Sulbactam/cefoperazone is generally well tolerated. The majority of adverse events are of mild or moderate severity and are tolerated with continued treatment.
In pooled clinical trial data from comparative and noncomparative studies to approximately 2500 patients, the following was observed: Gastrointestinal: As with other antibiotics, the most frequent side effects observed with sulbactam/cefoperazone have been gastrointestinal. Diarrhea/loose stools 3.9% have been reported most frequently followed by nausea and vomiting 0.6%.
Dermatologic Reactions: As with all penicillins and cephalosporins, hypersensitivity manifested by maculopapular rash, urticaria 0.08% has been reported. These reactions are more likely to occur in patients with a history of allergies, particularly to penicillin.
Hematology: Slight decreases in neutrophils have been reported. As with other β-lactam antibiotics, reversible neutropenia may occur with prolonged administration. Some individuals have developed a positive direct Coombs' test during treatment. Decreased hemoglobin 0.9% (13/1416) or hematocrit 0.9% (13/1409) have been reported, which is consistent with published literature on cephalosporins. Transient eosinophilia 3.5% (40/1130) and thrombocytopenia 0.8% (11/1414) have occurred and hypoprothrombinemia 3.8% (10/262) has been reported.
Miscellaneous: Headache 0.04%, fever 0.5%, injection pain 0.08% and chills 0.04% occurred in <1% of patients.
Laboratory Abnormalities: Transient elevations of liver function tests, SGOT 5.7% (94/1638), SGPT 6.2% (95/1529), alkaline phosphatase 2.4% (37/1518) and bilirubin 1.2% (12/1040) levels have been noted.
Local Reactions: Sulbactam/cefoperazone is well tolerated following IM administration. Occasionally, transient pain may follow administration by this route. As with other cephalosporins and penicillins, when sulbactam/cefoperazone is administered by an IV catheter some patients may develop phlebitis at the infusion site.
In post-marketing experience, the following additional undesirable effects have been reported: General: Anaphylactoid reaction (including shock).
Gastrointestinal: Pseudomembranous colitis.
Skin/Appendages: Pruritus, Stevens-Johnson syndrome.