CLAFORAN is generally well tolerated. The most common adverse reactions have been local reactions following IM or IV injection. Other adverse reactions have been encountered infrequently.

The most frequent adverse reactions (greater than 1%) are:
Local (4.3%) - Injection site inflammation with IV administration. Pain, induration, and tenderness after IM injection.
Hypersensitivity (2.4%) - Rash, pruritus, fever, eosinophilia and less frequently urticaria and anaphylaxis.
Gastrointestinal (1.4%) - Colitis, diarrhea, nausea, and vomiting.
Symptoms of pseudomembranous colitis can appear during or after antibiotic treatment.
Nausea and vomiting have been reported rarely.

Less frequent adverse reactions (less than 1%) are:
Cardiovascular System - Potentially life-threatening arrhythmias following rapid (less than 60 seconds) bolus administration via central venous catheter have been observed.
Hematologic System - Neutropenia, transient leukopenia, eosinophilia, thrombocytopenia and agranulocytosis have been reported. Some individuals have developed positive direct Coombs Tests during treatment with CLAFORAN (cefotaxime sodium injection) and other cephalosporin antibiotics. Rare cases of hemolytic anemia have been reported.
Genitourinary System - Moniliasis, vaginitis.
Central Nervous System - Headache.
Liver - Transient elevations in SGOT, SGPT, serum LDH, and serum alkaline phosphatase levels have been reported.
Kidney - As with some other cephalosporins, interstitial nephritis and transient elevations of BUN and creatinine have been occasionally observed with CLAFORAN.

Cutaneous-As with other cephalosporins, isolated cases of erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.

Cephalosporin Class Labeling

In addition to the adverse reactions listed above which have been observed in patients treated with cefotaxime sodium, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics: allergic reactions, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, and false-positive test for urinary glucose.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. See DOSAGE AND ADMINISTRATION and OVERDOSAGE. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.

Drug/Laboratory Test Interactions

Cephalosporins, including cefotaxime sodium, are known to occasionally induce a positive direct Coombs† test.

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