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 (ie, 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 and <1/10; uncommon ≥1/1000 and <1/100; rare ≥1/10,000 and <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.
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 Immune System Disorders as previously discussed.)
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