Zinacef Adverse Reactions

Tablet: Adverse drug reactions to Cefuroxime axetil (Zinacef) are generally mild and transient in nature.
The frequency categories assigned to the adverse reactions as follows 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 (Zinacef) 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.
The following convention has been used for the classification of frequency: very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥1/1000 to <1/100, rare ≥1/10,000 to <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 (see Precautions).
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 also Immune system disorders as previously mentioned.
Injection: Adverse drug reactions are very rare (<1/10,000) and are generally mild and transient in nature.
The frequency categories assigned to the adverse reactions as follows are estimates, as for most reactions suitable data for calculating incidence are not available. In addition the incidence of adverse reactions associated with Cefuroxime (as sodium) (Zinacef) may vary according to the indication.
Data from clinical trials 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 <1/1000) were mainly determined using post-marketing data, and refer to a reporting rate rather than a true frequency.
The following convention has been used for the classification of frequency: Very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥1/1000 to <1/100, rare ≥1/10,000 to <1/1000, very rare <1/10,000.
Infections and infestations: Rare: Candida overgrowth.
Blood and lymphatic system disorders: Common: Neutropenia, eosinophilia; Uncommon: Leukopenia, decreased haemoglobin concentration, positive Coomb's test; Rare: Thrombocytopenia; Very rare: Haemolytic anaemia.
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.
Immune system disorders: Hypersensitivity reactions including: Uncommon: Skin rash, urticaria and pruritus; Rare: Drug fever; Very rare: Interstitial nephritis, anaphylaxis, cutaneous vasculitis.
See also Skin and subcutaneous tissue disorders and Renal and urinary disorders as follows.
Gastrointestinal disorders: Uncommon: Gastrointestinal disturbance; Very rare: Pseudomembranous colitis (see Precautions).
Hepatobiliary disorders: Common: Transient rise in liver enzymes; Uncommon: Transient rise in bilirubin.
Transient rises in serum liver enzymes or bilirubin occur, particularly in patients with pre-existing liver disease, but there is no evidence of harm to the liver.
Skin and subcutaneous tissue disorders: Very rare: Erythema multiforme, toxic epidermal necrolysis and Stevens Johnson Syndrome.
See also Immune system disorders as previously mentioned.
Renal and urinary disorders: Very rare: Elevations in serum creatinine, elevations in blood urea nitrogen and decreased creatinine clearance (see Precautions).
See also Immune system disorders as previously mentioned.
General disorders and administration site conditions: Common: Injection site reactions which may include pain and thrombophlebitis.
Pain at the intramuscular injection site is more likely at higher doses. However it is unlikely to be a cause for discontinuation of treatment.