ArticleBMC pharmacology & toxicology2025
Post-market safety profile of cefiderocol: a real-world pharmacovigilance exploratory analysis based on U.S. FDA adverse event reporting system (FAERS).
Article in BMC pharmacology & toxicology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
What it found
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatment.Scientific reports · 2025Pooled it
- Reported Dosing-Related Medication Errors Involving Systemic Antibiotics in the Brazilian Pharmacovigilance Database (2018-2025): Distribution Across the WHO AWaRe Classification.Pharmacoepidemiology and drug safety · 2026Article
- Article
- Cefiderocol in Children with Hematologic Malignancies-The Multicenter Retrospective Experience of the Infection Working Group of the Italian Pediatric Hematology and Oncology Association (AIEOP).Journal of clinical medicine · 2026Article
- Resistance, Ineffectiveness, and Off-Label Use Related to Cephalosporins from the Reserve Group-A Pharmacovigilance Signal Detection Study on EudraVigilance Database.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Detection of drug-induced acute respiratory distress syndrome risk signals in FAERS: a real-world pharmacovigilance study.Frontiers in medicine · 2026Article
- Peripheral and central nervous system toxicities of Bruton tyrosine kinase Inhibitors: a real-world pharmacovigilance study.Frontiers in medicine · 2026Article
- Ranking the Diabetes-related Safety Profile of Different Statin Drugs.Current pharmaceutical design · 2026Article
- Review
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
backgroundCefiderocol is a new drug class, which is approved to treat Gram-negative bacteria infection. Its approval for marketing has provided clinicians with additional options for treating antimicrobial resistant gram-negative infections. The aim of our study was to assess the safety profiles of cefiderocol in real-world through data mining of the United States Food and Drug Administration Adverse Event Reporting System (FAERS).
methodsWe included adverse event (AE) reports regarding cefiderocol submitted to the FAERS from 2019 quarter 4 (2019Q4) to 2024 quarter 3 (2024Q3). Disproportionality analyses, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN) and Multi-item Gamma Poisson Shrinker (MGPS) techniques were performed to identify the signals of disproportionate reporting of AEs in patients receiving cefiderocol. A signal of disproportionate reporting was detected if the lower limit of the 95% confidence interval (CI) of ROR > 1, the PRR was ≥ 2(while the Chi-Square of PRR was ≥ 4), the lower limit of 95% CI of the information component (IC025) was > 0, the lower limit of 95% CI of the Empirical Bayes Geometric Mean (EBGM05) was > 2 and at least 3 AEs were reported.
resultsA total of 29 significant preferred terms (PTs) were identified among the 592 cefiderocol-associated adverse events (AEs) reports collected from the FAERS database. Cefiderocol-induced adverse events involved 24 System Organ Class (SOC). 29 positive signals of disproportionate reporting are also presented, such as Pathogen resistance (n = 16, ROR 189.35, PRR 184.26, IC 7.52, EBGM 183.89), Systemic candida (n = 3, ROR 138.79, PRR 138.19, IC7.11, EBGM 137.88), Drug resistance (n = 30, ROR 131.96, PRR 125.33, IC6.97, EBGM 125.16), and Drug effect less than expected (n = 6, ROR 68.42, PRR 67.74, IC6.08, EBGM 67.69). The most frequently observed were Death, Drug resistance and Treatment failure.
conclusionsOur findings offer significant evidence regarding the safety profile of cefiderocol in real-world settings. This information may assist clinicians and pharmacists in enhancing their vigilance and improving the overall safety of cefiderocol in clinical practice.
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