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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

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:

Diarrhea; headache; nausea; vomiting.

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

Cefepime Side Effects - for the Professional

Cefepime

• The most common adverse reactions (incidence ≥ 1 %) were local reactions (including phlebitis), pain and/or inflammation, and rash. (6)

Side Effects by Body System

General

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

Hypersensitivity

Hypersensitivity reactions have included anaphylaxis, including anaphylactic shock, rash, and pruritus. Acute hypersensitivity myocarditis has been reported. Cephalosporin class antibiotics have been associated with allergic reactions, Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis.

The incidence of discontinuation because of rash has been reported to increase with higher recommended doses.

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

Local

Local side effects associated with the administration of cefepime have included phlebitis (1.3%) after intravenous injection, and pain or inflammation (0.6%) after intramuscular injection. Infusion site reaction has also been reported.

Gastrointestinal

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

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%).

Nervous system

Neurological side effects have included headaches (0.1 to 1%). Encephalopathy (confusion, hallucinations, stupor, and coma), myoclonus, seizures, and nonconvulsive status epilepticus have been reported, mostly in patients receiving higher than recommended dosages. Somnolence has also been reported.

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 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.

Hematologic

Hematological side effects have included transient leukopenia, neutropenia, agranulocytosis, and thrombocytopenia. Cephalosporins as a class have been associated with aplastic anemia, hemolytic anemia, prolonged prothrombin time, hemorrhage, and pancytopenia. Epistaxis has also been reported.

Hepatic

Hepatic side effects associated with cephalosporins as a class have included hepatic dysfunction including cholestasis.

Renal

Renal side effects have included renal failure, mostly in patients with renal impairment who received higher than recommended doses of cefepime. Cephalosporins as a class have been associated with renal dysfunction and toxic nephropathy.

Dermatologic

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

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

Genitourinary

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

Other

Fever has been reported in 0.1% to 1% of patients.

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

Metabolic

Metabolic side effects have included hypokalemia, hypomagnesemia, and hypophosphatemia.

Respiratory

Respiratory side effects have included cough and dyspnea.

Cardiovascular

Cardiovascular side effects have included tachycardia.

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