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)
Onychoclasis23.02.05.0050.000683%Not Available
Peripheral swelling08.01.03.053; 02.05.04.0150.001007%Not Available
Bladder spasm20.02.02.0130.000246%
General physical health deterioration08.01.03.018--Not Available
Musculoskeletal chest pain22.09.01.001; 15.03.04.0120.000437%
Malignant neoplasm progression16.16.01.005--Not Available
Eye pruritus06.04.05.0060.000381%Not Available
Early satiety08.01.09.004; 07.01.06.027; 14.03.01.0100.000381%Not Available
Metastases to central nervous system17.02.10.013; 16.22.02.0040.000448%Not Available
Skin toxicity23.03.03.032; 12.03.01.0200.000112%Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.0270.000571%
Appetite disorder19.09.01.002; 14.03.01.0040.000246%Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.000246%Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.000246%Not Available
Neoplasm progression16.16.02.005--Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.013084%
Sensation of foreign body08.01.09.0020.000381%Not Available
Adverse drug reaction08.06.01.0090.003459%Not Available
Disease progression08.01.03.0380.000694%
Renal impairment20.01.03.0100.000280%Not Available
Unevaluable event08.01.03.051--Not Available
Liver injury12.01.17.012; 09.01.07.0220.000302%Not Available
Gastrointestinal sounds abnormal07.01.01.0020.000951%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.0040.000548%
Acute kidney injury20.01.03.016--
Faeces soft07.01.03.0080.000437%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.000112%Not Available
Breast cancer metastatic21.05.01.016; 16.10.01.0080.000694%Not Available
Illness08.01.03.0910.000683%Not Available
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