Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Neratinib
Drug ID BADD_D02489
Description Neratinib was approved in July 2017 for use as an extended adjuvant therapy in Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer. Approval was granted to Puma Biotechnology Inc. for the tradename Nerlynx. Neratinib is currently under investigation for use in many other forms of cancer.
Indications and Usage For use as an extended adjuvant treatment in adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy [FDA Label].
Marketing Status Not Available
ATC Code L01EH02
DrugBank ID DB11828
KEGG ID D08950
MeSH ID C487932
PubChem ID 9915743
TTD Drug ID D0U1ZV
NDC Product Code 70437-240
Synonyms neratinib | N-(4-(3-chloro-4-(2-pyridinylmethoxy)anilino)-3-cyano-7-ethoxy-6-quinolyl)-4-(dimethylamino)-2-butenamide | HKI 272 | HKI272 | HKI-272 | neratinib maleate | Nerlynx
Chemical Information
Molecular Formula C30H29ClN6O3
CAS Registry Number 698387-09-6
SMILES CCOC1=C(C=C2C(=C1)N=CC(=C2NC3=CC(=C(C=C3)OCC4=CC=CC=N4)Cl)C#N)NC(=O)C=CCN(C)C
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)
Skin fissures23.03.03.0080.000799%Not Available
Sneezing22.02.05.0110.000533%
Somnolence19.02.05.003; 17.02.04.0060.001598%
Stomatitis07.05.06.0050.003197%
Syncope02.01.02.008; 24.06.02.012; 17.02.04.008--
Thirst14.03.02.007; 08.01.09.0210.000799%Not Available
Tremor17.01.06.002--
Urinary tract infection20.08.02.001; 11.01.14.0040.002931%
Viral infection11.05.04.0010.000533%Not Available
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.0030.022379%
Weight decreased13.15.01.0050.006127%
Weight increased13.15.01.006--
White blood cell count decreased13.01.06.0120.001598%
Onychoclasis23.02.05.0050.001332%Not Available
Peripheral swelling02.05.04.015; 08.01.03.0530.001332%Not Available
Bladder spasm20.02.02.0130.000533%
Eye pruritus06.04.05.0060.000533%Not Available
Pruritus generalised23.03.12.0030.000533%Not Available
Early satiety08.01.09.004; 07.01.06.027; 14.03.01.0100.000533%Not Available
Metastases to central nervous system17.02.10.013; 16.22.02.0040.000417%Not Available
Hepatic enzyme increased13.03.01.0190.002131%Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.0270.000799%
Appetite disorder19.09.01.002; 14.03.01.0040.000533%Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.000139%Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.000533%Not Available
Decreased appetite08.01.09.028; 14.03.01.0050.020780%
Renal function test abnormal13.13.01.0120.000533%Not Available
Sensation of foreign body08.01.09.0020.000533%Not Available
Disease progression08.01.03.0380.000417%
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