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In this context, the aim of our study was to analyze the spontaneous reports of suspected adverse reactions (ARs) to performance enhancing herbal dietary supplements collected by the Italian Phytovigilance System. Between March 2002 and September 2020, 110 spontaneous reports were collected, 58 of which related to products containing botanicals, alone or in association. Twenty\u2010three serious reactions were reported, 21 of which required hospitalization, one was life\u2010threatening and another caused disability. Dermatological and cardiovascular reactions were the most frequent. Hepatic ARs were the most serious (9 out of 10). A positive dechallenge was indicated in 69% of cases, while a positive rechallenge occurred in 15%. Concomitant use of other products was present in 18 reports (31%), while predisposing conditions were indicated in 17 (29%). Present data highlight safety concerns on herbal dietary supplements used as cognitive and physical performance enhancers, mainly due to their quality and use without expert supervision. Considering that postmarketing surveillance is not required for these products, spontaneous reports represent the only tool to point out risks related to food supplements.<\/jats:p>","DOI":"10.1002\/ptr.7040","type":"journal-article","created":{"date-parts":[[2021,2,11]],"date-time":"2021-02-11T06:25:05Z","timestamp":1613024705000},"page":"3246-3261","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Suspected adverse reactions to performance enhancing dietary supplements: Spontaneous reports from the Italian phytovigilance system"],"prefix":"10.1002","volume":"35","author":[{"given":"Ilaria","family":"Ippoliti","sequence":"first","affiliation":[{"name":"National Centre for Drug Research and Evaluation National Institute of Health  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Menniti\u2010Ippolito","sequence":"additional","affiliation":[{"name":"National Centre for Drug Research and Evaluation National Institute of Health  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriela","family":"Mazzanti","sequence":"additional","affiliation":[{"name":"Department of Physiology and Pharmacology \u201cVittorio Erspamer\u201d Sapienza University of Rome  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3049-6644","authenticated-orcid":false,"given":"Silvia","family":"Di Giacomo","sequence":"additional","affiliation":[{"name":"Department of Physiology and Pharmacology \u201cVittorio Erspamer\u201d Sapienza University of Rome  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,2,10]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"Agenzia Italiana del Farmaco AIFA(2016).Sintrom \u2010 Fact Sheet. 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