ArticleEuropean journal of pediatrics2023
Drug-associated kidney injury in children: a disproportionality analysis of the FDA Adverse Event Reporting System.
Article in European journal of pediatrics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 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
13 citing papers in PubMed.
- Drug-Induced Noninfectious Myocarditis/Pericarditis: A Real-World Pharmacovigilance Study Using the FAERS Database.Cardiovascular toxicology · 2026Article
- Safety evaluation of finerenone and identification of factors contributing to nephrotoxicity: re-analysis using FDA adverse event reporting system data.International urology and nephrology · 2026Article
- Adverse events following HPV vaccine reported to the Vaccine Adverse Event Reporting System.PloS one · 2026Article
- Signal mining and safety profile analysis of lapatinib: a pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database.Journal of pharmaceutical policy and practice · 2026Article
- Triptorelin associated adverse events evaluated using FAERS pharmacovigilance data.Scientific reports · 2025Article
- Psychiatric disorders with antiseizure medications in children: an analysis of the FDA adverse event reporting system database.Acta epileptologica · 2025Article
- Diazepam exposure associated with an increased risk of acute kidney injury in children: an observational cohort study.BMC pediatrics · 2025Observational
- Renal injury in NSAIDs: a real-world analysis based on the FAERS database.International urology and nephrology · 2025Article
- The real-world safety profile of empagliflozin: a disproportionality analysis based on the FDA Adverse Event Reporting System (FAERS) database.BMC pharmacology & toxicology · 2025Article
- Safety assessment of cyclin-dependent kinase 4/6 inhibitors and comparison of time to adverse events.PloS one · 2025Article
- Piperacillin/tazobactam treatment in children: evidence of subtherapeutic concentrations.Frontiers in pharmacology · 2024Article
- Ceftriaxone-induced severe hemolytic anemia, renal calculi, and cholecystolithiasis in a 3-year-old child: a case report and literature review.Frontiers in pharmacology · 2024Article
- A disproportionality analysis of adverse events associated to pertuzumab in the FDA Adverse Event Reporting System (FAERS).BMC pharmacology & toxicology · 2023Article
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
Drug-associated kidney injury is related to longer hospitalization and increased risk of chronic kidney disease and mortality. However, there is currently a lack of large population studies on drug-associated kidney injury in children. This study aimed to study perform data mining to generate hypotheses on drugs, which may deserve to be assessed as per their potential risk of increasing kidney injury in children. We extracted and analyzed reports on drugs associated with kidney injury in children in the FDA Adverse Event Reporting System (FAERS). We conducted a disproportionality analysis using proportional reporting ratio (PRR) to evaluate the association between drugs and kidney injury in children. Meanwhile, comparisons were performed with drug labels to identify drugs that, despite not having kidney injury currently mentioned in their labels, may potentially be associated with risks of kidney injury in children. A total of 6347 children had drug-associated kidney injury in the FAERS database. The top five drugs with the highest PRR were gentamicin (PRR = 12.28, N = 157 cases, Chi-Squared = 1602.77), piperacillin-tazobactam (PRR = 9.77, N = 129 cases, Chi-Squared = 1003.24), amlodipine (PRR = 8.98, N = 271 cases, Chi-Squared = 1861.46), vancomycin (PRR = 8.91, N = 295 cases, Chi-Squared = 1998.64), and ceftriaxone (PRR = 8.00, N = 251 cases, Chi-Squared = 1494.02). According to drug labels, 9 drugs (9/30) were classified as potential nephrotoxins.
conclusionsApproximately one-third of drugs associated with kidney injury in children do not list kidney injury as a side effect in their drug labels. Future studies are therefore warranted to evaluate whether these drugs are associated with such a risk. WHAT IS KNOWN: • Nephrotoxic drugs are an increasingly common cause of acute kidney injury in hospitalized children. • Currently, no study has systematically combed drugs associated with kidney injury in children. WHAT IS NEW: • Approximately a third of drugs showing signals for potential kidney injury in children in data mining do not mention this side effect in their drug labels. • This study provides data on drugs needing further study to determine whether they might increase the risk of kidney injury in children.
Indexed as
Identifiers
37561197What Socratic 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 Socratic graph.