A real-world disproportionality analysis of cidofovir from the FDA Adverse Event Reporting System (FAERS) database.

Abstract

Background: Cidofovir, an antiviral drug used to treat cytomegalovirus retinitis in AIDS patients. While effective against several viruses, cidofovir's nephrotoxicity and other adverse events (AEs) limit its broader use. This study aims to evaluate the AE profile of cidofovir using data from the FAERS database.

Research design and methods: An analysis of FAERS data from the first quarter of 2004 to the fourth quarter of 2023 was performed. Signal detection was conducted using four algorithms: ROR, PRR, BCPNN, and EBGM. Data were categorized by system organ classes (SOCs) and preferred terms (PTs), and the strength of association between cidofovir and AEs was assessed.

Results: 1,874 AE reports involving 1,266 patients were identified. 'Renal and urinary disorders,' 'Infections and infestations,' and 'Immune system disorders' were the most frequently reported SOCs, with the highest signal detected for 'Renal and urinary disorders.' Off-label use was the most common PT, highlighting the importance of controlling the indication of medication in clinical practice.

Conclusion: This study identified significant signals related to cidofovir, suggesting that clinicians should carefully monitor patients, especially when using cidofovir for off-label purposes to mitigate potential risk outcomes. Further research is needed to optimize the safe and effective use of cidofovir.