ArticlePloS one2018
Safety of ibuprofen in infants younger than six months: A retrospective cohort study.
Article in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
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Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.
- Comparison of Acetaminophen (Paracetamol) With Ibuprofen for Treatment of Fever or Pain in Children Younger Than 2 Years: A Systematic Review and Meta-analysis.JAMA network open · 2020Pooled it
- A Multi-Center Evaluation of the Pharmacokinetics and Safety of Intravenous Ibuprofen in Infants 1-6 Months of Age.Paediatric drugs · 2023Trial
- Trial
- 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
- Management of Infants Treated for Respiratory Viral Infections: A Finnish Retrospective Register-Based Study.Health science reports · 2025Article
- The Use and Safety of Cough and Cold Medications in the Pediatric Population.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025Article
- Medical Expulsive Therapy for Pediatric Ureteral Stones: A Meta-Analysis of Randomized Clinical Trials.Journal of clinical medicine · 2023Review
- Efficacy and Safety of NSAIDs in Infants: A Comprehensive Review of the Literature of the Past 20 Years.Paediatric drugs · 2022Review
- Pediatric Perioperative Clinical Pharmacy Practice: Clinical Considerations and Management: An Opinion of the Pediatrics and Perioperative Care Practice and Research Networks of the American College of Clinical Pharmacy.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2022Article
- Article
Corrections and comments
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Authors and funding
3 authors at 3 institutions in 2 countries.
Funding
Abstract
objectiveWe hypothesized (1) that gastrointestinal (GI) and renal adverse events (AE) would occur more often in infants first prescribed ibuprofen before rather than after six months of age and (2) that ibuprofen would be associated with more adverse effects than acetaminophen in infants younger than six months.
methodsWe created two partly overlapping retrospective cohorts of infants aged less than six months when California Medicaid first paid for ibuprofen or acetaminophen between 2004 and 2010. In the first cohort we compared the incidence rate ratio (RR) of GI and renal AE between those infants first prescribed ibuprofen before six months of age with those first prescribed ibuprofen after six months of age. In the second cohort we compared the RR of GI and renal AE between infants younger than six months prescribed ibuprofen (+/-acetaminophen) with those prescribed only acetaminophen.
resultsWe identified 41,669 prescriptions for ibuprofen and 176,991 prescriptions for acetaminophen in 180,333 eligible infants (median age 2.1 months). We did not observe higher RR of any AE in infants first prescribed ibuprofen before rather than after six months of age. Most infants prescribed ibuprofen were also prescribed acetaminophen. Any GI (adjusted (a)RR 1.25, 95% CI 1.13-1.38) and moderate or severe GI AE (aRR 1.24, 95% CI 1.09-1.40) were more common in infants younger than six months who were prescribed ibuprofen versus acetaminophen alone. Severe GI (aRR 0.63, 95% CI 0.27-1.45) and renal AE (aRR 1.84 95% CI 0.66-5.19) were not different between the ibuprofen (+/-acetaminophen) and acetaminophen-only groups.
conclusionsGI and renal AEs were not higher in infants younger than six months who were prescribed ibuprofen compared with those aged six to 12 months. AEs were increased in infants younger than six months who were prescribed ibuprofen compared with infants who were prescribed acetaminophen alone.
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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.