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 Pexidartinib is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.[L7883]
Marketing Status approved; investigational
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; 11014-0481
UNII 6783M2LV5X
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
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)
Paraesthesia23.03.03.094; 17.02.06.0050.001198%
Photosensitivity reaction23.03.09.0030.000627%
Pollakiuria20.02.02.0070.000246%
Pruritus23.03.12.0010.006649%
Pyrexia08.05.02.0030.001198%
Rash23.03.13.0010.005429%Not Available
Rash erythematous23.03.13.0290.000381%Not Available
Rash pruritic23.03.13.0300.000627%Not Available
Rectal haemorrhage24.07.02.018; 07.12.03.0010.000112%
Skin discolouration23.03.03.0050.001500%Not Available
Skin exfoliation23.03.07.0030.000246%Not Available
Skin hypopigmentation23.05.02.0030.000381%
Sleep disorder19.02.04.0010.000571%Not Available
Somnolence19.02.05.003; 17.02.04.0060.002395%
Swelling08.01.03.0150.001142%Not Available
Swelling face23.04.01.018; 10.01.05.018; 08.01.03.1000.002451%Not Available
Therapeutic response unexpected08.06.01.0010.001007%Not Available
Thirst14.03.02.007; 08.01.09.0210.000683%Not Available
Tinnitus04.04.01.002; 17.04.07.0040.000112%
Tumour pain16.32.03.0030.000571%
Urticaria23.04.02.001; 10.01.06.0010.000492%
Vertigo17.02.12.002; 04.04.01.0030.000246%
Vision blurred06.02.06.007; 17.17.01.0100.000437%
Visual impairment06.02.10.0130.000985%Not Available
Vomiting07.01.07.0030.002395%
Wheezing22.03.01.0090.000246%
Seasonal allergy22.04.04.008; 10.01.04.001; 06.04.01.0130.000761%Not Available
Peripheral swelling08.01.03.053; 02.05.04.0150.000873%Not Available
Eye oedema06.08.03.0130.000381%Not Available
Cardiac flutter02.03.02.0120.000112%Not Available
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