In clinical studies the following adverse effects were observed and were considered to be related to CEFOBID (sterile cefoperazone) therapy or of uncertain etiology:
Hypersensitivity: As with all cephalosporins, hypersensitivity manifested by skin reactions (1 patient in 45), drug fever (1 in 260), or a change in Coombs' test (1 in 60) has been reported. These reactions are more likely to occur in patients with a history of allergies, particularly to penicillin.
Hematology: As with other beta-lactam antibiotics, reversible neutropenia may occur with prolonged administration. Slight decreases in neutrophil count (1 patient in 50) have been reported. Decreased hemoglobins (1 in 20) or hematocrits (1 in 20) have been reported, which is consistent with published literature on other cephalosporins. Transient eosinophilia has occurred in 1 patient in 10.
Hepatic: Of 1285 patients treated with cefoperazone in clinical trials, one patient with a history of liver disease developed significantly elevated liver function enzymes during CEFOBID (sterile cefoperazone) therapy. Clinical signs and symptoms of nonspecific hepatitis accompanied these increases. After CEFOBID (sterile cefoperazone) therapy was discontinued, the patient's enzymes returned to pre-treatment levels and the symptomatology resolved. As with other antibiotics that achieve high bile levels, mild transient elevations of liver function enzymes have been observed in 5–10% of the patients receiving CEFOBID (sterile cefoperazone) therapy. The relevance of these findings, which were not accompanied by overt signs or symptoms of hepatic dysfunction, has not been established.
Gastrointestinal: Diarrhea or loose stools has been reported in 1 in 30 patients. Most of these experiences have been mild or moderate in severity and self-limiting in nature. In all cases, these symptoms responded to symptomatic therapy or ceased when cefoperazone therapy was stopped. Nausea and vomiting have been reported rarely.
Symptoms of pseudomembranous colitis can appear during or for several weeks subsequent to antibiotic therapy (see WARNINGS).
Renal Function Tests: Transient elevations of the BUN (1 in 16) and serum creatinine (1 in 48) have been noted.
Local Reactions: CEFOBID (sterile cefoperazone) is well tolerated following intramuscular administration. Occasionally, transient pain (1 in 140) may follow administration by this route. When CEFOBID (sterile cefoperazone) is administered by intravenous infusion some patients may develop phlebitis (1 in 120) at the infusion site.