Background/Aims: H-2-receptor antagonists are widely used for the ther
apy of peptic disease, since they ensure a protracted and intense inhi
bition of gastric acidity, Niperotidine (piperonyl-ranitidine) is a ne
w H-2 blocking agent recently proposed for clinical use, Methods: Twen
ty-five cases of acute hepatitis associated with the use of niperotidi
ne were reported in Italy between March and August 1995. Intercurrent
viral infections, recent drug and alcohol consumption and blood transf
usions were excluded as causes, Results: All patients showed an increa
se in the parameters of liver cell injury and the clinical symptoms of
acute hepatitis, After withdrawal of the drug, all patients showed a
good outcome, except one who developed a fulminant hepatitis and died
from digestive tract bleeding, Conclusions: The absence of other cause
s of acute liver injury suggests that the observed liver injury may be
a niperotidine-adverse reaction. Moreover, the lack of a relationship
between the dose of the drug and the degree of liver damage, the vari
able latent period and the rarity and unpredictability of the injury a
re suggestive of an idiosyncratic reaction.