Ceftin Side Effects

Generic Name: cefuroxime

Please note - some side effects for Ceftin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Ceftin - for the Consumer

Ceftin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ceftin:

Diarrhea/loose stools; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; change in the amount of urine; dark urine; easy bruising or bleeding; fatigue; fever; seizures; severe diarrhea; stomach cramps/pain; vaginal irritation or discharge; yellowing of the skin or eyes.

Ceftin Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ceftin Suspension:

Diarrhea; headache; loose stools; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; change in the amount of urine; dark urine; easy bruising or bleeding; fatigue; fever; seizures; severe diarrhea; stomach cramps/pain; vaginal irritation or discharge; yellowing of the skin or eyes.

Side Effects by Body System

General

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

Cefuroxime is generally well-tolerated.

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

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.

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.

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

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.

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

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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