ArticleInternational journal of clinical pharmacy2022
Data mining for adverse drug reaction signals of daptomycin based on real-world data: a disproportionality analysis of the US Food and Drug Administration adverse event reporting system.
Article in International journal of clinical pharmacy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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Who cites it
16 citing papers in PubMed, 27 citations in OpenAlex.
- Drug-associated oropharyngeal infection: a real-world pharmacovigilance study using the FDA adverse event reporting system database.BMC oral health · 2026Article
- A pharmacovigilance study of daptomycin use in infants under 1 year old based on the FDA adverse event reporting system.Scientific reports · 2025Article
- Study on disproportionality in the detection of potential signals between quetiapine and diabetic ketoacidosis.European journal of clinical pharmacology · 2025Article
- Signal detection and safety analysis of three tyrosine kinase inhibitors for HER-2 positive breast cancer: a retrospective study based on the FAERS database.Frontiers in pharmacology · 2025Article
- Data mining in FAERS: association of newer-generation H1-antihistamines with nervous system disorders.BMC pharmacology & toxicology · 2024Article
- Adverse Event Profiles of the Third-Generation Aromatase Inhibitors: Analysis of Spontaneous Reports Submitted to FAERS.Biomedicines · 2024Article
- Pharmacovigilance Strategies to Address Resistance to Antibiotics and Inappropriate Use-A Narrative Review.Antibiotics (Basel, Switzerland) · 2024Review
- Toxicity Spectrum of Anti-GD2 Immunotherapy: A Real-World Study Leveraging the US Food and Drug Administration Adverse Event Reporting System.Paediatric drugs · 2024Article
- Safety analysis of quinolones use in minors-based on the FAERS database.Frontiers in medicine · 2024Article
- Drug-Induced Gynecomastia: Data Mining and Analysis of the FDA Adverse Event Reporting System Database.Clinical epidemiology · 2024Article
- Endocrine system-related adverse events associated with PD-1/PD-L1 inhibitors: data mining from the FDA adverse event reporting system.Frontiers in medicine · 2024Article
- Signal detection and analysis of adverse events associated with GenvoyaFrontiers in pharmacology · 2024Article
- Comparing the adverse effects of ketamine and esketamine between genders using FAERS data.Frontiers in pharmacology · 2024Article
- Pharmacovigilance Study on Eosinophilic Pneumonia Induced by Anti-MRSA Agents: Analysis Based on the FDA Adverse Event Reporting System.Open forum infectious diseases · 2023Article
- Reporting of Drug-Induced Myopathies Associated with the Combination of Statins and Daptomycin: A Disproportionality Analysis Using the US Food and Drug Administration Adverse Event Reporting System.Journal of clinical medicine · 2023Article
- Drug-induced tooth discoloration: An analysis of the US food and drug administration adverse event reporting system.Frontiers in pharmacology · 2023Article
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundPrevious reports on daptomycin's adverse drug reactions (ADRs) have been insufficient, often because of limited data. Pharmacovigilance risk signal detection is innovative and has been applied to the safety monitoring and reevaluation of drugs post-marketing.
aimThe study aimed to promote safe daptomycin prescribing by mining and evaluating the daptomycin ADR signals from the US Food and Drug Administration Adverse Event Reporting System (FAERS).
methodA disproportionality analysis (reporting odds ratio ROR and proportional reporting ratio PRR) was utilized for FAERS data mining from the first quarter of 2004 to the second quarter of 2021 (the most recent quarterly data at the time of the study). Preferred Terms of ADR reports were categorized by System Organ Class (SOC) based on the Medical Dictionary for Regulatory Activities.
resultsThis study retrieved 12,221 cases within the reporting period. A total of 140 repetitive signals were obtained by ROR and PRR, of which 53 new ADR signals were not recorded in the drug labels/datasheets. The top three ADR reports were "blood creatine phosphokinase elevation" (ROR, 56.66, 95% confidence interval (CI) 51.07-62.87, PRR 51.94), "eosinophilic pneumonia" (ROR 696.71, 95%CI 603.21-804.70, PRR 657.57), and "rhabdomyolysis" (ROR 22.85, 95%CI 19.94-26.18, PRR 21.83). The highest ROR of "antimicrobial susceptibility test resistant" was found at 9808.14. Reports of rare adverse events, such as "necrotizing fasciitis and compartment syndrome," have emerged. The significant SOCs were "Infections and Infestations" and "Investigations."
conclusionNew daptomycin ADR signals were detected. Clinicians should monitor these potential ADRs in patients receiving daptomycin.
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