Post-Marketing Safety Concerns with Nirmatrelvir: A Disproportionality Analysis of Spontaneous Reports Submitted to FDA Adverse Event Reporting System.

Our study identified that the main and specific safety signals of Nirmatrelvir were disease recurrence, dysgeusia, abdominal pain upper and skin toxicity. Clinicians and pharmacists should be vigilant of these AEs, although differentiating between COVID-19 symptoms and AEs can be challenging. Notably, a potential safety concern of Nirmatrelvir should be a warning based on a small number of events in the pregnant population. However, the available data are insufficient, and further continued pharmacovigilance and surveillance is needed to fully understand this issue.