ArticleFrontiers in immunology2026
A pharmacovigilance study of sirolimus-associated adverse events in organ transplantation.
Article in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Sirolimus (rapamycin), an antibiotic discovered in the 1970s, can effectively reduce allograft rejection, and plays an important role in the fields of immunosuppressive therapy and organ transplantation. Therefore, this study aimed to analyze adverse drug reactions (ADRs) associated with sirolimus using the FDA Adverse Event Reporting System (FAERS) database to inform clinical risk minimization strategies and guide safer therapeutic use. Methods: ADRs associated with sirolimus were retrospectively extracted from the FAERS database. Following the removal of duplicate entries, the final analytical dataset comprised 8,150,023 unique reports. Statistical analyses for signal detection of disproportionate reporting were performed using established pharmacovigilance metrics. Results: A total of 4,821 FAERS reports associated with sirolimus as the primary suspect drug were identified. Injury, poisoning and procedural complications (ROR = 1.61) \are the most common reports, followed by investigation (ROR = 2.19), infections and infestations (ROR = 1.74). The top ADRs matched known profiles, including kidney transplant rejection (ROR = 230.41). The analysis also revealed signals not prominently described in current prescribing information, including ovarian adenoma (ROR = 56.6), which should be interpreted cautiously as a hypothesis-generating pharmacovigilance signal rather than evidence of causality. Conclusion: This analysis details the ADR profile of sirolimus, revealing both known and potentially novel clinically significant adverse event signals that augment its known safety profile. Ongoing pharmacovigilance and targeted investigations are necessary to confirm these pharmacovigilance signals and inform optimal safety management strategies for sirolimus.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.