Paxlovid Adverse Reactions

Summary of the safety profile: The safety of Paxlovid is based on data from Study C4671005 (EPIC-HR), a Phase 2/3 randomised, placebo-controlled trial in non-hospitalised adult participants with a laboratory confirmed diagnosis of SARS-CoV-2 infection (see Pharmacology: Pharmacodynamics under Actions). A total of 1,349 symptomatic adult participants 18 years of age and older who are at high risk of developing severe COVID-19 illness received at least one dose of either Paxlovid (nirmatrelvir/ritonavir 300 mg/100 mg) (n=672) or placebo (n=677). Study drugs were to be taken twice daily for up to 5 days.
Adverse reactions in the Paxlovid group (≥ 1%) that occurred at a greater frequency than in the placebo group were diarrhoea (3.9% and 1.9%, respectively), vomiting (1.3% and 0.3%) and dysgeusia (4.8% and 0.1%).
Tabulated summary of adverse reactions: The adverse reactions in Table 6 are listed as follows by system organ class and frequency. Frequencies are defined as follows: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); not known (frequency cannot be estimated from the available data). (See Table 6.)

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Paediatric population: The safety and efficacy of Paxlovid in paediatric patients have not been established.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.