ArticleFrontiers in pharmacology2024
Adverse drug reactions in neonates: a brief analysis of the FDA adverse event reporting system.
Article in Frontiers in pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 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
7 citing papers in PubMed.
- Preliminary exploration of acute limit toxicity testing for nicotinamide mononucleotide in the neonatal population.Frontiers in pharmacology · 2026Article
- Integrative analysis of FAERS, network toxicology, and Mendelian randomization identifies potential targets in paclitaxel-associated systemic sclerosis.Frontiers in immunology · 2026Article
- A multidimensional investigation of myelosuppression associated with sintilimab: integrating pharmacovigilance signal mining with real-world clinical evidence.Frontiers in pharmacology · 2026Article
- Lorazepam during breastfeeding: a pharmacokinetic case report and exploratory pharmacovigilance assessment - a contribution from the ConcePTION project.Frontiers in pharmacology · 2026Article
- EudraVigilance insights: Suspected adverse drug reactions in infants through breastfeeding.British journal of clinical pharmacology · 2025Observational
- Spontaneous Adverse Drug Reaction Reporting of Congenital Malformations: A Danish National Register Study.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Editorial: Advances in perinatal and neonatal clinical pharmacology.Frontiers in pharmacology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction: Drug trials in neonates are scarce, and the neonates may consequently be at risk of adverse drug reactions (ADRs). Spontaneous ADR reporting is an important tool for expanding the knowledge on drug safety in neonates. This study explores the quality of current neonatal ADR reports and the ADR reports of the most common drugs used in neonatal departments. Methods: An observational cross-sectional study focused on neonates was conducted using data on spontaneous reports extracted from the U.S. Food and Drug Administration Adverse Events Reporting System (FAERS) from the third quarter of 2014 up to December 2022. Only the primary suspect drugs given to neonates or subjects aged <30 days were included in the analysis. Results: Spontaneous reports from 13 million patients of all ages, totaling 50 million ADRs, were evaluated. Information regarding the age was missing in 40% of the reports, and data on 43,737 neonates with 948 different suspected drugs were identified and included in the analysis. We report the frequency of spontaneous ADR reports in the FAERS database for the ten most frequently administered drugs in neonatal intensive care units in the USA. Conclusion: Overall, neonatal ADRs are still underreported. The FAERS database in its current form discriminates insufficiently between prenatal and postnatal drug exposures. Hence, improved neonatal pharmacovigilance systems are urgently needed.
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.