Kefsyn/Kefsyn 750 Adverse Reactions

Kefsyn FC tab: Gastrointestinal disturbances, including diarrhea, nausea, and vomiting, have occurred in some patients receiving Cefuroxime axetil.
There have been rare reports of erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Mild to moderate hearing loss has been reported in some children given Cefuroxime for the treatment of meningitis.
Kefsyn granules for oral susp: Adverse drug reactions to cefuroxime axetil 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 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 (eg, 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 (>1/1,000 and <1/100), rare (>1/10,000 and <1/1,000), very rare (<1/10,000).
Infections and infestations: Common: Overgrowth of Candida.
Blood and lymphatic system disorders: Common: Eosinophilia. Uncommon: Positive Coombs' test, thrombocytopenia, leucopenia (sometimes profound). Very rare: 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. 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 increase in 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.
Kefsyn 750: Cefuroxime is generally well tolerated. Adverse reactions have been generally mild and transient in nature.
Local reactions: Transient pain at the site of intramuscular injection, which is more likely to occur with higher doses.
Hypersensitivity reactions: Skin rashes (maculopapular and urticaria), drug fever and very rarely anaphylaxis have been reported.
Gastrointestinal: Diarrhea and nausea. Pseudomembranous colitis may occur during or after treatment.
Blood: Decreased hemoglobin concentration and/or eosinophilia, leukopenia and neutropenia may occur. As with other cephalosporins, there have been very rare reports of thrombocytopenia.
Hepatic: Transient rise in serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT), and bilirubin may occur.