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Study C4671006 (EPIC-PEP) investigated Paxlovid (nirmatrelvir/ritonavir 300 mg/100 mg) every 12 hours for 5 or 10 days in asymptomatic household contact of individuals with a recent diagnosis of SARS-CoV-2 infection. Participants were to have a negative SARS-CoV-2 result at baseline.
Across the three studies, 3,515 participants received a dose of Paxlovid and 2,585 participants received a dose of placebo. The most common adverse reactions (≥1% incidence in the Paxlovid group and occurring at a greater frequency than in the placebo group) were dysgeusia (5.9% and 0.4%, respectively) and diarrhoea (2.9% and 1.9%, respectively).
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 9.)
Click on icon to see table/diagram/imagePaediatric 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.
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