Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The most common adverse reactions are neutropenia, eosinophilia, transient rise in liver enzymes or bilirubin, particularly in patients with pre-existing liver disease, but there is no evidence of harm to the liver and injection site reactions.

The frequency categories assigned to the adverse reactions below are estimates, as for most reactions suitable data for calculating incidence are not available. In addition the incidence of adverse reactions associated with cefuroxime sodium may vary according to the indication.

Data from clinical trials were used to determine the frequency of very common to rare adverse reactions. The frequencies assigned to all other adverse reactions (i.e.
those occurring at <1/10,000) were mainly determined using post-marketing data, and refer to a reporting rate rather than a true frequency.

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                Common                    Uncommon             Not known class
Infections and                                                         Candida overgrowth, infestations                                                           overgrowth of Clostridium difficile
Blood and          neutropenia, eosinophilia,   leukopenia, positive   thrombocytopenia, lymphatic          decreased haemoglobin        Coomb’s test           haemolytic anaemia system             concentration disorders
Immune                                                                 drug fever, interstitial system                                                                 nephritis, anaphylaxis, disorders                                                              cutaneous vasculitis Gastrointestinal                                gastrointestinal       pseudomembranous colitis disorders                                       disturbance            (see section 4.4) Hepatobiliary          transient rise in liver              transient rise in disorders              enzymes                              bilirubin Skin and                                                    skin rash, urticaria and         erythema multiforme, subcutaneous                                                pruritus                         toxic epidermal tissue disorders                                                                             necrolysis and Stevens- Johnson syndrome,
angioneurotic oedema
Renal and                                                                                    elevations in serum urinary                                                                                      creatinine, elevations in disorders                                                                                    blood urea nitrogen and decreased creatinine clearance (see section 4.4)
General disorders      injection site reactions which and administration     may include pain and site conditions        thrombophlebitis
Description of selected adverse reactions
Cephalosporins as a class tend to be absorbed onto the surface of red cell membranes and react with antibodies directed against the drug to produce a positive Coomb’s test (which can interfere with cross matching of blood) and very rarely haemolytic anaemia.

Transient rises in serum liver enzymes or bilirubin have been observed which are usually reversible.

Pain at the intramuscular injection site is more likely at higher doses. However it is unlikely to be a cause for discontinuation of treatment.


Paediatric population
The safety profile for cefuroxime sodium in children is consistent with the profile in adults.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/