Applies to cefixime: oral capsules conventional tablets chewable tablets, oral for suspension.
Side effects include:
GI effects (diarrhea, loose or frequent stools, abdominal pain, nausea, dyspepsia, flatulence).
For Healthcare Professionals
Applies to cefixime: oral capsule, oral powder for reconstitution, oral tablet, oral tablet chewable.
General
The most commonly reported side effects included gastrointestinal effects, diarrhea, nausea, and/or frequent/loose stools.[Ref]
Gastrointestinal
Diarrhea more commonly occurred with higher doses. Treatment cessation was occasionally warranted in patients who developed moderate to severe diarrhea. Patients who develop marked diarrhea should discontinue treatment.[Ref]
Very common (10% or more): Gastrointestinal effects (up to 30%), diarrhea (up to 16%)
Common (1% to 10%): abdominal pain, dyspepsia, flatulence, frequent stools, loose stools, nausea
Uncommon (0.1% to 1%): Vomiting
Very rare (less than 0.01%): Antibiotic-associated colitis
Frequency not reported: Marked diarrhea, moderate diarrhea, severe diarrhea, pseudomembranous colitis
Postmarketing reports: Colitis[Ref]
Hepatic
Uncommon (0.1% to 1%): Alkaline phosphatase increased, ALT increased, AST increased, liver enzyme increased
Very rare (less than 0.01%): Cholestatic jaundice, hepatitis
Frequency not reported: Blood bilirubin increased, jaundice
Postmarketing reports: Cholestasis, hyperbilirubinemia, liver dysfunction[Ref]
Dermatologic
Uncommon (0.1% to 1%): Rash/skin rash
Rare (0.01% to 0.1%): Pruritus
Very rare (less than 0.01%): Drug rash with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome, toxic epidermal necrolysis
Frequency not reported: Erythema multiforme, face edema, urticaria[Ref]
Nervous system
Uncommon (0.1% to 1%): Headache
Rare (0.01% to 0.1%): Vertigo
Very rare (less than 0.01%): Psychomotor hyperactivity
Frequency not reported: Convulsions, consciousness impaired, dizziness, encephalopathy, movement disorders
Postmarketing reports: Seizures[Ref]
Encephalopathy included confusion, convulsions, impaired consciousness, and/or movement disorders; beta-lactams predispose patients to the risk of this side effect, especially in cases of overdose or renal dysfunction.
Convulsions occurred with cephalosporins.[Ref]
Immunologic
Rare (0.01% to 0.1%): Bacterial superinfection, fungal superinfection
Very rare (less than 0.01%): Serum sickness-like reaction/serum sickness
Postmarketing reports: Candidiasis, superinfection[Ref]
Hypersensitivity
Rare (0.01% to 0.1%): Angioneurotic edema, hypersensitivity
Very rare (less than 0.01%): Anaphylactic shock
Frequency not reported: Anaphylactic reaction/anaphylactoid reaction, angioedema
Postmarketing reports: Allergic reactions, anaphylactic shock, fatal anaphylactic reaction[Ref]
Other
Rare (0.01% to 0.1%): Mucosal inflammation, pyrexia
Very rare (less than 0.01%): Drug fever[Ref]
Hematologic
Rare (0.01% to 0.1%): Eosinophilia
Very rare (less than 0.01%): Agranulocytosis, hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia
Frequency not reported: Direct positive Coombs test, granulocytopenia, hypereosinophilia, indirect positive Coombs test, neutropenia, thrombocytosis
Postmarketing reports: Aplastic anemia, prothrombin time prolongation[Ref]
Renal
Tubulointerstitial nephritis was an underlying pathological condition of acute renal failure.[Ref]
Rare (0.01% to 0.1%): Blood urea increased
Very rare (less than 0.01%): Acute renal failure, blood creatinine increased, interstitial nephritis, tubulointerstitial nephritis
Postmarketing reports: Renal dysfunction, toxic nephropathy, transient blood urea nitrogen elevation (BUN)[Ref]
Metabolic
Rare (0.01% to 0.1%): Anorexia[Ref]
Respiratory
Frequency not reported: Dyspnea[Ref]
Musculoskeletal
Frequency not reported: Arthralgia[Ref]
Genitourinary
Frequency not reported: Genital pruritus, vaginitis[Ref]
Cardiovascular
Postmarketing reports: Hemorrhage[Ref]
Endocrine
Postmarketing reports: Elevated lactate dehydrogenase (LDH)[Ref]
Psychiatric
Frequency not reported: Confusion[Ref]
