Zifam CS1/CS2 Adverse Reactions

Zifam CS1/CS2 is generally well tolerated. The majority of adverse events is of mild or moderate severity and is tolerated with continued treatment. In pooled clinical trial data from comparative and noncomparative studies in 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 (0.6%) and 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 (0.4%, 5/1131) have been reported. As with other β-lactam antibiotics, reversible neutropenia (0.5%, 9/1696) may occur with prolonged administration. Some individuals have developed a positive direct Coombs' test (5.5%, 15/269) 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%), chills (0.04%).
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 0.1% at the infusion site.