ArticleDrugs - real world outcomes2018
Spontaneous Reporting on Adverse Events by Consumers in the United States: An Analysis of the Food and Drug Administration Adverse Event Reporting System Database.
Article in Drugs - real world outcomes, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 75 citations in OpenAlex.
- National adverse event reporting for medical devices in Israel, 2013-2024.Israel journal of health policy research · 2026Article
- Predicting Serious Adverse Events, Medication Abuse, Misuse, and Risk of Dependence for Medications with High Dependence Potential: Role of Patient-Reported Factors and Machine Learning Approach.Healthcare (Basel, Switzerland) · 2026Article
- Fluoropyrimidine-associated gastrointestinal toxicity: pharmacovigilance reporting signals andFrontiers in immunology · 2026Article
- Disproportionality Analysis of Adverse Events Associated with IL-1 Inhibitors in the FDA Adverse Event Reporting System (FAERS).Pharmaceuticals (Basel, Switzerland) · 2025Article
- Completeness of spontaneously reported adverse drug reactions in 4 databases.British journal of clinical pharmacology · 2025Article
- An analysis of awareness and acceptability of the Medicines Side Effect Reporting Form for Consumer and the quality of data entered by consumers - An Indian perspective.Indian journal of pharmacology · 2025Article
- Comparison of the Completeness of Spontaneously Reported Adverse Drug Reactions by Consumers, Healthcare Professionals, and Pharmaceutical Companies: An Evaluation of Databases From Two High-Income Countries.Pharmacology research & perspectives · 2025Article
- Safety profile of faricimab: a multi-source pharmacovigilance analysis using FAERS and JADER.BMC pharmacology & toxicology · 2025Article
- A Real-World Safety Profile in Neurological, Skin, and Sexual Disorders of Anti-Seizure Medications Using the Pharmacovigilance Database of the Korea Adverse Event Reporting System (KAERS).Journal of clinical medicine · 2024Article
- Real-World Safety Data of the Orphan Drug Onasemnogene Abeparvovec (ZolgensmaPharmaceuticals (Basel, Switzerland) · 2024Article
- CDK4/6 inhibitors in drug-induced liver injury: a pharmacovigilance study of the FAERS database and analysis of the drug-gene interaction network.Frontiers in pharmacology · 2024Article
- Harms in Systematic Reviews Paper 1: An introduction to research on harms.Journal of clinical epidemiology · 2022Article
- The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process.International journal of environmental research and public health · 2021Review
- Deep learning models in detection of dietary supplement adverse event signals from Twitter.JAMIA open · 2021Article
- A VigiBase descriptive study of fluoroquinolone induced disabling and potentially permanent musculoskeletal and connective tissue disorders.Scientific reports · 2021Article
- Global COVID-19 pandemic and reporting behavior - An analysis of the Food and Drug Administration adverse events reporting system.Pharmacoepidemiology and drug safety · 2021Article
- A Comparative View of Reported Adverse Effects of Statins in Social Media, Regulatory Data, Drug Information Databases and Systematic Reviews.Drug safety · 2021Article
- Comments to Drs. Gastaldon, Raschi, Kane, Barbui, and Schoretsanitis.Psychotherapy and psychosomatics · 2021Article
- Thromboembolic Safety Reporting of Tofacitinib and Baricitinib: An Analysis of the WHO VigiBase.Drug safety · 2020Article
- Assessment of factors associated with completeness of spontaneous adverse event reporting in the United States: A comparison between consumer reports and healthcare professional reports.Journal of clinical pharmacy and therapeutics · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
Abstract
backgroundVoluntary reports on adverse events (AEs) submitted by consumers have been facilitated through the MedWatch program in the United States (US), but few studies have described the characteristics of voluntary reports.
objectiveThe aim of this study was to reveal the characteristics of current voluntary reports on AEs reported by consumers and healthcare professionals.
methodsWe performed analysis on voluntary reports of AEs in the US Food and Drug Administration AE Reporting System (FAERS) database submitted in 2016. We compared reports by consumers with those by healthcare professionals.
resultsThe number of voluntary reports by consumers has increased since 2013 in the US. Reports by consumers were different from ones by health professionals in several important aspects such as demographics and outcomes of patients, AEs, and suspect drugs. The proportion of reports on female patients and on disability as a patient outcome were higher in reports by consumers than in those by healthcare professionals. Consumers more frequently reported concomitant drugs compared with healthcare professionals. Time to report varied among the occupations and depending on seriousness of outcomes.
conclusionsOur analysis of voluntary AE reports in the US FAERS database has shown that voluntary reports tended to include AEs related to subjective symptoms, as in some previous studies on patient reporting in the EU. Voluntary reports by consumers seemed to be different from ones by healthcare professionals in important aspects including demographics and reporting behaviors. These findings suggest that the heterogeneities should be addressed appropriately in using spontaneous reports.
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.