Adverse events associated with teriparatide: a real-world disproportionality analysis of the FDA adverse event reporting system (FAERS)

Abstract

ABSTRACT Background Teriparatide is widely used for osteoporosis treatment in various patients, but its safety profile is not fully documented. This study analyzes the FDA pharmacovigilance database to assess teriparatide’s safety. Research design and methods Data from the first quarter (Q1) of 2004 to the third quarter (Q3) of 2023 were extracted and analyzed for disproportionality between teriparatide and adverse effects (AE). Results A total of 66,991 AE reports identified teriparatide as the principal suspect medication, aggregating to 222,116 individual AEs. Notably, healthcare professionals authored 16.1% of these reports (n = 10,809), whereas consumers accounted for the majority with 81.3% (n = 54,474). Teriparatide revealed a marked association with an increased propensity for musculoskeletal and connective tissue disorders (ROR,3.95; 95% CI, 3.91–3.99) at the System Organ Class (SOC) level. Concurrently, 199 preferred terms (PTs) displayed significant disproportionality across all four employed algorithms. Conclusions Our study confirms several well-known adverse drug reactions and identifies potential safety issues associated with teriparatide treatment. This contributes to a deeper understanding of the complex relationship between adverse reactions and teriparatide. These findings emphasize the importance of continuous monitoring and ongoing surveillance to promptly identify and effectively manage adverse reactions, thereby enhancing overall patient safety and well-being.