What are the side effects of Cefuroxime (Cefuroxime axetil)?

From the Guidelines

Cefuroxime axetil can cause several side effects, including diarrhea, which is the most common adverse event, as well as other gastrointestinal disturbances, headaches, dizziness, and skin reactions, with more severe but less common side effects including Clostridioides difficile-associated diarrhea and allergic reactions 1.

Common Side Effects

• Diarrhea: the most common adverse event, observed in both treatment groups in the studies by Namyslowski 2002 1 and Namyslowski 1998 1
• Gastrointestinal disturbances: nausea, vomiting, and abdominal pain
• Headaches and dizziness
• Skin reactions: rash or itching

Less Common but More Serious Side Effects

• Clostridioides difficile-associated diarrhea (CDAD): can range from mild diarrhea to severe colitis
• Allergic reactions: ranging from mild skin rashes to severe anaphylaxis, particularly in patients with known penicillin allergies due to potential cross-reactivity
• Blood disorders: decreased white blood cell count, platelet count, or hemolytic anemia
• Temporary elevation in liver enzymes or, rarely, liver injury

Important Considerations

• Patients should contact their healthcare provider if they experience severe diarrhea, signs of allergic reaction (hives, difficulty breathing, swelling), unusual bleeding or bruising, or yellowing of the skin or eyes
• Cefuroxime axetil can affect normal body processes or trigger immune responses in some individuals, leading to these side effects
• The studies by Namyslowski 2002 1 and Namyslowski 1998 1 showed that adverse events, including diarrhea, were comparable between the cefuroxime and amoxicillin-clavulanate treatment groups.

From the FDA Drug Label

ADVERSE REACTIONS Cefuroxime for Injection is generally well-tolerated. The most common adverse effects have been local reactions following IV administration. Other adverse reactions have been encountered only rarely. Local Reactions: Thrombophlebitis has occurred with IV administration in 1 in 60 patients Gastrointestinal: Gastrointestinal symptoms occurred in 1 in 150 patients and included diarrhea (1 in 220 patients) and nausea (1 in 440 patients). Hypersensitivity Reactions: Hypersensitivity reactions have been reported in fewer than 1% of the patients treated with Cefuroxime for Injection and include rash (1 in 125) Pruritus, urticaria, and positive Coombs' test each occurred in fewer than 1 in 250 patients, and, as with other cephalosporins, rare cases of anaphylaxis, drug fever, erythema multiforme, interstitial nephritis, toxic epidermal necrolysis, and Stevens-Johnson syndrome have occurred Blood: A decrease in hemoglobin and hematocrit has been observed in 1 in 10 patients and transient eosinophilia in 1 in 14 patients. Hepatic: Transient rise in SGOT and SGPT (1 in 25 patients), alkaline phosphatase (1 in 50 patients), LDH (1 in 75 patients), and bilirubin (1 in 500 patients) levels has been noted Kidney: Elevations in serum creatinine and/or blood urea nitrogen and a decreased creatinine clearance have been observed, but their relationship to cefuroxime is unknown Postmarketing Experience with Cefuroxime for Injection: In addition to the adverse events reported during clinical trials, the following events have been observed during clinical practice in patients treated with Cefuroxime for Injection and were reported spontaneously. Immune System Disorders: Cutaneous vasculitis, angioedema, acute myocardial ischemia with or without myocardial infarction may occur as part of an allergic reaction. Nervous System Disorders: Seizure Cephalosporin-class Adverse Reactions: In addition to the adverse reactions listed above that have been observed in patients treated with cefuroxime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: Adverse Reactions: Vomiting, abdominal pain, colitis, vaginitis including vaginal candidiasis, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage.

The side effects of Cefuroxime (Cefuroxime axetil) include:

• Local Reactions: thrombophlebitis
• Gastrointestinal: diarrhea, nausea
• Hypersensitivity Reactions: rash, pruritus, urticaria, anaphylaxis
• Blood: decrease in hemoglobin and hematocrit, transient eosinophilia
• Hepatic: transient rise in SGOT and SGPT, alkaline phosphatase, LDH, and bilirubin levels
• Kidney: elevations in serum creatinine and/or blood urea nitrogen and a decreased creatinine clearance
• Immune System Disorders: cutaneous vasculitis, angioedema, acute myocardial ischemia
• Nervous System Disorders: seizure
• Cephalosporin-class Adverse Reactions: vomiting, abdominal pain, colitis, vaginitis, toxic nephropathy, hepatic dysfunction, aplastic anemia, hemolytic anemia, hemorrhage 2

From the Research

Side Effects of Cefuroxime (Cefuroxime Axetil)

• The majority of adverse events associated with cefuroxime axetil are mild to moderate in intensity and reversible upon discontinuation of treatment 3, 4, 5.
• Common side effects include:
  • Gastrointestinal disturbances, such as diarrhea, nausea, and vomiting 3, 4, 5, 6.
  • Other adverse reactions may occur, but are less frequently reported 3, 4, 5.
• Serious adverse events are rare, with only a few reported cases 4.
• Cefuroxime axetil is generally well-tolerated by adult and pediatric patients 4, 5.

Special Considerations

• Patients with a history of penicillin allergy may be at risk for cross-reactivity with cefuroxime axetil, although this is rare 7.
• Renal function should be closely monitored during therapy, especially in patients with pre-existing renal impairment 7.
• Cefuroxime axetil may interact with other medications, such as warfarin, and patients should be closely monitored for signs of interaction 4.