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)
Abdominal discomfort07.01.06.0010.005798%-
Abdominal distension07.01.04.0010.005227%
Abdominal pain07.01.05.0020.009368%
Abdominal pain upper07.01.05.0030.005138%
Abdominal tenderness07.01.05.0040.000381%-
Acne23.02.01.0010.002183%-
Alopecia23.02.02.0010.001063%
Anaemia01.03.02.0010.000582%
Arthralgia15.01.02.0010.002239%
Ascites02.05.04.002; 07.07.01.001; 09.01.05.003--
Asthenia08.01.01.0010.002933%-
Bone pain15.02.01.0010.000302%
Breast cancer16.10.01.001; 21.05.01.003---
Burning sensation08.01.09.029; 17.02.06.0010.000492%-
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.003---
Chills08.01.09.001; 15.05.03.0160.000571%
Colitis07.08.01.0010.000302%
Constipation07.02.02.0010.018132%
Death08.04.01.0010.004141%
Dehydration14.05.05.0010.004880%
Depressed mood19.15.02.0010.000358%-
Dermatitis acneiform23.02.01.0040.000627%
Diarrhoea07.02.01.0010.068108%
Diarrhoea haemorrhagic07.02.01.002; 24.07.02.0040.000112%-
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.0070.005104%
Dry mouth07.06.01.0020.002619%
Dry skin23.03.03.0010.001668%
Duodenal ulcer07.04.02.0020.000112%
Dysgeusia07.14.03.001; 17.02.07.0030.002015%
Dyspepsia07.01.02.0010.003873%
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