Adverse Events Associated with Nirmatrelvir/Ritonavir: A Pharmacovigilance Analysis Based on FAERS
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 Rep...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2022-11-01
|
| Series: | Pharmaceuticals |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1424-8247/15/12/1455 |
| _version_ | 1797455822724268032 |
|---|---|
| author | Meng Li Qing-Song Zhang Xin-Ling Liu Hui-Ling Wang Wei Liu |
| author_facet | Meng Li Qing-Song Zhang Xin-Ling Liu Hui-Ling Wang Wei Liu |
| author_sort | Meng Li |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-09T15:59:40Z |
| format | Article |
| id | doaj.art-c716f45ae4b74e9889cd6c0277961051 |
| institution | Directory Open Access Journal |
| issn | 1424-8247 |
| language | English |
| last_indexed | 2024-03-09T15:59:40Z |
| publishDate | 2022-11-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj.art-c716f45ae4b74e9889cd6c02779610512023-11-24T17:15:27ZengMDPI AGPharmaceuticals1424-82472022-11-011512145510.3390/ph15121455Adverse Events Associated with Nirmatrelvir/Ritonavir: A Pharmacovigilance Analysis Based on FAERSMeng Li0Qing-Song Zhang1Xin-Ling Liu2Hui-Ling Wang3Wei Liu4School of Pharmaceutical Sciences, Zhengzhou University, Zhengzhou 450001, ChinaSchool of Pharmaceutical Sciences, Zhengzhou University, Zhengzhou 450001, ChinaSchool of Pharmaceutical Sciences, Zhengzhou University, Zhengzhou 450001, ChinaSchool of Pharmaceutical Sciences, Zhengzhou Railway Vocational and Technical College, Zhengzhou 450002, ChinaSchool of Pharmaceutical Sciences, Zhengzhou University, Zhengzhou 450001, ChinaNirmatrelvir/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.https://www.mdpi.com/1424-8247/15/12/1455nirmatrelvir/ritonavirCOVID-19pharmacovigilanceFAERSadverse drug reaction |
| spellingShingle | Meng Li Qing-Song Zhang Xin-Ling Liu Hui-Ling Wang Wei Liu Adverse Events Associated with Nirmatrelvir/Ritonavir: A Pharmacovigilance Analysis Based on FAERS Pharmaceuticals nirmatrelvir/ritonavir COVID-19 pharmacovigilance FAERS adverse drug reaction |
| title | Adverse Events Associated with Nirmatrelvir/Ritonavir: A Pharmacovigilance Analysis Based on FAERS |
| title_full | Adverse Events Associated with Nirmatrelvir/Ritonavir: A Pharmacovigilance Analysis Based on FAERS |
| title_fullStr | Adverse Events Associated with Nirmatrelvir/Ritonavir: A Pharmacovigilance Analysis Based on FAERS |
| title_full_unstemmed | Adverse Events Associated with Nirmatrelvir/Ritonavir: A Pharmacovigilance Analysis Based on FAERS |
| title_short | Adverse Events Associated with Nirmatrelvir/Ritonavir: A Pharmacovigilance Analysis Based on FAERS |
| title_sort | adverse events associated with nirmatrelvir ritonavir a pharmacovigilance analysis based on faers |
| topic | nirmatrelvir/ritonavir COVID-19 pharmacovigilance FAERS adverse drug reaction |
| url | https://www.mdpi.com/1424-8247/15/12/1455 |
| work_keys_str_mv | AT mengli adverseeventsassociatedwithnirmatrelvirritonavirapharmacovigilanceanalysisbasedonfaers AT qingsongzhang adverseeventsassociatedwithnirmatrelvirritonavirapharmacovigilanceanalysisbasedonfaers AT xinlingliu adverseeventsassociatedwithnirmatrelvirritonavirapharmacovigilanceanalysisbasedonfaers AT huilingwang adverseeventsassociatedwithnirmatrelvirritonavirapharmacovigilanceanalysisbasedonfaers AT weiliu adverseeventsassociatedwithnirmatrelvirritonavirapharmacovigilanceanalysisbasedonfaers |