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 approved; investigational
ATC Code L01EH02
DrugBank ID DB11828
KEGG ID D08950
MeSH ID C487932
PubChem ID 9915743
TTD Drug ID D0U1ZV
NDC Product Code 70437-240
UNII JJH94R3PWB
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
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)
Muscle spasms15.05.03.0040.003492%
Muscular weakness17.05.03.005; 15.05.06.0010.000302%
Myalgia15.05.02.0010.001142%
Nail disorder23.02.05.0020.000302%
Nasal congestion22.04.04.0010.000492%
Nasal dryness22.04.03.0020.000627%Not Available
Nausea07.01.07.0010.032101%
Neck pain15.03.04.0090.000112%
Neuropathy peripheral17.09.03.0030.000739%Not Available
Oral mucosal blistering07.05.05.0170.000381%Not Available
Pancreatitis07.18.01.0010.000246%
Pericardial effusion02.06.01.002--
Pericarditis02.06.02.001--
Pyrexia08.05.02.0030.001556%
Rash23.03.13.0010.005585%Not Available
Rectal haemorrhage24.07.02.018; 07.12.03.0010.000168%
Renal disorder20.01.02.0020.000358%Not Available
Renal failure20.01.03.0050.000336%Not Available
Retching07.01.07.0020.000437%Not Available
Rhinorrhoea22.12.03.0210.000246%
Skin discolouration23.03.03.0050.000437%Not Available
Skin exfoliation23.03.07.0030.000739%Not Available
Skin fissures23.03.03.0080.000627%Not Available
Sleep disorder19.02.04.0010.000246%Not Available
Sneezing22.12.03.0240.000381%
Somnolence17.02.04.006; 19.02.05.0030.000851%
Stomatitis07.05.06.0050.002395%
Thirst14.03.02.007; 08.01.09.0210.000437%Not Available
Vertigo17.02.12.002; 04.04.01.003--
Vomiting07.01.07.0030.014674%
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