Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self-limiting in nature.
The most frequent side effects seen with Cefixime are diarrhoea and stool changes; diarrhoea has been more commonly associated with higher doses. Some cases of moderate to severe diarrhoea have been reported; this has occasionally warranted cessation of therapy. Cefixime should be discontinued if marked diarrhoea occurs. Other gastrointestinal side effects seen less frequently are nausea, abdominal pain, dyspepsia, vomiting and flatulence. Pseudomembranous colitis has also been reported.
Central Nervous System:
Headache and dizziness.
Allergies in the form of rash, pruritus, drug fever and arthralgia have been observed, including rare cases of urticaria or angioedema. These reactions usually subsided upon discontinuation of therapy. Rarely, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Haematological and Clinical Chemistry:
Thrombocytosis, thrombocytopenia, leucopenia, hypereosinophilia, neutropenia and agranulocytosis have been reported. These reactions were infrequent and reversible. Mild transient changes in liver and renal function tests have been observed.
Transient rises in liver transaminases, alkaline phosphatase and jaundice can also occur.
Other possible reactions include genital pruritus and vaginitis.
Most of adverse effects observed in clinical trials were of a mild and transient nature. Five percent (5%) of patients discontinued therapy because of drug-related adverse effects. The most commonly seen adverse effects were gastrointestinal events, which were reported in 30% of adult patients on either the BID or the QD regimen. Clinically mild gastrointestinal symptoms occurred in 20% of all patients, moderate events occurred in 9% of all patients and severe adverse effects occurred in 2% of all patients. Individual event rates included diarrhea 16%, loose or frequent stools 6%, abdominal pain 3%, nausea 7%, dyspepsia 3%, and flatulence 4%. These symptoms usually responded to symptomatic therapy or ceased when cefixime was discontinued. Several patients developed severe diarrhea and/or documented pseudomembranous colitis, and a few required hospitalization.
The following adverse effects have been reported following the use of cefixime. Incidence rates were less than 1 in 50 (less than 2%), excepts as noted previously for gastrointestinal events.
Diarrhea, loose stools, abdominal pain, dyspepsia, nausea, and vomiting. Several cases of documented pseudomembranous colitis were identified during the studies. The onset of pseudomembranous colitis symptoms may occur during or after therapy.
Anaphylactic/anaphylactoid reactions (including shock and fatalities), skin rashes, urticaria, drug fever, pruritus, angioedema, and facial edema. Erythema multiforme, Stevens-Johnson syndrome, and serum sickness like reactions have been reported.
Transient elevations in SGPT, SGOT, alkaline phosphatase, hepatitis, jaundice.
Transient elevations in BUN or creatinine, acute renal failure.
Central Nervous System:
Headaches, dizziness, seizures.
Hemic and Lymphatic Systems:
Transient thrombocytopenia, leukopenia, neutropenia, and eosinophilia. Prolongation in prothrombin time was seen rarely.
Abnormal Laboratory Tests:
Genital pruritus, vaginitis, candidiasis, toxic epidermal necrolysis.