|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 below are estimates, as for most reactions suitable data (for example 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 (i.e. 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. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.Treatment related adverse reactions, all grades, are listed below by MedDRA body system organ class, frequency and grade of severity. The following convention has been utilised 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).|
|System organ class||Common||Uncommon||Not known|
|Infections and infestations||Candida
|| ||Clostridium difficile
|Blood and lymphatic system disorders ||eosinophilia
||positive Coomb's test,
thrombocytopenia, leukopenia (sometimes profound)
|Immune system disorders || || ||drug fever, serum sickness, anaphylaxis, Jarisch-Herxheimer reaction
|Nervous system disorders||headache, dizziness
|| || |
|Gastrointestinal disorders||diarrhoea, nausea, abdominal pain
||pseudomembranous colitis (see section 4.4)
|Hepatobiliary disorders||transient increases of hepatic enzyme levels
|| ||jaundice (predominantly cholestatic), hepatitis
|Skin and subcutaneous tissue disorders|| ||skin rashes
||urticaria, pruritus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthematic necrolysis) (see Immune system disorders), angioneurotic oedema
|Description of selected adverse reactionsCephalosporins 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.
Transient rises in serum liver enzymes have been observed which are usually reversible.
Paediatric populationThe safety profile for cefuroxime axetil in children is consistent with the profile in adults.
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: email@example.com.