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Chronic migraine is very disabling, being characterized by at least 15 headache days per month of which at least 8 days present the features of migraine. Onabotulinumtoxin A, targeting the machinery for exocytosis of neurotransmitters and neuropeptides, has been approved for use in chronic migraine since 2010. This systematic review and meta-analysis appraises the safety of onabotulinumtoxin A treatment for chronic migraine and the occurrence of treatment-related adverse events (TRAEs) in randomized, clinical studies in comparison with placebo or other comparators and preventative treatments according to the most updated Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 recommendations. The search retrieved 888 total records. Nine studies are included and seven were eligible for meta-analysis. The present study demonstrates that toxin produces more TRAEs than placebo, but less than oral topiramate, supporting the safety of onabotulinumtoxin A, and highlights the heterogeneity of the studies present in the literature (I2 = 96%; p &lt; 0.00001). This points to the need for further, adequately powered, randomized clinical trials assessing the safety of onabotulinumtoxin A in combination with the newest treatment options.<\/jats:p>","DOI":"10.3390\/toxins15050332","type":"journal-article","created":{"date-parts":[[2023,5,12]],"date-time":"2023-05-12T09:26:13Z","timestamp":1683883573000},"page":"332","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["Safety of Onabotulinumtoxin A in Chronic Migraine: A Systematic Review and Meta-Analysis of Randomized Clinical Trials"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6472-0697","authenticated-orcid":false,"given":"Maria Tiziana","family":"Corasaniti","sequence":"first","affiliation":[{"name":"Department of Health Sciences, University \u201cMagna Graecia\u201d of Catanzaro, 88100 Catanzaro, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8540-6218","authenticated-orcid":false,"given":"Giacinto","family":"Bagetta","sequence":"additional","affiliation":[{"name":"Pharmacotechnology Documentation and Transfer Unit, Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierluigi","family":"Nicotera","sequence":"additional","affiliation":[{"name":"German Center for Neurodegenerative Diseases (DZNE), 53127 Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Assunta","family":"Tarsitano","sequence":"additional","affiliation":[{"name":"Pain Therapy Center, Provincial Health Authority (ASP), 87100 Cosenza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4867-1378","authenticated-orcid":false,"given":"Paolo","family":"Tonin","sequence":"additional","affiliation":[{"name":"Regional Center for Serious Brain Injuries, S. Anna Institute, 88900 Crotone, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giorgio","family":"Sandrini","sequence":"additional","affiliation":[{"name":"Department of Brain and Behavioral Sciences, IRCCS C. Mondino Foundation Neurologic Institute, University of Pavia, 27100 Pavia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5206-7763","authenticated-orcid":false,"given":"Gary W.","family":"Lawrence","sequence":"additional","affiliation":[{"name":"Department of Biotechnology, Dublin City University, Collins Avenue, D09 V209 Dublin, Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5846-7058","authenticated-orcid":false,"given":"Damiana","family":"Scuteri","sequence":"additional","affiliation":[{"name":"Pharmacotechnology Documentation and Transfer Unit, Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy"},{"name":"Regional Center for Serious Brain Injuries, S. Anna Institute, 88900 Crotone, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,5,12]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1186\/s10194-018-0846-2","article-title":"Migraine is first cause of disability in under 50s: Will health politicians now take notice?","volume":"19","author":"Steiner","year":"2018","journal-title":"J. Headache Pain"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1186\/s10194-022-01402-2","article-title":"The global prevalence of headache: An update, with analysis of the influences of methodological factors on prevalence estimates","volume":"23","author":"Stovner","year":"2022","journal-title":"J. Headache Pain"},{"key":"ref_3","doi-asserted-by":"crossref","unstructured":"(2013). The International Classification of Headache Disorders, 3rd edition (beta version). 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