Among 169 patients treated for supeficial bladder tumor with 150 mg Pasteur-strain bacillus Calmette-Guérin (BCG) intravesical instillation, 5 cases of 'BCGitis' were observed, i.e. a severe systemic BCG infection with bronchopulmonary lesions and granulomatous hepatitis. In 4 cases, the complications appeared at the early stage of treatment (after the 3rd, 6th, 6th and 8th instillations, respectively). In 1 case, treated with monthly maintenance therapy for 2 years, BCGitis appeared 6 months after treatment had been completed and, in addition to pulmonary basal infiltrate and granulomatous hepatitis, intramedullary granulomatosis was observed. In 3 patients, trauma must be taken into consideration as BCGitis appeared after traumatic instillation with bleeding. All patients were cured by treatment with rifampicin, isoniazid and prednisone.