ArticleInternational journal of clinical pharmacy2025
Post-marketing safety of pralsetinib: a real-world disproportionality analysis based on the FDA adverse event reporting system database.
Article in International journal of clinical pharmacy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
3 citing papers in PubMed.
- From class effects to specificity FAERS evidence and network mapping of adverse events in NSCLC targeted therapy.International journal of surgery (London, England) · 2026Article
- Comment on "Perioperative esketamine combined with butorphanol versus butorphanol alone for pain management following video-assisted lobectomy: a randomized controlled trial".International journal of clinical pharmacy · 2025Article
- Adverse drug events associated with tiotropium: a real-world pharmacovigilance study of FDA adverse event reporting system database.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2025Article
Corrections and comments
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Authors and funding
8 authors.
Funding
Abstract
backgroundPralsetinib is a novel rearranged during transfection (RET) inhibitor that is approved for treating non-small cell lung cancer and thyroid cancer. Although clinical trials have established its efficacy, real-world data on its safety profile remain limited.
aimThis study aimed to analyze pralsetinib-related adverse events (AEs) reported in the Food and Drug Administration adverse event reporting system (FAERS) database to identify potential safety signals.
methodWe conducted a retrospective pharmacovigilance analysis using FAERS database from Q3 2020 to Q2 2024. After deduplication, disproportionality analysis was performed using four algorithms: reporting odds ratio (ROR), proportional reporting ratio, Bayesian confidence propagation neural network, and empirical Bayes geometric mean.
resultsA total of 1064 pralsetinib-related reports were identified, encompassing 3608 AEs. The most common AEs were hypertension (n = 80), asthenia (n = 79), anemia (n = 65), white blood cell count decreased (n = 63), and constipation (n = 58). We also detected new and unexpected AE signals, including blood calcitonin increased (ROR: 853.54), myocardial necrosis marker increased (ROR: 201.79), cystitis bacterial (ROR: 134.84), fungal foot infection (ROR: 51.83), pulmonary tuberculosis (ROR: 39.5), and myocardial injury (ROR: 30.36). Additionally, hypertension was more prevalent among female patients (Female/Male = 53/19, ROR: 1.8 [1.06-3.05]) and olderpatients (≥ 65/ < 65 = 34/18, ROR: 1.8 [1.01-3.2]).
conclusionOur study identified some known and new significant AE signals associated with pralsetinib, emphasizing the importance of continued pharmacovigilance. While the findings provide valuable insights for clinical practice, further validation through large-scale prospective studies is needed.
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