Evidence map›Paper›PMID 40956485›Full record

ArticleDrug safety2026

Characterizing the FDA Adverse Event Reporting System (FAERS) as a Network to Improve Pattern Discovery.

Raechel Davis, Oanh Dang, Suranjan De, Robert Ball

Abstract read
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In one paragraph

Article in Drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Raechel DavisOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20903, USA.
Oanh DangOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20903, USA.
Suranjan DeOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20903, USA.
Robert BallOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20903, USA. robert.ball@fda.hhs.gov.ORCID 0000-0002-1609-7420

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn drug-safety monitoring systems, adverse events (AEs) associated with the use of medical products often consist of complex patterns of clinical events. Network analysis (NA) was used for pattern recognition and characterizing the Vaccine Adverse Event Reporting System (VAERS), but limited applications of NA to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) left its network description incomplete.

methodsIn this analysis, the network properties of FAERS were characterized and leveraged to facilitate pattern discovery. Reported AE information in FAERS is represented using preferred terms (PTs) in Medical Dictionary for Regulatory Activities terminology. The FAERS subsets were analyzed with drugs and PTs as nodes and interconnections as edges. Global characteristics, like the scale-free nature of the distribution, were examined to explore theoretical and structural considerations. Metrics that assess connectivity and edge weighting algorithms based on report co-occurrence or clustering were applied.

resultsSerious AE reports from 2016 to 2023 (2,062,099) were represented as a network of 20,965 nodes (16,847 PTs and 4116 drugs) with more than four million interconnections. Characteristics of FAERS subnetworks were determined with heavy-tailed degree distributions, high local clustering, and low diameters. Complexities related to structural and evolutionary characteristics were revealed as the log-normal model fits the degree distribution better than the power law.

conclusionsNetwork-based techniques identified clinically relevant patterns and clustering patterns representative of known adverse drug reactions. Comparisons to VAERS reveal similarities in networks of AE reporting systems. This initial systematic application of NA to FAERS describes the overall network characteristics of the FAERS database and provides insight into the use of network applications in drug safety research.

Indexed as

Adverse Drug Reaction Reporting SystemsDrug-Related Side Effects and Adverse ReactionsUnited States Food and Drug AdministrationAlgorithmsHumansPharmacovigilanceUnited States

Identifiers

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Registered trials

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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.