ArticleFrontiers in pharmacology2025
Real-world safety profile of elexacaftor/tezacaftor/ivacaftor: a disproportionality analysis using the U.S. FDA adverse event reporting system.
Article in Frontiers in pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed.
- Early effect of CFTR modulators on the mental health of patients with cystic fibrosis and parents.European journal of pediatrics · 2026Observational
- The clinical, psychosocial, and economic burden of cystic fibrosis lung disease in the era of CFTR modulator therapy.Annals of the American Thoracic Society · 2026Review
- Aging Gracefully: Does Elexacaftor/Tezacaftor/Ivacaftor Safety and Efficacy Stand the Test of Time?American journal of respiratory and critical care medicine · 2025Article
- Cystic Fibrosis Year in Review 2024.Pediatric pulmonology · 2025Review
- Reported Adverse Events in Patients with CF Receiving Treatment with Elexacaftor/Tezacaftor/Ivacaftor: 5 Years Observational Study.Journal of clinical medicine · 2025Article
- Neurological adverse events associated with baclofen: a pharmacovigilance study based on FDA adverse event reporting system.Frontiers in pharmacology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Elexacaftor/Tezacaftor/Ivacaftor (ETI) has demonstrated significant efficacy in enhancing clinical outcomes for patients with cystic fibrosis (CF). Despite this, comprehensive post-marketing assessments of its adverse drug events (ADEs) remain insufficient. This study aims to analyze the ADEs associated with ETI using the U.S. FDA Adverse Event Reporting System (FAERS). Methods: We conducted a pharmacovigilance analysis utilizing FAERS data from Q4 2019 to Q3 2024. Reports of ADEs related to ETI were extracted, and disproportionality analyses-including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS)-were employed to evaluate signal strength. Additionally, a time-to-onset (TTO) analysis was performed. Results: A total of 28,366 ETI-related ADEs were identified, spanning 27 organ systems. We identified 322 positive signals, with signals consistent with the drug label including headache (702 cases, ROR 2.75), infective pulmonary exacerbation of CF (691 cases, ROR 384.24), rash (538 cases, ROR 2.72), and cough (507 cases, ROR 3.79). Unexpected signals were also noted, such as anxiety (494 cases, ROR 4.16), depression (364 cases, ROR 4.59), insomnia (281 cases ROR 2.83), nephrolithiasis (79 cases, ROR 3.63) and perinatal depression (4 cases, ROR 13.59). The TTO analysis indicated that the median onset of ADEs was 70 days, with 37.08% occurring within the first month. Subgroup analyses revealed that females exhibited a higher reporting rank for mental disorder and constipation, whereas in males, they were insomnia, abdominal pain, and nasopharyngitis. Conclusion: This study highlights both recognized and unexpected ADEs associated with ETI, underscoring the necessity for ongoing monitoring, particularly concerning psychiatric conditions. The subgroup analysis suggests a need for personalized treatment strategies to optimize patient care.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.