Cefepime Side Effects

Not all side effects for cefepime may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to cefepime: injection powder for solution

In addition to its needed effects, some unwanted effects may be caused by cefepime. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking cefepime, check with your doctor or nurse immediately:

More common
  • Abdominal or stomach cramps
  • back, leg, or stomach pains
  • bleeding gums, nosebleeds
  • confusion
  • convulsions
  • dark urine
  • difficulty with breathing
  • fever, chills
  • general body swelling
  • headache
  • irregular heartbeats
  • loss of appetite
  • mood or mental changes
  • muscle cramps in the hands, arms, feet, legs, or face
  • nausea or vomiting
  • numbness and tingling around the mouth, fingertips, or feet
  • tremor
  • yellowing of the eyes or skin
Less common
  • Bluish color
  • pain, tenderness
  • swelling of the foot or leg
Rare
  • Diarrhea
  • inflammation or swelling
  • watery or bloody diarrhea
Incidence not known
  • Agitation
  • blistering, peeling, or loosening of the skin
  • bloody or cloudy urine
  • bloody, black, or tarry stools
  • blurred vision
  • change in consciousness
  • chest pain
  • cough or hoarseness
  • difficult or painful urination
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • general feeling of tiredness or weakness
  • itching, hives
  • muscle twitching or jerking
  • paralysis
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • rhythmic movement of the muscles
  • seeing, hearing, or feeling things that are not there
  • seizures
  • severe sleepiness
  • stiff neck
  • sudden decrease in the amount of urine
  • swollen or painful glands
  • unpleasant breath odor
  • unusual bleeding or bruising
  • vomiting of blood

Some of the side effects that can occur with cefepime may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Red streaks on the skin
  • swelling, tenderness, or pain at the injection site
Rare
  • Itching of the vagina or genital area
  • pain during sexual intercourse
  • redness of the skin
  • sore mouth or tongue
  • thick, white vaginal discharge with no odor or with a mild odor
  • white patches in the mouth, tongue, or throat

For Healthcare Professionals

Applies to cefepime: injectable powder for injection, injectable solution

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%).

Uncommon (0.1% to 1%): Colitis (including pseudomembranous colitis), diarrhea, nausea, vomiting, oral moniliasis
Frequency not reported: Abdominal pain, anorexia, stomatitis, Clostridium difficile associated diarrhea

Local

Local reactions (3%), including phlebitis (1.3%) and pain and/or inflammation (0.6%), have been reported irrespective to cefepime in patients who received intravenous infusion.

Common (1% to 10%): Local reactions (3%)
Uncommon (0.1% to 1%): Phlebitis (1.3%), pain and/or inflammation (0.6%)
Frequency not reported: Infusion site reaction

Nervous system

Uncommon (0.1% to 1%): Headache
Frequency not reported: Somnolence
Postmarketing reports: Neurotoxicity, encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, coma), myoclonus, seizures, nonconvulsive status epilepticus

Encephalopathy, myoclonus, seizures, and nonconvulsive status epilepticus have been reported. Although most cases occurred in patients with renal impairment who received higher than recommended doses of cefepime, some cases of neurotoxicity occurred in patients receiving an appropriate dosage for their degree of renal impairment. In the majority of cases, symptoms of neurotoxicity were reversible and resolved after discontinuation of cefepime and/or after hemodialysis.

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

Common (1% to 10%): Rash (1.1%)
Uncommon (0.1% to 1%): Urticaria, pruritus, erythema
Rare (less than 0.1%): Red man syndrome (at least 1 case)
Frequency not reported: Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis

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

Cephalosporin class antibiotics have been associated with Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis.

Hematologic

Cephalosporins as a class have been associated with aplastic anemia, hemolytic anemia, prolonged prothrombin time, hemorrhage, and pancytopenia.

Very common (10% or more): Positive Coombs' test (without hemolysis; 16.2%)
Common (1% to 10%): Increased eosinophils (1.7%), abnormal PTT (1.6%), abnormal PT (1.4%)
Uncommon (0.1% to 1%): Decreased hematocrit, decreased neutrophils, decreased platelets, decreased white blood cells, anemia
Frequency not reported: Epistaxis, aplastic anemia, hemolytic anemia, prolonged prothrombin time, hemorrhage, pancytopenia

Hypersensitivity

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

Cephalosporin class antibiotics have been associated with allergic reactions.

Frequency not reported: Acute hypersensitivity myocarditis, allergic reactions
Postmarketing reports: Anaphylaxis (including anaphylactic shock, transient leukopenia, neutropenia, agranulocytosis, thrombocytopenia)

Hepatic

Cephalosporins as a class have been associated with hepatic dysfunction including cholestasis.

Common (1% to 10%): Increased ALT (2.8%), increased AST (2.4%)
Uncommon (0.1% to 1%): Increased alkaline phosphatase, increased total bilirubin
Frequency not reported: Hepatic dysfunction including cholestasis

Metabolic

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

Common (1% to 10%): Decreased phosphorus (2.8%)
Uncommon (0.1% to 1%): Decreased calcium, increased calcium, increased phosphorus, increased potassium
Frequency not reported: Hypokalemia, hypomagnesemia

Other

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

Uncommon (0.1% to 1%): Fever

Renal

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.

Uncommon (0.1% to 1%): Increased BUN, increased creatinine
Frequency not reported: Renal failure, renal dysfunction, toxic nephropathy

Genitourinary

Uncommon (0.1% to 1%): Vaginitis

Respiratory

Frequency not reported: Cough, dyspnea

Cardiovascular

Frequency not reported: Tachycardia

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