Cefepime Side Effects

Brand Names: Maxipime

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

Cefepime

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 Cefepime:

Mild pain, redness, or swelling at the injection site.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody stools; fever; mood or mental changes (eg, coma, confusion, fainting, hallucinations); muscle twitching; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe nausea or vomiting; severe pain, redness, or swelling at the injection site; stomach pain/cramps; unusual bruising or bleeding; unusual tiredness; vaginal irritation or discharge; white patches in the mouth; 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

Cefepime Side Effects - for the Professional

Cefepime

Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials using multiple doses of Cefepime, 4137 patients were treated with the recommended dosages of Cefepime (500 mg to 2 g intravenous every 12 hours). There were no deaths or permanent disabilities thought related to drug toxicity. Sixty-four (1.5%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. Thirty-three (51%) of these 64 patients who discontinued therapy did so because of rash. The percentage of Cefepime-treated patients who discontinued study drug because of drug-related adverse events was very similar at daily doses of 500 mg, 1 g, and 2 g every 12 hours (0.8%, 1.1%, and 2.0%, respectively). However, the incidence of discontinuation due to rash increased with the higher recommended doses.

The following adverse events were thought to be probably related to Cefepime during evaluation of the drug in clinical trials conducted in North America (n=3125 Cefepime-treated patients).

Table 10: Adverse Reactions Cefepime Multiple-Dose Dosing Regimens Clinical Trials – North America

* local reactions, irrespective of relationship to Cefepime in those patients who received intravenous infusion (n=3048).
INCIDENCE EQUAL TO OR GREATER THAN 1%	Local reactions (3.0%), including phlebitis (1.3%), pain and/or inflammation (0.6%)*; rash (1.1%)
INCIDENCE LESS THAN 1% BUT GREATER THAN 0.1%	Colitis (including pseudomembranous colitis), diarrhea, fever, headache, nausea, oral moniliasis, pruritus, urticaria, vaginitis, vomiting

At the higher dose of 2 g every 8 hours, the incidence of probably-related adverse events was higher among the 795 patients who received this dose of Cefepime. They consisted of rash (4%), diarrhea (3%), nausea (2%), vomiting (1%), pruritus (1%), fever (1%), and headache (1%).

The following adverse laboratory changes, irrespective of relationship to therapy with Cefepime, were seen during clinical trials conducted in North America.

Table 11: Adverse Laboratory Changes Cefepime Multiple-Dose Dosing Regimens Clinical Trials – North America

* Hypocalcemia was more common among elderly patients. Clinical consequences from changes in either calcium or phosphorus were not reported.
INCIDENCE EQUAL TO OR GREATER THAN 1%	Positive Coombs’ test (without hemolysis) (16.2%); decreased phosphorus (2.8%); increased ALT/SGPT (2.8%), AST/SGOT (2.4%), eosinophils (1.7%); abnormal PTT (1.6%), PT (1.4%)
INCIDENCE LESS THAN 1% BUT GREATER THAN 0.1%	Increased alkaline phosphatase, BUN, calcium, creatinine, phosphorus, potassium, total bilirubin; decreased calcium*, hematocrit, neutrophils, platelets, WBC

A similar safety profile was seen in clinical trials of pediatric patients.

Postmarketing Experience

In addition to the events reported during North American clinical trials with Cefepime, the following adverse experiences have been reported during worldwide postmarketing experience.

As with some other drugs in this class, encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, and seizures have been reported. Although most cases occurred in patients with renal impairment who received doses of Cefepime that exceeded the recommended dosage schedules, some cases of encephalopathy occurred in patients receiving a dosage adjustment for their renal function. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated. Precautions should be taken to adjust daily dosage in patients with renal insufficiency or other conditions that may compromise renal function to reduce antibiotic concentrations that can lead or contribute to these and other serious adverse events, including renal failure.

As with other cephalosporins, anaphylaxis including anaphylactic shock, transient leukopenia, neutropenia, agranulocytosis and thrombocytopenia have been reported.

Cephalosporin-Class Adverse Reactions

In addition to the adverse reactions listed above that have been observed in patients treated with Cefepime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, hepatic dysfunction including cholestasis, and pancytopenia.

Top

Side Effects by Body System - for Healthcare Professionals

General

Cefepime is generally well tolerated. It has been reported that 1.5% of patients discontinued medication due to adverse events.

