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)
Dysgeusia17.02.07.003; 07.14.03.0010.003359%
Dysphagia07.01.06.0030.009823%
Eating disorder19.09.01.008; 14.03.01.0080.000423%Not Available
Eczema23.03.04.0060.001101%
Emphysema22.01.02.0020.000282%Not Available
Erythema23.03.06.0010.003387%Not Available
Erythema multiforme23.03.01.003; 10.01.03.0150.000282%
Feeling abnormal08.01.09.0140.003387%Not Available
Feeling hot08.01.09.0090.001101%Not Available
Haematemesis24.07.02.011; 07.12.02.0020.000565%Not Available
Haematochezia24.07.02.012; 07.12.02.0030.001468%Not Available
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.0060.000762%
Haemorrhage subcutaneous24.07.06.010; 23.06.07.0020.000423%Not Available
Hallucination19.10.04.0030.000903%
Hallucination, visual19.10.04.0070.000565%Not Available
Hepatic function abnormal09.01.02.0010.001185%Not Available
Hypothermia12.05.03.001; 08.05.01.0030.000423%
Hypoxia22.02.02.0030.000847%
Intestinal obstruction07.13.01.0020.000282%Not Available
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.0050.000960%Not Available
Loss of consciousness17.02.04.0040.001129%Not Available
Marasmus14.03.02.0130.000706%Not Available
Melaena07.12.02.004; 24.07.02.0130.000565%Not Available
Mouth haemorrhage24.07.02.014; 07.05.02.0010.000621%
Nasal congestion22.04.04.0010.000960%
Nausea07.01.07.0010.013690%
Pallor24.03.04.001; 23.03.03.031; 08.01.03.0320.000621%Not Available
Palpitations02.11.04.0120.001524%
Productive cough22.02.03.0050.001185%
Pruritus23.03.12.0010.007311%
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