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 approved; investigational
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
UNII SQ8A3S5101
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
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 distension07.01.04.0010.000777%
Abdominal pain07.01.05.0020.000503%
Abdominal pain upper07.01.05.0030.000777%
Arthralgia15.01.02.0010.000892%
Back pain15.03.04.0050.000617%
Death08.04.01.0010.003658%
Depressed mood19.15.02.0010.000777%Not Available
Diarrhoea07.02.01.0010.009831%
Disturbance in attention19.21.02.002; 17.03.03.0010.000777%
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.001669%
Drug ineffective08.06.01.0060.012277%Not Available
Dyspnoea02.11.05.003; 22.02.01.004--
Epistaxis24.07.01.005; 22.04.03.0010.000892%
Fluid retention20.01.02.003; 14.05.06.0020.001166%Not Available
Frequent bowel movements07.02.04.0020.000777%Not Available
Gastrointestinal disorder07.11.01.0010.001166%Not Available
Headache17.14.01.0010.002949%
Hypertension24.08.02.0010.003612%
Malaise08.01.01.0030.002446%
Nausea07.01.07.0010.003887%
Petechiae23.06.01.003; 01.01.03.002; 24.07.06.0040.000777%Not Available
Rash erythematous23.03.13.0290.000777%Not Available
Somnolence19.02.05.003; 17.02.04.0060.000777%
Vision blurred17.17.01.010; 06.02.06.0070.000503%
Vomiting07.01.07.0030.001555%
Adverse event08.06.01.0100.002286%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.000777%
Disease progression08.01.03.0380.000777%
Treatment noncompliance12.09.02.006; 08.06.01.0670.000777%Not Available
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