ArticlePharmacoepidemiology and drug safety2021
Global COVID-19 pandemic and reporting behavior - An analysis of the Food and Drug Administration adverse events reporting system.
Article in Pharmacoepidemiology and drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed, 19 citations in OpenAlex.
- Persistent rise in device-related errors for CGRP monoclonal antibodies: impact of the COVID-19 pandemic and post-pandemic implications.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Proton Pump Inhibitors and Disproportionate Reporting of Acute Kidney Injury and Tubulointerstitial Nephritis: A FAERS Pharmacovigilance Study, 2020-2025.Journal of clinical medicine · 2026Article
- Statin use and the risk of tubulointerstitial nephritis: a real-world signal detection analysis using FDA Adverse Event Reporting System.Frontiers in medicine · 2025Article
- Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis.Drug safety · 2024Article
- Impact of Covid-19 Vaccination on Spontaneous Pharmacovigilance Reporting in France.Drug safety · 2023Article
- Impact of the COVID-19 pandemic on the spontaneous reporting and signal detection of adverse drug events.Scientific reports · 2023Article
- Article
- Analysis of pharmacovigilance databases for spontaneous reports of adverse drug reactions related to substandard and falsified medical products: A descriptive study.Frontiers in pharmacology · 2022Article
- Facial nerve palsy following the administration of COVID-19 mRNA vaccines: analysis of a self-reporting database.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2021Article
- SARS-CoV-2 Pandemic and Food Safety Oversight: Implications in Canada and Coping Strategies.Foods (Basel, Switzerland) · 2021Review
- Global COVID-19 pandemic and reporting behavior - An analysis of the Food and Drug Administration adverse events reporting system.Pharmacoepidemiology and drug safety · 2021Article
Corrections and comments
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Authors and funding
4 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo describe the characteristics of adverse event reporting in the United States (US) Food and Drug Administration Adverse Event Reporting System (FAERS) before and after the outbreak of the COVID-19 pandemic.
methodsWe included all FAERS reports from the US and Canada from November 7, 2019 to July 15, 2020 and divided the study period into three equal time intervals (pre-pandemic, first pandemic, second pandemic). We focused on methotrexate, a broadly used drug unrelated to COVID-19, and (hydroxy)chloroquine, another broadly used drug implicated in COVID-19 treatment. Using descriptive statistics, we compared reporting characteristics before and after the COVID-19 outbreak.
resultsDuring the study period, 366 998 cases (60% female, median age: 59 years) were submitted to FAERS. The daily median number of reports (1796 in the pre-pandemic, 1810 in the second pandemic time interval) and other characteristics remained stable. The daily median number of reports for methotrexate decreased from 28 in the pre-pandemic to 15 in the second pandemic time interval, with no considerable differences in other characteristics. The daily median number of reports for (hydroxy)chloroquine increased slightly from 1 in the pre-pandemic to 3 in the second pandemic time interval, while there were also changes in the demographics of cases and an increase in the proportion of cases reported by health professionals.
conclusionsThe overall reporting to FAERS did not change after the outbreak of the COVID-19 pandemic. However, some stimulated reporting was observed for (hydroxy)chloroquine, highlighting the need for caution when conducting pharmacovigilance analyses with substances related to COVID-19.
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