Cefuroxime Side Effects

Some side effects of cefuroxime may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to cefuroxime: oral powder for reconstitution, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking cefuroxime: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• diarrhea that is watery or bloody;

• fever, chills, body aches, flu symptoms;

• chest pain, fast or pounding heartbeats;

• unusual bleeding;

• blood in your urine;

• seizure (convulsions);

• pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• jaundice (yellowing of the skin or eyes);

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

• skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

• increased thirst, loss of appetite, swelling, weight gain, feeling short of breath; or

• painful or difficult urination, urinating less than usual or not at all.

Less serious side effects of cefuroxime may include:

• nausea, vomiting, stomach pain, mild diarrhea, gas, upset stomach;

• cough, stuffy nose;

• stiff or tight muscles, muscle pain;

• joint pain or swelling;

• headache, drowsiness;

• feeling restless, irritable, or hyperactive;

• white patches or sores inside your mouth or on your lips;

• unusual or unpleasant taste in your mouth;

• diaper rash in an infant taking liquid cefuroxime;

• mild itching or skin rash; or

• vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to cefuroxime: injectable powder for injection, intravenous solution, oral powder for reconstitution, oral tablet

General

Cefuroxime is generally well-tolerated.

Side effects may be more likely and more severe in patients with liver disease and/or renal dysfunction.

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting (1% to 3%), diarrhea/loose stools (1% to 8.6%), abdominal pain, abdominal cramps, flatulence, indigestion, mouth ulcers, and anorexia, dyspepsia, excess salivation, and pseudomembranous colitis.

Pseudomembranous colitis has been reported in patients treated with cephalosporins, including cefuroxime, and may occur during or after treatment. If diarrhea occurs and it is unresponsive to discontinuation of the drug and/or standard therapy, pseudomembranous colitis should be considered.

Hepatic

Hepatic side effects have included transient elevations of AST (2% to 4%), ALT (1.6% to 4%), and LDH (1%), alkaline phosphatase (2%, IV route), elevated bilirubin, hepatitis, cholestasis, and jaundice.

Nervous system

Nervous system side effects have included headache, sleepiness, dizziness, somnolence, lockjaw-type reaction (less than 1%), and seizures. Cephalosporin class antibiotics, including cefuroxime, have been associated with seizures, especially in renally impaired patients.

Hypersensitivity

Hypersensitivity reactions have included anaphylaxis, angioedema, rash, pruritus, serum sickness-like reaction, urticaria, drug fever, interstitial nephritis, toxic epidermal necrolysis, and Stevens-Johnson syndrome. At least one case of Kounis syndrome type I variant has been reported.

Rare cases of erythema multiforme and Stevens-Johnson syndrome have been reported. There is a 10% to 20% incidence of allergy to cefuroxime in patients allergic to penicillin.

A case of occupational contact dermatitis due to cephalosporin allergy has been reported in a nurse who prepared cephalosporin solutions for administration to patients. The dermatitis resolved after the nurse stopped preparing the solutions.

A 90-year-old man, with no history of coronary artery disease, diabetes mellitus, hypertension, or hyperlipidemia, was administered 750 mg cefuroxime axetil intramuscularly for urinary tract infection. About 10 minutes after the injection, the patient developed chest pain and pruritic skin rashes. Kounis syndrome type I variant was diagnosed secondary to cefuroxime axetil. Five days after stopping cefuroxime axetil, the patient's symptoms had resolved.

Hematologic

Hematologic side effects have included eosinophilia (1.1%), positive Coombs' test (less than 1%), decreased hemoglobin and hematocrit (10%, IV route), transient neutropenia (less than 1%), leukopenia (0.1%), hemolytic anemia, pancytopenia, increased prothrombin time, thrombocytopenia, and autoimmune granulocytopenia. Cephalosporin class antibiotics have been associated with aplastic anemia, hemorrhage, neutropenia, and agranulocytosis.

Rare cases of eosinophilia and positive direct Coombs' tests have been reported without other evidence of hypersensitivity.

Immune hemolytic anemia has been reported in a pediatric patient.

Renal

Acute renal failure has been reported in a patient treated with cefuroxime. Renal function improved after cefuroxime was stopped, and deteriorated upon rechallenge.

Renal side effects have included renal dysfunction (less than 1%) and acute renal failure. Cephalosporin class antibiotics have been associated with toxic nephropathy, increased BUN, increased creatinine, and interstitial nephritis. Reversible fever, azotemia, pyuria, and eosinophilia are the hallmarks of cephalosporin-induced interstitial nephritis.

Genitourinary

Genitourinary side effects have included vaginitis, vaginal candidiasis, vaginal discharge, vaginal itch, vulvar itch, dysuria, urethral pain and/or bleeding, and kidney pain in less than 1% of patients, and urinary tract infection (less than 1% of pediatric patients). Cephalosporin class antibiotics have been associated with false positive tests for urinary glucose.

Dermatologic

Dermatologic side effects have included rash, hives, pruritus, urticaria, and erythema in less than 1% of patients, diaper rash (3.4% of pediatric patients), acute generalized exanthematous pustulosis, erythema multiforme, and toxic epidermal necrolysis.

Metabolic

Metabolic side effects have included thirst (less than 1%).

Other

Other side effects have included chest pain or tightness, chills, viral illness, gastrointestinal infection, swollen tongue, candidiasis, and fever in less than 1% of patients. At least one case of disulfiram reaction has been reported with cefuroxime axetil. Complaints about taste were reported in 5% of pediatric patients, leading to discontinuation in 1.4%.

The Jarisch-Herxheimer reaction has been reported in 5.6% of Lyme Disease patients.

Respiratory

Respiratory side effects have included shortness of breath (less than 1%), and sinusitis, cough, and upper respiratory infection in less than 1% of pediatric patients.

Musculoskeletal

Musculoskeletal side effects have included muscle cramps, muscle stiffness, and muscle spasm of the neck in less than 1% of patients, and joint swelling and arthralgia in less than 1% of pediatric patients.

Cardiovascular

Cardiovascular side effects have included tachycardia (less than 1%).

Local

Local side effects have included thrombophlebitis with intravenous administration (1.7%).

Immunologic

Immunologic side effects have included cutaneous vasculitis (postmarketing experience).

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