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 class              Common                      Uncommon                  Not known 
Infections and                                                                Candida overgrowth, infestations                                                                  overgrowth of Clostridium difficile
Blood and lymphatic    neutropenia,eosinophilia,       leukopenia, positive   thrombocytopenia, system disorders       decreased haemoglobin           Coomb’s test           haemolytic anaemia concentration

Immune system                                                                 drug fever, interstitial disorders                                                                     nephritis, anaphylaxis, cutaneous vasculitis
Gastrointestinal                                       gastrointestinal       pseudomembranous disorders                                              disturbance            colitis (see section 4.4) 
Hepatobiliary          transient rise in liver         transient rise in disorders              enzymes                         bilirubin
Skin and                                               skin rash, urticaria   erythema multiforme, subcutaneous tissue                                    and pruritus           toxic epidermal necrolysis disorders                                                                     and Stevens-Johnson syndrome,
angioneurotic oedema
Renal and urinary                                                             elevations in serum disorders                                                                     creatinine, elevations in blood urea nitrogen and decreased creatinine clearance (see section 4.4)

General disorders      injection site reactions and administration     which may include pain site conditions        and 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