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)
Abdominal distension07.01.04.0010.002823%
Abdominal pain07.01.05.0020.004347%
Abdominal pain upper07.01.05.0030.001665%
Acute myocardial infarction02.02.02.001; 24.04.04.0010.000282%-
Acute respiratory failure14.01.04.004; 22.02.06.0010.000706%-
Altered state of consciousness17.02.04.001; 19.07.01.0030.000423%-
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.0010.001383%-
Anuria20.01.03.0020.000423%-
Arrhythmia02.03.02.0010.000282%-
Aspiration22.02.07.0070.000847%
Bradycardia02.03.02.0020.001185%-
Burning sensation08.01.09.029; 17.02.06.0010.001722%-
Cardiac failure02.05.01.0010.000988%
Choking22.12.03.0030.000282%-
Choking sensation19.01.02.002; 22.12.03.0040.000960%-
Chromaturia20.02.01.0020.000903%
Chronic obstructive pulmonary disease22.03.01.0070.000565%-
Cold sweat08.01.03.024; 23.02.03.0020.000621%-
Colitis ischaemic07.08.01.004; 24.04.08.0120.000282%-
Condition aggravated08.01.03.0040.004262%-
Cyanosis02.11.04.004; 22.02.02.007; 23.06.04.005; 24.03.01.0070.000621%
Death08.04.01.0010.008044%
Dehydration14.05.05.0010.001609%
Delirium19.13.02.0010.000282%
Dermatitis allergic10.01.03.014; 23.03.04.0030.000423%-
Diabetes mellitus05.06.01.001; 14.06.01.0010.000282%-
Diarrhoea07.02.01.0010.025121%
Diarrhoea haemorrhagic07.02.01.002; 24.07.02.0040.000282%-
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.0070.011234%
Drug eruption08.01.06.015; 10.01.01.005; 23.03.05.0010.007028%-
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