Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fostamatinib
Drug ID BADD_D02499
Description Fostamatinib has been investigated for the treatment and basic science of Rheumatoid Arthritis and Immune Thrombocytopenic Purpura (ITP). It was approved on April 17, 2018, under the trade name Tavalisse for use in ITP [L2644, FDA Label]. Fostamatinib has also been granted orphan drug status by the FDA [L2644]. Recently, fostamatinib has been identified as a potential therapeutic for controlling acute respiratory distress syndrome (ARDS) in patients with severe COVID-19 through its ability to modulate the SYK kinase.[A235008, A235013, A235018]
Indications and Usage Fostamatinib is indicated for use in the treatment of chronic immune thrombocytopenia (ITP) in patients who have had insufficient response to previous therapy [FDA Label].
Marketing Status Not Available
ATC Code B02BX09
DrugBank ID DB12010
KEGG ID D09347
MeSH ID C523665
PubChem ID 11671467
TTD Drug ID D0V8HJ
NDC Product Code 71332-001; 71332-002
Synonyms fostamatinib | 2H-pyrido(3,2-b)-1,4-oxazin-3(4H)-one, 6-((5-fluoro-2-((3,4,5-trimethoxyphenyl)amino)-4-pyrimidinyl)amino)-2,2-dimethyl-4-((phosphonooxy)methyl)- | fostamatinib disodium anhydrous | 2H-pyrido(3,2-b)-1,4-oxazin-3(4H)-one, 6-((5-fluoro-2-((3,4,5-trimethoxyphenyl)amino)-4-pyrimidinyl)amino)-2,2-dimethyl-4-((phosphonooxy)methyl)-, sodium salt (1:2) | R935788 sodium anhydrous | R-935788 sodium anhydrous | R788 sodium anhydrous | R-788 sodium anhydrous | fostamatinib disodium hydrate | fostamatinib disodium salt hexahydrate | R-788 sodium | R788 sodium | R788 sodium hydrate | R-935788 sodium hydrate | R935788 sodium hydrate | fostamatinib disodium | (6-((5-fluoro-2-((3,4,5-trimethoxyphenyl)amino)pyrimidin-4-yl)amino)-2,2-dimethyl-3-oxo-2,3-dihydro-4H-pyrido(3,2-b)-1,4-oxazin-4-yl)methyl disodium phosphate hexahydrate | Tavalisse | R-788 sodium hydrate | R788 free acid | R-935788 free acid | R935788 free acid | R-788 free acid
Chemical Information
Molecular Formula C23H26FN6O9P
CAS Registry Number 901119-35-5
SMILES CC1(C(=O)N(C2=C(O1)C=CC(=N2)NC3=NC(=NC=C3F)NC4=CC(=C(C(=C4)OC)OC)OC)COP(=O)(O)O) C
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 pain upper07.01.05.0030.001089%
Anxiety19.06.02.0020.001089%
Death08.04.01.0010.000568%
Diarrhoea07.02.01.0010.009257%
Disturbance in attention19.21.02.002; 17.03.03.0010.001089%
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.0040.001634%
Fluid retention20.01.02.003; 14.05.06.0020.001634%Not Available
Gastrointestinal disorder07.11.01.0010.001089%Not Available
Headache17.14.01.0010.003267%
Hypertension24.08.02.0010.001634%
Malaise08.01.01.0030.001634%
Nausea07.01.07.0010.002178%
Platelet count decreased13.01.04.0010.005445%
Rash23.03.13.0010.001089%Not Available
Rash erythematous23.03.06.0030.001089%Not Available
Urinary tract infection20.08.02.001; 11.01.14.0040.001089%
Platelet count increased13.01.04.0020.001089%Not Available
Disease progression08.01.03.0380.000284%
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