ArticleFrontiers in medicine2026
Real world pharmacovigilance study of FDA adverse event reporting system events for Spiriva Respimat.
Article in Frontiers in medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Pharmacovigilance analysis of immune checkpoint inhibitor-associated optic nerve toxicity based on the FAERS database.Frontiers in pharmacology · 2026Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Spiriva Respimat (tiotropium bromide) is a first-line therapy for chronic obstructive pulmonary disease (COPD) and asthma, prescribed to millions worldwide. However, its comprehensive real-world safety profile, particularly rare and late-onset adverse events, remains incompletely characterized in clinical practice. Objective: To identify and characterize adverse drug reactions (ADRs) associated with Spiriva Respimat in real-world settings and provide evidence-based recommendations for clinical risk management. Methods: We analyzed 3,962 primary suspect reports from the FDA Adverse Event Reporting System (2004-2024). Disproportionality analyses (ROR, PRR, BCPNN, MGPS) identified safety signals, while Weibull survival analysis characterized temporal patterns. Results: Beyond confirming known anticholinergic effects consistent with established clinical trial data (including dry mouth and pharyngitis), we identified clinically significant novel signals requiring heightened monitoring: ocular complications (glaucoma ROR 5.67, 95% CI 4.89-6.58; cataracts ROR 4.92, 95% CI 4.25-5.70), musculoskeletal events (fractures 4.8%), and urogenital complications (urinary retention ROR 6.01, 95% CI 5.32-6.79). Temporal analysis revealed distinct risk patterns: 81.4% of events occurred within 30 days (predominantly respiratory and gastrointestinal), while late-onset complications (>360 days; median 507 days, IQR: 422.5-674.5 days) primarily involved ocular and skeletal systems. Conclusion: This study identifies previously underrecognized safety risks of Spiriva Respimat with direct implications for clinical practice. We recommend baseline ophthalmologic screening, annual monitoring for ocular complications, and careful patient selection in elderly populations with comorbidities. These findings support personalized risk-benefit assessment in COPD and asthma management. Our risk stratification framework enables clinicians to identify high-risk patients and implement targeted surveillance protocols, potentially preventing serious adverse outcomes.
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Registered trials
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