ArticleJournal of the American Medical Informatics Association : JAMIA2016
OpenFDA: an innovative platform providing access to a wealth of FDA's publicly available data.
Article in Journal of the American Medical Informatics Association : JAMIA, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 1 of them a synthesis that pooled 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.
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
48 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Fluoroquinolones and the risk of panic attacks: a systematic review and disproportionality analysis using individual case safety reports from the FDA Adverse Event Reporting System (FAERS) database.The Journal of antimicrobial chemotherapy · 2026Pooled it
- Microbiological Hazards, Not Undeclared Allergens, Dominate United States Food Recalls: An Analysis of 24,761 Product Recall Records, 2013-2025.Foods (Basel, Switzerland) · 2026Article
- Adverse Event Landscape of Pulsed Field Ablation Catheters: A Computational Review of FDA MAUDE Post-Market Surveillance Data.Reviews in cardiovascular medicine · 2026Article
- Integration of Clinical Pharmacokinetic Database With Compartmental Modeling and Regulatory Data Analysis.Current therapeutic research, clinical and experimental · 2026Article
- The safety of rituximab in pediatric nephrotic syndrome patients: a pharmacovigilance study of the FAERS database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- DrugPred: an EdgeConv-GNN and Bio_ClinicalBERT based polypharmacy ADR prediction and specialist recommendation model.Frontiers in artificial intelligence · 2026Article
- Reply: Severe Acute Respiratory Failure Associated With Trimethoprim/Sulfamethoxazole Among Adolescent and Young Adults: An Active Comparator-Restricted Disproportionality Analysis From the FDA Adverse Event Reporting System (FAERS) Database.The Annals of pharmacotherapy · 2025Article
- 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
- Building and Sustaining Open-Source Medical Device Projects.IEEE transactions on bio-medical engineering · 2025Review
- β-blockers and risk of neuropsychiatric adverse events: An active-comparator restricted disproportionality on the FAERS.Journal of psychopharmacology (Oxford, England) · 2025Article
- Artificial Intelligence in Infectious Disease Diagnostic Technologies.Diagnostics (Basel, Switzerland) · 2025Review
- Trimethoprim/sulfamethoxazole and risk of haemophagocytic lymphohistiocytosis (HLH): a literature review and disproportionality analysis using individual case safety reports from FAERS.The Journal of antimicrobial chemotherapy · 2025Review
- Fluoroquinolones and risk of nightmares: A literature review and disproportionality analysis using individual case safety reports from Food and Drug Administration Adverse Event Reporting System database.Journal of psychopharmacology (Oxford, England) · 2025Review
- Visualization of FDA Adverse Drug Reaction Reports: Development and Usability Study of the VisDrugs Web Server.JMIR formative research · 2025Article
- Safety evaluation of baloxavir marboxil: analysis and discussion utilizing real adverse events from the FAERS database.BMC pharmacology & toxicology · 2025Article
- Postmarketing adverse events associated with onasemnogene abeparvovec: a real-world pharmacovigilance study.Orphanet journal of rare diseases · 2025Article
- Establishing a Pharmacoinformatics Repository of Approved Medicines: A Database to Support Drug Product Development.Molecular pharmaceutics · 2025Article
- A post-marketing pharmacovigilance study of triazole antifungals: adverse event data mining and analysis based on the FDA adverse event reporting system database.Frontiers in pharmacology · 2025Article
- Developing a quality and safety surveillance system: A protocol for a realist review and synthesis of the literature.PloS one · 2025Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe objective of openFDA is to facilitate access and use of big important Food and Drug Administration public datasets by developers, researchers, and the public through harmonization of data across disparate FDA datasets provided via application programming interfaces (APIs). MATERIALS AND
methodsUsing cutting-edge technologies deployed on FDA's new public cloud computing infrastructure, openFDA provides open data for easier, faster (over 300 requests per second per process), and better access to FDA datasets; open source code and documentation shared on GitHub for open community contributions of examples, apps and ideas; and infrastructure that can be adopted for other public health big data challenges.
resultsSince its launch on June 2, 2014, openFDA has developed four APIs for drug and device adverse events, recall information for all FDA-regulated products, and drug labeling. There have been more than 20 million API calls (more than half from outside the United States), 6000 registered users, 20,000 connected Internet Protocol addresses, and dozens of new software (mobile or web) apps developed. A case study demonstrates a use of openFDA data to understand an apparent association of a drug with an adverse event.
conclusionWith easier and faster access to these datasets, consumers worldwide can learn more about FDA-regulated products.
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.