Abstract
Background
Famciclovir, mainly used to treat herpes zoster, is a precursor drug of penciclovir that rapidly transforms into penciclovir when taken orally and sustains an extended half-life intracellularly. The information on its adverse drug reactions (ADRs) mainly comes from clinical trials, lacking large-scale real-world studies. This study evaluates the adverse events (AEs) of famciclovir by mining data from the FDA Adverse Event Reporting System (FAERS) database, providing references for clinical safety.
Methods
Utilized disproportionality analysis (including reported odds ratio and proportional reporting ratio) and Bayesian methods (including Bayesian Confidence Propagation Neural Network and Gamma-Poisson Shrinkage) to quantify AE signals associated with famciclovir.
Results
A total of 17,652,186 case reports were obtained from the FAERS database, with 432 reports of famciclovir-related AEs identified. The most common AEs were nausea, headache, altered mental status, vomiting, and dizziness, corresponding to the AEs reported in guidelines and clinical trials. However, there were AEs not mentioned in the medication guide, such as toxic encephalopathy, encephalopathy, ataxia, dysarthria, dementia, cerebral infarction, tremor, purpura, skin ulcers, acute pancreatitis, rhabdomyolysis, muscle twitching, increased blood urea, lowered blood pressure, hepatitis, disease recurrence, drug interactions, and pancytopenia.
Conclusion
Our study identified potential famciclovir AE signals, providing references for physicians in clinical use to reduce potential side effects and promote safe implementation of the drug in clinical settings.