Sulperazon 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 in approximately 2500 patients the following was observed:
Gastrointestinal: As with other antibiotics, the most frequent side effects observed with Sulperazon 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 urticarial 0.8%, 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. Some cases of hemolytic anemia have been reported following treatment with cephalosporins.
Miscellaneous: Headache 0.04%, fever 0.5%, injection pain 0.08%, chills 0.04%.
Laboratory Abnormalities: Transient elevations of liver function test, 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: Sulperazon is well tolerated following IM administration. Occasionally, transient pain at the infusion site may follow administration by this route. As with other cephalosporins and penicillins, when Sulperazon is administered by an IV catheter, some patients 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.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving β-lactam or cephalosporin therapy. These reactions are more apt to occur in individuals with a history of hypersensitivity reactions to multiple allergens. If an allergic reaction occurs, Sulperazon should be discontinued and the appropriate therapy instituted.
Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, IV steroids and airway management, including intubation, should be administered as indicated.
A reaction characterized by flushing, sweating, headache and tachycardia has been reported when alcohol was ingested during and as late as the 5th day after cefoperazone administration. A similar reaction has been reported with certain other cephalosporins and patients should be cautioned as to the possible adverse events following the ingestion of alcoholic beverages in conjunction with administration of Sulperazon. For patients requiring artificial feeding orally or parenterally, solutions containing ethanol should be avoided.