Safety Profile of Molnupiravir in the Treatment of COVID-19: A Descriptive Study Based on FAERS Data
Santi Laurini et al.,
Safety Profile of Molnupiravir in the Treatment of COVID-19: A Descriptive Study Based on FAERS Data,
Journal of Clinical Medicine, doi:10.3390/jcm12010034
Safety analysis of molnupiravir reporting an unexpectedly high rate of serious adverse reactions.
Santi Laurini et al., 21 Dec 2022, Italy, peer-reviewed, survey, 3 authors.
Contact:
domenico.motola@unibo.it (corresponding author).
Abstract: Journal of
Clinical Medicine
Article
Safety Profile of Molnupiravir in the Treatment of COVID-19: A
Descriptive Study Based on FAERS Data
Greta Santi Laurini 1 , Nicola Montanaro 2
1
2
*
and Domenico Motola 1, *
Unit of Pharmacology, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of
Bologna, 40126 Bologna, Italy
The Alma Mater Studiorum University of Bologna, 40126 Bologna, Italy
Correspondence: domenico.motola@unibo.it; Tel.: +39-051-2091779
Abstract: Concerns have been raised about the actual benefit and safety of molnupiravir, a new
antiviral treatment for coronavirus disease 2019 (COVID-19). In order to provide additional evidence
to support its use, we aimed to evaluate the real safety profile based on post-marketing pharmacovigilance data. Molnupiravir safety data were captured from the FDA Adverse Event Reporting
System (FAERS). We performed a descriptive analysis of the baseline demographic characteristics of
patients who experienced at least one adverse drug reaction (ADRs) related to molnupiravir, and
then evaluated those most frequently reported. As of 31 March 2022, 612 reports of ADRs related
to molnupiravir were submitted to the FDA, 301 (49.18%) were related to females and 281 (45.92%)
to males. Most reports (524; 85.62%) were submitted by healthcare professionals and 345 (56.37%)
concerned serious outcomes. The most common reported ADRs were diarrhoea (57; 4.51%), rash
(36; 2.85), nausea (29; 2.30%), and COVID-19 pneumonia (22; 1.74%). The most frequent adverse
reactions reported with molnupiravir in the U.S. post-marketing experience are consistent with the
safety evaluation of the antiviral medicine. Even if no evident safety concerns emerged, an unexpectedly high rate of serious adverse reactions together with a few cases of potential new adverse
reactions occurred.
Citation: Santi Laurini, G.;
Keywords: molnupiravir; COVID-19; safety; pharmacovigilance; FAERS
Montanaro, N.; Motola, D. Safety
Profile of Molnupiravir in the
Treatment of COVID-19: A
Descriptive Study Based on FAERS
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