Most adverse effects reported with cefixime were similar to those reported with other oral cephalosporins and were usually mild and transient in nature.
Gastrointestinal Effects: Abdominal pain, anorexia, diarrhea, dry mouth, dyspepsia, flatulence, loose or frequent stools, nausea, vomiting, pseudomembranous colitis, pruritus ani.
Hypersensitivity Reactions: Anaphylactic/anaphylactoid reactions (including shock and fatalities), angioedema, arthralgia, drug fever, erythema multiforme, facial edema, pruritus, skin rashes, serum sickness-like reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.
Hepatic Effects: Transient elevation of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, bilirubin and lactate dehydrogenase (LDH); hepatitis, jaundice.
Renal and Genitourinary Effects: Transient elevations in blood urea nitrogen (BUN) and serum creatinine levels, acute renal failure, dysuria, pyuria, genital pruritus, vaginitis, vaginal candidiasis.
Central Nervous System Effects: Dizziness, headache, fatigue, insomnia, malaise, nervousness, seizures, somnolence.
Hematologic Effects: Transient thrombocytopenia, thrombocytosis, leukopenia, leukocytosis, neutropenia, and eosinophilia; prolongation of prothrombin time and partial thromboplastin time, decreased hemoglobin concentration and hematocrit.
Abnormal Laboratory Test: Hyperbilirubinemia.
Other Adverse Effects: Increased serum amylase concentrations.
In addition to the adverse reactions listed previously which have been observed in patients treated with cefixime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: Allergic reactions, hypersensitivity reactions including chills, joint pain or inflammation, hypotension; renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis; aplastic anemia, hemolytic anemia, epistaxis or hemorrhage, agranulocytosis, thrombocythemia, granulocytosis, monocytosis, lymphocytopenia, basophilia, hypoprothrombinemia (with or without bleeding), menstrual irregularities, tenesmus, epigastric pain, glossitis, candidiasis (oral thrush), taste alteration, decreased salivation, heartburn, colitis, nightmares, vertigo, chest pain, pleural effusion, pulmonary infiltrate, dyspnea or respiratory distress, cough, and rhinitis, increased or decreased serum glucose concentration, superinfection.
Abnormal Laboratory Tests: Positive Coombs' test, pancytopenia, transient increase in Y-glutamyl transferase, decreased serum albumin and/or total protein