Adverse drug reactions to cefuroxime 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 example from placebo-controlled studies) for calculating incidence were not available. In addition, the incidence of adverse reactions associated with cefuroxime 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 adverse 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: Tablet: Common: Overgrowth of Candida. Injection: Rare: Overgrowth of Candida.
Blood and lymphatic system disorders: Common: Tablet: Eosinophilia. Injection: Neutropenia, eosinophilia. Uncommon: Positive Coombs' test, leukopenia (sometimes profound). Tablet: Thrombocytopenia. Injection: Decreased hemoglobin concentration. Rare: Injection: Thrombocytopenia. Very rare: Tablet: Hemolytic anemia.
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 Coombs' test (which can interfere with cross-matching of blood) and very rarely hemolytic anemia.
Immune system disorders: Hypersensitivity reactions including: Uncommon: Skin rashes. Injection: Urticaria and pruritus. Rare: Tablet: Urticaria, pruritus. Injection: Drug fever. Very rare: Tablet: Drug fever, serum sickness, anaphylaxis. Injection: Interstitial nephritis, anaphylaxis, cutaneous vasculitis.
Nervous system disorders: Tablet: Common: Headache, dizziness.
Gastrointestinal disorders: Common: Gastrointestinal disturbances including diarrhea, nausea, abdominal pain. Uncommon: Tablet: Vomiting. Injection: Gastrointestinal disturbance. Rare: Tablet: Pseudomembranous colitis (see Precautions). Very rare: Injection: Pseudomembranous colitis (see Precautions).
Hepatobiliary disorders: Common: Transient increases of hepatic enzyme levels, [ALT (SGPT), AST (SGOT), LDH]. Uncommon: Injection: Transient rise in bilirubin. Very rare: Tablet: Jaundice (predominantly cholestatic), hepatitis.
Transient rises in serum liver enzymes or bilirubin occur, particularly in patients with preexisting liver disease, but there is no evidence of harm to the liver.
Skin and subcutaneous tissue disorders: Very rare: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthematic necrolysis).
See also Immune system disorders.
Renal and urinary disorders: Injection: Very rare: Elevations in serum creatinine, elevations in blood urea nitrogen and decreased creatinine clearance (see Precautions).
General disorders and administration site conditions: Injection: 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.