Retrospective analysis of adverse events with systemic onychomycosis medications reported to the United States Food and Drug Administration

Abstract

Background

Onychomycosis is the most common nail condition and when left untreated, has esthetic, physical and emotional-social sequelae.

Objective

To classify the most common adverse reactions with the oral onychomycosis medications terbinafine, itraconazole, and off-label fluconazole.

Methods

The United States Food and Drug Administration Adverse Event Reporting (FAERS) database was analyzed for common adverse reactions with terbinafine, itraconazole, and off-label fluconazole. Transaminase elevations reported with terbinafine usage were further subdivided by the age group. Google Trends was used to examine public interest in these medications and compare yearly data with adverse events in the FAERS database.

Results

The most common adverse reaction with terbinafine was taste disturbance and the most common adverse events with itraconazole and fluconazole were drug interactions. Transaminase elevations associated with terbinafine were extremely rare in the pediatric population. Increased Google searches for all three medications were also associated with increased reporting of adverse events in the FAERS database.

Conclusion

Patients should be counseled that taste disturbance with terbinafine is the most common adverse event. Concomitant medications must be reviewed carefully before prescribing itraconazole or fluconazole since drug interactions are relatively common. Public interest in onychomycosis has increased in recent years, potentially explaining increased prescribing of oral onychomycosis medications and increased reporting to FAERS.

Keywords:

• Onychomycosis
• fungal nail infection
• FDA
• FAERS
• adverse events
• liver toxicity
• terbinafine
• fluconazole
• itraconazole
• taste disturbance
• AST
• ALT
• drug interaction
• Google
• Google Trends

Disclosure statement

Yu Wang and Dr Lipner have no conflicts of interest relevant to the content of the submission. This work has not been previously published.