Aims: The object of this review was to collect available data on 1) adverse effects observed in humans from the intake of plant food supplements (PFS) or botanical preparations; 2) the misidentification of poisonous plants; 3) interactions between PFS/botanicals and conventional drugs or nutrients. Methods: PubMed/MEDLINE and Embase were searched from database inception to June 2014, using the terms "adverse effect/s", "poisoning/s", "plant food supplement/s", "misidentification/s", and

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... tion/s" in combination with the relevant plant name. All papers were critically evaluated according to the WHO Guidelines for causality assessment. Results: Data were obtained for 66 plants that are common ingredients of PFS; of the 488 papers selected, 398 (81.6%) dealt with adverse effects directly associated with the botanical and 89 (18.2%) concerned interactions with conventional drugs. Only 1 case was associated with misidentification. Adverse effects were reported for 39 out of the 66 botanical substances searched. Of the total references, 86.5% were associated with 14 plants, including Glycine max/soybean (19.3%), Glycyrrhiza glabra/liquorice (12.5%), Ginkgo biloba/ginkgo and Camellia sinensis/green tea (both 8.6%). Conclusions: Considering the length of time examined and the number of plants included in the review, it is remarkable that: 1) the adverse effects due to botanical ingredients were relatively infrequent, if assessed for causality; 2) the number of severe clinical reactions was very limited, but some fatal cases have been described. Data presented in this review were assessed for quality in order to make the results maximally useful for clinicians in identifying or excluding deleterious effects of botanicals. Word count: 4709; number of Tables: 6. 26 27 SUMMARY 28 Aims: The object of this review was to collect available data on 1) adverse effects observed in humans from the 29 intake of plant food supplements (PFS) or botanical preparations; 2) the misidentification of poisonous plants; 30 3) interactions between PFS/botanicals and conventional drugs or nutrients. 31 Methods: PubMed/MEDLINE and Embase were searched from database inception to June 2014, using the terms 32 "adverse effect/s", "poisoning/s", "plant food supplement/s", "misidentification/s", and "interaction/s" in 33 combination with the relevant plant name. All papers were critically evaluated according to the WHO 34 Guidelines for causality assessment. 35 Results: Data were obtained for 66 plants that are common ingredients of PFS; of the 488 papers selected, 398 36 (81.6%) dealt with adverse effects directly associated with the botanical and 89 (18.2%) concerned interactions 37 with conventional drugs. Only 1 case was associated with misidentification. Adverse effects were reported for 38 39 out of the 66 botanical substances searched. Of the total references, 86.5% were associated with 14 plants, 39 including Glycine max/soybean (19.3%), Glycyrrhiza glabra/liquorice (12.5%), Ginkgo biloba/ginkgo and 40 Camellia sinensis/green tea (both 8.6%). 41 Conclusions: Considering the length of time examined and the number of plants included in the review, it is 42 remarkable that: 1) the adverse effects due to botanical ingredients were relatively infrequent, if assessed for 43 causality; 2) the number of severe clinical reactions was very limited, but some fatal cases have been described. 44 Data presented in this review were assessed for quality in order to make the results maximally useful for 45 clinicians in identifying or excluding deleterious effects of botanicals. 47 Accepted Article 97 PubMed/MEDLINE and Embase, were systematically searched to create the present work. The following search 98 strategy and selection criteria were used: data were collected from database inception to June 2014, with the 99 terms "adverse effect/s", "poisoning/s", "plant food supplement/s", "misidentification/s", and "interaction/s" in 100 combination with the relevant plant name. 102 Causality assessment 103 The assessment of reports on adverse reactions to PFS and/or their botanical ingredients was performed 104 according to the WHO Causality Assessment Criteria as described in Table 2 [7].