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.[Ref]

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%).[Ref]

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[Ref]

Local

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[Ref]

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.[Ref]

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[Ref]

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.[Ref]

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[Ref]

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.[Ref]

Hematologic

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

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[Ref]

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.[Ref]

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

Hepatic

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

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[Ref]

Metabolic

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

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[Ref]

Other

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

Uncommon (0.1% to 1%): Fever[Ref]

Renal

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

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.[Ref]

Genitourinary

Uncommon (0.1% to 1%): Vaginitis[Ref]

Respiratory

Frequency not reported: Cough, dyspnea[Ref]

Cardiovascular

Frequency not reported: Tachycardia[Ref]

References

1. "Product Information. Maxipime (cefepime)." Bristol-Myers Squibb, Princeton, NJ.

2. Cordonnier C, Herbrecht R, Pico JL, Gardembas M, Delmer A, Delain M, Moreau P, Ladeb S, Nalet V, Rollin C, Gres JJ "Cefepime/amikacin versus ceftazidime/amikacin as empirical therapy for febrile episodes in neutropenic patients: a comparative study." Clin Infect Dis 24 (1997): 41-51

3. Zervos M, Nelson M "Cefepime versus ceftriaxone for empiric treatment of hospitalized patients with community-acquired pneumonia." Antimicrob Agents Chemother 42 (1998): 729-33

4. Grossman RF, Campbell DA, Landis SJ, Garber GE, Murray G, Stiver HG, Saginur R, McIvor RA, Laforge J, Rotstein C, Dubois J "Treatment of community-acquired pneumonia in the elderly: the role of cefepime, a fourth-generation cephalosporin." J Antimicrob Chemother 43 (1999): 549-54

5. Ramphal R, Gucalp R, Rotstein C, Cimino M, Oblon D "Clinical experience with single agent and combination regimens in the management of infection in the febrile neutropenic patient." Am J Med 100 (1996): s83-9

6. McCabe R, Chirurgi V, Farkas SA, Haddow A, Heinz G, Greene S "A new therapeutic option for the treatment of pneumonia." Am J Med 100 (1996): s60-7

7. Yamamura D, Gucalp R, Carlisle P, Cimino M, Roberts J, Rotstein C "Open randomized study of cefepime versus piperacillin-gentamicin for treatment of febrile neutropenic cancer patients." Antimicrob Agents Chemother 41 (1997): 1704-8

8. Wynd MA, Paladino JA "Cefepime: a fourth-generation parenteral cephalosporin." Ann Pharmacother 30 (1996): 1414-24

9. Panos G, Watson DC, Sargianou M, Kampiotis D, Chra P "Red man syndrome adverse reaction following intravenous infusion of cefepime." Antimicrob Agents Chemother 56 (2012): 6387-8

10. Leophonte P, Bertrand A, Nouvet G, Muir JF, Lucht F, Delaval P, Depierre A, Hughes F, Ulmer M, Gres JJ, et al "A comparative study of cefepime and ceftazidime in the treatment of community-acquired lower respiratory tract infections." J Antimicrob Chemother 32 Suppl B (1993): 165-73

11. Holloway WJ, Palmer D "Clinical applications of a new parenteral antibiotic in the treatment of severe bacterial infections." Am J Med 100 (1996): s52-9

12. Sharifi R, Geckler R, Childs S "Treatment of urinary tract infections: selecting an appropriate broad- spectrum antibiotic for nosocomial infections." Am J Med 100 (1996): s76-82

13. Neu HC "Safety of cefepime: a new extended-spectrum parenteral cephalosporin." Am J Med 100 (1996): s68-75

14. Barradell LB, Bryson HM "Cefepime. A review of its antibacterial activity, pharmacokinetic properties and therapeutic use." Drugs 47 (1994): 471-505

15. Schwartz R, Das-Young LR, Ramirez-Ronda C, Frank E "Current and future management of serious skin and skin-structure infections." Am J Med 100 (1996): s90-5

16. Bow EJ, Rotstein C, Noskin GA, et al. "A randomized, open-label, multicenter comparative study of the efficacy and safety of piperacillin-tazobactam and cefepime for the empirical treatment of febrile neutropenic episodes in patients with hematologic malignancies." Clin Infect Dis 43 (2006): 447-59

17. Abanades S, Nolla J, Rodriguez-Campello A, Pedro C, Valls A, Farre M "Reversible coma secondary to cefepime neurotoxicity." Ann Pharmacother 38 (2004): 606-8

18. Chow KM, Szeto CC, Hui AC, Wong TY, Li PK "Retrospective review of neurotoxicity induced by cefepime and ceftazidime." Pharmacotherapy 23 (2003): 369-73

19. Capparelli FJ, Diaz MF, Hlavnika A, Wainsztein NA, Leiguarda R, Del Castillo ME "Cefepime- and cefixime-induced encephalopathy in a patient with normal renal function." Neurology 65 (2005): 1840

20. Martinez-Rodriguez JE, Barriga FJ, Santamaria J, et al. "Nonconvulsive status epilepticus associated with cephalosporins in patients with renal failure." Am J Med 111 (2001): 115-9

21. Lam S, Gomolin IH "Cefepime Neurotoxicity: Case Report, Pharmacokinetic Considerations, and Literature Review." Pharmacotherapy 26 (2006): 1169-1174

22. Fernandez-Torre JL, Martinez-Martinez M, Gonzalez-Rato J, et al. "Cephalosporin-induced nonconvulsive status epilepticus: clinical and electroencephalographic features." Epilepsia 46 (2005): 1550-2

23. Plensa E, Gallardo E, Ribera JM, Batlle M, Oriol A, Costa J "Nonconvulsive status epilepticus associated with cefepime in a patient undergoing autologous stem cell transplantation." Bone Marrow Transplant 33 (2004): 119-20

24. Barbey F, Bugnon D, Wauters JP "Severe Neurotoxicity of Cefepime in Uremic Patients." Ann Intern Med 135 (2001): 1011

25. Wong BB, Ko GJ "Neutropenia in patients receiving long-term cefepime therapy for osteomyelitis." Am J Health Syst Pharm 60 (2003): 2229-32

26. Dahlgren AF "Two cases of possible cefepime-induced neutropenia." Am J Health Syst Pharm 54 (1997): 2621-2

27. Romano A, Mayorga C, Torres MJ, Artesani MC, Suau R, Sanchez F, Perez E, Venuti A, Blanca M "Immediate allergic reactions to cephalosporins: Cross-reactivity and selective responses." J Allerg Clin Immunol 106 (2000): 1177-83

28. Chikwava KR, Savell VH Jr, Boyd TK "Fatal cephalosporin-induced acute hypersensitivity myocarditis." Pediatr Cardiol 27 (2006): 777-80

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