What are the contraindications for Terbinafine (oral antifungal medication) therapy?

Contraindications for Oral Terbinafine

Oral terbinafine is absolutely contraindicated in patients with a history of allergic reaction to the drug due to anaphylaxis risk, and should not be used in patients with active or chronic liver disease. 1, 2

Absolute Contraindications

• History of hypersensitivity or allergic reaction to terbinafine is the only FDA-labeled absolute contraindication due to risk of anaphylaxis 1

• Serious hypersensitivity reactions documented with terbinafine include Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome, making any prior severe cutaneous reaction an absolute contraindication 2, 3

• Active or chronic liver disease represents a strong clinical contraindication, as terbinafine is explicitly not recommended in these patients by the British Association of Dermatologists 2, 3

  • While one case report describes successful use in stable autoimmune hepatitis with extensive precautions 4, this should be considered exceptional rather than standard practice
  • The FDA warns that liver failure leading to transplant or death has occurred with oral terbinafine 1

Relative Contraindications and High-Risk Populations

• Severe renal impairment is a practical contraindication because terbinafine clearance is significantly decreased in severe kidney disease 2, 3

  • Terbinafine is primarily cleared by the kidneys, and the British Association of Dermatologists explicitly lists renal impairment as a contraindication rather than recommending dose adjustment 3

• Pediatric onychomycosis represents an unlicensed indication requiring baseline monitoring if use is considered 2, 3

Mandatory Baseline Monitoring Before Initiation

If terbinafine must be used despite concerns, baseline liver function tests and complete blood count are mandatory in the following populations 2, 3:

• History of heavy alcohol consumption
• History of hepatitis
• Hematological abnormalities
• Pediatric patients (as terbinafine is not licensed for pediatric onychomycosis)

Critical Patient Counseling Requirements

• Taste and smell disturbances can be permanent, requiring explicit patient counseling before initiation 2, 3, 1

  • The FDA recommends discontinuing terbinafine if taste or smell disturbance occurs 1
  • These disturbances may be severe, prolonged, or permanent 3, 1

• Severe neutropenia has been reported; terbinafine should be discontinued if neutrophil count drops to ≤1,000 cells/mm³ 1

• Depressive symptoms have been reported with terbinafine use, requiring vigilance for development of mood changes 1