Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pexidartinib
Drug ID BADD_D02515
Description Pexidartinib is a selective tyrosine kinase inhibitor that works by inhibiting the colony-stimulating factor (CSF1)/CSF1 receptor pathway. Pexidartinib was originally developed by Daiichi Sankyo, Inc. and it was approved by the FDA in August 2019 as the first systemic therapy for adult patients with symptomatic tenosynovial giant cell tumor.[L7901] Tenosynovial giant cell tumor is a rare form of non-malignant tumor that causes the synovium and tendon sheaths to thicken and overgrow, leading to damage in surrounding joint tissue.[A182240,L7901] Debilitating symptoms often follow with tenosynovial giant cell tumors, along with a risk of significant functional limitations and a reduced quality of life in patients.[L7901] While surgical resection is a current standard of care for tenosynovial giant cell tumor, there are tumor types where surgeries are deemed clinically ineffective with a high risk of lifetime recurrence.[L7895] Pexidartinib works by blocking the immune responses that are activated in tenosynovial giant cell tumors. In clinical trials, pexidartinib was shown to promote improvements in patient symptoms and functional outcomes in TGCT.[A182243] Pexidartinib is available in oral formulations and it is commonly marketed as Turalio.[L7901]
Indications and Usage Not Available
Marketing Status Not Available
ATC Code L01EX15
DrugBank ID DB12978
KEGG ID D11270
MeSH ID C000600259
PubChem ID 25151352
TTD Drug ID D09TAB
NDC Product Code 65597-402; 11014-0394
Synonyms pexidartinib | 5-((5-chloro-1H-pyrrolo(2,3-b)pyridin-3-yl)methyl)-N-((6-(trifluoromethyl)pyridin-3-yl)methyl)pyridin-2-amine | PLX3397 | pexidartinib hydrochloride | Turalio
Chemical Information
Molecular Formula C20H15ClF3N5
CAS Registry Number 1029044-16-3
SMILES C1=CC(=NC=C1CC2=CNC3=C2C=C(C=N3)Cl)NCC4=CN=C(C=C4)C(F)(F)F
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 discomfort07.01.06.0010.001332%Not Available
Abdominal distension07.01.04.0010.000799%
Abdominal pain upper07.01.05.0030.001066%
Alanine aminotransferase increased13.03.01.0030.001865%
Alopecia23.02.02.0010.000533%
Anxiety19.06.02.0020.000799%
Arthralgia15.01.02.0010.002131%
Aspartate aminotransferase increased13.03.01.0060.001865%
Asthenia08.01.01.0010.000533%Not Available
Back pain15.03.04.0050.001332%
Bilirubin conjugated increased13.03.01.0070.000533%Not Available
Blood bilirubin increased13.03.01.0080.001332%
Blood glucose increased13.02.02.0020.000533%Not Available
Blood pressure increased13.14.03.0050.001332%Not Available
Body temperature increased13.15.01.0010.000533%Not Available
Bone pain15.02.01.0010.000533%
Burning sensation17.02.06.001; 08.01.09.0290.000799%Not Available
Chest discomfort08.01.08.019; 02.02.02.009; 22.02.08.0010.000533%Not Available
Chills15.05.03.016; 08.01.09.0010.000533%
Chromaturia20.02.01.0020.000533%
Cough22.02.03.0010.001066%
Dehydration14.05.05.0010.000533%
Diarrhoea07.02.01.0010.003463%
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.0040.002398%
Dry eye06.08.02.0010.000533%
Dry mouth07.06.01.0020.001066%
Dry skin23.03.03.0010.000799%
Dysgeusia17.02.07.003; 07.14.03.0010.001865%
Dyspepsia07.01.02.0010.000533%
Erythema23.03.06.0010.000533%Not Available
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