ArticlePharmaceuticals (Basel, Switzerland)2021
Cardiac Events Potentially Associated to Remdesivir: An Analysis from the European Spontaneous Adverse Event Reporting System.
Article in Pharmaceuticals (Basel, Switzerland), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 2 of them syntheses 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
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
27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.
- Pooled it
- 2022 AHA/ACC Key Data Elements and Definitions for Cardiovascular and Noncardiovascular Complications of COVID-19: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards.Journal of the American College of Cardiology · 2022Guideline
- Cardiac Adverse Events and Remdesivir in Hospitalized Patients With COVID-19: A Post Hoc Safety Analysis of the Randomized DisCoVeRy Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Trial
- Efficacy of the early treatment with tocilizumab-hydroxychloroquine and tocilizumab-remdesivir in severe COVID-19 Patients.Journal of infection and public health · 2022Trial
- Cardiovascular Risks of COVID-19 Therapeutics: Integrated Analysis of FAERS, Electronic Health Records, and Transcriptomics.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Elevated Troponin, D-Dimers and D-Dimers/Fibrinogen Ratio Increase Mortality Risk in Remdesivir-Treated COVID-19 Patients.Journal of personalized medicine · 2025Article
- Comparative Pharmacovigilance Analysis of Approved and Repurposed Antivirals for COVID-19: Insights from EudraVigilance Data.Biomedicines · 2025Article
- Adverse drug reactions associated with COVID-19 management.Naunyn-Schmiedeberg's archives of pharmacology · 2024Review
- Elevated Cardiac Troponin I as a Mortality Predictor in Hospitalised COVID-19 Patients.Medicina (Kaunas, Lithuania) · 2024Observational
- Acute Kidney Injury and Electrolyte Imbalances Caused by Dapagliflozin Short-Term Use.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Modeling drug-induced mitochondrial toxicity with human primary cardiomyocytes.Science China. Life sciences · 2024Article
- Hepatobiliary Adverse Reactions during Treatment with Cladribine: Analysis of Data from the European Spontaneous Reporting System.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Peripheral Neuropathy Potentially Associated to Poly (ADP-Ribose) Polymerase Inhibitors: An Analysis of the Eudravigilance Database.Current oncology (Toronto, Ont.) · 2023Article
- Article
- Impact of COVID-19 on Cardiovascular Disease.Viruses · 2023Review
- COVID-19 and atrial fibrillation: Intercepting lines.Frontiers in cardiovascular medicine · 2023Review
- Permanent Pacemaker Placement Secondary to Remdesivir Induced Bradycardia: A Case Report.Cureus · 2022Article
- Did the COVID-19 Pandemic Affect Contrast Media-Induced Adverse Drug Reaction's Reporting? A Pharmacovigilance Study in Southern Italy.Journal of clinical medicine · 2022Article
- The potential of remdesivir to affect function, metabolism and proliferation of cardiac and kidney cells in vitro.Archives of toxicology · 2022Article
- 2022 AHA/ACC Key Data Elements and Definitions for Cardiovascular and Noncardiovascular Complications of COVID-19: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards.Circulation. Cardiovascular quality and outcomes · 2022Review
Corrections and comments
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Authors and funding
10 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Remdesivir was recommended for hospitalized patients with COVID-19. As already reported in the Summary of Product Characteristics, most of remdesivir's safety concerns are hepatoxicity and nephrotoxicity related. However, some cases have raised concerns regarding the potential cardiac events associated with remdesivir; therefore, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency requested to investigate all available data. Therefore, we analyzed all Individual Case Safety Reports (ICSRs) collected in the EudraVigilance database focusing on cardiac adverse events. From April to December 2020, 1375 ICSRs related to remdesivir were retrieved from EudraVigilance, of which 863 (62.8%) were related to male and (43.3%) adult patients. A total of 82.2% of all AEs (N = 2604) was serious and one third of the total ICSRs (N = 416, 30.3%) had a fatal outcome. The most frequently reported events referred to hepatic/hepatobiliary disorders (19.4%,), renal and urinary disorders (11.1%) and cardiac events (8.4%). Among 221 cardiac ICSRs, 69 reported fatal outcomes. Other drugs for cardiovascular disorders were reported as suspected/concomitant together with remdesivir in 166 ICSRs (75.1%), 62 of which were fatal. Moreover, the mean time to overall cardiac event was 3.3 days (±2.2). Finally, disproportionality analysis showed a two-fold increased risk of reporting a cardiac adverse event associated with remdesivir compared to both hydroxychloroquine and azithromycin. This study showed that remdesivir could be associated to risk of cardiac events, suggesting a potential safety signal which has not been completely evaluated yet. Further studies are needed to confirm these findings.
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