Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fedratinib
Drug ID BADD_D02554
Description Fedratinib, also known as SAR302503 and TG101348, is a tyrosine kinase inhibitor used to treat intermediate-2 and high risk primary and secondary myelofibrosis.[A183176,L8090] It is an anilinopyrimidine derivative.[A183188] Fedratinib was granted FDA approval on August 16, 2019.[L8090]
Indications and Usage Fedratinib is indicated to treat adults with primary or secondary myelofibrosis that is either intermediate-2 or high risk.[L8090]
Marketing Status approved; investigational
ATC Code L01EJ02
DrugBank ID DB12500
KEGG ID D10630
MeSH ID C528327
PubChem ID 16722836
TTD Drug ID D0G8BM
NDC Product Code Not Available
UNII 6L1XP550I6
Synonyms Fedratinib | N-tert-butyl-3-(5-methyl-2-(4-(2-(pyrrolidin-1-yl)ethoxy)phenylamino) pyrimidin-4-ylamino)benzenesulfonamide | TG101348 | SAR302503 | fedratinib hydrochloride | Inrebic
Chemical Information
Molecular Formula C27H36N6O3S
CAS Registry Number 936091-26-8
SMILES CC1=CN=C(N=C1NC2=CC(=CC=C2)S(=O)(=O)NC(C)(C)C)NC3=CC=C(C=C3)OCCN4CCCC4
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)
Myocardial infarction02.02.02.007; 24.04.04.0090.000168%
Nausea07.01.07.0010.003459%
Pruritus23.03.12.0010.000761%
Pulmonary oedema02.05.02.003; 22.01.03.0030.000112%
Pyrexia08.05.02.003--
Rash pruritic23.03.13.0300.000246%-
Renal disorder20.01.02.0020.000246%-
Renal failure20.01.03.0050.000280%-
Respiratory disorder22.02.07.0020.000112%-
Spleen disorder01.09.02.0030.000112%-
Splenomegaly01.09.02.0010.000246%-
Tinnitus04.04.01.002; 17.04.07.0040.000381%
Vomiting07.01.07.0030.001768%
Peripheral swelling02.05.04.015; 08.01.03.0530.000761%-
Adverse event08.06.01.010---
Cardiac disorder02.11.01.0030.000224%-
Decreased appetite08.01.09.028; 14.03.01.0050.000683%
Blood disorder01.05.01.004---
Adverse drug reaction08.06.01.0090.002149%-
Drug intolerance08.06.01.0130.000571%-
Renal impairment20.01.03.0100.000168%-
Unevaluable event08.01.03.0510.000112%-
Chronic kidney disease20.01.03.0170.000112%
Cytopenia01.03.03.0120.000112%-
Acute kidney injury20.01.03.0160.000224%
Vitamin B1 deficiency14.12.02.0120.000571%-
Illness08.01.03.0910.000951%-
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