ArticleDrugs - real world outcomes2022
Serious Cardiovascular Adverse Events Associated with Hydroxychloroquine/Chloroquine Alone or with Azithromycin in Patients with COVID-19: A Pharmacovigilance Analysis of the FDA Adverse Event Reporting System (FAERS).
Article in Drugs - real world outcomes, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
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
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Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.
- Cardiovascular adverse events associated with immune checkpoint inhibitors: a meta-analysis.Frontiers in immunology · 2024Pooled it
- Adverse Reactions Identified after Approval of Novel Medicines: Analysis of 339 New Molecular Entities and Therapeutic Biologics.Clinical pharmacology and therapeutics · 2026Article
- Strategic Preparedness of Broad-Spectrum Antivirals for Rapid Response Towards Next Pandemics.Small science · 2026Article
- Demographic Variation In US Outpatient Hydroxychloroquine And Ivermectin Use During The COVID-19 Pandemic.Health affairs (Project Hope) · 2025Article
- Aging Model for Analyzing Drug-Induced Proarrhythmia Risks Using Cardiomyocytes Differentiated from Progeria-Patient-Derived Induced Pluripotent Stem Cells.International journal of molecular sciences · 2023Article
- Development of SARS-CoV-2 infection in patients with rheumatic conditions on hydroxychloroquine monotherapy vs. patients without rheumatic conditions: A retrospective, propensity-matched cohort study.The American journal of the medical sciences · 2023Observational
- A report on SARS-CoV-2 first wave in Ecuador: drug consumption dynamics.Frontiers in pharmacology · 2023Article
- Cardiovascular Adverse Events Associated with Monoclonal Antibody Products in Patients with COVID-19.Pharmaceuticals (Basel, Switzerland) · 2022Article
- A Comprehensive Review on the Efficacy of Several Pharmacologic Agents for the Treatment of COVID-19.Life (Basel, Switzerland) · 2022Review
- Antiparasitic Drugs against SARS-CoV-2: A Comprehensive Literature Survey.Microorganisms · 2022Review
- Synthesis of flower-like MoSUltrasonics sonochemistry · 2022Article
- Safety of Short-Term Treatments with Oral Chloroquine and Hydroxychloroquine in Patients with and without COVID-19: A Systematic Review.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Adverse drug events in the prevention and treatment of COVID-19: A data mining study on the FDA adverse event reporting system.Frontiers in pharmacology · 2022Article
Corrections and comments
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Authors and funding
12 authors at 4 institutions in 3 countries.
Funding
Abstract
backgroundThe use of hydroxychloroquine or chloroquine (HCQ/CQ) as monotherapy or combined with azithromycin for the treatment of coronavirus disease 2019 (COVID-19) may increase the risk of serious cardiovascular adverse events (SCAEs).
objectiveOur objective was to describe and evaluate the risk of SCAEs with HCQ/CQ as monotherapy or combined with azithromycin compared with that for therapeutic alternatives.
methodsWe performed a disproportionality analysis and descriptive case series using the US FDA Adverse Event Reporting System.
resultsCompared with remdesivir, HCQ/CQ was associated with increased reporting of SCAEs (reporting odds ratio [ROR] 2.1; 95% confidence interval [CI] 1.8-2.5), torsade de pointes (TdP)/QTc prolongation (ROR 35.4; 95% CI 19.4-64.5), and ventricular arrhythmia (ROR 2.5; 95% CI 1.6-3.9); similar results were found in comparison with other therapeutic alternatives. Compared with lopinavir/ritonavir, HCQ/CQ was associated with increased reporting of ventricular arrhythmia (ROR 10.5; 95% CI 3.3-33.4); RORs were larger when HCQ/CQ was used in combination with azithromycin. In 2020, 312 of the 575 reports of SCAEs listed concomitant use of HCQ/CQ and azithromycin, including QTc prolongation (61.4%), ventricular arrhythmia (12.0%), atrial fibrillation (8.2%), TdP (4.9%), and cardiac arrest (4.4%); 88 (15.3%) cases resulted in hospitalization and 79 (13.7%) resulted in death. In total, 122 fatal QTc prolongation-related cardiovascular reports were associated with 1.4 times higher odds of reported death than those induced by SCAEs; 87 patients received more than one QTc-prolonging agent.
conclusionsPatients treated with HCQ/CQ monotherapy or HCQ/CQ + azithromycin may be at increased risk of SCAEs, TdP/QTc prolongation, and ventricular arrhythmia. Cardiovascular risks need to be considered when evaluating the benefit/harm balance of treatment with HCQ/CQ, especially with the concurrent use of QTc-prolonging agents and cytochrome P450 3A4 inhibitors when treating COVID-19.
Identifiers
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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.