Cefotaxime Side Effects

Brand Names: Claforan

Please note - some side effects for Cefotaxime 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 Cefotaxime - for the Consumer

Cefotaxime

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 Cefotaxime:

Headache; mild diarrhea; nausea; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody diarrhea or stools; decreased urination; fever, chills, or persistent sore throat; irregular heartbeat; pain, swelling, or redness at the injection site; red, swollen, or blistered skin; seizures; severe diarrhea; severe nausea or vomiting; stomach pain or cramps; unusual bruising or bleeding; unusual tiredness or weakness; vaginal irritation or discharge; white patches in mouth; yellowing of the eyes and skin.

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

Cefotaxime Side Effects - for the Professional

Cefotaxime

Clinical Trials Experience
Cefotaxime for injection is generally well tolerated. The most common adverse reactions have been local reactions following IM or IV injection. Other adverse reactions have been encountered infrequently.

The most frequent adverse reactions (greater than 1%) are:
 
Local (4.3%) - Injection site inflammation with IV administration. Pain, induration, and tenderness after IM injection.
 
Hypersensitivity (2.4%) - Rash, pruritus, fever, eosinophilia.
 
Gastrointestinal (1.4%) - Colitis, diarrhea, nausea, and vomiting.
 
Symptoms of pseudomembranous colitis can appear during or after antibiotic treatment.
 
Nausea and vomiting have been reported rarely.

Less frequent adverse reactions (less than 1%) are:
 
Hematologic System - Neutropenia, transient leukopenia, have been reported. Some individuals have developed positive direct Coombs Tests during treatment with Cefotaxime for injection and other cephalosporin antibiotics.
 
Genitourinary System - Moniliasis, vaginitis.
 
Central Nervous System - Headache.
 
Liver - Transient elevations in AST, ALT, serum LDH, and serum alkaline phosphatase levels have been reported.
 
Kidney - As with some other cephalosporins, transient elevations of BUN have been occasionally observed with Cefotaxime for injection.

Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of Cefotaxime for injection. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
 
Cardiovascular System - Potentially life-threatening arrhythmias following rapid (less than 60 seconds) bolus administration via central venous catheter have been observed.

Central Nervous System- Administration of high doses of beta-lactam antibiotics, including Cefotaxime, particularly in patients with renal insufficiency may result in encephalopathy (e.g. impairment of consciousness, abnormal movements and convulsions).
 
Cutaneous - As with other cephalosporins, isolated cases of toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme have been reported.
 
Hematologic System - Hemolytic anemia, agranulocytosis, thrombocytopenia.
 
Hypersensitivity - Anaphylaxis (e.g., angioedema, bronchospasm, malaise possibly culminating in shock), urticaria.
 
Kidney - Interstitial nephritis, transient elevations of creatinine.
 
Liver - Hepatitis, jaundice, cholestasis, elevations of gamma GT and bilirubin.

Cephalosporin Class Labeling
In addition to the adverse reactions listed above which have been observed in patients treated with Cefotaxime sodium, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics: allergic reactions, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, and false-positive test for urinary glucose .       

Several cephalosporins have been implicated in triggering seizures,particularly in patients with renal impairment when the dosage was not reduced. See DOSAGE AND ADMINISTRATION and OVERDOSAGE. 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

The majority of cefotaxime adverse effects are mild and transient and rarely require discontinuation of the medication.

Gastrointestinal

Gastrointestinal side effects have included colitis, nausea, vomiting, and diarrhea in 1.4% of patients. Clostridium difficile associated diarrhea has been reported with almost all antibiotics, including the cephalosporins.

Clostridium difficile should be suspected in any patient who develops persistent or severe diarrhea following cephalosporin therapy.

One small study indicates that elderly patients treated with cefotaxime may be more likely than younger patients to experience Clostridium difficile colitis.

Hypersensitivity

Hypersensitivity reactions, such as rash and pruritus, are relatively uncommon, but may require discontinuation of the drug.

A 75-year-old female developed toxic epidermal necrolysis (TEN) over 40% of her body surface area after receiving cefotaxime for 6 days. After cefotaxime discontinuation and some improvement, meropenem was started. The TEN immediately recurred and spread to previously unaffected areas of the skin, and the patient died. The authors recommend avoiding chemically similar drugs to the precipitating drug when treating patients with drug-induced TEN.

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.

Hypersensitivity side effects have included rash, pruritus, fever, eosinophilia, urticaria, and anaphylaxis (e.g., angioedema, bronchospasm, malaise possibly culminating in shock) in 2.4% of patients. Allergic cross-reactivity with penicillin and carbapenems may occur. Cases of Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis have been reported. Allergic reactions have been reported with cephalosporins as a class.

Other

Other side effects have included overgrowth of nonsusceptible organisms and have resulted in superinfection. False-positive test for urinary glucose have been reported with cephalosporins as a class.

Local

Local side effects have included injection site inflammation and phlebitis with intravenous administration and pain, induration, and tenderness following intramuscular injection in 4.3% of patients.

Nervous system

Nervous system side effects have included headache and encephalopathy (e.g., impairment of consciousness, abnormal movements, and convulsions) in less than 1% of patients. Some cephalosporins have been associated with seizures, particularly in renally impaired patients when the dosage was not reduced.

Administration of high doses of beta-lactams, including cefotaxime, particularly in patients with renal insufficiency may result in encephalopathy.

In one case, a 68-year-old man with moderate renal insufficiency underwent surgery for repair of an abdominal aortic aneurysm. He developed renal failure requiring hemodialysis. Cefotaxime was administered for an abdominal abscess. The patient developed encephalopathic symptoms. Cefotaxime was discontinued and hemodialysis was performed. The mental status of the patient improved. Cefotaxime was reinstituted. No further toxicity occurred.

Hepatic

Hepatic side effects have included transient elevations in SGOT, SGPT, serum lactate dehydrogenase, gamma glutamyltransferase, bilirubin, and serum alkaline phosphatase in less than 1% of patients. These laboratory abnormalities (which may be due to the infection) may rarely exceed twice the upper limit of the normal and elicit a pattern of liver injury, usually cholestatic and most often asymptomatic. Hepatitis, sometimes with jaundice, has been reported. Cephalosporins as a class have been associated with hepatic dysfunction including cholestasis.

Hematologic

Unlike other cephalosporins, severe alterations in coagulation parameters have not been reported in association with cefotaxime therapy. The methylthiotetrazole moiety found on other cephalosporins may be responsible for the development of coagulation defects.

Hematologic side effects have included granulocytopenia, eosinophilia, transient leukopenia, neutropenia, thrombocytopenia, agranulocytosis, positive direct Coombs' tests, and hemolytic anemia in less than 1% of patients. Cephalosporins as a class have been associated with aplastic anemia, prolonged prothrombin time, and hemorrhage.

Renal

Renal side effects have included interstitial nephritis and transient increases in BUN and creatinine in less than 1% of patients. Reversible fever, azotemia, pyuria, and eosinophilia are the hallmarks of cephalosporin-induced interstitial nephritis. Cephalosporins as a class have been associated with renal dysfunction and toxic nephropathy.

Dermatologic

Dermatologic side effects have included rash, urticaria, pruritus, and cases of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and telangiectasia.

Cardiovascular

Cardiovascular side effects have included potentially life-threatening arrhythmias following rapid (less than 60 seconds) bolus administration through a central venous catheter (less than 1%).

Genitourinary

Genitourinary side effects have included moniliasis and vaginitis.

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.