Gastrointestinal

If diarrhea occurs which is unresponsive to discontinuation of cefepime and/or standard therapy, pseudomembranous colitis should be considered.

Higher doses (2 grams every 8 hours) have been associated with a greater incidence of side effects, including diarrhea (3%), nausea (2%), and vomiting (1%).

Gastrointestinal side effects have included colitis (including pseudomembranous colitis), diarrhea, nausea, vomiting, and oral moniliasis in 0.1% to less than 1% of patients. Abdominal pain, anorexia, stomatitis, and Clostridium difficile-associated diarrhea have also been reported.

Local

Local side effects have included local reactions (3%), including phlebitis (1.3%) and pain and/or inflammation (0.6%), irrespective to cefepime in patients who received intravenous infusion. Infusion site reaction has also been reported.

Nervous system

Nervous system side effects have included headache (0.1% to less than 1%). Encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and nonconvulsive status epilepticus have been reported during postmarketing experience, mostly in patients with renal impairment receiving higher than recommended dosages. Somnolence has also been reported.

Some cases of encephalopathy occurred in patients receiving an appropriate dosage for their degree of renal impairment.

Case reports of seizure activity, with and without convulsions, associated with cefepime have been published in the medical literature. In the vast majority of cases, the patient involved had a clinically significant degree of renal dysfunction. In each case, seizure activity abated upon the discontinuation of cefepime.

Higher doses (2 grams every 8 hours) have been associated with a greater incidence of side effects, including headache (1%).

A 66-year-old female developed acute renal failure, altered level of consciousness (Glasgow Coma Scale 6), and nonconvulsive status epilepticus after 10 days of cefepime 2 g every 8 hours. Symptoms resolved and she completely recovered 72 hours after discontinuation of cefepime.

Dermatologic

Dermatologic side effects have included rash (1.1%), urticaria (0.1% to less than 1%), and pruritus (0.1% to less than 1%).

Higher doses (2 grams every 8 hours) have been associated with a higher incidence of side effects, including rash (4%) and pruritus (1%).

Hematologic

Hematological side effects have included positive Coombs' test (without hemolysis; 16.2%), increased eosinophils (1.7%), abnormal PTT (1.6%), and abnormal PT (1.4%). Decreased hematocrit, neutrophils, platelets, and white blood cells have been reported in 0.1% to less than 1% of patients. Cephalosporins as a class have been associated with aplastic anemia, hemolytic anemia, prolonged prothrombin time, hemorrhage, and pancytopenia. Epistaxis has also been reported.

Hypersensitivity

Anaphylactic reactions are rare, but may occur, especially in patients with a history of penicillin allergy.

Hypersensitivity side effects have included anaphylaxis (including anaphylactic shock, transient leukopenia, neutropenia, agranulocytosis, and thrombocytopenia) during postmarketing experience. Acute hypersensitivity myocarditis has been reported. Cephalosporin class antibiotics have been associated with allergic reactions, Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis.

Hepatic

Hepatic side effects have included increased ALT (2.8%), AST (2.4%), alkaline phosphatase (0.1% to less than 1%), and total bilirubin (0.1% to less than 1%). Cephalosporins as a class have been associated with hepatic dysfunction including cholestasis.

Metabolic

Metabolic side effects have included decreased phosphorus (2.8%) and calcium (0.1% to less than 1%). Increased calcium, phosphorus, and potassium have been reported in 0.1% to less than 1% of patients. Hypokalemia and hypomagnesemia have been reported.

Hypocalcemia was more common among elderly patients. Clinical consequences from changes in either calcium or phosphorus were not reported.

Other

Higher doses (2 grams every 8 hours) have been associated with a greater incidence of side effects, including fever (1%).

Other side effects have included fever (0.1% to less than 1%).

Renal

Renal side effects have included increased BUN and creatinine in 0.1% to less than 1% of patients. Renal failure, mostly in patients with renal impairment who received higher than recommended doses of cefepime, has been reported. Cephalosporins as a class have been associated with renal dysfunction and toxic nephropathy.

Genitourinary

Genitourinary side effects have included vaginitis (0.1% to less than 1%).

Respiratory

Respiratory side effects have included cough and dyspnea.

Cardiovascular

Cardiovascular side effects have included tachycardia.

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.