ArticleEuropean journal of clinical pharmacology2014
Association between an excess risk of acute kidney injury and concomitant use of ibuprofen and acetaminophen in children, retrospective analysis of a spontaneous reporting system.
Article in European journal of clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.
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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.
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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
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- Symptomatic fever management in children: A systematic review of national and international guidelines.PloS one · 2021Pooled it
- Prescribing Controversies: An Updated Review and Meta-Analysis on Combined/Alternating Use of Ibuprofen and Paracetamol in Febrile Children.Frontiers in pediatrics · 2019Pooled it
- Acute Pain Management in Children: A Systematic Review and GRADE-Based Recommendations.Journal of clinical medicine · 2026Review
- Adverse Event Profiles of Acetaminophen and Ibuprofen in Infants: A Food and Drug Administration Adverse Event Reporting System Database Retrospective Cohort Study.Turkish archives of pediatrics · 2025Article
- New perspectives for optimizing fever and pain management in pediatrics: evidence supporting therapeutic awareness in clinical practice.Italian journal of pediatrics · 2025Review
- The Risk of Nonsteroidal Anti-Inflammatory Drugs in Pediatric Medicine: Listen Carefully to Children with Pain.Children (Basel, Switzerland) · 2021Article
- Prescribing patterns, indications and adverse events of ibuprofen in children: results from a national survey among Italian pediatricians.Italian journal of pediatrics · 2021Article
- Association of Ibuprofen Prescription With Acute Kidney Injury Among Hospitalized Children in China.JAMA network open · 2021Article
- Overview on the Discovery and Development of Anti-Inflammatory Drugs: Should the Focus Be on Synthesis or Degradation of PGEJournal of inflammation research · 2021Review
- Acute pain management in children: a survey of Italian pediatricians.Italian journal of pediatrics · 2019Article
- Frequency and Nature of Adverse Drug Reactions Due to Non-Prescription Drugs in Children: A Retrospective Analysis from the French Pharmacovigilance Database.Paediatric drugs · 2018Article
- Fever in Children: Pearls and Pitfalls.Children (Basel, Switzerland) · 2017Review
- Working Towards an Appropriate Use of Ibuprofen in Children: An Evidence-Based Appraisal.Drugs · 2017Review
- Efficacy and Safety of Ibuprofen in Infants Aged Between 3 and 6 Months.Paediatric drugs · 2017Review
- Detecting drug-herbal interaction using a spontaneous reporting system database: an example with benzylpenicillin and qingkailing injection.European journal of clinical pharmacology · 2015Article
- Combined and alternating acetaminophen and ibuprofen therapy for febrile children.Paediatrics & child health · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeIbuprofen and acetaminophen are frequently alternated or simultaneously used to treat fever or pain in children, while the evidence for the safety of such a combination is lacking. In this study, we analyzed the association of acute kidney injury (AKI) with ibuprofen, acetaminophen, and the combination of both drugs in children (0-12 years) by using the FDA Adverse Event Reporting System (AERS) database between January 2004 and June 2012.
methodsAdverse event reports in children aged 0 to ≤12 years were included in the study. Cases were defined as reports of AKI according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology, non-cases as all other reports. Exposure categories were divided into three index groups: two groups where ibuprofen or acetaminophen were used in absence of one another and another group where both drugs were used concomitantly. There was also a reference group, in which neither ibuprofen nor acetaminophen was used. These index groups were compared with the reference group using reporting odds ratios (RORs).
resultsIn total, 47,803 reports were included in the study. After adjusting for year of reporting, age, and sex, the ROR for an AKI in children who used only ibuprofen or acetaminophen compared with children who used neither ibuprofen nor acetaminophen was 2.14 (95 % CI: 1.59-2.88) and 1.53 (95 % CI: 1.18-1.97), respectively, while the adjusted ROR was 4.01 (95 % CI: 2.96-5.43) when both drugs were concomitantly used.
conclusionsThe results illustrate that the concomitant use of ibuprofen and acetaminophen in children might be associated with increased risk of AKI.
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