ArticleTherapie
Nirmatrelvir/ritonavir (Paxlovid®): French pharmacovigilance survey 2022.
Article in Therapie. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed, 18 citations in OpenAlex.
- Managing High-Risk Drug Interactions With Nirmatrelvir/Ritonavir: Experience From a Dedicated Pharmacology Advice Service.Clinical and translational science · 2026Article
- Adverse Events Associated with Antivirals for COVID-19: An Analysis Based on FDA Adverse Event Reporting System (FAERS).Current drug safety · 2025Article
- Can large language models detect drug-drug interactions leading to adverse drug reactions?Therapeutic advances in drug safety · 2025Article
- Evaluation of the drug-drug interactions management system for appropriate use of nirmatrelvir/ritonavir: a retrospective observational study.Journal of pharmaceutical health care and sciences · 2024Article
- Ritonavir: 25 Years' Experience of Concomitant Medication Management. A Narrative Review.Infectious diseases and therapy · 2024Review
- Article
- Adaptative Strategy of Immunosuppressive Drugs Dosage Adjustments When Combined With Nirmatrelvir/Ritonavir in Solid Organ Transplant Recipients With COVID-19.Transplant international : official journal of the European Society for Organ Transplantation · 2024Article
- Safety Profile of Paxlovid in the Treatment of COVID-19.Current pharmaceutical design · 2024Article
Corrections and comments
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Authors and funding
9 authors at 9 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionNirmatrelvir/ritonavir (Paxlovid®) is currently one of the few therapeutic options for coronavirus disease 2019 (COVID-19) curative treatment in non-oxygen-requiring adult patients at-high risk of progressing to severe disease. This recently approved boosted antiviral therapy presents a significant risk of drug-drug interactions (DDI). As part of the enhanced surveillance program in France for COVID-19 drugs and vaccines, the French national pharmacovigilance database (BNPV [base nationale de pharmacovigilance]) was queried in order to better characterize the drug safety profile, with a special focus on DDI. The aim of the study was to describe the adverse drug reactions reported through the BNPV.
methodAll nirmatrelvir/ritonavir reports validated in the BNPV from the first authorization in France (January, 20th 2022) to December, 3rd 2022 (date of the query) were considered. An analysis of the scientific literature (PubMed®) and from the WHO pharmacovigilance database (Vigibase) was also performed.
resultsOver this period (11 months), 228 reports (40% of serious reports) were registered with a sex ratio of 1.9 female/1 male and a mean age of 66 years old. DDI reports account for more than 13% of reports (n=30) and were mainly related to immunosuppressive drugs overexposure (n=16). A total of 10/228 reports with fatal outcomes were reported in complex clinical settings. The main reported unexpected adverse drug reaction (ADRs) were high blood pressure (n=7), confusion (n=5), acute kidney injuries (AKI, n=7) and various skin reactions (n=22). Apart from situations of disease recurrence (not found in this analysis), data from Pubmed® and Vigibase also reported the above-mentioned events of interest.
conclusionOverall, this analysis shows that nirmatrelvir/ritonavir safety profile was conform to current summary of product characteristics (SmPC). The main concern was the risk of DDI. Therefore, SmPC and expert recommendations should be systematically consulted before initiation of this antiviral, which is particularly indicated in polypharmacy patients. A case-by-case multidisciplinary approach including a clinical pharmacologist is required in these complex situations. Blood pressure elevation, confusion, cutaneous reactions and AKIs were the main unexpected ADRs of interest to follow, but need to be confirmed with a qualitative approach over time and new reports.
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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.