ArticleDrug safety2014
Stimulated reporting: the impact of US food and drug administration-issued alerts on the adverse event reporting system (FAERS).
Article in Drug safety, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 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
51 citing papers in PubMed.
- Orlistat-Associated Gastrointestinal, Hepatobiliary, Pancreatic, and Anorectal Safety Signals: A FAERS Disproportionality and Regulatory Label Concordance Study.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Patient-Level Risk Characterization of Drug-Associated Hidradenitis Suppurativa Using Machine Learning.medRxiv : the preprint server for health sciences · 2026Article
- Comment on Wei et al.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2026Article
- Changes in the consumption of immediate-release fentanyl between 2018 and 2022 in the province of Santa Cruz de Tenerife after the implementation of regulatory measures by health authorities.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Severe Cutaneous Adverse Reactions Associated With Newer-Generation Antiseizure Medications: A Real-World Pharmacovigilance Study Based on FAERS and JADER.CNS neuroscience & therapeutics · 2026Article
- Large-Scale Signal Detection and Personalized Risk Prediction for Cardiovascular Drug Adverse Reactions in Elderly Patients: Real-World Evidence from Western China.Cardiovascular toxicology · 2026Article
- Ecopharmacovigilance and pharmacovigilance: an analysis of environment-related reporting in VigiBase.Environmental science and pollution research international · 2026Article
- The real-world safety evaluation of the selective NaV1.8 inhibitor suzetrigine: disproportionality analysis and flexible empirical bayes signals from FAERS with external triangulation.Frontiers in pharmacology · 2026Article
- Drug spectrum and disproportionality signals for diabetes insipidus in FAERS: multi-method analysis, JADER cross-database assessment, and PubMed-based case-level evidence.Frontiers in pharmacology · 2026Article
- QT-related adverse events with ondansetron and olanzapine: a real-world FAERS analysis with implications for oncology anti-emetic practice.Frontiers in pharmacology · 2026Article
- Trastuzumab-TKI combination in HER2-Positive tumors: a FAERS-Based safety profile and multimodal analysis of Tanespimycin's role in enhancing targeting of the HSP90AA1-PI3K-Akt-mTOR axis.Frontiers in pharmacology · 2026Article
- Altered eating experience during GLP-1 receptor agonist therapy: a sensory-liking-wanting framework for food preference and nutritional behaviour.Frontiers in nutrition · 2026Review
- High Throughput Pharmacovigilance Screening for Roflumilast Adverse Effects in Real-World Settings: A Sequence Symmetry Analysis.Basic & clinical pharmacology & toxicology · 2025Article
- Analyses of Adverse Drug Reactions to Fluoroquinolones in Spontaneous Reports Before and After the Referral and in Clinical Routine Cases.Drugs in R&D · 2025Article
- Disproportionality analysis of Raynaud's phenomenon associated with calcitonin gene-related peptide inhibitors using the Food and Drug Administration adverse event reporting system.Scientific reports · 2025Article
- Unveiling unexpected adverse events: post-marketing safety surveillance of gilteritinib and midostaurin from the FDA Adverse Event Reporting database.Therapeutic advances in drug safety · 2025Article
- Long-term hepatobiliary disorder associated with trastuzumab emtansine pharmacovigilance study using the FDA Adverse Event Reporting System database.Scientific reports · 2024Article
- Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis.Drug safety · 2024Article
- Descriptive Analysis of Adverse Events Reported for New Multiple Myeloma Medications Using FDA Adverse Event Reporting System (FAERS) Databases from 2015 to 2022.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Response to: Correspondence on 'Cardiovascular toxicities associated with bispecific T-cell engager therapy' by NoguchiJournal for immunotherapy of cancer · 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
5 authors.
Funding
Abstract
backgroundThe US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs. Currently, almost one million case reports are submitted to FAERS each year, making it a vast repository of drug safety information. Sometimes cited as a limitation of FAERS, however, is the assumption that "stimulated reporting" of adverse events (AEs) occurs in response to warnings, alerts, and label changes that are issued by the FDA.
objectiveTo determine the extent of "stimulated reporting" in the modern-day FAERS database.
methodsOne hundred drugs approved by the FDA between 2001 and 2010 were included in this analysis. FDA alerts were obtained by a comprehensive search of the FDA's MedWatch and main websites. Publicly available FAERS data were used to assess the "primary suspect" AE reporting pattern for up to four quarters before, and after, the issuance of an FDA alert.
resultsA few drugs did demonstrate "stimulated reporting" trends. A majority of the drugs, however, showed little evidence for significant reporting changes associated with the issuance of alerts. When we compared the percentage changes in reporting after an FDA alert with those after a sham "control alert", the overall reporting trends appeared to be quite similar. Of 100 drugs analyzed for short-term reporting trends, 21 real alerts and 25 sham alerts demonstrated an increase (greater than or equal to 1 %) in reporting. The long-term analysis of 91 drugs showed that 24 real alerts and 28 sham alerts demonstrated a greater than or equal to 1 % increase.
conclusionsOur results suggest that most of modern day FAERS reporting is not significantly affected by the issuance of FDA alerts.
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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.