Back to the roots: safety and tolerability of standardised Ashwagandha (withania somnifera) root extract in healthy adults : a systematic review of biomarkers and adverse events

Background: Standardised Ashwagandha root extract (SARE), characterised by its content of bioactive withanolides, is widely used for its antioxidant and adaptogenic properties; however, recent case reports have raised safety concerns, primarily involving non-standardised or multi-ingredient formulat...

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Autores: Coope, Olivia, Willems, Mark Elisabeth Theodorus, Levington, Alex, Tallon, Mark, Roman-Viñas, Blanca, Spurr, Tilly
Tipo de recurso: artículo
Fecha de publicación:2026
País:España
Institución:Universitat Ramon Llull (URL)
Repositorio:DAU Arxiu Digital de la Universitat Ramon Llull
OAI Identifier:oai:dnet:dau_________::ba2984863a99b9bb5784f21e6d369797
Acceso en línea:https://hdl.handle.net/20.500.14342/6349
https://doi.org/10.3390/ph19050725
Access Level:acceso abierto
Palabra clave:Ashwagandha
Extractes de plantes
Seguretat
Tolerabilitat
Marcadors bioquímics
Efectes adversos
Suplements nutritius
Assaigs clínics
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spelling Back to the roots: safety and tolerability of standardised Ashwagandha (withania somnifera) root extract in healthy adults : a systematic review of biomarkers and adverse eventsCoope, OliviaWillems, Mark Elisabeth TheodorusLevington, AlexTallon, MarkRoman-Viñas, BlancaSpurr, TillyAshwagandhaExtractes de plantesSeguretatTolerabilitatMarcadors bioquímicsEfectes adversosSuplements nutritiusAssaigs clínicsBackground: Standardised Ashwagandha root extract (SARE), characterised by its content of bioactive withanolides, is widely used for its antioxidant and adaptogenic properties; however, recent case reports have raised safety concerns, primarily involving non-standardised or multi-ingredient formulations. This systematic review evaluated the safety and tolerability of SARE in healthy adults, with a focus on clinical biomarkers and adverse event reporting. Methods: Randomised trials were identified through searches of PubMed, Web of Science and Google Scholar, published from 2010 to April 2026. Studies administering single-ingredient, standardised root-only extracts to generally healthy populations were included. Risk of bias was assessed using the Cochrane RoB 2 tool. Results: Twenty-three studies with a total of 2317 participants met the inclusion criteria, with doses ranging from 125 to 600 mg/day and intervention durations from a single dose to 180 days. Across studies, hepatic, renal, haematological, endocrine, and cardiovascular biomarkers remained within normal clinical ranges, with no clinically meaningful adverse alterations reported. Reductions in cortisol were consistently observed, while increases in testosterone remained within physiological ranges. No serious adverse events attributable to SARE were reported. Mild adverse events, including gastrointestinal discomfort, headache, and transient drowsiness, were infrequently reported and occurred in both intervention and comparator groups. Conclusions: SARE was well tolerated in healthy adults at the studied doses and durations. However, limited long-term data (>180 days) and heterogeneity in study design and reporting warrant further large-scale, standardised trials to confirm safety across extended use and diverse populations.info:eu-repo/semantics/publishedVersionMDPIUniversitat Ramon Llull. Facultat de Ciències de la Salut BlanquernaUniversitat Ramon Llull. Facultat de Psicologia, Ciències de l’Educació i de l’Esport Blanquerna2026202620262026info:eu-repo/semantics/article29 p.application/pdfhttps://hdl.handle.net/20.500.14342/6349https://doi.org/10.3390/ph19050725reponame:DAU Arxiu Digital de la Universitat Ramon Llullinstname:Universitat Ramon Llull (URL)InglésPharmaceuticals, 2026, 19(5): 725© L'autor/aAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:dnet:dau_________::ba2984863a99b9bb5784f21e6d3697972026-06-21T06:40:37Z
dc.title.none.fl_str_mv Back to the roots: safety and tolerability of standardised Ashwagandha (withania somnifera) root extract in healthy adults : a systematic review of biomarkers and adverse events
title Back to the roots: safety and tolerability of standardised Ashwagandha (withania somnifera) root extract in healthy adults : a systematic review of biomarkers and adverse events
spellingShingle Back to the roots: safety and tolerability of standardised Ashwagandha (withania somnifera) root extract in healthy adults : a systematic review of biomarkers and adverse events
Coope, Olivia
Ashwagandha
Extractes de plantes
Seguretat
Tolerabilitat
Marcadors bioquímics
