Paxlovid Adverse Reactions

Summary of the safety profile: The safety of PAXLOVID was based on data from three Phase 2/3 randomized, placebo-controlled trials in adult participants 18 years of age and older (see Pharmacology: Pharmacodynamics under Actions): Study C4671005 (EPIC-HR) and Study C4671002 (EPIC-SR) investigated PAXLOVID (nirmatrelvir/ritonavir 300 mg/100 mg) every 12 hours for 5 days in symptomatic participants with a laboratory confirmed diagnosis of SARS-CoV-2 infection. Participants were to present with mild-to-moderate COVID-19 at baseline.
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 diarrhea (2.9% and 1.9%, respectively).
Tabulated summary of adverse drug reactions (ADRs): The adverse drug reactions in Table 8 are listed as follows by system organ class. (See Table 8.)

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