Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Baloxavir marboxil
Drug ID BADD_D02520
Description Baloxavir marboxil is an antiviral drug developed by Shionogi Co., a Japanese pharmaceutical company and Roche for the treatment of influenza A and influenza B infections. The drug was initially approved for use in Japan in February 2018 and approved by the FDA on October 24, 2018 [L4779], [A39895] for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours [FDA label]. Baloxavir marboxil, a cap-endonuclease inhibitor, has a unique mechanism of action when compared to the currently existing neuraminidase inhibitor drug class used to treat influenza infections [A39894].
Indications and Usage For the treatment of influenza A and B virus infection [L1473, L1475], [FDA label] in patients 12 and older who have been symptomatic for no more than 48 hours. Clinical trials of this drug did not include subjects 65 years of age and older to determine whether they respond in a different way than younger subjects [FDA label].
Marketing Status approved; investigational
ATC Code J05AX25
DrugBank ID DB13997
KEGG ID D11021
MeSH ID C000628402
PubChem ID 124081896
TTD Drug ID D0O5AG
NDC Product Code 50242-583; 12806-8600; 12806-8770; 53044-877; 53044-828; 53044-004; 50242-877; 14501-0109; 53044-836; 62128-0394; 50242-860; 53044-860
UNII 505CXM6OHG
Synonyms baloxavir | (12aR)-12-((11S)-7,8-difluoro-6,11-dihydrodibenzo(b,e)thiepin-11-yl)-7-hydroxy-3,4,12,12a-tetrahydro-1h-(1,4)oxazino(3,4-c)pyrido(2,1-f)(1,2,4)triazine-6,8-dione | Xofluza | baloxavir marboxil | (((12aR)-12-((11S)-7,8-difluoro-6,11-dihydrodibenzo(b,E)thiepin-11-yl)-6,8-dioxo-3,4,6,8,12,12ahexahydro-1H-(1,4)oxazino(3,4-C)pyrido(2,1-F)(1,2,4)triazin-7-yl)oxy)methyl methyl carbonate
Chemical Information
Molecular Formula C27H23F2N3O7S
CAS Registry Number 1985606-14-1
SMILES COC(=O)OCOC1=C2C(=O)N3CCOCC3N(N2C=CC1=O)C4C5=C(CSC6=CC=CC=C46)C(=C(C=C5)F)F
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 pain07.01.05.0020.002230%
Abdominal pain upper07.01.05.0030.002399%
Acute respiratory distress syndrome24.03.02.034; 10.02.01.067; 22.01.03.0010.000282%
Altered state of consciousness17.02.04.001; 19.07.01.0030.001976%-
Amnesia19.20.01.001; 17.03.02.0010.000621%
Anaphylactic reaction24.06.03.006; 10.01.07.0010.003105%
Anaphylactic shock24.06.02.004; 10.01.07.0020.001552%-
Blister12.01.06.002; 23.03.01.0010.000960%-
Cardiac failure02.05.01.0010.000423%
Cardio-respiratory arrest22.02.06.007; 02.03.04.0020.000423%-
Chromaturia20.02.01.0020.000621%
Colitis ischaemic24.04.08.012; 07.08.01.0040.001835%-
Cyanosis22.02.02.007; 23.06.04.005; 02.11.04.004; 24.03.01.0070.000423%
Cystitis haemorrhagic20.03.02.0030.000423%-
Dehydration14.05.05.0010.001948%
Delirium19.13.02.0010.001694%
Depressed level of consciousness17.02.04.0020.000706%
Diarrhoea07.02.01.0010.008327%
Disseminated intravascular coagulation24.01.01.010; 01.01.02.0020.000565%
Drug eruption23.03.05.001; 10.01.01.005; 08.01.06.0150.000706%-
Dysgeusia17.02.07.003; 07.14.03.0010.000423%
Eczema23.03.04.0060.000282%
Encephalopathy17.13.02.0010.001129%
Enterocolitis07.08.03.0030.000565%
Enterocolitis haemorrhagic24.07.02.006; 07.08.01.0070.000282%-
Epistaxis24.07.01.005; 22.04.03.0010.000565%
Erythema multiforme10.01.03.015; 23.03.01.0030.001411%
Eye swelling06.08.03.0030.001242%-
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.0030.001468%
Facial paralysis17.04.03.0080.000423%-
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