Efectes adversos
Suplements nutritius
Assaigs clínics
title_short Back to the roots: safety and tolerability of standardised Ashwagandha (withania somnifera) root extract in healthy adults : a systematic review of biomarkers and adverse events
title_full Back to the roots: safety and tolerability of standardised Ashwagandha (withania somnifera) root extract in healthy adults : a systematic review of biomarkers and adverse events
title_fullStr Back to the roots: safety and tolerability of standardised Ashwagandha (withania somnifera) root extract in healthy adults : a systematic review of biomarkers and adverse events
title_full_unstemmed Back to the roots: safety and tolerability of standardised Ashwagandha (withania somnifera) root extract in healthy adults : a systematic review of biomarkers and adverse events
title_sort Back to the roots: safety and tolerability of standardised Ashwagandha (withania somnifera) root extract in healthy adults : a systematic review of biomarkers and adverse events
dc.creator.none.fl_str_mv Coope, Olivia
Willems, Mark Elisabeth Theodorus
Levington, Alex
Tallon, Mark
Roman-Viñas, Blanca
Spurr, Tilly
author Coope, Olivia
author_facet Coope, Olivia
Willems, Mark Elisabeth Theodorus
Levington, Alex
Tallon, Mark
Roman-Viñas, Blanca
Spurr, Tilly
author_role author
author2 Willems, Mark Elisabeth Theodorus
Levington, Alex
Tallon, Mark
Roman-Viñas, Blanca
Spurr, Tilly
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Ramon Llull. Facultat de Ciències de la Salut Blanquerna
Universitat Ramon Llull. Facultat de Psicologia, Ciències de l’Educació i de l’Esport Blanquerna
dc.subject.none.fl_str_mv Ashwagandha
Extractes de plantes
Seguretat
Tolerabilitat
Marcadors bioquímics
Efectes adversos
Suplements nutritius
Assaigs clínics
topic Ashwagandha
Extractes de plantes
Seguretat
Tolerabilitat
Marcadors bioquímics
Efectes adversos
Suplements nutritius
Assaigs clínics
description Background: Standardised Ashwagandha root extract (SARE), characterised by its content of bioactive withanolides, is widely used for its antioxidant and adaptogenic properties; however, recent case reports have raised safety concerns, primarily involving non-standardised or multi-ingredient formulations. This systematic review evaluated the safety and tolerability of SARE in healthy adults, with a focus on clinical biomarkers and adverse event reporting. Methods: Randomised trials were identified through searches of PubMed, Web of Science and Google Scholar, published from 2010 to April 2026. Studies administering single-ingredient, standardised root-only extracts to generally healthy populations were included. Risk of bias was assessed using the Cochrane RoB 2 tool. Results: Twenty-three studies with a total of 2317 participants met the inclusion criteria, with doses ranging from 125 to 600 mg/day and intervention durations from a single dose to 180 days. Across studies, hepatic, renal, haematological, endocrine, and cardiovascular biomarkers remained within normal clinical ranges, with no clinically meaningful adverse alterations reported. Reductions in cortisol were consistently observed, while increases in testosterone remained within physiological ranges. No serious adverse events attributable to SARE were reported. Mild adverse events, including gastrointestinal discomfort, headache, and transient drowsiness, were infrequently reported and occurred in both intervention and comparator groups. Conclusions: SARE was well tolerated in healthy adults at the studied doses and durations. However, limited long-term data (>180 days) and heterogeneity in study design and reporting warrant further large-scale, standardised trials to confirm safety across extended use and diverse populations.
publishDate 2026
dc.date.none.fl_str_mv 2026
2026
2026
2026
dc.type.none.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/20.500.14342/6349
https://doi.org/10.3390/ph19050725
url https://hdl.handle.net/20.500.14342/6349
https://doi.org/10.3390/ph19050725
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Pharmaceuticals, 2026, 19(5): 725
dc.rights.none.fl_str_mv © L'autor/a
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv © L'autor/a
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 29 p.
application/pdf
dc.publisher.none.fl_str_mv MDPI
publisher.none.fl_str_mv MDPI
dc.source.none.fl_str_mv reponame:DAU Arxiu Digital de la Universitat Ramon Llull
instname:Universitat Ramon Llull (URL)
instname_str Universitat Ramon Llull (URL)
reponame_str DAU Arxiu Digital de la Universitat Ramon Llull
collection DAU Arxiu Digital de la Universitat Ramon Llull
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,812455

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