Z-Fix 400 Adverse Reactions

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%), except as noted previously mentioned for gastrointestinal events.
Gastrointestinal: 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.
Hypersensitivity Reactions: 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.
Hepatic: Transient elevations in SGPT, SGOT, alkaline phosphatase, hepatitis, jaundice.
Renal: 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: Hyperbilirubinemia.
Other: Genital pruritus, vaginitis, candidiasis, toxic epidermal necrolysis.