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Cefzil - Side Effects & Drug Interactions

[Cefprozil]




ADVERSE REACTIONS

The adverse reactions to cefprozil are similar to those observed with other orally administered cephalosporins. Cefprozil was usually well tolerated in controlled clinical trials. Approximately 2% of patients discontinued cefprozil therapy due to adverse events. The most common adverse effects observed in patients treated with cefprozil are:

Gastrointestinal:

Diarrhea (2.9%), nausea (3.5%), vomiting (1%), and abdominal pain (1%).

Hepatobiliary:

Elevat ions of AST (SGOT) (2%), ALT (SGPT) (2%), alkaline phos-phatase (0.2%), and bilirubin values ( <0.1%). As with some penicillins and some other cephalosporin antibiotics, cholestatic jaundice has been reported rarely.

Hypersensitivity:

Rash (0.9%), urticaria (0.1%). Such reactions have been reported more frequently in children than in adults. Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy.

CNS:

Dizziness (1%). Hyperactivity, headache, nervousness, insomnia, confusion, and somnolence have been reported rarely ( <1%). All were reversible.

Hematopoietic:

Decreased leukocyte count (0.2%), eosinophilia (2.3%).

Renal:

Elevated BUN (0.1%), serum creatinine (0.1%).

Other:

Diaper rash and superinfection (1.5%), genital pruritus and vaginitis (1.6%). The following adverse events, regardless of established causal relationship to CEFZIL, have been rarely reported during postmarketing surveillance: anaphylaxis, angioedema, colitis (including pseudomembranous colitis), erythema multiforme, fever, serum-sick-ness like reactions, Stevens-Johnson syndrome, and thrombocytopenia.

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