Adverse drug reactions to cefuroxime axetil are generally mild and transient in nature. The frequency categories assigned to the adverse reactions below are estimates, as for most reactions suitable data (eg, from placebo-controlled studies) for calculating incidence were not available. In addition the incidence of adverse reactions associated with cefuroxime axetil may vary according to the indication.
Data from large clinical studies were used to determine the frequency of very common to rare undesirable effects. The frequencies assigned to all other undesirable effects (ie, those occurring at <1/10,000) were mainly determined using post-marketing data and refer to a reporting rate rather than true frequency. Placebo-controlled trial data were not available. Where incidences have been calculated from clinical trial data, these were based on drug-related (investigator assessed) data.
The following convention has been used for the classification of frequency: Very common ≥1/10; common ≥1/100 and <1/10; uncommon ≥1/1000 and <1/100; rare ≥1/10,000 and <1/1000; very rare <1/10,000.
Infections and Infestations: Common: Overgrowth of Candida.
Blood and Lymphatic System Disorders: Common: Eosinophilia. Uncommon: Positive Coombs' test, thrombocytopenia, leukopenia (sometimes profound). Very Rare: Haemolytic anaemia.
Cephalosporins as a class tend to be absorbed onto the surface of red cells membranes and react with antibodies directed against the drug to produce a positive Coombs' test (which can interfere with cross-matching of blood) and very rarely haemolytic anaemia.
Immune System Disorders: Hypersensitivity reactions including: Uncommon: Skin rashes. Rare: Urticaria, pruritus. Very Rare: Drug fever, serum sickness, anaphylaxis.
Nervous System Disorders: Common: Headache, dizziness.
Gastrointestinal Disorders: Common: Gastrointestinal disturbances including diarrhoea, nausea, abdominal pain. Uncommon: Vomiting. Rare: Pseudomembranous colitis.
Hepatobiliary Disorders: Common: Transient increases of hepatic enzyme levels, [ALT (SGPT), AST (SGOT), LDH]. Very Rare: Jaundice (predominantly cholestatic), hepatitis.
Skin and Subcutaneous Tissue Disorders: Very Rare: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthematic necrolysis) (See Immune System Disorders as previously discussed.)