Adverse Drug Reactions of Nirmatrelvir/Ritonavir in COVID-19 Treatment
Author Information
Author(s): Sun Ji, Deng Xuanyu, Huang Juanjuan, He Gefei, Huang Shiqiong
Primary Institution: The Affiliated Changsha Hospital of Xiangya School of Medicine, Central South University, Changsha, China
Hypothesis
This study aims to mine the adverse reaction signals of Nirmatrelvir/Ritonavir for the antiviral treatment of COVID-19.
Conclusion
The study identified both known and new adverse drug reactions associated with Nirmatrelvir/Ritonavir, highlighting the need for clinical attention to these effects.
Supporting Evidence
- Nirmatrelvir/Ritonavir has been shown to reduce the risk of death or hospitalization from COVID-19 by 89%.
- The study found a high signal intensity of dysgeusia, diarrhea, and headache as adverse reactions.
- New adverse reactions not included in the drug's instructions were identified, such as pale-colored stools and chromaturia.
- Females accounted for a higher proportion of adverse event reports compared to males.
- Most adverse events were reported from America, with a significant number of reports from healthcare professionals.
Takeaway
This study looked at side effects from a COVID-19 medicine called Nirmatrelvir/Ritonavir and found some new problems that doctors should watch for.
Methodology
The study analyzed adverse event reports from the FDA's FAERS database using reporting odds ratios to identify signals of adverse drug reactions.
Potential Biases
Potential biases include randomness and inaccuracies in reporting adverse events.
Limitations
The study is limited by the nature of spontaneous reporting, which can lead to underreporting and inaccuracies.
Participant Demographics
{"gender":{"male":11432,"female":20450,"not_specified":3368},"age":{"under_18":298,"age_18_to_64":15938,"age_65_and_over":12269,"not_specified":6745},"country":{"America":32294,"Europe":1667,"Asia":1163,"Africa":11,"Oceania":114,"not_specified":1}}
Digital Object Identifier (DOI)
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