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 Not Available
ATC Code J05AX25
DrugBank ID DB13997
KEGG ID D11021
MeSH ID C000628402
PubChem ID 124081896
NDC Product Code 50242-860; 53044-860; 62128-0394; 14501-0109; 53044-836; 50242-583; 50090-4102; 50242-828; 50090-4104; 53044-877; 53044-828; 50242-877; 53044-004
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
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal pain07.01.05.0020.005787%
Abdominal pain upper07.01.05.003--
Acute respiratory distress syndrome22.01.03.0010.000377%
Alanine aminotransferase increased13.03.01.0030.002170%
Altered state of consciousness19.07.01.003; Available
Anaphylactic reaction24.06.03.006;
Anaphylactic shock24.06.02.004; Available
Aspartate aminotransferase increased13.03.01.0060.001447%
Asthenia08.01.01.001--Not Available
Blood creatine phosphokinase increased13.04.01.0010.002170%
Blood pressure decreased13.14.03.0020.004340%Not Available
C-reactive protein increased13.09.01.0070.002170%Not Available
Cardiac failure02.05.01.001--
Cardio-respiratory arrest22.02.06.007; Available
Colitis ischaemic24.04.08.012; Available
Cystitis haemorrhagic20.03.02.0030.002170%Not Available
Depressed level of consciousness17.02.04.0020.003617%
Disseminated intravascular coagulation24.01.01.010;
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