Ceftin Side Effects

Generic Name: cefuroxime,cefuroxime axetil

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.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Ceftin:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Ceftin Suspension:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Top

Ceftin Side Effects - for the Professional

Ceftin

Ceftin TABLETS IN CLINICAL TRIALS

Multiple-Dose Dosing Regimens 7 to 10 Days Dosing

Using multiple doses of cefuroxime axetil tablets, 912 patients were treated with cefuroxime axetil (125 to 500 mg twice daily). There were no deaths or permanent disabilities thought related to drug toxicity. Twenty (2.2%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. Seventeen (85%) of the 20 patients who discontinued therapy did so because of gastrointestinal disturbances, including diarrhea, nausea, vomiting, and abdominal pain. The percentage of cefuroxime axetil tablet-treated patients who discontinued study drug because of adverse events was very similar at daily doses of 1,000, 500, and 250 mg (2.3%, 2.1%, and 2.2%, respectively). However, the incidence of gastrointestinal adverse events increased with the higher recommended doses.

The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroxime axetil tablets in multiple-dose clinical trials (n = 912 cefuroxime axetil-treated patients).

Table 4. Adverse Reactions--Ceftin Tablets

Multiple-Dose Dosing Regimens--Clinical Trials

Incidence ≥1%	Diarrhea/loose stools 3.7% Nausea/vomiting 3.0% Transient elevation in AST 2.0% Transient elevation in ALT 1.6% Eosinophilia 1.1% Transient elevation in LDH 1.0%
Incidence <1% but >0.1%	Abdominal pain Abdominal cramps Flatulence Indigestion Headache Vaginitis Vulvar itch Rash Hives Itch Dysuria Chills Chest pain Shortness of breath Mouth ulcers Swollen tongue Sleepiness Thirst Anorexia Positive Coombs test

5-Day Experience

In clinical trials using Ceftin in a dose of 250 mg twice daily in the treatment of secondary bacterial infections of acute bronchitis, 399 patients were treated for 5 days and 402 patients were treated for 10 days. No difference in the occurrence of adverse events was found between the 2 regimens.

In Clinical Trials for Early Lyme Disease With 20 Days Dosing

Two multicenter trials assessed cefuroxime axetil tablets 500 mg twice a day for 20 days. The most common drug-related adverse experiences were diarrhea (10.6% of patients), Jarisch-Herxheimer reaction (5.6%), and vaginitis (5.4%). Other adverse experiences occurred with frequencies comparable to those reported with 7 to 10 days dosing.

Single-Dose Regimen for Uncomplicated Gonorrhea

In clinical trials using a single dose of cefuroxime axetil tablets, 1,061 patients were treated with the recommended dosage of cefuroxime axetil (1,000 mg) for the treatment of uncomplicated gonorrhea. There were no deaths or permanent disabilities thought related to drug toxicity in these studies.

The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroxime axetil in 1,000-mg single-dose clinical trials of cefuroxime axetil tablets in the treatment of uncomplicated gonorrhea conducted in the United States.

Table 5. Adverse Reactions--Ceftin Tablets

1-g Single-Dose Regimen for Uncomplicated Gonorrhea—Clinical Trials

Incidence ≥1%	Nausea/vomiting 6.8% Diarrhea 4.2%
Incidence <1% but >0.1%	Abdominal pain Dyspepsia Erythema Rash Pruritus Vaginal candidiasis Vaginal itch Vaginal discharge Headache Dizziness Somnolence Muscle cramps Muscle stiffness Muscle spasm of neck Tightness/pain in chest Bleeding/pain in urethra Kidney pain Tachycardia Lockjaw-type reaction

Ceftin FOR ORAL SUSPENSION IN CLINICAL TRIALS

In clinical trials using multiple doses of cefuroxime axetil powder for oral suspension, pediatric patients (96.7% of whom were younger than 12 years of age) were treated with the recommended dosages of cefuroxime axetil (20 to 30 mg/kg/day divided twice a day up to a maximum dose of 500 or 1,000 mg/day, respectively). There were no deaths or permanent disabilities in any of the patients in these studies. Eleven US patients (1.2%) discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or vomiting. During clinical trials, discontinuation of therapy due to the taste and/or problems with administering this drug occurred in 13 (1.4%) pediatric patients enrolled at centers in the United States.

The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroxime axetil for oral suspension in multiple-dose clinical trials (n = 931 cefuroxime axetil-treated US patients).

Table 6. Adverse Reactions—Ceftin for Oral Suspension

Multiple-Dose Dosing Regimens—Clinical Trials

Incidence ≥1%	Diarrhea/loose stools 8.6% Dislike of taste 5.0% Diaper rash 3.4% Nausea/vomiting 2.6%
Incidence <1% but >0.1%	Abdominal pain Flatulence Gastrointestinal infection Candidiasis Vaginal irritation Rash Hyperactivity Irritable behavior Eosinophilia Positive direct Coombs test Elevated liver enzymes Viral illness Upper respiratory infection Sinusitis Cough Urinary tract infection Joint swelling Arthralgia Fever Ptyalism

POSTMARKETING EXPERIENCE WITH Ceftin

In addition to adverse events reported during clinical trials, the following events have been identified during clinical practice in patients treated with Ceftin Tablets or with Ceftin for Oral Suspension and were reported spontaneously. Data are generally insufficient to allow an estimate of incidence or to establish causation.

General

The following hypersensitivity reactions have been reported: Anaphylaxis, angioedema, pruritus, rash, serum sickness-like reaction, urticaria.

Gastrointestinal

Pseudomembranous colitis.

Hematologic

Hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia, and increased prothrombin time.

Hepatic

Hepatic impairment including hepatitis and cholestasis, jaundice.

Neurologic

Seizure.

Skin

Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Urologic

Renal dysfunction.

CEPHALOSPORIN-CLASS ADVERSE REACTIONS

In addition to the adverse reactions listed above that have been observed in patients treated with cefuroxime axetil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: Toxic nephropathy, aplastic anemia, hemorrhage, increased BUN, increased creatinine, false-positive test for urinary glucose, increased alkaline phosphatase, neutropenia, elevated bilirubin, and agranulocytosis.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Top

Side Effects by Body System - for Healthcare Professionals

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).

Top

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.