A slightly increased number of basophilic hepatic foci were observed in chronic rat studies with budesonide and in carcinogenicity studies an increased incidence of primary hepatocellular neoplasms, astrocytomas (in male rats) and mammary tumours (female rats) were observed. These tumours are probably due to the specific steroid receptor action, increased metabolic burden on the liver and anabolic effects, effects which are also known from other glucocorticosteroids in rat studies and therefore represent a class effect. No similar effects have ever been observed in man for budesonide, neither in clinical trials nor from spontaneous reports.
Investigation to detect a possible sensitizing effect of Scheriproct or of the active ingredients contained therein has not been carried out. According to relevant data gained from spontaneous reports as well as contained in the literature, it is possible that not only individual ingredients of the formulation base but also the active ingredients themselves are responsible for the allergenic skin reactions which were observed only sporadically after the use of Scheriproct. There is, however, no risk of a sensitizing effect occurring other than in sporadic cases.