Can cefepime cause ototoxicity?

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Last updated: July 2, 2025View editorial policy

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From the Guidelines

Cefepime can cause ototoxicity, although it is considered a relatively uncommon adverse effect. Ototoxicity from cefepime typically manifests as hearing loss, tinnitus, or vertigo. The risk increases in patients with renal impairment, as decreased kidney function leads to higher serum concentrations of the drug. Elderly patients, those receiving high doses, and patients on concurrent ototoxic medications (such as aminoglycosides, loop diuretics, or platinum-based chemotherapeutics) are at greater risk. The mechanism behind cefepime-induced ototoxicity likely involves direct damage to the hair cells in the inner ear. If a patient develops symptoms of ototoxicity while on cefepime, healthcare providers should consider dose adjustment, especially in those with impaired renal function, or switching to an alternative antibiotic. Monitoring renal function and maintaining appropriate dosing based on creatinine clearance can help minimize this risk. Most cases of cefepime-induced ototoxicity are reversible after discontinuation of the drug, but permanent damage can occur in some instances 1.

Some key points to consider:

  • Cefepime is a fourth-generation cephalosporin antibiotic with a broad spectrum of activity against gram-positive and gram-negative bacteria.
  • The risk of ototoxicity with cefepime is increased in patients with renal impairment, as the drug is primarily excreted by the kidneys.
  • Patients receiving high doses of cefepime or concurrent ototoxic medications are also at increased risk of developing ototoxicity.
  • Monitoring of renal function and audiometric testing can help identify patients at risk of ototoxicity and allow for early intervention.
  • In cases where ototoxicity is suspected, dose adjustment or switching to an alternative antibiotic may be necessary to prevent further damage.

It is essential to weigh the benefits of cefepime against the potential risks, including ototoxicity, when making treatment decisions. Healthcare providers should carefully monitor patients for signs of ototoxicity and adjust treatment accordingly to minimize the risk of permanent damage.

From the FDA Drug Label

7.2 Aminoglycosides Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Cefepime Injection because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs.

The FDA drug label does not answer the question of whether cefepime itself can cause ototoxicity, but it does mention that concomitant administration of aminoglycosides with cefepime may increase the potential for ototoxicity of the aminoglycoside antibacterial drugs 2, 2, 2.

From the Research

Cefepime and Ototoxicity

  • There is no direct evidence in the provided studies that cefepime causes ototoxicity.
  • The studies focus on the neurotoxic effects of cefepime, including encephalopathy, myoclonus, seizures, and coma, particularly in patients with renal dysfunction 3, 4, 5, 6, 7.
  • None of the studies mention ototoxicity as a potential side effect of cefepime.

Neurotoxicity of Cefepime

  • Cefepime has been associated with neurotoxicity, particularly in patients with renal dysfunction 3, 4, 5, 6, 7.
  • Risk factors for cefepime-induced neurotoxicity include renal dysfunction, excessive dosing, and preexisting brain injury 3, 4.
  • Symptoms of cefepime neurotoxicity include altered mental status, myoclonus, seizures, and coma 3, 4, 5, 6, 7.

Renal Dysfunction and Cefepime

  • Patients with renal dysfunction are at higher risk of developing cefepime-induced neurotoxicity 3, 4, 5, 6, 7.
  • The dose of cefepime should be adjusted for renal clearance to minimize the risk of neurotoxicity 3, 4.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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