ArticlePharmaceuticals (Basel, Switzerland)2022
Adverse Events Associated with Nirmatrelvir/Ritonavir: A Pharmacovigilance Analysis Based on FAERS.
Article in Pharmaceuticals (Basel, Switzerland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 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
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.
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Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.
- Real-world untreated risk of hospitalization and death in a nirmatrelvir/ritonavir treatment-eligible population with mild-to-moderate COVID-19 in the United States: a systematic literature review.BMC infectious diseases · 2026Pooled it
- Visualization of FDA Adverse Drug Reaction Reports: Development and Usability Study of the VisDrugs Web Server.JMIR formative research · 2025Article
- Comparative Pharmacovigilance Analysis of Approved and Repurposed Antivirals for COVID-19: Insights from EudraVigilance Data.Biomedicines · 2025Article
- Effectiveness and safety of azvudine versus nirmatrelvir/ritonavir in hospitalized patients with COVID-19.BMC infectious diseases · 2025Article
- Incidence of COVID-19 Symptom Rebound After Treatment with Remdesivir.Infectious disease reports · 2025Article
- Genetic Predictors of Paxlovid Treatment Response: The Role of IFNAR2, OAS1, OAS3, and ACE2 in COVID-19 Clinical Course.Journal of personalized medicine · 2025Article
- Antiviral Activity of Halogenated Compounds Derived from L-Tyrosine Against SARS-CoV-2.Molecules (Basel, Switzerland) · 2025Article
- Comparative Analysis of Neuropsychiatric Adverse Reactions Associated with Remdesivir and Nirmatrelvir/Ritonavir in COVID-19 Treatment: Insights from EudraVigilance Data.Journal of clinical medicine · 2025Article
- Adverse Events Associated with Antivirals for COVID-19: An Analysis Based on FDA Adverse Event Reporting System (FAERS).Current drug safety · 2025Article
- Patient-Reported Adverse Events Among Elderly Patients Receiving Novel Oral COVID-19 Antivirals: A Nationwide Sampled Survey in Korea.Journal of Korean medical science · 2024Article
- Effectiveness and safety of nirmatrelvir-ritonavir in kidney transplant recipients with severe kidney dysfunction infected with COVID-19.Antimicrobial agents and chemotherapy · 2024Article
- Exploring Paxlovid Efficacy in COVID-19 Patients with MAFLD: Insights from a Single-Center Prospective Cohort Study.Viruses · 2024Article
- A SONAR report on Nirmatrelvir/ritonavir-associated rebound COVID-19: Using new databases for evaluating new diseases.PloS one · 2024Article
- Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Nirmatrelvir/ritonavir is approved for the treatment of adults and pediatric patients with mild to moderate COVID-19, but information on adverse events associated with its use is limited. We aim to evaluate adverse events with potential risk for nirmatrelvir/ritonavir using the FDA Adverse Event Reporting System (FAERS). Disproportionality analysis was performed using the reporting odds ratio (ROR) method, and subset analysis based on patient age and gender, as well as sensitivity analysis restricting the type of reporter to healthcare professionals. Nirmatrelvir/ritonavir was the most commonly reported COVID-19 drug, and 87.66% of the outcomes were non-serious. The most frequently reported events were disease recurrence (40.43%), dysgeusia (17.55%), and diarrhea (8.80%). In disproportionality analysis, the use of nirmatrelvir/ritonavir was significantly associated with disease recurrence (ROR: 212.01, 95% CI: 162.85-276.01), whereas no signal of disease recurrence was detected for any other COVID-19 drug. Disease recurrence (ROR: 421.38, 95% CI: 273.60-648.99) was more significant when limiting the reporter type to healthcare professionals. No significant differences in adverse event reports were found based on patient gender or age. Our study confirms that the risk of serious adverse events is low with nirmatrelvir/ritonavir, but its association with disease recurrence should not be ignored.
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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.