ArticlePloS one2016
OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications.
Article in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 114 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
114 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Five Years of Sacubitril/Valsartan-a Safety Analysis of Randomized Clinical Trials and Real-World Pharmacovigilance.Cardiovascular drugs and therapy · 2022Pooled it
- Interstitial lung disease associated with antiandrogen agents: a pharmacovigilance study based on FDA adverse event reporting system.International urology and nephrology · 2026Article
- Beyond pooled analysis: sex-specific cardiovascular adverse event reporting signals with antiarrhythmic drugs in FAERS.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Adverse events of givosiran in the treatment of acute hepatic porphyria: a pharmacovigilance study using the FAERS and VigiAccess databases.Orphanet journal of rare diseases · 2026Article
- The Safety Profile of Ticagrelor among Older Adults (Age ≥75 years): A Pharmacovigilance Analysis.Cardiology · 2026Article
- Estriol Is Likely Not Associated With Mouth Ulcerations in Pharmacovigilance Data.International dental journal · 2026Article
- Triple-M Overlap Syndrome Associated with Immune Checkpoint Inhibitors: A FAERS Pharmacovigilance Analysis.Healthcare (Basel, Switzerland) · 2026Article
- Cerebral venous sinus thrombosis risk across various oral contraceptives: a disproportionality analysis of the FDA adverse event reporting system.Journal of neurology · 2026Article
- Pharmacovigilance study of spinal epidural hematoma reports associated with direct oral anticoagulants and warfarin.Acta neurochirurgica · 2026Article
- Signal detection of drug-induced esophageal ulcer across 20 years of real-world study: Focus on 49 high-risk medicines.The Journal of international medical research · 2026Article
- Real-world safety assessment of burosumab: a pharmacovigilance study utilizing the FDA adverse event reporting system.Orphanet journal of rare diseases · 2026Article
- Suicide adverse events associated with zopiclone and eszopiclone: A pharmacovigilance analysis based on FAERS, JADER and CVARD.PloS one · 2026Article
- Adverse events related to drug-drug interactions in tocilizumab combination therapy: a retrospective analysis and clinical implications.Frontiers in medicine · 2026Article
- Signal mining and safety profile analysis of lapatinib: a pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database.Journal of pharmaceutical policy and practice · 2026Article
- Article
- Kidney adverse events associated with calcineurin inhibitors: a real-world study based on the FAERS database and network pharmacology.Frontiers in medicine · 2026Article
- Drug-Induced Intestinal Angioedema: A Disproportionality Analysis Using the United States Food and Drug Administration Adverse Event Reporting System Database and Literature Review.Medical sciences (Basel, Switzerland) · 2025Review
- Peripheral neuropathy associated with immunomodulatory drugs: a pharmacovigilance analysis based on the FDA adverse event reporting system database.International journal of clinical pharmacy · 2025Article
- Osimertinib-related myotoxicity: a disproportionality analysis of the FDA adverse event reporting system.BMC cancer · 2025Article
- Age and Sex Differences in Adverse Events Associated With Antipsychotics: An Analysis of the FDA Adverse Events Database.International journal of geriatric psychiatry · 2025Article
54 more citing papers are in PubMed but not listed here.
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
Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs.
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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.