Can a 34-year-old woman with a glomerular filtration rate of 116 mL/min/1.73 m² and elevated aspartate aminotransferase (113 U/L) and alanine aminotransferase (261 U/L) safely take oral terbinafine?

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No, oral terbinafine should NOT be prescribed to this patient due to significantly elevated liver transaminases

This 34-year-old woman with ALT 261 U/L (approximately 6.5× upper limit of normal) and AST 113 U/L (approximately 2.8× upper limit of normal) has a clear contraindication to terbinafine therapy, as systemic terbinafine is not recommended in patients with active or chronic liver disease. 1

Why Terbinafine is Contraindicated

Pre-existing Liver Disease Exclusion

  • The British Association of Dermatologists explicitly states that systemic terbinafine is not recommended in patients with active or chronic liver disease 1
  • Baseline liver function tests are recommended before initiating terbinafine specifically to identify patients like this one who should not receive the drug 1
  • Although terbinafine is associated with only minimal hepatic toxicity in healthy patients, rare reports of serious hepatotoxicity have occurred, usually in patients with pre-existing liver disease 1

Severity of Transaminase Elevation

  • This patient's ALT of 261 U/L represents a >3× upper limit of normal elevation, which is the threshold used to define clinically significant hepatotoxicity 1
  • Her transaminase pattern (ALT >> AST) suggests active hepatocellular injury, not just chronic stable liver disease 1
  • Even in patients already on terbinafine, the drug should be held when ALT rises to ≥3× ULN 1

Renal Function is NOT the Issue

  • Her GFR of 116 mL/min/1.73 m² is normal to high-normal and poses no contraindication 1
  • Terbinafine clearance is decreased only in patients with severe kidney disease, not at this GFR level 1
  • More than 99% of terbinafine is cleared by the kidney, but dose adjustment is not needed until severe renal impairment is present 1

Clinical Reasoning Algorithm

Step 1: Check baseline liver function → This patient has ALT >6× ULN
Step 2: Determine if liver disease is active → Yes, significantly elevated transaminases indicate active hepatocellular injury
Step 3: Apply contraindication → Do not prescribe terbinafine 1

What Should Be Done Instead

Immediate Actions

  • Investigate the cause of her elevated transaminases before treating any fungal infection 1
  • Evaluate for viral hepatitis, autoimmune hepatitis, medication-induced liver injury, alcohol use, non-alcoholic fatty liver disease, and other hepatobiliary pathology
  • Repeat liver function tests in 48-72 hours to assess trajectory 1

Alternative Antifungal Options (Once Liver Status Clarified)

  • Topical antifungals (ciclopirox, amorolfine) can be used for onychomycosis without systemic absorption concerns 1
  • Griseofulvin may be considered if oral therapy is absolutely necessary, though it also requires baseline liver monitoring and is less effective than terbinafine 1
  • Itraconazole is an alternative oral agent but also carries hepatotoxicity risk and would require the same caution in this patient 1

Common Pitfalls to Avoid

  • Do not assume normal renal function makes terbinafine safe — the contraindication here is hepatic, not renal 1
  • Do not start terbinafine with a plan to "monitor closely" — the drug should not be initiated in the presence of active liver disease 1
  • Do not overlook that onychomycosis is not life-threatening — delaying treatment until liver function normalizes is appropriate 1
  • Do not forget that terbinafine-induced hepatotoxicity can be severe — cases of cholestatic hepatitis requiring 11-15 months for resolution have been reported 2

Risk Context from the Literature

  • Post-marketing surveillance shows serious adverse events occur in only 0.04% of terbinafine users 1
  • However, when hepatotoxicity does occur, it can be severe and prolonged, with peak bilirubin reaching 718 μmol/L and recovery taking over a year 2
  • Most hepatotoxicity occurs in patients with pre-existing liver disease, making this patient particularly high-risk 1

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Terbinafine-induced hepatic dysfunction.

European journal of gastroenterology & hepatology, 2001

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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