Phlebitis was reported in <1% after IV administration.
Hypersensitivity: Rash (1.7%).
Less frequently reported (<1%) were anemia, hemolytic anemia, neutropenia, lymphopenia, thrombocytopenia and prolongation of the prothrombin time.
Gastrointestinal: Diarrhea (2.7%).
Less frequently reported (<1%) were nausea or vomiting and dysgeusia.
The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment.
Hepatic: Elevations of SGOT (serum glutamic-oxaloacetic transaminase 3.1%) or SGPT (serum glutamic-pyruvic transaminase 3.3%).
Less frequently reported (<1%) were elevations of alkaline phosphatase and bilirubin.
Renal: Elevations of BUN (1.2%).
Less frequently reported (<1%) were elevations of creatinine and the presence of casts in the urine.
Central Nervous System: Headache or dizziness were reported occasionally (<1%).
Genitourinary: Moniliasis or vaginitis were reported occassionally (<1%).
Miscellaneous: Diaphoresis and flushing were reported occasionally (<1%).
Other rarely observed adverse reactions (0.1%) include abdominal pain, agranulocytosis, allergic pneumonitis, anaphylaxis, basophilia, biliary lithiasis, bronchospasm, colitis, dyspepsia, epistaxis, flatulence, gallbladder sludge, glycosuria, hematuria, jaundice, leukocytosis, lymphocytosis, monocytosis, nephrolithiasis, palpitations, decrease in prothrombin time, renal palpitations, seizures, and serum sickness.
Other reported adverse events are stomatitis, glossitis, pseudomembranous colitis (mostly caused by Clostridium difficile), pancreatitis (possibly caused by obstruction of bile ducts), allergic skin reactions such as maculopapular rash or exanthema, urticaria, dermatitis, pruritus, edema, erythema multiforme, Stevens Johnson syndrome, Lyell's syndrome/toxic epidermal necrolysis, oliguria, dehydration or immobilization, anuria, renal impairment and rigors.
Sulbactam: The only adverse effect observed after parenteral administration of Sulbactam to humans was pain at the site of IM injection. The pain subsided rapidly and disappeared within 1 hour.
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