective evaluation to inform safe therapy selection.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study1

1 result from studies that gave the peptide. 1 result from people.

01HumanObservational studySafety outcome
In FAERS reports, abaloparatide was linked to the lowest reporting odds ratios across cardiovascular outcomes, alongside denosumab.
In plain wordsAbaloparatide was linked to the lowest cardiovascular reporting odds among studied drugs, alongside denosumab.
Peptide
Abaloparatide (Tymlos)
Outcome
DecreaseCardiovascular reporting odds
Study
n: not reported in source
Comparator
Other studied osteoporosis medications
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
Dose not stated
Source sentences
Summary
Denosumab and abaloparatide were associated with the lowest RORs across all cardiovascular outcomes.
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a retrospective pharmacovigilance analysis of FAERS reports between January 2019 and December 2024, identifying all reports involving alendronate, risedronate, zoledronic acid, denosumab, teriparatide, abaloparatide, or romosozumab.
Summary · context
All analyses were descriptive and hypothesis-generating.
Show in the study text Report a problemFND-4275653601

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Version history

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Version 2Current
22 Oct 2026, 02:25 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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