TABLE 7.

Causality assessment results for 1,099 combinations of licensed herbal medicine products and adverse events.

Causality assessment	Cases, n (%)	Most frequent HMP–AE combination (n)
Certain	27 (2.5)	Jagyakgamcho-tang: constipation (3) Banggiwhanggi-tang: Dry mouth (2), Insomnia (2) Bangpungtongseong-san: Dry mouth (2)
Probable/likely	161 (14.6)	Eunkyo-san: Urticaria (7), Angioedema (5), Rash (4) Woohwangchungsim-won: Somnolence (4)
Possible	616 (56.1)	Bangpungtongseong-san: Insomnia (36) Kyuongok-go: Diarrhoea (19)
Unlikely	132 (12.0)	Bangpungtongseong-san: Dry mouth (8), Somnolence (4), Tremor (4), Dizziness (3), Sleep disorder (3) Galgeun-tang: Generalised oedema (3), Weight decreased (3)
Conditional/unclassified	19 (1.7)	Bojungikgi-tang: Weight increased (3) Kyuongok-go: Abdominal discomfort (2) Ssanghwa-tang: Diarrhoea (2)
Unassessable/unclassifiable	138 (12.6)	Kyuongok-go: Pyrexia (6), Diarrhoea (5), Erythema (5), Hypersensitivity (5), Rash (5), Flushing (4), Pruritus (4), Urticaria (4) Gongjin-dan: Pruritus (4)
Not applicable	6 (0.5)	Ssanghwa-tang: Product quality issue (2) Banhasasim-tang: Vertigo (1), Vomiting (1) Bangpungtongseong-san: Product prescribing error (1) Ssanghwa-tang: Expired product administered (1)