{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T21:44:35Z","timestamp":1783115075738,"version":"3.54.6"},"reference-count":45,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2023,1,11]],"date-time":"2023-01-11T00:00:00Z","timestamp":1673395200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2023,3]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>Several reports have suggested an association between febuxostat and muscle injury. The purpose of this study was to determine whether febuxostat increases the risk of muscle injury. This study included an analysis of the US Food and Drug Administration Adverse Event Reporting System (FAERS) database and a systematic review\/meta\u2010analysis of randomized controlled trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>First, evaluation of the FAERS data included a disproportionality analysis that compared patients with and without rhabdomyolysis according to whether they were receiving febuxostat or allopurinol. Second, a systematic review\/meta\u2010analysis was performed to assess the risk of rhabdomyolysis and muscle injury in patients who used febuxostat or allopurinol.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Analysis of the FAERS data revealed disproportionality for increasing rhabdomyolysis in patients who received febuxostat (reporting odds ratio 4.49, 95% confidence interval [CI] 3.72\u20135.38, <jats:italic>P<\/jats:italic>\u00a0&lt;\u2009.01) and allopurinol (reporting odds ratio 2.49, 95% CI 2.25\u20132.75, <jats:italic>P<\/jats:italic>\u00a0&lt;\u2009.01). Nineteen studies were eligible for inclusion in the systematic review\/meta\u2010analysis. Rhabdomyolysis was reported in only 1 study. The risk of any type of muscle damage was not significantly increased with febuxostat compared with placebo (risk ratio 0.92, 95% CI 0.73\u20131.17, <jats:italic>P<\/jats:italic>\u00a0=\u2009.52, <jats:italic>I<\/jats:italic><jats:sup>2<\/jats:sup>\u00a0=\u00a00%; 8 studies including 2597 participants, high\u2010certainty evidence) or allopurinol (risk ratio 1.03, 95% CI 0.94\u20131.11, <jats:italic>P<\/jats:italic>\u00a0=\u2009.56, <jats:italic>I<\/jats:italic><jats:sup>2<\/jats:sup>\u00a0=\u00a00%; 9 studies including 17\u2009644 participants, moderate\u2010certainty evidence).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Febuxostat does not seem to affect the risk of muscle injury. However, the findings of this meta\u2010analysis indicate a need for further high\u2010quality observational studies with long\u2010term follow\u2010up.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.15655","type":"journal-article","created":{"date-parts":[[2022,12,31]],"date-time":"2022-12-31T04:54:47Z","timestamp":1672462487000},"page":"956-966","source":"Crossref","is-referenced-by-count":7,"title":["Association between use of febuxostat and muscle injury: A disproportionality analysis and meta\u2010analysis of randomized controlled trials"],"prefix":"10.1111","volume":"89","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6244-1253","authenticated-orcid":false,"given":"Satoru","family":"Mitsuboshi","sequence":"first","affiliation":[{"name":"Department of Pharmacy Kaetsu Hospital  Niigata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9869-1177","authenticated-orcid":false,"given":"Kazumasa","family":"Kotake","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Okayama Saiseikai General Hospital  Okayama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,1,11]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.7326\/M16\u20100461"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ackd.2013.07.001"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.41404"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0221504"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.24180"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.08280816"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.nmd.2014.05.005"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.freeradbiomed.2010.10.704"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.1988.00380070059015"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.5694\/mja14.01404"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/jcpt.12144"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbspin.2016.10.008"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264\u2010014\u20100180\u20109"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1001"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2008.09.873"},{"key":"e_1_2_9_17_1","unstructured":"MedDRA. 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