Comparative Pharmacovigilance Analysis of Approved and Repurposed Antivirals for COVID-19: Insights from EudraVigilance Data.

ingentiumby ingentium

In Clinical Literature.

Publication date: Jun 05, 2025

Background/Objectives: During the COVID-19 pandemic, several antivirals were approved or repurposed, but their safety profiles have not been fully compared. Pharmacovigilance data help clarify how these drugs perform in real-world use. Methods: This study performed a comparative pharmacovigilance analysis of eight antivirals used or tested during the COVID-19 pandemic, based on individual case safety reports (ICSRs) retrieved from the EudraVigilance database, reported up to 9 February 2025 and extracted from the official platform on 12 February 2025. Adverse reactions were assessed by system organ class (SOC), demographic patterns, and seriousness, and disproportionality analysis (reporting odds ratio (ROR)) was conducted to identify potential safety signals. Results: A total of 64,776 ICSRs were analyzed. Among approved antivirals, nirmatrelvir/ritonavir (NTV/r) accounted for 13. 4% (n = 8693) of reports, while remdesivir (RDV) represented 6. 3% (n = 4105). Repurposed antivirals such as ribavirin and lopinavir/ritonavir dominated the dataset, together making up over 80% (n = 51,978) of all reports. RDV was associated with a high proportion of serious adverse events (84%, n = 3448), and showed consistent ROR signals in hepatobiliary, renal, cardiac, and general disorders, with values exceeding 2 in several comparisons. NTV/r displayed a milder overall profile, but with positive RORs for psychiatric disorders, gastrointestinal disorders, and product-related issues. The most affected SOCs across all drugs included general disorders (31. 6%, n = 20,493), gastrointestinal (19. 5%, n = 12,625), nervous system (17. 8%, n = 11,511), and investigations (20. 4%, n = 13,219). Demographic analysis showed that most events occurred in adults aged 18-64, with RDV more often reported in elderly patients and NTV/r more frequently associated with reports from female patients and non-healthcare reporters. Conclusions: This study highlights distinct pharmacovigilance profiles of COVID-19 antivirals and supports the role of real-world data in guiding safer therapeutic choices.

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Concepts Keywords
February antivirals
Organ COVID-19
Pandemic EudraVigilance
Pharmacovigilance pharmacovigilance
system organ class

Semantics

Type Source Name
disease MESH COVID-19
drug DRUGBANK Ritonavir
drug DRUGBANK Ribavirin
drug DRUGBANK Lopinavir
disease MESH psychiatric disorders
disease MESH gastrointestinal disorders
disease IDO role
disease MESH morbidity
disease MESH infection
disease IDO immunodeficiency
disease MESH influenza
drug DRUGBANK Favipiravir
disease MESH virus infections
drug DRUGBANK Umifenovir
drug DRUGBANK Darunavir
pathway KEGG Viral replication
disease MESH viral load
disease IDO replication
disease MESH Emergency
drug DRUGBANK Oxygen
disease MESH bradycardia
disease MESH hypotension
disease MESH atrial fibrillation
disease IDO susceptibility
disease MESH myocardial infarction
disease MESH stroke
disease MESH hypertension
disease IDO symptom
disease MESH death
disease MESH hepatitis
disease MESH Marburg virus infection
disease MESH Dysgeusia
disease MESH drug interactions
disease MESH Hyperuricemia
disease MESH chronic hepatitis
disease MESH viral hemorrhagic fever
disease MESH Hemolytic anemia
drug DRUGBANK Nelfinavir
drug DRUGBANK Atazanavir
disease MESH Hyperbilirubinemia
disease MESH jaundice
disease MESH cardiac arrhythmias
disease MESH severe acute respiratory syndrome
disease MESH Middle East respiratory syndrome
drug DRUGBANK Trestolone
disease MESH adverse drug reaction
disease MESH anomalies
disease MESH causality
disease MESH clinical significance
disease MESH nervous system disorders
disease MESH confusion
disease IDO blood
disease MESH anemia
disease MESH neutropenia
disease MESH thrombocytopenia 1
disease MESH pneumonia
disease MESH sepsis
disease MESH oral candidiasis
disease MESH urticaria
disease MESH insomnia
disease MESH anxiety
disease MESH depression
disease MESH complications
disease MESH dyspnea
disease MESH respiratory failure
pathway REACTOME Metabolism
disease MESH nutrition disorders
disease MESH hyperglycemia
disease MESH Hepatobiliary disorders
disease MESH acute kidney injury
drug DRUGBANK Creatinine
disease MESH renal failure
disease MESH arthralgia
disease MESH back pain
disease MESH Cardiac disorders
disease MESH tachycardia
disease MESH cardiac arrest
disease MESH deep vein thrombosis
disease MESH Eye disorders
disease MESH visual impairment
disease MESH Immune system disorders
disease MESH hypersensitivity
disease MESH anaphylactic reaction
disease MESH syndrome
disease MESH Neoplasms
disease MESH cysts
disease MESH polyps
disease MESH lymphoma
disease MESH leukemia
disease MESH diabetes mellitus
disease MESH adrenal insufficiency
disease MESH spontaneous abortion
disease MESH preterm labor
disease MESH low birth weight
disease IDO intervention
disease MESH tinnitus
disease MESH hearing loss
disease MESH vertigo
disease MESH genetic disorders
disease MESH gynecomastia
disease MESH erectile dysfunction
disease MESH caregiver burden
drug DRUGBANK L-Valine
drug DRUGBANK Coenzyme M
disease IDO quality
disease IDO history
drug DRUGBANK L-Alanine
pathway REACTOME Immune System
disease MESH opportunistic infections
drug DRUGBANK Prothrombin
drug DRUGBANK Potassium
disease MESH secondary infections

Original Article

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