{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T01:43:17Z","timestamp":1792460597083,"version":"4.5.0"},"reference-count":37,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2022,11,23]],"date-time":"2022-11-23T00:00:00Z","timestamp":1669161600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004423","name":"World Health Organization","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004423","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Phytotherapy Research"],"published-print":{"date-parts":[[2023,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Tea tree (<jats:italic>Melaleuca alternifolia<\/jats:italic>) essential oil is widely used as an antiseptic. It mainly consists of monoterpenes with terpinen\u20104\u2010ol as the major constituent. The aim of this study was to review literature on safety data about tea tree oil and to assess its safety by investigating 159 cases of adverse reactions possibly caused by the oil, reported to the World Health Organization (WHO) from December 1987 until September 2021. To extract these data, VigiBase, the WHO global database of individual case safety reports maintained by the Uppsala Monitoring Centre (UMC), was used. All cases were categorized and analysed and 16 serious cases further assessed. It was concluded that tea tree oil should never be administered orally, as it can lead to central nervous system depression and pneumonitis. Applied topically, skin disorders may occur, especially when the oil had been exposed to light or air. This yields monoterpene oxidation products, being potent skin irritants. Tea tree oil stored under appropriate conditions and not exceeding the expiration date should be considered safe to use by non\u2010vulnerable people for non\u2010serious inflammatory skin conditions, although the occurrence of adverse reactions such as contact allergies is difficult to predict.<\/jats:p>","DOI":"10.1002\/ptr.7687","type":"journal-article","created":{"date-parts":[[2022,11,24]],"date-time":"2022-11-24T13:21:35Z","timestamp":1669296095000},"page":"1309-1318","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Safety assessment and adverse drug reaction reporting of tea tree oil (<i>Melaleuca aetheroleum<\/i>)"],"prefix":"10.1002","volume":"37","author":[{"given":"Anne\u2010Sophie M. W.","family":"Bekhof","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Technology and Biopharmacy University of Groningen  Groningen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8965-3224","authenticated-orcid":false,"given":"Florence P. A. M.","family":"van Hunsel","sequence":"additional","affiliation":[{"name":"Netherlands Pharmacovigilance Centre Lareb  's\u2010Hertogenbosch The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonja","family":"van de Koppel","sequence":"additional","affiliation":[{"name":"Netherlands Pharmacovigilance Centre Lareb  's\u2010Hertogenbosch The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9450-5880","authenticated-orcid":false,"given":"Herman J.","family":"Woerdenbag","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Technology and Biopharmacy University of Groningen  Groningen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,11,23]]},"reference":[{"key":"e_1_2_15_2_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.chemrestox.5b00530"},{"key":"e_1_2_15_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/104063879801000223"},{"key":"e_1_2_15_4_1","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.19.1.50-62.2006"},{"key":"e_1_2_15_5_1","doi-asserted-by":"publisher","DOI":"10.3109\/15563659509000474"},{"key":"e_1_2_15_6_1","unstructured":"Committee on Herbal Medicinal Products (HMPC)(2013).Community herbal monograph onMelaleuca alternifolia(Maiden and Betch) Cheel M. linariifoliaSmith M. dissitifloraF. Mueller and\/or other species ofMelaleuca aetheroleum. European Medicines Agency.https:\/\/www.ema.europa.eu\/en\/documents\/herbal\u2010monograph\/draft\u2010community\u2010herbal\u2010monograph\u2010melaleuca\u2010alternifolia\u2010maiden\u2010betch\u2010cheel\u2010m\u2010linariifolia\u2010smith\u2010m\/other\u2010species\u2010melaleuca\u2010aetheroleum\u2010first\u2010version_en.pdf"},{"key":"e_1_2_15_7_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2672.2000.00943.x"},{"key":"e_1_2_15_8_1","first-page":"557","article-title":"Melaleuca oil poisoning in a 17\u2010month\u2010old","volume":"37","author":"Del Beccaro M. A.","year":"1995","journal-title":"Veterinary and Human Toxicology"},{"key":"e_1_2_15_9_1","volume-title":"Tea tree oil: A medicine kit in a bottle, version 1.0","author":"Drury S.","year":"1996"},{"key":"e_1_2_15_10_1","volume-title":"European Pharmacopoeia Edition (Ph. 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