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)
Dry mouth07.06.01.0020.004263%
Dry skin23.03.03.0010.002931%
Dysgeusia17.02.07.003; 07.14.03.0010.003197%
Dyspepsia07.01.02.0010.005861%
Dysphagia07.01.06.003--
Dysphonia22.02.05.005; 19.19.03.002; 17.02.08.0040.000533%
Dyspnoea22.02.01.004; 02.01.03.002--
Dysuria20.02.02.0020.001066%
Electrolyte imbalance14.05.01.0020.000533%Not Available
Epistaxis24.07.01.005; 22.04.03.0010.001598%
Eructation07.01.02.0030.000533%
Erythema23.03.06.0010.002131%Not Available
Fatigue08.01.01.0020.045823%
Feeling abnormal08.01.09.014--Not Available
Flatulence07.01.04.0020.001332%
Fluid retention20.01.02.003; 14.05.06.0020.000533%Not Available
Gastritis07.08.02.0010.000799%
Gastrooesophageal reflux disease07.02.02.0030.003463%
Haematochezia24.07.02.012; 07.12.02.0030.000533%Not Available
Hair growth abnormal23.02.06.0060.000533%Not Available
Headache17.14.01.0010.008525%
Heart rate increased13.14.04.0020.000799%Not Available
Herpes zoster23.09.03.002; 11.05.02.0030.000533%
Hiccups22.02.04.002; 07.01.06.0090.000533%
Hypersensitivity10.01.03.0030.001066%
Hypoaesthesia17.02.06.0230.000799%Not Available
Hypokalaemia14.05.03.0020.000533%
Hypotension24.06.03.0020.001598%
Infection11.01.08.002--Not Available
Insomnia19.02.01.002; 17.15.03.0020.001598%
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