Cefudyne Adverse Reactions

Film-coated tablet: The most common adverse reactions are Candida overgrowth, eosinophilia, headache, dizziness, gastrointestinal disturbances and transient rise in liver enzymes.
The frequency categories assigned to the adverse reactions as follows are estimates, as for most reactions suitable data for calculating incidence were not available. In addition, the incidence of adverse reactions associated with cefuroxime axetil may vary according to the indication.
Treatment-related adverse reactions, all grades, are listed as follows by MedDRA body system organ class, frequency and grade of severity. The following convention has been utilized for the classification of frequency: very common ≥1/10; common ≥1/100 to <1/10; uncommon ≥1/1,000 to <1/100; rare ≥1/10,000 to <1/1,000; very rare <1/10,000 and not known (cannot be estimated from the available data). (See Table 6.)

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Pediatric population: The safety profile for cefuroxime axetil in children is consistent with the profile in adults.
Powder for Suspension: Gastrointestinal disturbances, including diarrhea, nausea, and vomiting, have occurred in some patients receiving cefuroxime. There have been rare reports of erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.