Gastro-intestinal tract tolerance is one of the major aspect to be considered regarding oral betalactams antibiotics. We report two studies performed in France in order to collect precise informations on the tolerance of cefuroxime axetil in general practice: 1) a pharmacovigilance cohort which enrolled 371 patients, 2) a study of efficacy and tolerance of cefuroxime axetil in acute bronchitis involving 8267 patients. In the pharmacovigilance cohort (non comparative open study) side effects in 66 patients, including 2 treatment discontinuation were reported. Diarrhoae and nausea (representing 2.9 % each) were the most frequent side effects. The epidemiologic and therapeutic study confirmed cefuroxime axetil efficacy in bronchial infections, and permitted better knowledge of some factors linked to therapeutic efficacy. In this late study 334 drug related side effects were registered in 275 patients (3.3 %), which were considered as of medium or light intensity. In both studies, cefuroxime axetil appeared as well tolerated with a low incidence of digestive tract side effects and a low rate of therapy discontinuation. This report emphasizes the interest of a pharmacovigilance cohort study in the evaluation of clinical tolerance of an oral compound in general practice.
