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)
Abdominal discomfort07.01.06.0010.000761%Not Available
Abdominal distension07.01.04.0010.000437%
Abdominal pain upper07.01.05.0030.000381%
Alopecia23.02.02.0010.000112%
Anaemia01.03.02.0010.000604%
Asthenia08.01.01.0010.000851%Not Available
Back pain15.03.04.0050.000381%
Bone pain15.02.01.0010.000571%
Calculus bladder20.04.03.0010.000112%Not Available
Cerebral haemorrhage24.07.04.001; 17.08.01.0030.000112%Not Available
Confusional state19.13.01.001; 17.02.03.0050.000548%
Constipation07.02.02.0010.001198%
Cough22.02.03.0010.000437%
Death08.04.01.0010.003078%
Dehydration14.05.05.0010.000246%
Diarrhoea07.02.01.0010.005361%
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.001388%
Dyspepsia07.01.02.0010.000761%
Dysphagia07.01.06.0030.000381%
Dyspnoea02.11.05.003; 22.02.01.0040.000795%
Eating disorder19.09.01.008; 14.03.01.0080.000112%Not Available
Fatigue08.01.01.0020.001936%
Feeling abnormal08.01.09.0140.000571%Not Available
Flatulence07.01.04.0020.000571%
Gastrointestinal disorder07.11.01.0010.001198%Not Available
Gout15.01.06.001; 14.09.01.0010.000246%Not Available
Leukaemia16.01.03.001; 01.10.03.0010.000112%
Malaise08.01.01.0030.000683%
Memory impairment19.20.01.003; 17.03.02.0030.000246%
Myelofibrosis16.21.03.001; 01.13.03.0050.000492%Not Available
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