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 infarction24.04.04.009; 02.02.02.0070.000168%
Nausea07.01.07.0010.003459%
Pruritus23.03.12.0010.000761%
Pulmonary oedema22.01.03.003; 02.05.02.0030.000112%
Pyrexia08.05.02.003--
Rash pruritic23.03.13.0300.000246%Not Available
Renal disorder20.01.02.0020.000246%Not Available
Renal failure20.01.03.0050.000280%Not Available
Respiratory disorder22.02.07.0020.000112%Not Available
Spleen disorder01.09.02.0030.000112%Not Available
Splenomegaly01.09.02.0010.000246%Not Available
Tinnitus17.04.07.004; 04.04.01.0020.000381%
Vomiting07.01.07.0030.001768%
Peripheral swelling08.01.03.053; 02.05.04.0150.000761%Not Available
Adverse event08.06.01.010--Not Available
Cardiac disorder02.11.01.0030.000224%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.000683%
Blood disorder01.05.01.004--Not Available
Adverse drug reaction08.06.01.0090.002149%Not Available
Drug intolerance08.06.01.0130.000571%Not Available
Renal impairment20.01.03.0100.000168%Not Available
Unevaluable event08.01.03.0510.000112%Not Available
Chronic kidney disease20.01.03.0170.000112%
Cytopenia01.03.03.0120.000112%Not Available
Acute kidney injury20.01.03.0160.000224%
Vitamin B1 deficiency14.12.02.0120.000571%Not Available
Illness08.01.03.0910.000951%Not Available
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