ADReCS

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)
Dysphagia	07.01.06.003	0.000548%
Dysphonia	22.12.03.006; 19.19.03.002; 17.02.08.004	0.000381%
Dyspnoea	02.11.05.003; 22.02.01.004	-	-
Dysuria	20.02.02.002	0.000817%
Electrolyte imbalance	14.05.01.002	0.000168%		Not Available
Epistaxis	24.07.01.005; 22.04.03.001	0.001366%
Eructation	07.01.02.003	0.000246%
Erythema	23.03.06.001	0.001119%		Not Available
Fatigue	08.01.01.002	0.029739%
Feeling abnormal	08.01.09.014	0.001041%		Not Available
Flatulence	07.01.04.002	0.000873%
Fluid retention	20.01.02.003; 14.05.06.002	0.000246%		Not Available
Gastritis	07.08.02.001	0.000571%
Gastrooesophageal reflux disease	07.02.02.003	0.002317%
Haematemesis	07.12.02.002; 24.07.02.011	0.000302%		Not Available
Haematochezia	24.07.02.012; 07.12.02.003	0.000492%		Not Available
Headache	17.14.01.001	0.005373%
Hepatic function abnormal	09.01.02.001	0.000112%		Not Available
Hiccups	22.12.01.001; 07.01.06.009	0.000112%
Hypoaesthesia	23.03.03.081; 17.02.06.023	0.000526%		Not Available
Hypokalaemia	14.05.03.002	0.000224%
Influenza like illness	08.01.03.010	0.000246%
Insomnia	17.15.03.002; 19.02.01.002	0.001254%
Lip swelling	23.04.01.007; 10.01.05.005; 07.05.04.005	0.000381%		Not Available
Liver disorder	09.01.08.001	0.000246%		Not Available
Loss of consciousness	17.02.04.004	-	-	Not Available
Malaise	08.01.01.003	0.001757%
Memory impairment	17.03.02.003; 19.20.01.003	0.000224%
Migraine	24.03.05.003; 17.14.02.001	0.000492%		Not Available
Mood swings	19.04.03.001	0.000246%		Not Available

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