Safety Profile of Molnupiravir in the Treatment of COVID-19: A Descriptive Study Based on FAERS Data

{ 'indexed': { 'date-parts': [[2022, 12, 24]], 'date-time': '2022-12-24T06:08:15Z', 'timestamp': 1671862095015}, 'reference-count': 41, 'publisher': 'MDPI AG', 'issue': '1', 'license': [ { 'start': { 'date-parts': [[2022, 12, 21]], 'date-time': '2022-12-21T00:00:00Z', 'timestamp': 1671580800000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0/'}], 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'abstract': '<jats:p>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.</jats:p>', 'DOI': '10.3390/jcm12010034', 'type': 'journal-article', 'created': { 'date-parts': [[2022, 12, 21]], 'date-time': '2022-12-21T08:31:06Z', 'timestamp': 1671611466000}, 'page': '34', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Safety Profile of Molnupiravir in the Treatment of COVID-19: A Descriptive Study Based on FAERS ' 'Data', 'prefix': '10.3390', 'volume': '12', 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-7897-2956', 'authenticated-orcid': False, 'given': 'Greta', 'family': 'Santi Laurini', 'sequence': 'first', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-5710-8077', 'authenticated-orcid': False, 'given': 'Nicola', 'family': 'Montanaro', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-6253-4014', 'authenticated-orcid': False, 'given': 'Domenico', 'family': 'Motola', 'sequence': 'additional', 'affiliation': []}], 'member': '1968', 'published-online': {'date-parts': [[2022, 12, 21]]}, 'reference': [ { 'key': 'ref_1', 'unstructured': 'World Health Organization (2022, July 28). 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