ArticleClinical rheumatology2026
Sex-stratified disproportionality signals of adverse events with allopurinol and febuxostat: a retrospective pharmacovigilance analysis of FAERS and EudraVigilance.
Article in Clinical rheumatology, 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
9 authors.
Funding
Abstract
backgroundXanthine oxidase inhibitors (XOIs), including allopurinol, febuxostat, and topiroxostat, are widely used for the treatment of hyperuricemia and gout. While their efficacy is well established, sex-associated differences in adverse event (AE) profiles remain poorly understood, despite evidence suggesting that sex may influence drug safety and response.
aimThis study aimed to systematically evaluate sex-associated differences in AE safety signals for XOIs using large-scale pharmacovigilance data from two international databases.
methodsAE reports of XOIs from the FDA Adverse Event Reporting System (FAERS) were extracted from the first quarter of 2004 to the fourth quarter of 2024. Reporting odds ratios (RORs) were calculated separately within female and male reports to assess drug event disproportionality for each sex. Selected findings from the FAERS analysis were further examined in EudraVigilance (EV) for directional consistency.
resultsAnalysis indicated notable sex-associated safety signals. In female reports, allopurinol showed strong disproportionality signals for haematological irregularities such as pancytopenia (ROR = 6.87, 95% CI: 6.09-7.75, cases = 271). In male reports, febuxostat showed strong disproportionality signals for rhabdomyolysis (ROR = 4.55, 95% CI: 3.64-5.68, cases = 79). Several of these sex-associated signals showed directionally consistent patterns in EV. For topiroxostat, only raw descriptive counts are provided in the supplementary material.
conclusionNotable sex associated safety signals for allopurinol and febuxostat showed directionally consistent patterns across two databases but should be interpreted as hypothesis generating. Allopurinol showed disproportionality signals for haematological irregularities in female reports, while febuxostat showed signals for rhabdomyolysis in male reports. Topiroxostat data were insufficient for analysis. The findings identify exploratory reporting patterns that require confirmation in studies with exposure denominators and adjustment for confounding.
Indexed as
Identifiers
42814218What Socratic 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 Socratic graph.