Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Molnupiravir
Drug ID BADD_D02574
Description Molnupiravir (EIDD-2801, MK-4482) is the isopropylester prodrug of [N4-hydroxycytidine].[A193014,A193026] With improved oral bioavailability in non human primates, it is hydrolyzed _in vivo_, and distributes into tissues where it becomes the active 5’-triphosphate form.[A193026] The active drug incorporates into the genome of RNA viruses, leading to an accumulation of mutations known as viral error catastrophe.[A193029] Recent studies have shown molnupiravir inhibits replication of human and bat coronaviruses, including SARS-CoV-2, in mice and human airway epithelial cells.[A193014] A [remdesivir] resistant mutant mouse hepatitis virus has also been shown to have increased sensitivity to N4-hydroxycytidine.[A193014] Molnupiravir was granted approval by the UK's Medicines and Health products Regulatory Agency (MHRA) on 4 November 2021.[L39050]
Indications and Usage [N4-hydroxycytidine] and its prodrug molnupiravir are being studied for its activity against a number of viral infections including influenza, MERS-CoV, and SARS-CoV-2.[A193014, A193029] Molnupiravir is approved in the UK for reducing the risk of hospitalization and death in mild to moderate COVID-19 cases for patients at increased risk of severe disease (eg. with obesity, diabetes mellitus, heart disease, or are over 60 years old).[L39050,L39055]
Marketing Status investigational
ATC Code J05AB18
DrugBank ID DB15661
KEGG ID D11943
MeSH ID C000656703
PubChem ID 145996610
TTD Drug ID Not Available
NDC Product Code 0006-5055; 59285-040; 73435-018; 14501-0106; 53922-0137; 62331-063; 66406-0332; 80397-101; 67651-0365; 50683-0596
UNII YA84KI1VEW
Synonyms molnupiravir | ((2R,3S,4R,5R)-3,4-dihydroxy-5-((4Z)-4-(hydroxyimino)-2-oxo-3,4- dihydropyrimidin-1(2H)-yl)oxolan-2-yl)methyl 2-methylpropanoate | Lagevrio | EIDD-2801 | MK-4482
Chemical Information
Molecular Formula C13H19N3O7
CAS Registry Number 2492423-29-5
SMILES CC(C)C(=O)OCC1C(C(C(O1)N2C=CC(=NC2=O)NO)O)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Pyrexia08.05.02.0030.005165%
Rash23.03.13.0010.025093%Not Available
Rash erythematous23.03.13.0290.001242%Not Available
Rash pruritic23.03.13.0300.001863%Not Available
Respiratory depression17.02.05.047; 22.02.01.0100.000621%Not Available
Respiratory disorder22.02.07.0020.000565%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.000988%
Skin discolouration23.03.03.0050.000621%Not Available
Stomatitis07.05.06.0050.001101%
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.0180.001101%Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.0030.000282%Not Available
Syncope17.02.04.008; 02.11.04.015; 24.06.02.0120.001609%
Therapeutic response unexpected08.06.01.0010.000960%Not Available
Throat irritation22.12.03.029; 07.05.05.0370.000621%Not Available
Tongue discolouration07.14.02.0060.000282%Not Available
Tremor17.01.06.0020.001044%
Urinary retention20.02.02.0110.000706%
Urticaria23.04.02.001; 10.01.06.0010.010246%
Vaginal haemorrhage24.07.03.005; 21.08.01.0010.000762%
Vomiting07.01.07.0030.015044%
Mental status changes19.07.01.0010.000282%Not Available
Lip blister23.03.01.016; 07.05.01.0070.000621%Not Available
Paraesthesia oral07.05.05.035; 17.02.06.0080.000282%Not Available
Toxic skin eruption12.03.01.073; 23.03.05.003; 10.01.01.0080.000847%Not Available
Adverse event08.06.01.0100.005645%Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.001129%Not Available
Abnormal behaviour19.01.01.0010.000282%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.004911%
Parkinson's disease17.01.05.0100.000282%Not Available
Sensation of foreign body08.01.09.0020.001440%Not Available
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