Herbal hepatotoxicity by Greater Celandine (Chelidonium majus): Causality assessment of 22 spontaneous reports

► Toxic liver injury by the herb Greater Celandine (GC) created regulatory concern in Europe. ► In Germany, 22 spontaneous cases of assumed GC hepatotoxicity have been presented. ► Regulatory causality for GC was probable in 16 and possible in 6 cases. ► With a liver specific method, causality was now probable or higher in 8 cases. ► Regulators should use a liver specific rather than unspecific causality assessment method.